Malaysia Standard MS 2058: 2018 Draft Version

DRAFT
MALAYSIAN 15R001R2
STANDARD
STAGE : PUBLIC COMMENT (40.20)
DATE : 01/10/2017-01/11//2017
Code of practice for good engineering

maintenance management of active medical
devices
(Second revision)
ICS: 11.040.01
Descriptors: medical electrical equipment, code of practice, biomedical engineering, maintenance,
services, active medical device
© Copyright 2017
15R001R2
Contents
Page
Committee representation .........................................................................................................iv
Foreword .................................................................................................................................... v
1 Scope ............................................................................................................................ 1
2 Normative references ................................................................................................... 1
3 Terms and definitions ................................................................................................... 2
4 General ......................................................................................................................... 6
5 Responsibilities ............................................................................................................. 7
6 Testing & commissioning and acceptance ................................................................. 10
7 User maintenance ...................................................................................................... 11
8 Scheduled maintenance ............................................................................................. 12
9 Unscheduled maintenance ......................................................................................... 17
10 Mechanisms to avoid failure or breakdown during use .............................................. 18
11 Uptime ........................................................................................................................ 19
12 Quality assurance programme (QAP) ........................................................................ 19
13 Maintenance management information system (MMIS) ............................................. 21
14 Management of warranties ......................................................................................... 21
15 Decommissioned of active medical device ................................................................. 22
16 Disposal of active medical device .............................................................................. 22
17 Processes for handling hazardous/contaminated active medical device ................... 23
18 Incidents investigation and reporting .......................................................................... 23
19 Alerts, safety, field corrective action and recall notices .............................................. 24
20 User training ............................................................................................................... 24
21 Genuine parts ............................................................................................................. 25
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Contents (continued)
Page
22 On-site library ............................................................................................................. 25
23 Workshop setup .......................................................................................................... 26
24 Safety, health and environment .................................................................................. 28
25 Advisory service ......................................................................................................... 29
26 Procurement of active medical device ........................................................................ 30
27 Risk management ....................................................................................................... 31
28 Technical audit ........................................................................................................... 33
29 Manpower ................................................................................................................... 35
30 Technical training ....................................................................................................... 36
31 Active medical device replacement plan .................................................................... 37
Annex A Biomedical Technical Personnel (BTP) competency and career development

guidelines ............................................................................................................. 39
Annex B Examples of active medical device tags .............................................................. 97
Annex C Maintenance consumables and user related consumables ............................... 101
Annex D PPM checklist based on manufacturer’s service manual .................................. 102
Annex E Routine Inspection (RI) checklist ....................................................................... 108
Annex F Work order form ................................................................................................. 109
Annex G Example of Electrical Safety Test (EST) printed report ..................................... 110
Annex H Recommended uptime target for active medical device .................................... 113
Annex J Calculation of uptime.......................................................................................... 116
Annex K MMIS for Biomedical Engineering Services ....................................................... 117
Annex L Key performance indicator (KPI) ........................................................................ 122
Annex M Spare parts management .................................................................................. 125
Annex N Examples of workshop setup ............................................................................. 130
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Contents (concluded)
Page
Annex P Job designation .................................................................................................. 133
Annex Q Example of an active medical device replacement plan .................................... 135
Bibliography ........................................................................................................................... 137
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Committee representation
The Industry Standards Committee on Medical Devices and Facilities for Healthcare (ISC R) under whose authority
this Malaysian Standard was developed, comprises representatives from the following organisations:
Association of Malaysian Medical Industries

Association of Private Hospitals of Malaysia
Atomic Energy Licensing Board
Biomedical Engineering Association Malaysia
Department of Standards Malaysia
Federation of Malaysian Manufacturers
Institute for Medical Research
Malaysia Medical Device Association
Malaysian Association of Standards Users
Malaysian Medical Association
Malaysian Nuclear Agency
Malaysian Organisation of Pharmaceutical Industry
Malaysian Rubber Board
Malaysian Rubber Export Promotion Council
Medical Device Authority, Ministry of Health Malaysia
Ministry of Health Malaysia
Pharmaceutical Association of Malaysia
Radiation Physics, Biophysics and Medical Physics Sub-Group of Institute of Physics Malaysia
SIRIM QAS International Sdn Bhd
Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences)
Universiti Teknologi Malaysia (Faculty of Science)
The Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical
Equipment/System for Healthcare Facilities which developed this Malaysian Standard consists of representatives
from the following organisations:
Association of Private Hospitals of Malaysia

Biomedical Engineering Association Malaysia
Edgenta Mediserve Sdn Bhd
Jabatan Kerja Raya Malaysia (Cawangan Kejuruteraan Elektrik)
KPJ Healthcare Berhad
Malaysia Medical Device Association
Malaysian Medical Association
Medical Device Authority, Ministry of Health Malaysia
Medical Electronic Engineering Association Malaysia
Medivest Sdn Bhd
Ministry of Health Malaysia
Radicare (M) Sdn Bhd
SIRIM Berhad (Secretariat)
The Institution of Engineers, Malaysia
Universiti Kebangsaan Malaysia (Faculty of Health Sciences)
Universiti Kebangsaan Malaysia Medical Centre
Universiti Malaya (Department of Biomedical Engineering)
Universiti Malaya Medical Centre
Universiti Sains Malaysia (Department of Development)
Universiti Teknologi Malaysia (Faculty of Biosciences and Medical Engineering)
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Foreword
This Malaysian Standard was developed by the Technical Committee on Code of Practice of
Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare
Facilities under the authority of the Industry Standards Committee on Medical Devices and
Facilities for Healthcare.
Major modifications in this revision are as follows:
a) New clauses have been added;
i) Clause 6, Testing & commissioning and acceptance;
ii) Clause 18, Incident investigation and reporting;
iii) Clause 19, Alerts, safety, field corrective action and recall notices;
iv) Clause 21, Genuine parts;
v) Clause 24, Safety, health and environment;
vi) Clause 27, Risk management;
vii) Clause 28, Technical audit;
viii) Clause 29, Manpower;
ix) Clause 30, Technical training; and
x) Clause 31, Active medical device replacement plan.
b) Addition of subclause on Routine Inspection (RI) in scheduled maintenance.
c) Annex A on Biomedical Technical Personnel (BTP) competency and career development

guidelines has been revised.
d) New annexes have been added;
i) Annex C, Maintenance consumables and user related consumables;
ii) Annex E, Routine Inspection checklist;
iii) Annex G, Examples of Electrical Safety Test (EST) printed report;
iv) Annex M, Spare parts management;
v) Annex P, Job designation; and
vi) Annex Q, Example of an active medical device replacement plan.
e) Examples of equipment tags in Annex B have been amended.
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Foreword (continued)
f) PPM checklist examples in Annex D have been amended.
g) Incorporation of new Figure N.2 and amendment to Figure N.3.
h) Introduction of Appointed Biomedical Engineering Services Representative (ABR).
i) The terms equipment and medical device have been changed to active medical device.
This Malaysian Standard cancels and replaces MS 2058:2009, Code of practice for good
engineering maintenance management of active medical devices (First revision).
Compliance with a Malaysian Standard does not of itself confer immunity from legal
obligations.
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Code of practice for good engineering maintenance management of

active medical devices
1 Scope
This Malaysian Standard prescribes the active medical devices placed for use in any
healthcare facility or any other facility which requires maintenance.
This standard is not applicable to any medical device placed and used in any facility not
intended to be used on human.
2 Normative references
The following normative references are indispensable for the application of this standard. For
dated references, only the edition cited applies. For undated references, the latest edition of
the normative reference (including any amendments) applies.
MS 838, Code of practice for radiation protection (Medical X-ray diagnosis)
MS 2650, Guidance on disposal of medical devices
MS ISO 14971, Medical devices - Application of risk management to medical devices
MS IEC 60364-7-710, Electrical installations of buildings - Part 7-710: Requirements for

special installations or locations - Medical locations
MS IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance
MS IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirements
MS IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical
electrical equipment
MS ISO/IEC 17024, Conformity assessment - General requirements for bodies operating

certification of persons
Atomic Energy Licensing Act 304
Medical Device Act 2012 (Act 737)
Occupational Safety and Health Act 1994
Registration of Engineers Act 1967
Technologists and Technicians Act 2015 (Act 768)
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Garis Panduan dan Peraturan bagi Perancangan Bangunan oleh Jawatankuasa Standard
dan Kos Unit Perancang Ekonomi, Jabatan Perdana Menteri, Edisi Tahun 2008
MDA/GD/0014, Mandatory Problem Reporting
MDA/GD/0028, Requirements for Installation, Testing & Commissioning and Acceptance of

Medical Device
3 Terms and definitions

For the purposes of this standard, the following terms and definitions apply.
3.1 acceptance testing
Qualitative and quantitative tests carried out on the medical device upon completion of
installation and prior to use for clinical service, to ensure its safety and performance are in
accordance with manufacturer’s specifications, purchase agreement and statutory
requirements.
3.2 active medical device
Any medical device, operation of which depends on a source of electrical energy or any
source of power other than that is directly generated by the human body or gravity and which
acts by converting this energy. Medical devices intended to transmit energy, substances or
other elements between an active medical device and the patient, without any significant
change, are not considered to be active medical devices.
[Source: GHTF Document N15 dated June 27, 2005]
NOTE. Active medical device is also referred as medical equipment or biomedical equipment.
3.3 appointed Biomedical Engineering Services representative (ABR)
Management representative for Biomedical Engineering Services.
3.4 authorised agency
Any agency approved by the Ministry of Health Malaysia.
3.5 authorised representative (AR)
An authorised representative appointed by manufacturer having a principal of business

outside Malaysia.
3.6 Biomedical Engineering Services
Any in-house or third party personnel or organisation or manufacturer/AR recognised by an

authorised agency responsible to carry out, implement and/or manage Biomedical
Engineering activities.
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3.7 biomedical technical personnel (BTP)
Biomedical engineer and biomedical technician/other technical personnel.
3.8 breakdown maintenance
The actions taken to restore the defect in the operation or the usage of active medical device
usually detected by the user who takes the active medical devices out of clinical use.
3.9 corrective maintenance
The actions performed to restore an item to a specified condition when it fails to function as
per manufacturer’s specification. Corrective maintenance includes routine corrective
maintenance, breakdown maintenance and emergency maintenance.
3.10 competence
Competence is a standardised requirement for an individual to properly perform a specific job.

It encompasses a combination of knowledge, skills and behaviour utilised to improve
performance. More generally, competence is the state or quality of being adequately or well
qualified, having the ability to perform a specific job/role.
3.11 downtime (for a particular piece of active medical device)
The percentage of time during which a particular active medical device is not available from a
minimum number of "common functional units" in a ward, a department or a specific area.
Downtime does not include upgrading time or the time when the active medical device is not
required to be available.
3.12 emergency maintenance
Emergency maintenance is performed as necessary, such as when no other medical device

substitutes are available and action taken in the quickest and most efficient manner to ensure
restoration of affected services.
3.13 active medical device user/user
3.13.1 home user
An individual who owns and uses active medical device for personal care.
3.13.2 operator of active medical device
An individual who handles or operates active medical device in a healthcare facility, such as
doctors, nurses, medical assistants, radiologists, etc.
3.14 establishment
a) A person who is either manufacturer, importer, or distributor who is responsible for

placing any medical device in the market but does not include retailer; and
b) an authorised representative appointed by manufacturer having a principal of business

outside Malaysia.

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And such person and authorised representative being;
a) a person domiciled or resident in Malaysia; or
b) a firm or company constituted under the laws of Malaysia; and
c) carrying on business or practice principally in Malaysia.
3.15 healthcare facility
Any premises in which one or more members of the public receive healthcare services, which
includes:
a) medical, dental, nursing, midwifery, allied health, pharmacy, and ambulance services and
any other service provided by a healthcare professional;
b) accommodation for the purpose of any service provided;
c) any service for the screening, diagnosis or treatment of persons suffering from, or
believed to be suffering from, any disease, injury or disability of mind or body;
d) any service for preventive or promotion of health purposes;
e) any service provided by any healthcare para-professional;
f) any service for curing or alleviating abnormal condition of the human body by the
application of any apparatus, active medical device, instrument or device or any other
medical technology; or
g) any health-related services.
3.16 healthcare facility authority
The management of healthcare organisation.
3.17 in service
Active medical device placed at user location and functioning to manufacturer’s specification.
3.18 key performance indicator (KPI)
Measurable indicator used in the development of a quality assurance programme.
3.19 medical device
Any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or

calibrator, software, material or other similar or related article, intended by the manufacturer
to be used, alone or in combination, for human beings for one or more of the specific
purpose(s) of;
a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
b) diagnosis, monitoring, treatment, alleviation of or compensation for injury;

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c) investigation, replacement, modification, or support of the anatomy or of a physiological

process;
d) supporting or sustaining life;
e) control of conception;
f) disinfection of medical devices;
g) providing information for medical or diagnostic purposes by means of in vitro examination

of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means.
3.20 preventive maintenance
A planned maintenance programme which specifies frequency, tasks and activities to be done
in order to ensure that all active medical device is operating as per manufacturer’s
specifications and is in safe working condition.
3.21 product technical specialist (PTS)
Establishment’s biomedical technical personnel (BTP).
3.22 other technical personnel
Technologist, scientist, medical researcher or medical physicist who is involved in the

biomedical maintenance.
3.23 recognised organisation
Established local or international body in Biomedical Engineering.
3.24 risk management
Systematic application of management policies, procedures and practices to the tasks of

analysing, evaluating, controlling and monitoring risk.
3.25 routine inspection (RI)
User area periodic inspections or rounds to check active medical device’s physical integrity,
functionality and safety aspect.
3.26 scheduled corrective maintenance (SCM)
Corrective maintenance required for active medical device determined during the RI or PPM
which could not be executed immediately upon detection.
3.27 scheduled maintenance
A planned maintenance programme to ensure an optimum performance, safe operation,

minimum downtime, and maximum useful life from each active medical device.
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3.28 self-inspection
An organised method of internal review that allows a manager to view critical areas and
available resources. It focuses on the mission, resources, training, and personnel within the
department.
3.29 service uptime
The percentage of time during which a particular Biomedical Engineering Service is available
from a minimum number of "common functional units" in a ward, a department or a specific
area. Uptime includes upgrading time and the time when the active medical device is not
required to be available.
3.30 supplier
Supplier refers to establishment that supply active medical devices to healthcare facilities.
3.31 unscheduled maintenance
Unscheduled maintenance involves those actions necessary to restore normal function,

safety, performance, and reliability to malfunctioning active medical device.
3.32 uptime (for a particular piece of active medical device)
The percentage of time during which a particular piece of active medical device is performing
or is available to perform its intended function. Uptime includes upgrading time and the time
when the active medical device is not required to be available.
3.33 uptime target
The list of uptime percentage predetermined based on healthcare facility authority agreed
benchmark for active medical device to achieve, to reflect effectiveness of maintenance and
active medical device reliability.
3.34 warranty
Scope of services and liability coverage by the supplier of active medical device within a
contractual/defined period.
4 General
4.1 Maintenance consists of scheduled maintenance and unscheduled maintenance. The
former includes servicing undertaken by the user in the sequence and intervals indicated in
the instructions for use, a periodic maintenance performed by the Biomedical Engineering
Services, by an outside maintenance firm preferably approved by the manufacturer, or by the
manufacturer himself or his agent.
4.2 The active medical device maintenance programme ensures the device is serviceable,
safe and properly configured. The maintenance of active medical device shall include:
a) technical assistance in evaluating and selecting active medical device before it is

purchased, and to ensure the device has optimum performance and fulfils safety criteria;

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b) initial inspections, scheduled preventive maintenance, safety evaluations and verification

of active medical device and supporting utilities;
c) a responsive repair service that minimises active medical device downtime;
d) a quality assurance programme for continuous improvement;
e) assistance in training medical personnel on how to operate active medical device safely
and effectively; and
f) upkeep of documentation that meets both regulatory and accreditation requirements and
the needs of the overall active medical device management programme.
4.3 The reason for servicing active medical device is to maintain its usability in such a way
that:
a) the active medical device functions are in the intended manner;
b) the active medical device is safe for the patient and for the user; and
c) the interruptions of use are minimised.
5 Responsibilities
These responsibilities are furnished as minimum requirements and are not intended to limit
management functions to the areas.
5.1 The healthcare facility authority shall ensure the healthcare facility complies with
international/national electrical safety standards (e.g. MS IEC 60364-7-710). Healthcare
facilities shall ensure that the active medical devices to be purchased conform to
MS IEC 60601-1, IEC 60601-1 Collateral Standards and IEC 60601-2 particular standards.
5.2 The Biomedical Engineering Services shall:
a) implement and manage the organisation’s active medical device maintenance

programme;
b) obtain required facilities and test equipment for the organisation’s maintenance
programme;
c) ensure active medical device is maintained in a serviceable condition at all times;
d) plan for active medical device support in the conceptual phase of each new equipment
system;
e) develop an active medical device management plan;
f) develop and publish local policies and operating instructions (OI) as required;
g) develop references from the maintenance management report to evaluate the

effectiveness of the maintenance programmes;

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h) establish a work control and priority system to ensure uninterrupted service to supported
activities;
i) establish a periodic maintenance and inspection schedule and ensure maintenance

personnel perform scheduled maintenance;
j) manage the appropriate use and supply of spare parts;
k) outsource maintenance service of those systems when there are no adequate training,
tools, test equipment and staff;
l) ensure that all ionising radiation emitting equipment maintenance comply with the Atomic
Energy Licensing Act 304 and MS 838;
m) develop a self-inspection checklist and perform at least annual self-inspection to ensure

that required functions are properly managed;
n) perform a customer survey at least annually to determine the adequacy, quality,

effectiveness of maintenance support and the degree of compliance;
o) assist in investigation of active medical device adverse events and near incidents when
requested;
p) regular monitoring for hazards and alerts relating to medical devices;
q) all activities related to maintenance programme comply with Act 737; and
r) apply to be listed with Medical Device Authority.
5.3 The Biomedical Technical Personnel (BTP) shall:
a) comply with competency requirements as stipulated in Annex A and shall be listed with
Medical Device Authority based on Act 737;
b) The Biomedical Engineer shall register with the Board of Engineers as per specified in the
Registration of Engineers Act 1967 as appropriate;
c) Biomedical Technician/Other Technical Personnel shall register with the Malaysian Board
of Technologist per specified in the Technologists and Technicians Act 2015 (Act 768) as
appropriate;
d) attend relevant trainings and/or continuing professional development (CPD) trainings with
recognised and authorised professional bodies; and
e) manage and administer Biomedical Engineering Services as per 5.2.
5.4 Active medical device users shall:
a) ensure only active medical device authorised by the Biomedical Engineering Services is
used. For an example of the active medical device authorisation certificate/sticker/report,
refer Annex B;
b) ensure active medical device is used only for its intended purpose;

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c) operate active medical device in accordance with user’s manuals;
d) care for and upkeep the active medical device to ensure it is always operating properly
and in serviceable condition;
e) immediately report active medical device malfunctions or damage to the biomedical

maintenance services;
f) ensure appropriate user maintenance is performed;
g) not attempt repairs beyond the operating techniques described in the user’s manual;
h) ensure active medical device requiring user calibration is calibrated before use;
i) replace user maintenance consumables as and when required. The list of example for
maintenance consumables and user related consumables are given as in Table C.1 in
Annex C;
j) routinely clean and dust active medical device;
k) be aware of conditions that may injure the patient or damage the active medical device;
l) report to the Biomedical Technical Personnel of any anomalies such as erratic meter
responses, electrical flashing or arcing, or unusual sounds that may indicate malfunction;
m) initiate a request for maintenance;
n) immediately impound any active medical device and consumables involved in an incident
and notify the relevant department;
o) clean and decontaminate active medical device in compliance with local infection control
policies;
p) properly place the active medical device during use, store and protect the active medical
device; and
q) report active medical device adverse events and near incidents to appropriate parties.
5.5 Appointed biomedical engineering services representative (ABR)
An appointed biomedical engineering services representative (ABR) shall have the defined
responsibility and authority that includes;
a) ensuring the biomedical maintenance services are established, implemented and

maintained;
b) reporting to top management on the performance of the Biomedical Engineering Services

and compliance with regulatory requirements;
c) ensuring the awareness on obligations to comply with regulatory requirements and any
other applicable statutory requirements and any decision thereof made by top
management throughout the healthcare facilities; and

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d) liaising with external parties on matters relating to the Malaysia medical device regulatory
requirements.
5.6 Home users shall ensure that only competent individual/organisation carry out
maintenance on their active medical device in accordance with this standard. In the event that
the home user brings the active medical device to the healthcare facility, it shall/shall not be
subjected to maintenance by the Biomedical Engineering Services depending on the policy of
the healthcare facility, where applicable.
6 Testing & commissioning and acceptance

Testing & commissioning and acceptance shall be carried out for all newly introduced (new or
used) active medical device before it is placed into clinical service and shall include but not
limited to other safety aspect, visual inspection, electrical safety test and performance test.
6.1 The user shall notify Biomedical Engineering Services on the arrival of new active
medical device.
6.2 The user shall ensure that the correct item(s) are delivered in good condition based on
the purchase document. The supplier shall provide a copy of the purchase document to the
Biomedical Engineering Services during or prior to the testing & commissioning and
acceptance.
6.3 The supplier shall declare the manufacturing date and the date of the first release of
the model into market.
6.4 The supplier shall carry out testing & commissioning and acceptance in the presence of
Biomedical Engineering Services and the user. The results of the acceptance testing shall be
verified by the Biomedical Engineering Services. Results shall be documented and handed
over together with all relevant certificates to the Biomedical Engineering Services.
6.5 When a contractor installation is required, Biomedical Engineering Services shall verify
correct installation is done based on the required specification.
6.6 Biomedical Engineering Services shall review the relevant contracts and literature for
warranty provisions, and advice the user to complete the warranty registration data, if
applicable, and forward it to the manufacturer.
6.7 Biomedical Engineering Services shall give unique identification for newly introduced
active medical device. The active medical device shall be registered into a master list.
6.8 The supplier shall provide complete copies of the following items to Biomedical
Engineering Services:
a) user manual;
b) service or maintenance manuals;
c) circuit diagrams and drawings;
d) parts list;
e) PPM checklist according to manufacturer’s recommendation; and

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f) other necessary documents/items.
6.9 The supplier shall provide a list of required test equipment and special tools to
Biomedical Engineering Services.
6.10 The user should ensure that testing & commissioning and acceptance have been
conducted on leased, loaned, consigned or privately owned active medical device to be used
within healthcare facility.
6.11 If rectifications on the active medical device are required to pass the testing &
commissioning and acceptance, the rectifications shall be carried out by the supplier or
relevant parties and the active medical device shall be subjected to testing & commissioning
and acceptance again.
6.12 Biomedical Engineering Services shall monitor the warranty period of the active
medical device.
6.13 The detail of testing & commissioning and acceptance are specified in MDA document,
MDA/GD/0028, Requirements for Installation, Testing & Commissioning and Acceptance of
Medical Device.
7 User maintenance
It is the responsibility of the active medical device user department to carry out the basic
maintenance on routine basis such as daily, weekly or monthly activities to ensure condition
and functionality of the active medical device are maintained as recommended by the
manufacturer.
User maintenance is important for effective operation of active medical device. It helps
prevent deterioration, defects and will increase the life of the active medical device and its
components.
The healthcare facility shall establish a schedule for user maintenance based on either
manufacturer’s recommendation or standard practices.
User shall ensure all consumables used are in compliance with manufacturer’s
recommendation.
The user shall have a user maintenance programme to ensure clean, sanitised, safe and
functioning active medical device. Part of the user maintenance activities are regular cleaning,
disinfection, inspection, proper storage, etc.
7.1 Cleaning and disinfecting
Active medical device shall be cleaned and sanitised using recommended procedures given
by the manufacturer or departmental standard operating procedures (if any).
7.2 Inspection
The user shall ensure the active medical device is inspected before each use and after
cleaning; and check active medical device functionality, tightness of connections and
condition of parts (including accessories).

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7.3 Storage
All active medical device are to be stored in a clean and proper location to protect them from
damage, contamination, dust, sunlight, extreme temperatures, excessive moisture, damaging
chemicals, etc.
7.4 Record
User shall record all user maintenance activities.
User that performs user maintenance at any circumstances shall not attempt to repair beyond
those specified in the operation manual. User shall report all defects or faults and all repairs
or adjustments are only to be carried out by Biomedical Engineering Services.
User maintenance training shall be given to the user either by the manufacturer/agent or
Biomedical Engineering Services as required or as requested by the user.
8 Scheduled maintenance
The scheduled maintenance programme consists of a series of planned maintenance
requirements and inspections. The programme is designed to ensure that active medical
device is maintained in the highest possible state of operational throughout its life cycle. The
programme has the following purposes:
a) simplifies complex maintenance tasks;
b) provides a readily manageable maintenance programme;
c) facilitates scheduling and controlling maintenance actions;
d) provides a means for detecting impending active medical device failures; and
e) forecasts and plans manpower and material requirements.
Scheduled maintenance can be divided into three categories:
a) planned preventive maintenance (PPM);
b) calibration; and
c) routine inspection (RI).
8.1 The minimum scheduled maintenance frequencies shall be developed based on the
following sequence:
a) the manufacturer’s recommended frequencies as established in active medical device

servicing or operation manual;
b) established industry norms such as frequencies recommended by any recognised

organisation in Biomedical Engineering recognised authorised agencies; or
c) area of use, active medical device user experience and patient risk assessment subject
to user recommendation and approval by the Ministry of Health Malaysia.
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Biomedical Engineering Services personnel shall perform the scheduled maintenance at

these minimum frequencies and may increase scheduled frequencies when appropriate.
Scheduled maintenance frequencies shall not be reduced without written approval of the
healthcare facility authority. The schedule changes shall not adversely affect patient care or
user and patient safety.
8.2 The individual active medical device scheduled maintenance activity checklist shall be
established from the following sources:
a) scheduled maintenance checklist as recommended by the manufacturer as stated in user,

service or operation manual; or
b) generic scheduled maintenance checklist as recommended by recognised organisation in

Biomedical Engineering recognised by authorised agencies for active medical device
without manufacturer recommendation; and
c) additional checklist developed by healthcare facility authority.
8.3 The scheduled maintenance workload shall be programmed and distributed evenly
throughout the year, taking into consideration the following constraints:
a) peak workloads and periods when personnel may be absent due to training, leaves,
holidays, deployments, exercises, etc;
b) availability of test equipment and special tools, taking into consideration the test
equipment calibration requirement;
c) user department constraints; and
d) whenever possible, the scheduled PPM and calibration execution date shall be
concurrently programmed in order to increase efficiency.
8.4 Planned preventive maintenance (PPM)
PPM is a planned maintenance of active medical device that is designed to improve active
medical device life and avoid any unplanned maintenance activity. PPM includes lubricating,
cleaning, adjusting and PPM kit replacement (if applicable) to extend the life of active medical
device and facilities.
8.4.1 PPM is a comprehensive programme of planned maintenance on all relevant active

medical device in healthcare facility, provided with the following objectives:
a) fewer machine breakdowns, resulting in reduced active medical device downtime;
b) better conservation of assets and increased life expectancy of assets, thereby eliminating
premature replacement of system and active medical device;
c) reduced costs and more economical use of maintenance workers due to working on a
scheduled basis instead of an ad hoc basis to repair breakdowns;
d) timely, corrective maintenance repairs circumvent fewer large-scale repairs;

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e) reduced cost of repairs by reducing secondary failures. When parts fail in service, they
usually damage other parts;
f) identification of active medical device with excessive maintenance costs; indicating the
need for corrective maintenance, user training or replacement of obsolete active medical
device; and
g) improved safety and quality of the equipment.
8.4.2 PPM is the joint responsibility of active medical device user and Biomedical
Engineering Services.
8.4.3 The Biomedical Engineering Services personnel shall perform the following
qualitative, preventive and quantitative activities as stated in PPM checklist on each regular
inspection/maintenance of active medical device where applicable (an example of a PPM is in
Annex D).
8.4.3.1 The quantitative task
The measurable tasks in specific values or ranges are as specified by the manufacturer to
determine the active medical device functionality, safety and performances. Example of such
tasks are as follows.
a) Performance test
Test shall be as recommended by the manufacturer or as recommended by standard

practices using appropriate test equipment as specified by the manufacturer. All
qualitative measurement results shall be recorded onto the PPM checklist by the
Biomedical Engineering Services personnel. (For an example of PPM checklist please
refer Annex D).
b) Medical electrical safety test
The active medical device electrical safety test shall conform (as appropriate) to
manufacturer recommendation or MS IEC 60601 or MS IEC 61010 or MS IEC 62353. It
describes electro-active medical device according to the type of protection provided
against electric shock (defined as Class I, II or internal power (IP)), and the degree of
protection provided against electric shock (defined as Type B, BF or CF). During PPM
inspections, the Biomedical Engineering Services personnel shall perform a general
safety inspection on all active medical device and an electrical safety test, if applicable. In
addition to pass or fail, numerical results of the electrical safety inspections shall be
recorded. Refer to Annex G.
c) Preventive maintenance task
Tasks shall be performed to prevent future defects or deteriorations of active medical

device, such as the following.
i) Clean the interior and exterior (where applicable) of the active medical device such
as blowers, filters, fans and coils (remove corrosion, dirt, solutions, dust, lint, blood or
deposits).
ii) Lubricate any motors, gears, bearings, casters and other moving components where
applicable. Use only non-petroleum based non-flammable lubricants on active
medical device that uses oxygen.
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iii) Inspect and service battery compartments and replace batteries if necessary.
iv) Service or replace all maintenance consumables such as filters and tubings.
v) Align and tighten all moving components not specifically covered in the calibration
procedures, such as doors, drawers, panels, shelves, catches, latches, casters and
hinges.
vi) Replace the PPM kit if applicable or as recommended by the manufacturer.
8.4.3.2 The qualitative task
The non-measurable tasks to ensure the quality of the active medical device component or
fixtures are in good conditions, such as:
a) verify or test the active medical device component, sub-component, accessories and any
other related feature on its physical and functionality conditions; and
b) check or examine fittings/connectors, alarms/interlocks, label, cables, etc.
8.4.4 The Biomedical Engineering Services shall propose the maintenance time required
and provide annual PPM schedule for all active medical device identified for PPM service.
The user shall be given a copy of the yearly planned schedules.
8.4.5 The user shall inform Biomedical Engineering Services if there is any change in
active medical device location and any unavailability of active medical device due to usage for
the purposes of PPM rescheduling.
8.4.6 Biomedical Engineering Services shall request for approval from the user department
for any rescheduling of PPM.
8.4.7 PPM should be performed together with the components and accessories designated
to the active medical device being serviced. Example: Servicing of ultrasound machine with
probes.
8.4.8 Active medical device which fails testing and/or inspection shall not be used until
deficiencies are corrected. User shall be notified on the anticipated time of repair. Portable
active medical device may be removed from user location until repairs are completed. Active
medical device shall be tagged as “out of service” and user will confirm by signing the tag.
Sample of tag are as per Annex B.
8.4.9 When an active medical device fails to meet the appropriate safety standards, it shall
be discontinued from use and tagged with “out of order” tag to the active medical device until
the problem is corrected. Sample of tags are as per Annex B.
8.4.10 PPM record shall be maintained for the life of the device.
8.4.11 Biomedical Engineering Services personnel shall evaluate the condition of active
medical device and verify that the active medical device is fit to be used.
8.5 Calibration
Calibration is the measurement and adjustment of various device parameters to ensure its
accuracy within prescribed standards.
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Maintenance related calibration is the measurement and adjustment of various device

parameters to ensure its accuracy is within manufacturer’s specification.
Biomedical Engineering Services personnel shall record and document all calibrations on the
appropriate form or work sheet (PPM checklist). All calibration records and certificates shall
be filed and kept by Biomedical Engineering Services and copy shall be provided to the user
upon request.
Biomedical Engineering Services personnel shall enter the appropriate information for a
completed calibration into the maintenance management information system (MMIS) or on
the work order form.
The Biomedical Engineering Services personnel shall affix the calibration certificate/PPM
tag/sticker in a location visible to the user.
Calibration can be divided into the following three categories.
8.5.1 Active medical device functionality calibration
The calibration performed by Biomedical Engineering Services personnel or active medical

device user in accordance to manufacturer specifications as part of PPM activities if any of
the quantitative result deviate from specified range. No certificate is required, however the
calibration result shall be recorded in the PPM checklist or active medical device log either
written manually or by attaching the printed result (if feature available). This calibration can be
classified into:
a) built-in self-calibration, designed as part of active medical device feature; and
b) manual calibration using appropriate calibration equipment, tools or test equipment.
8.5.2 Calibration of measuring or test equipment
The calibration shall be carried out by approved or authorised calibration centre conforming to
nationally/internationally recognised accreditation body.
Biomedical Engineering Services personnel are to ensure test equipment used for calibration
of active medical device is calibrated according to manufacturer’s specifications.
8.5.3 Certified calibration
Healthcare facility shall identify and calibrate medical devices requiring calibration by external
accredited laboratories based on regulatory and accreditation requirements.
The examples of active medical devices are weighing scale, pipette and medical refrigerators.
8.6 Routine inspection (RI)
8.6.1 Routine inspection covers active medical device in healthcare facilities which are not
included in the PPM.
8.6.2 Biomedical Engineering Services shall provide schedule of routine inspection.

Routine inspection should be carried out based on location and the frequency shall be once a
year.

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8.6.3 Routine inspection details shall contain the followings:
i) Verify that active medical device shows no signs of abuse or damage.
ii) Check for devices, adapters and accessories that may be defective and may pose safety
risk.
iii) Perform qualitative and functional test.
iv) Biomedical engineering services will alert the user upon detection of any defect and
create schedule corrective maintenance work order to rectify the defect.
v) Biomedical engineering services shall repair the defect identified during RI following the
corrective maintenance procedure.
vi) Biomedical engineering services shall provide technical advice to the user on any
improper usage or common problem detected during RI.
vii) Biomedical engineering services shall analyse and record the overall findings.
Sample of routine inspection checklist is given as in Annex E.
9 Unscheduled maintenance
9.1 Biomedical Engineering Services shall ensure that all requests for unscheduled
maintenance are entered into the MMIS system.
9.2 Biomedical Engineering Services shall assign work based on a priority system to each
request.
9.3 While the priority of repair is determined locally, factors such as the type and
importance of the active medical device, availability of alternate active medical device, and
the effect of downtime on the medical service should be considered.
9.4 If the repair involves ordering repair parts, the Biomedical Engineering Services shall
list all required parts on the work order and enter this information into the MMIS system. See
Annex F for an example of work order form.
9.5 Biomedical Engineering Services shall document the parts needed on the work order.
9.6 Biomedical Engineering Services shall establish a method to monitor the status of work
orders awaiting parts. The active medical device shall be tagged to indicate the serviceability
and facilitate traceability. An example of the tag is shown in Annex B.
9.7 Biomedical Engineering Services shall initiate the appropriate request for contract
services if the active medical device requires contract, warranty or third party repair service.
9.8 After completing any unscheduled maintenance, Biomedical Engineering Services shall
perform safety test in accordance with MS IEC 62353, performance and calibration check of
the active medical device.

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9.9 Biomedical Engineering Services shall perform an electrical safety test if the
unscheduled maintenance involves replacement of defective electrical components or
dismantling of active medical device before releasing the active medical device to the user.
9.10 The Biomedical Engineering Services shall brief the user on work carried out upon
completion of repair prior to acceptance by the user. Both parties shall sign the work order to
verify the completion of work.
9.11 The Biomedical Engineering Services shall file the work order sheet to ensure
traceability.
9.12 Types of unscheduled maintenance
9.12.1 Breakdown maintenance
The defect in the operation or the usage of active medical device is detected by user who
takes the active medical device out of service for rectification.
9.12.2 Corrective maintenance
The action performed to restore the defective active medical device back to the specified
condition. The defect is detected by the user or staff of Biomedical Engineering Services
during operation or scheduled maintenance.
9.12.3 Emergency maintenance
9.12.3.1 Emergency maintenance services shall be made available at all times to cater for
emergency breakdowns. Maintenance staff list and contact information shall be made
available to the users.
9.12.3.2 The user shall initiate a request for emergency maintenance.
9.12.3.3 On receiving a call for emergency maintenance, the designated Biomedical

Engineering Service staff shall promptly organise inspection and repair.
9.12.3.4 In the event that an emergency maintenance cannot be successfully done to the
active medical device within the required time, the user shall be informed such that alternative
measures can be taken by the user to minimise clinical service disruption.
10 Mechanisms to avoid failure or breakdown during use

Biomedical Engineering Services shall provide mechanisms to avoid failure or breakdown of
active medical device during patient treatment, diagnosis and therapy.
Biomedical Engineering Services shall review health alerts, active medical device failures,
incident reports, use errors, component failures and carry out corrective action.
10.1 Prepare, review and adjust preventive maintenance programme and periodically
assess the effectiveness of the programme.
10.2 Perform active medical device audit (when necessary), document review and advise
users on proper handling during inspection visits.

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10.3 Communicate and give feedback to user on active medical device maintenance
status.
10.4 Coordinate with user in the event of utility shutdown.
10.5 Provide training for user and Biomedical Engineering Services personnel to reduce
hazards and to avoid potential risk/incident. Such training shall exclude clinical application.
10.6 Take prompt action in response to recall or hazard information.
10.7 Perform comprehensive maintenance.
10.8 Provide effective and responsive active medical device repair including on-call
services.
10.9 Undertake supervision, quality control and documentation of inspection, performance

testing, preventive maintenance and repair services.
10.10 Advise user on the removal or disposal of hazardous, unserviceable, or unwanted

active medical device, accessories or consumables.
10.11 Annual evaluation report shall include active medical device failures statistics and
recommendation.
10.12 Assist in any recalls of active medical device that may be required.
11 Uptime
Achieved uptime targets are as specified in Biomedical Engineering Services KPI for all active
medical device in service.
11.1 Biomedical Engineering Services shall identify applicable uptime target for the active
medical device with reference to KPI. A list of recommended uptime target is as per Annex H.
Uptime calculation is as per Annex J.
11.2 Biomedical Engineering Services shall record applicable uptime target in active
medical device register.
11.3 Biomedical Engineering Services shall administer and monitor active medical device
compliance with uptime targets.
11.4 All maintenance time shall be recorded in MMIS.
11.5 Biomedical Engineering Services shall produce reports on uptimes for all active
medical device on a periodic basis for review.
12 Quality assurance programme (QAP)

QAP shall be developed for continuous improvement on Biomedical Engineering Services in
healthcare facilities.

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12.1 Biomedical Engineering Services shall identify the KPI of the services and set
appropriate standards to be achieved. Examples of the indicators are as follows:
a) percentage of PPM schedule completed as scheduled;
b) percentage of asset meeting uptime target;
c) percentage of response time meeting target; and
d) percentage of repair time.
12.2 Standards set should be measurable qualitatively and quantitatively. These

measurable standards should be set at the optimum achievable level, instead of the ideal
level and it should be appropriate to the Biomedical Engineering Services.
12.3 KPI shall be agreed by the healthcare facility authority and Biomedical Engineering
Services.
12.4 The QAP shall consist of:
a) Structure
The Biomedical Engineering Services shall define the structure in which the QAP will
work in terms of:
i) physical setting;
ii) selection of active medical device;
iii) working environment; and
iv) documentation and information systems.
b) Processes
The Biomedical Engineering Services shall identify the methodology of the QAP as below:
i) identification of problem;
ii) prioritisation of problem;
iii) problem analysis;
iv) identification of remedial actions;
v) implementation of remedial actions; and
vi) re-evaluation of the effectiveness of the remedial actions.
c) Outcome
Outcome refers to the end result.

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12.5 The healthcare facility authority shall review the QAP proposed by the Biomedical
Engineering Services and comment accordingly.
12.6 Biomedical Engineering Services shall provide healthcare facility authority the agreed
information and maintain accurate records, procedures and other documents in the QAP. The
data collected shall be analysed for further improvement of the structure and processes.
12.7 For ionising/non-ionising active medical device quality assurance shall be performed
as determined by relevant regulatory authority.
13 Maintenance management information system (MMIS)

13.1 Healthcare facilities shall have MMIS in place to manage all aspects of the
Biomedical Engineering Services. MMIS shall be maintained and updated.
13.2 Biomedical Engineering Services shall train all relevant parties to use MMIS.
13.3 The MMIS shall consist, but not limited to, the following modules and be accessible to
authorised users:
a) asset register module with links to other modules;
b) work order module;
c) planned preventive maintenance module;
d) maintenance history module; and
e) supplier-client register module.
An example of MMIS data and report is listed in Annex K.
13.4 Data back-up shall be carried out at periodic intervals.
13.5 Healthcare facilities without Biomedical Engineering Services shall maintain a record
of maintenance activities.
13.6 ABR shall provide any documents related to maintenance activities upon request by
the authority.
14 Management of warranties
The purpose of warranty management is to ensure that all faults occurring within the warranty
period are detected, reported and repaired under warranty provisions where applicable. This
is to ensure that all planned preventive maintenance covered under the warranty provision is
carried out within the warranty period as per agreed schedule.
14.1 The warranty provider shall provide PPM schedule and warranty register shall be
updated and maintained accordingly by Biomedical Engineering Services.

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14.2 Biomedical Engineering Services shall refer to device warranty documents to

determine the extent of scope of work and the responsibilities of each party.
14.3 PPM covered under the warranty provisions shall be monitored accordingly and
notification shall be given to warranty provider to comply with warranty provisions. The user
shall be informed if warranty provider fails to comply with warranty provisions.
14.4 PPM and corrective maintenance carried out by warranty provider shall be
supervised and monitored. The details of maintenance work carried out by the warranty
provider or its appointed party shall be recorded accordingly.
14.5 The warranty provider shall be responsible to ensure the medical device is in good
working condition upon warranty expiry. Any faults reported during warranty period shall be
rectified by the warranty provider or any party appointed by the warranty provider.
14.6 The user department shall inform the Biomedical Engineering Services at least 30
days prior to warranty expiry of any faults of the device that require rectification by the
warranty provider.
15 Decommissioned active medical device
Decommissioned active medical device is active medical device that has been taken out of
service pending disposal.
15.1 The user shall provide notification and the list of decommissioned active medical
device to the Biomedical Engineering Services and asset register shall be updated
accordingly.
15.2 Biomedical Engineering Services and user shall ensure all active medical device is
safe for disposal.
15.3 Any ionising radiation equipment shall be decommissioned as per the Atomic Energy
Licensing Act 304.
15.4 Biomedical Engineering Services shall remove all decommissioned active medical
device from use. All decommissioned active medical device shall be placed into a designated
area.
15.5 All decommissioned active medical device details shall be updated into MMIS.
16 Disposal of active medical device

16.1 Healthcare facility shall ensure that disposal of active medical device is in
accordance with Act 737 and MS 2650.
16.2 The user shall obtain appropriate approval for disposal of active medical device from
healthcare facility authority.
16.3 The disposal of potentially hazardous equipment, material or components such as

batteries, X-ray tubes, vacuum tubes, pressure vessels, radioactive materials and devices
that contain toxic materials such as lead, beryllium, mercury or other heavy metals,
polychlorinated biphenyls and asbestos, shall be carried out according to established
procedures as laid out in relevant national/international standards or national regulations.

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17 Processes for handling hazardous/contaminated active medical

device
Decontamination is the process of handling hazardous/contaminated active medical device
that may involve cleaning, disinfecting and sterilisation and may vary according to the device.
Failure to decontaminate active medical device properly may lead to post-operative infection
and the spread of diseases. Failure to maintain active medical device decontamination and
sustain proper working practices can raise health and safety issues to staff and patients.
17.1 Procedure for handling hazardous/contaminated active medical device
17.1.1 The user shall decontaminate any active medical device such as aspirators, dialysis
related medical device, surgical related medical device, laboratory equipment, or any active
medical device suspected to be hazardous or being contaminated prior to any maintenance
activity.
17.1.2 The user shall declare in the maintenance request that the decontamination has been
performed.
17.1.3 The decontamination process shall follow established procedures and be carried out
by trained personnel.
17.1.4 Biomedical Engineering Services shall identify and set their own KPI for these
activities. Annex L gives examples of KPI in all government hospitals and institutions.
18 Incidents investigation and reporting

This procedure shall be followed in order to carry out investigation and corrective actions on
incidents.
18.1 The healthcare facility shall produce written report on all incidents related to medical
device to the manufacturer or authorised representative (AR) and voluntary reporting to the
authority.
18.2 Respective active medical device, its accessories and consumables shall be taken
out of use, tagged and stored in a secured area.
18.3 All incidents involving the failure of active medical device shall be investigated and
relevant parties including Biomedical Engineering Services shall cooperate fully with the
healthcare facility and the report shall be submitted to the manufacturer or authorised
representative (AR).
18.4 Manufacturer or authorised representative (AR) shall submit the initial and final report
to the authority, as prescribed in MDA/GD/0014, Mandatory Problem Reporting.
18.5 In the event of an incident that involves the same model of active medical device in
any country or location, the manufacturer or authorised representative (AR) shall inform the
healthcare facility authority, user and Biomedical Engineering Services and take corrective
action to ensure the active medical device is safe to use.

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19 Alerts, safety, field corrective action and recall notices

19.1 Manufacturer or authorised representative (AR) shall inform healthcare facility on any
alerts, safety, field corrective action and recall notices.
19.2 Upon receiving alerts, safety, field corrective action and recall notices, healthcare
facility/Biomedical Engineering Services shall advise the user and take appropriate action to
the affected active medical device. Where appropriate, the active medical device shall be
isolated from use and tagged with appropriate label.
19.3 Biomedical Engineering Services shall communicate relevant information about

active medical device failures and use errors to the relevant parties, as appropriate.
20 User training
Users shall be trained on the proper and correct usage and operation of the active medical
device.
20.1 Biomedical Engineering Services shall offer or coordinate user training when a new
active medical device system is introduced or periodically as requested by the user.
20.2 When the need arises, either requested or planned, Biomedical Engineering Services
shall provide or coordinate training to users to cover among others the following:
a) safety precautions in operating the active medical device;
b) proper operation including features unique to the particular manufacturer or model of

active medical device;
c) user maintenance;
d) cleanliness and decontamination awareness;
e) operational verification procedures;
f) recognition and correction of common operational problems;
g) recognition of defective active medical device and potential hazards; and
h) proper reporting procedures for maintenance requests.
20.3 Biomedical Engineering Services and users shall maintain training records.
20.4 Biomedical Engineering Services shall periodically analyse the maintenance record
to see the need for further user training. Biomedical Engineering Services who see such
problems should document the discrepancies, and offer user training to the relevant user
department and active medical device users.
20.5 Biomedical Engineering Services, the manufacturer, qualified third parties, or medical
staff members can provide user training.

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20.6 When procuring new active medical device, healthcare facility authority shall include
a requirement in the contract that the manufacturer or its representative shall provide training
for both Biomedical Engineering Services and users.
21 Genuine parts
Stock of genuine spares shall guarantee the availability of genuine spare parts from the active
medical device manufacturer to meet uptime target and availability of active medical device
for minimal interruption of clinical services.
21.1 Biomedical Engineering Services shall survey all active medical device and identify
required spare parts.
21.2 Biomedical Engineering Services shall source required genuine or equivalent spare
parts.
21.3 Biomedical Engineering Services shall recommend with supporting document to the
healthcare facility authority or appointed authority on the use of equivalent genuine or original
equipment manufacturer (OEM) spare parts authorisation.
21.4 Biomedical Engineering Services shall report to the healthcare facility authority or
appointed authority in the event that the manufacturers do not assist in providing supporting
document.
21.5 Biomedical Engineering Services shall maintain adequate stock of required genuine
spare parts and practice good store management.
21.6 Any equivalent spare parts shall be endorsed by the appointed biomedical
engineering services representative (ABR).
21.7 Annex M shows typical spare part management for Biomedical Engineering Services.
22 On-site library
Biomedical Engineering Services shall maintain and manage an on-site library at an
accessible and designated area. The library should consist of documents such as:
a) operation and maintenance manuals;
b) drawings;
c) software;
d) relevant standards and regulations;
e) training materials; and
f) other related documents.

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23 Workshop setup
Setting-up of an adequately equipped workshop facility for maintenance of active medical
device, safe storage for active medical device under maintenance and efficient space
utilisation.
23.1 Healthcare facility authority shall determine the requirement for establishing a
Biomedical Engineering Services workshop.
23.2 In the event that a workshop is required, healthcare facility authority shall set up the
workshop based on the size of the healthcare institution and the healthcare services available
in the institution.
23.3 The workshop area shall be adequate in size based on the number of technical
personnel. Refer Annex N for examples of workshop setup. Figure N.1 indicates layout for a
maximum of two personnel and Figure N.3 indicates layout for a maximum of seven technical
personnel.
23.4 The workshop shall be equipped with proper tools, and test equipment inventory
(refer to Table 1 for lists of common test equipment that may be needed); and personal
protective equipment (PPE) to perform the maintenance services.
23.5 Biomedical Engineering Services workshop shall consist of the following, where
applicable.
a) Environmentally controlled room: used to calibrate and maintain intricate sensitive active
medical device such as anaesthesia equipment, fiber optic systems, lasers and
ventilators.
b) Active medical device storage area: secure area to store active medical device awaiting
parts or maintenance without excessive dust, moisture and other adverse environmental
elements.
c) Repair parts storage area: secure area to properly store repair parts.
d) Administrative area: a well-lit area for administrative functions and customer service
(preferably one administration workstation for every two maintenance personnel).
e) General work area: a well-lit area for technician workbenches (preferably one workbench
for every maintenance personnel).
f) Proper mercury handling facility and procedure shall be established where applicable and
in compliance with relevant regulations.
g) Active medical device maintenance facility requirements may include multiple 230 V
outlets and at least one each 400 V, 63 A single and three-phase AC power outlet.
Requirements also include residual current device (RCD), telephone service, emergency
eyewash, internet and LAN connectivity, medical air, nitrous oxide and scavenging
system (if it has analgesic or anaesthetic devices), vacuum system, ventilation and
temperature control, and wash sink.
23.6 The maintenance area shall be kept clean and orderly. Equipment and work surfaces
should be cleaned, waste removed and disposed off properly on a regular basis.

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23.7 Biomedical Engineering Services shall ensure work flow and status of pending repair
works are clearly indicated and recorded.
23.8 Accessibility
23.8.1 Healthcare facility authority shall locate the workshop facility where active medical
device can be brought in without unnecessary handling and exposure to bad weather.
23.8.2 The workshop shall preferably be in the proximity of the critical clinical area of the
healthcare facility.
23.9 Facilities for proper cleaning of active medical device and hand washing shall be
provided to prevent unnecessary exposure of potential hazard and infectious agents.
23.10 Ventilation in the work area shall comply with regulatory requirements related to the
adequate dissipation of vapours associated with chemicals (fluids, agents, substances,
compounds, etc.) that are used in the work area.
23.11 All recommended requirement shall be applicable to any party involved in carrying
out Biomedical Engineering maintenance.
Table 1. List of common test equipment
Type Equipment
General Function Generator
Electrical Safety Analysers
Oscilloscopes
Digital Multimetres
Pressure Gauges
Digital Tachometer
DC Power Supply
Patient Simulator
Calibrated Weights
Digital Thermometer
Digital Luxmeter
Specialty Ventilator Analyser
Electrosurgical Unit Analyser
Defibrillator Analyser
Radiation Detector/Survey Meter
Infusion Pump Analyser
kVp Meter
Collimator Test Tool

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24 Safety, health and environment
24.1 The Biomedical Engineering Services shall provide safe working environment for its
personnel covering fire safety, safety programme, disaster plans and safe medical device
disposal.
24.2 The Biomedical Engineering Services shall have a written Environmental, Health and
Safety Policy statement. Specific policies and procedures shall support and be consistent with
the Environmental, Health and Safety Policy statement in line with relevant regulatory
requirements including Occupational Safety and Health Act 1994.
The Appointed Biomedical Engineering Services Representative (ABR) shall be responsible

for environmental, health and safety activities to ensure:
a) the provision of quality performance with staff involvement in the continuous safety and
quality improvement activities of the services;
b) a structured orientation programme where new staff are briefed on their services,
operational policies and relevant aspects of the facility to prepare them for their roles and
responsibilities;
c) continuing education activities for staff to pursue professional interests and to prepare for
current and future changes in practice;
d) adequate and proper utilisation of space and active medical device to enable staff to
carry out their professional and administrative functions;
e) the infrastructure complies with relevant legislation relating to fire safety;
f) promotion of occupational safety and health programmes that ensure a safe and healthy
environment for customers/patients, staff and visitors;
g) planned safety activities that monitor and evaluate the performance of safety
programmes;
h) regular safety inspections to monitor compliance to indoor air quality, health surveillance
and hazardous and chemical risk assessment requirements according to the Safety
Programme;
i) the medical devices management during internal and external disasters;
j) waste disposal is carried out in accordance with environmental, statutory and legislation
requirements; and
k) biomedical technical personnel (BTP) shall be vaccinated against any common infection.
24.3 Work environment
24.3.1 The Biomedical Engineering Services shall establish documented requirements for
health, cleanliness and clothing of personnel if contact between such personnel and the work
environment could adversely affect either the health of personnel or safety of the active
medical device, for example when work on active medical device is to be undertaken in the
environmentally controlled areas such as operating theatres or controlled laboratory
environments.

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24.3.2 The Biomedical Engineering Services shall ensure that all personnel who are
required to work temporarily under special environmentally controlled conditions within the
work environment are appropriately trained or supervised by a competent BTP (trainer).
24.3.3 The Biomedical Engineering Services shall establish and document the control of
contaminated or potentially contaminated medical equipment in order to prevent
contamination of the work environment.
25 Advisory service
25.1 Advice on the following maintenance provisions shall be obtained from the Biomedical
Engineering Services during the entire lifecycle of medical devices:
a) selection of active medical device;
b) active medical device installation, testing and commissioning, operation and

maintenance;
c) upgrading and modification;
d) discontinuation of use of active medical device;
e) replacement of active medical device;
f) any adverse events;
g) condition appraisal of active medical device; and
h) dismantle and disposal.
25.1.1 Proposal for removal of active medical device from operation
Active medical device shall be proposed by either from user, Biomedical Engineering
Services or manufacturer for removal from operation when it satisfies one or more of the
following:
a) beyond economical repair:
i) cost of repair exceeds depreciated value; or
ii) accumulated maintenance cost plus the estimated cost of impending upcoming
repairs exceeds the depreciated value of the active medical device;
b) worn out - when the active medical device is not functioning properly even though repairs
have been carried out;
c) unreliable - when it is not meeting its acceptable level of performance for its intended use;
d) obsolescence - when it is obsolete due to any of the following factors:
i) a new model of the same active medical device has a design change resulting in a
better efficiency and increased capacity;

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ii) a new concept for the service provided by the active medical device is introduced;
iii) new safety requirements render the active medical device unsafe; or
iv) spare parts are no longer available;
e) changes in local policies for device use;
f) absence of manufacturer/supplier support;
g) increased capacity is required due to expanded operations or less labour available;
h) possible benefits of new model (features, usability, more clinically effective, lower running
costs); or
i) exceeded lifespan of the active medical device as recommended by recognised

organisation.
26 Procurement of active medical device

26.1 Healthcare facility authority shall ensure procurement of active medical device from
an establishment with:
a) establishment license (lesen establismen); and
b) medical device registration certificate (sijil pendaftaran peranti perubatan).
26.2 Healthcare facility authority shall ensure local policies for procurement of active
medical device addresses safety, quality and performance are observed.
26.3 Policies should include the need to establish advisory groups to ensure the
procurement requirements take into account the needs of all parties involved in the use,
commissioning, decontamination, maintenance and decommissioning of active medical
device.
26.4 Biomedical Engineering Services shall provide advice upon request by healthcare
facility authority prior to procurement, such as:
a) installation requirements, utility services and commissioning procedure;
b) reliability and previous performance;
c) past history of problems with the device or type of device;
d) compatibility with other relevant active medical device and systems;
e) safety publications, manufacturer’s advisory notices or other relevant publications related

to the active medical device;
f) training needs (user and technical training);
g) warranty coverage; and
h) other support facilities.

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26.5 All active medical device supplied to the healthcare facility shall conform to relevant
international/national electrical safety standard, i.e. MS IEC 60601-1 for medical electrical
equipment and MS IEC 61010-1 for laboratory equipment and relevant product standards.
26.6 The active medical device to be procured shall comply with Malaysian power supply
rating of 230 V with a tolerance of +10 % -6 %, 50 Hz ±1 % (single phase) and 400 V with a
tolerance of +10 % -6 %, 50 Hz ±1 % (three-phase).
26.7 The condition for purchase shall include provision for future modification of active
medical device and provision for software upgrades.
26.8 The criteria for selection shall be based on efficacy, effectiveness, performance,
safety, reliability, features, ease of use, cost-effectiveness, service, training and continuous
support for the user and equipment maintenance.
26.9 Supplier shall provide complete copies of the following items to the healthcare facility
authority and Biomedical Engineering Services:
a) user manual;
b) service or maintenance manuals;
c) circuit diagrams and drawings;
d) relevant software inclusive of access codes;
e) parts list;
f) PPM checklist according to manufacturer recommendation; and
g) other necessary documents/items.
26.10 Supplier shall provide complete technical training to the Biomedical Engineering
Services and user training.
26.11 Final payment shall be paid to the supplier upon meeting the terms and conditions of
contract/purchase order and clearance from Biomedical Engineering Services.
27 Risk management
27.1 Risk management process
The healthcare facility/Biomedical Engineering Services/manufacturer/AR shall establish,

document and maintain throughout the life-cycle an ongoing process for identifying hazards
associated with a medical device inventory of the healthcare facility, estimating and
evaluating the associated risks, controlling these risks and monitoring the effectiveness of the
controls. This process shall include the following elements:
a) risk analysis;
b) risk evaluation;
c) risk control; and

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d) risk register.
27.2 Risk analysis
Risk analysis shall be performed for all active medical devices in the healthcare facility with
reference to MS ISO 14971. The implementation of the planned risk analysis activities and
the results of the risk analysis shall be recorded in the risk management file.
27.3 Risk evaluation
For each identified hazardous situation, the healthcare facility/Biomedical Engineering

Services shall decide, using the criteria defined in the risk management plan, if risk reduction
is required. The results of this risk evaluation shall be recorded in the risk management file.
Compliance is checked by inspection of the risk management file.
27.4 Risk control
27.4.1 Risk reduction
When risk reduction is required, risk control activities shall be performed.
27.4.2 Risk control option analysis
The healthcare facility/Biomedical Engineering Services shall identify risk control measure(s)
that are appropriate for reducing the risk(s) to an acceptable level.
The healthcare facility/Biomedical Engineering Services shall use one or more of the following
risk control options in the priority order listed:
a) inherent safety by design;
b) protective measures by the users and operators; and
c) information for safety.
The risk control measures selected shall be recorded in the risk management file.
27.4.3 Implementation of risk control measure(s)
The healthcare facility/Biomedical Engineering Services shall implement the risk control
measure(s) selected in 27.4.2.
Implementation of each risk control measure shall be verified. This verification shall be
recorded in the risk management file.
The effectiveness of the risk control measure(s) shall be verified and the results shall be
recorded in the risk management file.

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27.4.4 Residual risk evaluation
After the risk control measures are applied, any residual risk shall be evaluated using the
criteria defined in the risk management plan. The results of this evaluation shall be recorded
in the risk management file.
If the residual risk is not judged acceptable using these criteria, further risk control measures
shall be applied (see 27.4.2).
For residual risks that are judged acceptable, the healthcare facility/Biomedical Engineering
Services shall decide which residual risks to disclose and what information is necessary to
include in the accompanying documents in order to disclose those residual risks.
Compliance is checked by inspection of the risk management file and the accompanying
documents.
27.4.5 Risks arising from risk control measures
The effects of the risk control measures shall be reviewed with regard to:
a) the introduction of new hazards or hazardous situations; and
b) whether the estimated risks for previously identified hazardous situations are affected by
the introduction of the risk control measures.
Any new or increased risks shall be managed accordingly.
The results of this review shall be recorded in the risk management file.
27.4.6 Completeness of risk control
The healthcare facility shall ensure that the risk(s) from all identified hazardous situations
have been considered. The results of this activity shall be recorded in the risk management
file.
27.5 Risk register
All risk analysis shall be registered in the risk management file.
28 Technical audit
Technical audit is to ensure quality, safety and performance of active medical devices in the
healthcare facility is maintained throughout its life span.
The technical audit shall be conducted by healthcare facility/Biomedical Engineering Services

providing maintenance management of active medical device.

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28.1 The purpose of technical audit shall be as below:
a) to ensure active medical device is being used properly as per manufacturer

recommendations;
b) to ensure active medical device functions are as per the technical specifications;
c) to ensure compliance to the Medical Device Act 2012 (Act 737), Atomic Energy Licensing
Act 304 and any other relevant statutory requirements;
d) to ensure maintenance are being carried out in accordance with manufacturer’s

maintenance documentations; and
e) to ensure all processes are being recorded, monitored and managed properly.
28.2 The technical audit process shall consist of the following activities.
a) The Biomedical Engineering Services shall prepare an annual audit programme. The
annual audit programme shall be submitted to the healthcare facility for
acknowledgement. The audit frequency shall be determined based on the requirement of
the healthcare facility and it should be at least once a year.
b) The Biomedical Engineering Services shall submit the audit plan, scope of audit, audit
team member, list of document and record need to be accessed during the audit to the
c) The Biomedical Engineering Services shall send audit notice with audit programme to the
healthcare facility at least two week prior to the audit date.
d) The audit team shall consist of trained auditors and at least one technically competent
personnel in the subject that they want to audit.
e) The technical audit assessment shall consist of the following:
i) Accuracy of asset and services information system contents of asset details against
the physical asset.
ii) Maintenance records are filled in correctly and maintained properly.
iii) Maintenance is done in compliance with the statutory requirement.
iv) Safety requirements are met.
v) Proper usage of the active medical device.
vi) Active medical device is performing as its intended purpose.
f) User shall provide full access to the location of the active medical device.
g) All parties shall make corrections, take corrective and preventive action on non-
compliance report raised during the audit.
h) All parties shall monitor the corrective action taken and prepare corrective implementation
report including analysis and effectiveness of the corrective action taken.

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i) The Biomedical Engineering Services shall keep all the records of the audits.
29 Manpower
29.1 Manpower norm for Biomedical Engineering Services for healthcare facilities
29.1.1 Manpower norm shall be determined based on the ratio of 400 active medical device
per quantity of technical staff for a particular category of healthcare facilities. The total number
of Biomedical Technical Personnel for a particular healthcare facilities depends on the total
number of asset available at the healthcare facilities.
29.1.2 The asset shall be of functioning active medical device and maintained by the
Biomedical Engineering Services. Total number of active medical device shall be of current
and updated data obtained from the asset register.
29.1.3 For a network of healthcare facilities managed by the Biomedical Engineering

Services, Table P.1 provides an example for the number of job designation identified based
on the total asset for all healthcare facilities and institutions based on the category of the
29.1.4 The number of Biomedical Engineering Services technical staff per job description
shall also consider competency level and qualification of the staff as provided in this standard.
The actual number of Biomedical Engineering Services technical staff at the healthcare
facility may be varied than the norm based on other factors such as:
a) current number of active medical device at the healthcare facility;
b) the healthcare facility is the main or reference healthcare facility at the region which
increases the clinical/Biomedical Engineering Services operation demand;
c) types of active medical device; highly specialised, intermediate or basic; and
d) availability of in-house manpower for specialised active medical device.
29.1.5 Details of Biomedical Engineering Services manpower for their implementation at the
healthcare facilities such as number of manpower, personnel name, job designation,
academic qualification, experience and related information on competency or dedicated field
shall be documented.
29.1.6 For healthcare facilities which do not have in-house biomedical technical personnel,
the appointed Biomedical Engineering Services personnel shall be declared and recorded.
29.2 Manpower norm for medical device establishment
29.2.1 The number of biomedical technical personnel shall be determined by the medical
device establishment based on the manufacturer requirement and volume of medical devices
distributed in the market and provision of after sales technical support to be provided/being
provided.
For job designation please refer to Table P.1 in Annex P.

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29.3 Appointment of responsible person for Biomedical Engineering Services
29.3.1 Appointed biomedical engineering services representative (ABR)
The healthcare facilities shall appoint an ABR who comply with Management Level 2
according to Annex A and should be a Professional Engineer (PE) in Biomedical.
29.4 Competency
29.4.1 The criteria on the level competent biomedical technical personnel shall consist of
academic qualification, work experience in related field, type of active medical device and
courses/training and any other requirement deemed necessary by the Medical Device
Authority .
29.4.2 For the purpose of identifying competency, active medical devices can be divided into
three different categories;
a) Basic – medical device that operates on DC voltage (i.e. battery or AC adapter) with
simple electronics circuit design. Common repairs such as repair minor defect related to
power supply, replacement of light bulbs, probes, electrode, tubing and equipment
consumable.
b) Intermediate – medical device that operates on DC or AC voltage, single or 3-phase

supply with complex electronics circuit design. Breakdown maintenance scope: repair and
replace of equipment modules, assemblies or boards (PCB), component or
subcomponent and ensure of equipment’s calibration before use on patient.
c) High – medical device that operates on AC voltage (single or 3-phase supply) with
various complex electronics circuit design. Performing complex maintenance task that
calls for special skills, tools or equipment, software re-programming, specialised
calibration, modification and upgrading device system and software, total overhaul or
refurbishment.
Details of competency are given as in Annex A.
30 Technical training
30.1 Active medical device training
Medical device establishment shall provide on-site hands-on active medical device training.
The active medical device training module shall include, but not limited to the following:
a) safety precautions in operating the medical device;
b) proper operation/application including features unique to the particular manufacturer or

model of medical device;
c) user maintenance;
d) cleanliness and decontamination;
e) operational verification procedures;
f) recognition and correction of common operational problems;

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g) recognition of defective active medical device and potential hazards; and
h) the risk associated with the device.
Certificate of attendance shall be issued by medical device establishment to the biomedical

technical personnel upon completion of the training.
30.2 Specialist technical training
30.2.1 Medical device establishment shall offer factory technical training upon request to the
biomedical technical personnel at cost. The technical training module shall include, but not
limited to the following:
a) application software;
b) PPM according to manufacturers’ specification; and
c) repair and calibration.
Certificate of competency shall be issued by medical device establishment to the competent

biomedical technical personnel upon completion of the training.
31 Active medical device replacement plan

31.1 Healthcare facility should include active medical device replacement plan to ensure
active medical device is replaced whenever required based on an objective and uniform
assessment.
31.2 The main purpose of the plan is to provide an objective and systematic approach to
active medical device replacement taking into considerations the actual conditions of the
active medical device, related technology development and the requirement of the users. It
provides an unbiased decision on the prioritisation for active medical device to be replaced
and thus, proper planning and utilisation of budget/expenses.
31.3 The parameters listed below should be further expanded to provide weightage for
every condition of the active medical device. Scorings are assigned to give an overall point for
each active medical device replacement. Those active medical device with the higher scores
should be replaced sooner than those with lower overall scores. The considerations for active
medical device replacement plan may include, but not limited to the following:
a) Patient safety, i.e. hazard, recalls.
b) Age of the active medical device - equal or above 125 % from the recommended life
span.
c) Active medical device maintenance status, i.e. parts availability, technical support
availability, maintenance cost exceeded a certain defined percentage of an active medical
device value.
d) Obsolescence, i.e. newer technology available.
e) Active medical device reliability based on maintenance history - breakdown frequency.

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f) Impact of the active medical device to the service delivery, i.e. highly required for patient
care, alternative active medical device.
g) Cost of replacement.
h) Regulatory compliance.
Example of an active medical device replacement plan is given as in Annex Q.

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Annex A
(normative)
Biomedical Technical Personnel (BTP) competency and career

development guidelines
A.1 Introduction
Biomedical Engineering is one of several professional disciplines contributing to safe,
effective and economical healthcare. The role and primary responsibility of a Biomedical
Engineering services are management of medical device technologies, including adherence
to recognised safety, quality, cost, and efficiency standards.
Biomedical Engineering is a learned profession that combines expertise and responsibilities in

engineering, science, technology, and medicine. Since public health and welfare are
paramount considerations in each of these areas, biomedical technical personnel (BTP) shall
uphold an appropriate level of competencies embodied in its professional practice, research,
patient care, and training. The level of competencies shall reflect the standards of
professional and personal practice for BTP.
A.2 Competency levels of Biomedical Technical Personnel (BTP)

The BTP competency levels are categorised into three technical levels with one product
technical specialist (PTS) and management. To determine the individual competency levels,
the guidelines shall be cross-referred to the medical device maintenance specialisation
classification, competency skills, breakdown maintenance level and management skills level
of the BTP. The details of the competency levels are as per the relevant matrix (refer Figures
A.1 to A.7 and Tables A.1 to A.10).
A.3 Career development plan for Biomedical Technical Personnel (BTP)

To ensure the career development and progress of the BTP in achieving various levels of
competencies, a systematic career development plan shall be followed by the Biomedical
Engineering Services organisation as a guideline. Details of the career development plan are
as per the BTP career development matrix in Table A.5.
A.4 Assessment of competency

The BTP shall have their competency assessed through a Competency Examination,
conducted by the recognised Competency Certifying Body (CCB), authorised by Medical
Device Authority and having the MS ISO/IEC 17024 accreditation or equivalent. The
examination will be based on the competence and commitment standards developed as per
this Malaysian Standard and relevant national regulation. The decision whether or not to
accept an applicant for competency examination registration shall be made by the CCB
authorised by the Medical Device Authority, which is responsible for governing the
competency registration. Details of the competency certification requirements are as per
Table A.5.

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A.5 Biomedical Engineering maintenance competency of Biomedical

Technical Personnel (BTP)
With reference to Medical Device Act 2012 (Act 737) under Section 43, a person – installing,
testing, commissioning, maintaining and disposing shall have the qualification and
competency.
A.5.1 Requirement for competency level
A.5.1.1 Level
Competent Biomedical Technical Personnel shall be divided into two categories which are:
a) Maintenance: Level 1, Level 2, Level 3 and Product Technical Specialist (PTS); and
b) Management: Level 1, Level 2 and Level 3.
A.5.1.2 Maintenance Engineer and Technician
Competent Biomedical Technical Personnel in the category as in Tables A.1 and A.2 can be
divided into several levels.
A.5.1.2.1 Level 1
Competent Biomedical Technical Personnel at this level shall be able to perform the operation
for medical devices in the category of basic based on the following.
a) Understanding of the anatomy, physiology and active medical device classification.
b) Understanding of medical devices operations and its applications.
c) Understanding of manufacturer Planned Preventive Maintenance (PPM) procedures and

be able to follow appropriate steps to complete the task.
d) Understanding of test fixtures and test equipment.
e) Understanding of acts, regulations and standards relevant to medical devices.
f) Be able to identify and verify operation of all safety features.
g) Be able to perform an effective performance testing and verification.
h) Performing an effective electrical safety procedure.
i) First Line Repair: Be able to identify and perform breakdown and corrective maintenance
at the point of care.
j) Be able to complete accurately the necessary Biomedical Engineering related

documentation.

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A.5.1.2.2 Level 2
Competent Biomedical Technical Personnel at this level shall be able to perform the operation
for medical devices in the category of intermediate based on the following.
b) Understanding operations and its applications.
c) Understanding of manufacturer’s Planned Preventive Maintenance (PPM) procedures

and be able to follow appropriate steps to complete the task.
h) Be able to perform an effective electrical safety procedure.
j) Second Line Repair: Be able to identify intermediate corrective actions required for the
corrective maintenance up to module/board levels at maintenance workshop either
internal or external.
k) Be able to complete accurately the necessary Biomedical Engineering related

documentation.
l) Understanding of Biomedical Engineering maintenance services management Level 1.
m) Understanding of Biomedical Engineering maintenance services management Level 2

(optional).
A.5.1.2.3 Level 3
Competent Biomedical Technical Personnel at this level should be able to perform the
operation for medical devices in the category of high as follows (optional for medical devices
in the category of intermediate):
b) Understanding of its operations and its applications.

and follows appropriate steps to complete the task.

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h) Be able to perform an effective electrical safety procedure.
corrective maintenance of the medical devices in the category of basic, intermediate and
high up to module/board levels at maintenance workshop either internal or external.
k) Third Line Repair: Be able to identify advance corrective actions required for the
breakdown maintenance up to component levels and complete overhaul at specialized or
manufacturer facilities.
l) Be able to complete accurately the necessary biomedical engineering related

documentation.
m) Understanding of Biomedical Engineering maintenance services management Level 1.
n) Understanding of Biomedical Engineering maintenance services management Level 2

(optional).
A.5.1.2.4 Product Technical Specialist (PTS)
Product Technical Specialist should be able to perform the operation as follows (for medical
devices in the category of intermediate or high by manufacturer model and brand):
a) Understanding of the anatomy, physiology and active medical device classification for
medical devices.
b) Understanding of medical devices in term of its operations and its applications.

and be able to follow appropriate steps to complete the task for medical devices.
d) Understanding of test fixtures and test equipment specific to the medical devices.
e) Be able to identify and verify operation of all safety features for medical devices.
f) Understanding of acts, regulations and standards relevant to medical devices.
g) Be able to perform an effective performance testing and verification on the medical

devices.
h) Be able to perform an effective electrical safety procedure on the medical devices.
of the medical devices at the point of care.

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corrective maintenance of the medical devices up to module/board levels at maintenance
workshop either internal or external.
k) Third Line Repair: Be able to identify advance corrective actions required for the
breakdown maintenance of the medical devices up to component levels and complete
overhaul at specialized or manufacturer facilities.
l) Be able to complete accurately the necessary biomedical engineering related

documentation for medical devices.
m) Understanding of Biomedical Engineering maintenance services management Level 1.
n) Understanding of Biomedical Engineering maintenance services management Level 2.
o) Understanding of Biomedical Engineering maintenance services management Level 3

(optional).
A.5.1.3 Active medical device Management
Competent biomedical technical personnel in this category can be divided into several levels.
A.5.1.3.1 Level 1
operation based on the following:
a) General technical support and facilities.
b) Scheduled maintenance management.
c) Unscheduled maintenance management.
d) Communication skill.
e) Biomedical Engineering Services documentations.
f) Hospital Biomedical Engineering Services administrative functions.
A.5.1.3.2 Level 2
operation based on the following.

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g) Education and training for biomedical.
h) Staff supervision and monitoring.
i) Relevant contractual management and implementation.
j) Standard, quality and risk management.
k) An advisory service on available Biomedical Engineering technology.
l) Planning, evaluation and procurement of medical devices.
A.5.1.3.3 Level 3
operation based on the following.
g) Education and training for biomedical.
h) Staff supervision and monitoring.
i) Relevant contractual management and implementation.
j) Standard, quality and risk management.
k) An advisory service on available Biomedical Engineering technology.
l) Planning, evaluation and procurement of medical devices.
m) Service management - to provide organisation with vision, leadership and resources to

achieve planned service goals and objectives.
n) Biomedical Engineering research and development.
A.5.2 Qualification, experience and skill
Competent Biomedical Technical Personnel is recognised by criteria as below:
a) academic qualification;

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b) experience in related field; and
c) certificate of competency possessed.
A.5.2.1 Competent Biomedical Technical Personnel academic qualification can be divided

into several levels:
A.5.2.1.1 Maintenance
A.5.2.1.1.1 BTP Level 1
a) Academic Qualification: Degree in Biomedical Engineering or Degree in Medical

Electronics or Degree in Engineering Technology (Biomedical/Medical Electronics)
i) 6 months experience in related field.
ii) Possess basic device maintenance certificate.
iii) Passed CCM.
or
b) Academic qualification: Degree in Electronics Engineering or Diploma in Biomedical

Engineering or Diploma in Medical Electronics or Diploma in Electronics (Major in
Biomedical) or Diploma in Biomedical or Diploma in Engineering Technology in Medical
Electronics
i) 9 months experience in related field.
iii) Passed CCM.
or
c) Academic qualification: Degree in other relevant engineering or Degree in Engineering

Technology (Electronics/Electrical/Mechanical) or Diploma in Electronics Engineering or
Diploma in other relevant engineering or Diploma in Engineering Technology
i) 1 year experience in related field.
iii) Passed CCM.
or
d) Academic Qualification: Certificate in Biomedical Engineering
i) 2 years experience in related field.
iii) Passed CCM.

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or
e) Academic Qualification: Certificate in Electronics Engineering or other relevant

engineering field
iii) Passed CCM.
A.5.2.1.1.2 BTP Level 2
a) Academic Qualification: Degree in Biomedical Engineering
i) 1 year experience in related field.
ii) Possess intermediate device maintenance certificate.
iii) Passed CCM.
or
b) Academic qualification: Degree in Medical Electronics
i) 1 ½ years experience in related field.
iii) Passed CCM.
or
c) Academic qualification: Degree in Engineering Technology (Biomedical/Medical

Electronics or Degree in Electronics Engineering
iii) Passed CCM.
or
d) Academic Qualification: Degree in other relevant engineering or Degree in Engineering

Technology (Electronics/Electrical/Mechanical) or Diploma in Biomedical Engineering or
Diploma in Medical Electronics or Diploma in Electronics (Major in Biomedical) or Diploma
in Electronics Engineering
iii) Passed CCM.

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or
e) Academic Qualification: Diploma in Biomedical or Diploma in Engineering Technology in

Medical Electronics
iii) Passed CCM.
or
g) Academic Qualification: Diploma in other relevant engineering field or Diploma in

Engineering Technology
iii) Passed CCM.
or
h) Academic Qualification: Certificate in Biomedical Engineering or Electronic Engineering or

other relevant engineering
iii) Passed CCM.
A.5.2.1.1.3 BTP Level 3
a) Academic Qualification: Degree in Biomedical or Medical Electronics or Electronics

Engineering
ii) Possess high device maintenance certificate.
iii) Passed CCM.
or
b) Academic Qualification: Degree in Engineering Technology (Biomedical/Medical

Electronics)
iii) Passed CCM.

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or
c) Academic Qualification: Degree in other relevant engineering
iii) Passed CCM.
or
d) Academic Qualification: Degree in Engineering Technology

(Electronics/Electrical/Mechanical) or Diploma in Biomedical Engineering or Diploma in
Medical Electronics or Diploma in Electronics (Major in Biomedical) or Diploma in
Biomedical/Engineering Technology in Medical Electronics or Diploma in Electronics
Engineering
iii) Passed CCM.
or
e) Academic Qualification: Diploma other relevant engineering field or Diploma in

Engineering Technology
iii) Passed CCM.
A.5.2.1.1.4 BTP (Product Technical Specialist)
All relevant academic qualifications as in Table A.5.
iii) Passed CCM.

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A.5.2.1.2 Management
a) Academic Qualification: Degree in Biomedical Engineering or Medical Electronics or

Electronics Engineering or Engineering Technology (Biomedical/Medical
Electronics/Electronics/Electrical/Mechanical) or any other relevant engineering
ii) Passed CCM.
or
b) Academic Qualification: Diploma in Biomedical Engineering or Medical Electronics or

Electronics (Major in Biomedical) or Biomedical or Engineering Technology in Medical
Electronics or Electronics Engineering or Engineering Technology or any other relevant
engineering field
ii) Passed CCM.
As overall, academic qualification plays a major role in recognising the level of competent
BTP. Please refer Table A.5 (Annex A) for the total summary.
A.5.3 Certification process
In order to be recognised as competent, a technical personnel has to earn the following

certificates.
A.5.3.1 Compulsary Competency Module (CMM) Certificate
A Compulsary Competency Module comprises anatomy, physiology, regulatory, safety and

healthcare for biomedical module. The certificate is awarded to Biomedical Technical
Personnel who has attended the course and successfully passed in the given examination.
This certificate is mandatory to all Biomedical Technical Personnel.
Start
Attending Compulsary
Competency Module
Fail* Exam
Pass
Awarded with Compulsory

Competency Module
certificate
* The candidates who fail in the exam is allowed to re-sit the exam twice without attending the course.
Figure A.1. Flow chart for Compulsory Competency Module Certificate
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A.5.3.2 Maintenance Certificate A (Level 1) and/or B (Level 1), C (Level 1), D (Level 1)
This certificate is awarded to Biomedical Technical Personnel who has attended the course
and successfully passed in the given examination for the group equipment in the category of
basic only.
Start
Attending course on maintenance of equipment

in the category A, B, C or D of Basic.
e.g.: Category A Basic - Radiology & Imaging
Fail* Exam
**
Fail*
Pass
Awarded with CERT A (Level 1)

- i.e. certificate of competency Biomedical
Engineering Maintenance Level 1 specially for
basic group of Radiology & Imaging.
Figure A.2. Example of flow chart for Maintenance Certificate A (Level 1)
and successfully passed in the given examination for the specific equipment in the category of
intermediate.

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Start
Attending course on maintenance of

equipment in the category of intermediate.
e.g. Haemodialysis
Fail*
Exam
Pass
Awarded with Certificate of Competency

Biomedical Engineering Maintenance Level 2
specifically for Haemodialysis
i.e. CERT D (Level 2) - Haemodialysis
Figure A.3. Example of flow chart for Maintenance Certificate D (Level 2)
and successfully passed in the given examination for the specific equipment in the category of
high.
Start
Attending course on maintenance of

equipment in the category of high
e.g. Linear Accelerator
Fail*
Exam
Pass
Awarded with Certificate of Competency Biomedical
Engineering Maintenance Level 3 (C1) specifically for
Linear Accelerator
i.e. CERT A (Level 3) - Linear Accelerator
Figure A.4. Example of flow chart for Maintenance Certificate A (Level 3)

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A.5.3.5 Maintenance Certificate A (PTS) and/or B (PTS), C (PTS), D (PTS)
and successfully passed in the given examination for the specific model of the equipment
(factory training).
Start
Attending course on maintenance of Magnetic

Resonance Imaging for model MRI 1.5T:
Philips Achieva Pulsar HP System by Philips
Healthcare (factory training)
Fail*
Exam
Pass
Awarded with Certificate of Competency Biomedical Engineering

Maintenance PTS (D) specifically for model MRI 1.5T: Philips Achieva
Pulsar HP System
i.e. CERT A (PTS) - MRI 1.5T: Philips Achieva Pulsar HP System
Figure A.5. Example of flow chart for Maintenance Certificate A (PTS)

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Figure A.6. Competency level

Table A.1. Medical device maintenance specialisation classification matrix for BTP level
54
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Biomedical Engineering maintenance competency level
Product
Medical device maintenance specialisation classification b technical
Level 1 Level 2 Level 3 Managementd
specialist
(Level 4)c
Compulsory Compulsory
Basic certificatef and Compulsory Competency Modules
1 Basic active medical device (refer Tables A.7 to A.10e) (CCM)
Competency Competency
Modules (CCM) Modules (CCM)
Cert A; and/or
Cert B; and/or
2 Intermediate active medical device (refer Tables A.7 to A.10e) Cert C; and/or Optional Optional
Cert Aa; and/or
Cert D.
Cert B; and/or
Cert C; and/or
Cert A; and/or
Cert D.
Cert B; and/or
3 High active medical device (refer Tables A.7 to A.10e) Cert C; and/or Optional
Cert D.
Cert A - Radiology & Imaging; Cert B - Laboratory; Cert C - Diagnostic; Cert D - Therapeutic
 STANDARDS MALAYSIA 2017 - All rights reserved
NOTE. Mandatory course to all certification: Compulsory competency modules (CCM) includes;
i) human anatomy and physiology;
ii) regulatory;
iii) safety; and
iv) healthcare for biomedical.
a Area of specialisation to be declared based on specific model of medical devices.

b For Level 3 competency, the person is given an option to expand their specialisation level based on their training advancement and experiences.
c For PTS competency, the person at vendor and manufacturer are given an option to exclude the lower specialisation level.
d For management level, the manager is required to obtain a minimum competency on general/basic level medical device specialisation.
e The sample of medical devices specialisation are given in Tables A.7 to A.10 and subject to changes.
f Basic certificate on basic equipment is optional.
Table A.2. Biomedical Engineering maintenance competency levels and skills matrix
Skills Competency level
Level 1 Level 2 Level 3 Product Management

Technical
Specialist
Theory Understanding of the anatomy, physiology and active medical device classification for specific     
medical device (Refer Tables A.7 to A.10).
Operations Understanding of specific medical devices operations and its applications.     
Be able to identify and verify operation of all safety features for specific medical devices.     
Safety Be able to perform an effective electrical safety procedure on the specific medical device.     
Understanding of test fixtures and test equipment specific to the medical device.     
Servicing Understanding of manufacturer Planned Preventive Maintenance (PPM) procedures and follows     
appropriate steps to complete the task for specific medical devices.
Be able to perform an effective performance testing and verification on the specific medical device.     
Repair First Line Repair: Be able to identify and perform breakdown and corrective maintenance of the     
medical devices at the point of care.
Second Line Repair: Be able to identify intermediate corrective actions required for the corrective -    Optional
maintenance of the specific medical device up to module/board levels at maintenance workshop
either internal or external.
Third Line Repair: Be able to identify advance corrective actions required for the breakdown - -   Optional
maintenance of the specific medical device up to component levels and complete overhaul at
specialised or manufacturer facilities.
Managing Be able to complete accurately the necessary Biomedical Engineering related documentation.     
15R001R2
Understanding of Biomedical Engineering Maintenance Services management Level 1. Refer -    
Management Level Matrix.
Understanding of Biomedical Engineering Maintenance Services management Level 2. Refer - Optional Optional  
Management Level Matrix (Table A.4).
Understanding of Biomedical Engineering Maintenance Services management Level 3. Refer to - - - Optional 
55
Management Level Matrix (Table A.4).

56
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Table A.3. Biomedical Engineering breakdown maintenance levels
Breakdown maintenance level

Breakdown maintenance scope of repair
First line Second line Third line
  
1 Breakdown response
  
2 Equipment resetting and general checking
  
3 Common repair such as replacement of light bulbs, batteries, probes, electrode, tubing and equipment consumables
  
4 Troubleshoot and repair minor defect related to power supply
  
5 Spare parts identifications
-  
6 Repair and replacement of equipment modules, assemblies or boards (PCB)
-  
7 Ensure equipment requiring calibration is calibrated before use on a patient
-  
8 Repair and replacement of component or subcomponent of the equipment PCB
- - 
9 Performing complex maintenance tasks that call for special skills, tools or equipment
- - 
10 Software re-programming of medical device
- - 
11 Performing specialised verification on medical device
- - 
12 Modification and upgrading of medical device system and software.
- - 
13 Total overhaul or refurbishment of medical device
NOTE. Refer to Tables A.7 to A.10 for specific medical device except for first line breakdown maintenance levels.
Table A.4. Management skills level matrix
Management level
Management skills
Management 1 Management 2 Management 3
1 General technical support and facilities   
2 Scheduled maintenance management   
3 Unscheduled maintenance management   
4 Communication skills   
  
5 Biomedical Engineering Services documentations
6 Hospital Biomedical Engineering Services administrative functions   
7 Education and training for Biomedical Engineering -  
8 Staff supervision and monitoring -  
9 Relevant contractual management and implementation -  
10 Standard, quality and risk management -  
11 Advisory services on available Biomedical Engineering technology -  
12 Planning, evaluation, procurement and asset management of medical devices -  
Service management: To provide organisation with vision, leadership and resources to 

13 - -
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achieve planned service goals and objectives
14 Biomedical Engineering research and development - - 
57
58
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Table A.5. Biomedical Technical Personnel (BTP) career development matrix
BTP competency levels

Product Technical
Entry levels Level 1 Level 2 Level 3 Management
Specialist
Quala Expb Certc Qual Exp Cert Qual Exp Cert Qual Exp Cert Qual Exp Cert
Passed Passed Passed Passed

Degree in Biomedical Basic Intermediate 3 High 3 High 5 Passed
1  6 mths  1 year   
Engineering Device + Device + years Device + years Device + years CCM
CCM CCM CCM CCM
Passed
Passed Passed Passed
Degree in Medical Basic 1½ 3 3 5 Passed
2  6 mths  Intermediate  High  High 
Electronics Device + years years years years CCM
Device + Device + Device +
CCM
CCM CCM CCM
Degree in engineering Passed

technology Basic 2 3½ 3 5 Passed

(Biomedical/Medical Device + years years years years CCM
Electronics) CCM
CCM CCM CCM
Passed
Degree in Electronics Basic 2 3 3 5 Passed
Engineering Device + years years years years CCM
CCM
CCM CCM CCM
Passed
Degree in other relevant Basic 3 4 3 5 Passed
5  1 year  Intermediate  High  High 
engineering Device + years years years years CCM
CCM
CCM CCM CCM
Passed Passed
Degree in engineering Passed Passed
Basic 3 Intermediate 5 3 5 Passed
6 technology (Electronics/  1 year   High  High 
Device + years Device + years years years CCM
Electrical/Mechanical) Device + Device +
CCM CCM
CCM CCM
Table A.5. Biomedical Engineering career development matrix (continued)
Product Technical
Entry levels Level 1 Level 2 Level 3 Management
specialist
Diploma in Biomedical
Engineering/Medical Passed Passed Passed Passed
3 5 3 10 Passed
7 Electronics/  9 mths Basic Device  Intermediate  High  High 
years years years years CCM
Electronics (Major in + CCM Device + Device + Device +
Biomedical) CCM CCM CCM
Diploma in
Biomedical/ Passed Passed Passed Passed
3½ 5 3 10 Passed
8 Engineering  9 mths Basic Device  Intermediate  High  High 
years years years years CCM
Technology in + CCM Device + Device + Device +
Medical Electronics CCM CCM CCM
Passed Passed Passed Passed

Diploma in Electronics 3 5 3 10 Passed
9  1 year Basic Device  Intermediate  High  High 
Engineering years years years years CCM
+ CCM Device + Device + Device +
CCM CCM CCM
Diploma in other Passed Passed

Passed Passed
relevant engineering 4 6 High 3 High 10 Passed
10  1 year Basic Device  Intermediate   
field/Engineering years years Device + years Device + years CCM
+ CCM Device +
Technology CCM CCM
CCM
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Table A.5. Biomedical Engineering career development matrix (concluded)

Level 1 Level 2 Level 3 Product Technical
Management
Entry levels specialist
Passed
Certificate in Passed
7 Intermediate
11 Biomedical  2 years Basic Device 
years Device +
Engineering + CCM
CCM
Passed
Certificate in Passed
7 Intermediate
12 Electronic  3 years Basic Device 
years Device +
Engineering + CCM
CCM
Passed
Certificate in Other Passed
7 Intermediate
13 Relevant Engineering  3 years Basic Device 
years Device +
field + CCM
CCM
NOTES:
1. Passed basic device is optional.

2. Minimum topic under degree and diploma:
a) Electronics, Digital and Communication.
b) Anatomy and Physiology.
3. Working confirmation:
a) Government: 1 year to 3 years.
b) Private: 6 months to 1 year.
4. Experiences can be obtained under the supervision and responsibility of a competent BTP in the same competency level.
a
This means “qualification”.
b
This means “experience”. Experience refers to accumulative years of related experiences.
c
This means “certificate A and/or B, C, D”.
d
This means “management”.
Table A.6. Biomedical Engineering Certification Category
Device Certification
complexity category Biomedical Engineering competency certifications description
Basic Active medical device Maintenance Certification. Provided by competent certifying body recognised by MOH.
(Certificate of Competency Biomedical Engineering Maintenance Level 1- Radiology and Imaging, Laboratory,
Basic Diagnostics and Therapeutic) (optional)
Certificate
BASIC
and CCM
Compulsary Competency Module (CCM)
Intermediate Active medical device Maintenance Certification. Provided by competent certifying body recognised by
A (LEVEL 2) MOH (Certificate of Competency Biomedical Engineering Maintenance Level 2 - Radiology and Imaging)
B (LEVEL 2) MOH (Certificate of Competency Biomedical Engineering Maintenance Level 2 - Laboratory)
INTERMEDIATE Intermediate Active medical device Maintenance Certification. Provided by competent certifying body recognised by
C (LEVEL 2) MOH (Certificate of Competency Biomedical Engineering Maintenance Level 2 - Diagnostics)
D (LEVEL 2) MOH (Certificate of Competency Biomedical Engineering Maintenance Level 2 - Therapeutic)
High Active medical device Specialisation Maintenance Certification in Radiology (Ionising & Non-Ionising) and
Imaging medical devices. Provided by competent certifying body recognised by MOH (Certificate of Competency
A (LEVEL 3)
Biomedical Engineering Maintenance Level 3 - Radiology and Imaging)
HIGH
High Active medical device Specialisation Maintenance Certification in Laboratory equipment and devices. Provided by
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B (LEVEL 3) competent certifying body recognised by MOH (Certificate of Competency Biomedical Engineering Maintenance Level
3 - Laboratory)
61
Table A.6. Biomedical Engineering career development matrix (continued)
62
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Device Certification
complexity category Biomedical Engineering maintenance competency certifications description
High Active medical device Specialisation Maintenance Certification in Diagnostic medical devices. Provided
by competent certifying body recognised by MOH (Certificate of Competency Biomedical Engineering
C (LEVEL 3)
Maintenance Level 3 - Diagnostics)
High Active medical device Specialisation Maintenance Certification in Therapeutic medical devices. Provided
by competent certifying body recognised by MOH (Certificate of Competency Biomedical Engineering
D (LEVEL 3)
Maintenance Level 3 - Therapeutic)
High Active medical device Specialisation Maintenance Certification in any specialisation of medical devices.
Provided by equipment manufacturer and endorsed by competent certifying body recognised by MOH
A (PTS) [Certificate of Competency Biomedical Engineering Maintenance Level 4 - Radiology and Imaging (by Medical
Device Model)]
HIGH Provided by equipment manufacturer and endorsed by competent certifying body recognised by MOH
B (PTS) [Certificate of Competency Biomedical Engineering Maintenance Level 4 - Laboratory (by Medical Device
Model)]
C (PTS) [Certificate of Competency Biomedical Engineering Maintenance Level 4 - Diagnostics (by Medical Device
Model)]
D (PTS) [Certificate of Competency Biomedical Engineering Maintenance Level 4 - Therapeutic (by Medical Device
Model)]
Table A.7. Diagnostic equipment specialisation classification (sample)
Basic Intermediate High
Description (UMDNS) (UMDNS) Description (UMDNS) (UMDNS) Description (UMDNS) (UMDNS)
Airflow Detectors, Airway Analysers, Point-of-Care - -

Airflow Detectors, Airway 17-764 Analysers, Point-of-Care, Whole
- -
Blood, Cardiac
Analysers, Point-of-Care Analysers - -
Analyser, Point-of-Care, Breath, 17-475 ECG Monitor Analysers 11-379
- -
Alcohol
Balances Analysers, Physiologic - -
Balances, Mechanical 10-264 Analysers, Physiologic, Body 17-417
- -
Composition
Scales, Clinical, Autopsy 13-457 Analysers, Physiologic, 17-441
- -
Erection/Tumescence
Scales, Clinical, Blood Collection 13-459 Analysers, Physiologic, Joint Laxity 17-727 - -
Scales, Clinical, Laboratory 15-175 Analysers, Physiologic, Middle Ear 15-634 - -
Scales, Infant 13-462 Analysers, Physiologic, Middle Ear, 18-784 - -
Acoustic Reflectometry
Scales, Patient, Chair 13-460 Analysers, Physiologic, Middle Ear, 18-783 - -
Impedance Tympanometry
Scales, Patient, Floor 13-461 Analysers, Physiologic, 17-929 - -
Neuromuscular Function, Body
Motion
Calipers Analysers, Physiologic, Peristaltic 18-779 - -
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Motility
Calipers 10-546 Analysers, Physiologic, Peristaltic 18-780 - -
Motility, Colon/Rectum
63
Table A.7. Diagnostic equipment specialisation classification (sample) (continued)
64
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Calipers, Skinfold, Manual 10-547 Analysers, Physiologic, 15-036 - -

Peristaltic Motility,
Gastrointestinal
Dialysis Analysers, Physiologic, - -
Pressure Points
Dialysate Conductivity Meters 11-206 Analysers, Physiologic, 17-698 - -
Pulmonary Function
Endoscopy Analysers, Physiologic, 13-182 - -
Pulmonary Function, Adult
Laryngoscopes 12-293 Analysers, Physiologic, 17-456 - -
Somnography
Laryngoscopes, Rigid 15-076 Analysers, Physiologic, Visual 14-382 - -
Function
Printers, Video 17-508 Analysers, Point-of-Care - -

Eye Equipment Analysers, Point-of-Care, Whole 16-749 - -
Blood, Coagulation
Charts, Eye 11-652 Analysers, Point-of-Care, Whole 23-482 - -
Blood, Multianalyte,
Cardiovascular Marker
Charts, Eye, Visual Acuity 16-800 Audiometers - -
HESS Chart Audiometers 10-228 - -
Magnets, Eye 15-269 Audiometric Booths 10-229 - -
Ophthalmoscopes 12-815 Auditory Function Screening - -
Devices
Ophthalmoscopes, Direct 12-817 Auditory Function Screening 17-601 - -
Devices
Ophthalmoscopes, Indirect 12-818 - -
Projectors, chart eye 16-890 Auditory Function Screening 20-167 - -

Devices, Newborn
Fetal Heart Detectors Biofeedback Systems - -
Fetal Heart Detectors 11-692 Biofeedback Systems 10-396 - -
Fetal Heart Detectors, Phono 11-695 Blood-Flow Detectors, - -
Ultrasonic
Fetal Heart Detectors, Ultrasonic 11-696 Blood-Flow Detectors, Ultrasonic 10-429 - -
Light Sources Carbon Dioxide Monitors - -
Light Sources 12-340 Carbon Dioxide Monitors 17-224 - -
Light Sources, Fiberoptic 12-345 Carbon Dioxide Monitors, 16-938 - -
Exhaled Gas
Light Sources, Fiberoptic, 12-343 Carbon Dioxide Monitors, 16-855 - -
Flexible Endoscopic Laboratory Incubator
Light Sources, Fiberoptic, Rigid 16-831 Cardiac Output Units - -
Endoscopic/Multipurpose
Light Sources, Microscope 16-438 Cardiac Output Units 10-613 - -
Ophthalmoscopes/Otoscopes Cardiographs - -
Ophthalmoscopes/Otoscopes 18-595 Cardiographs 18-328 - -
Recorders Cardiotocographs - -
Recorders, Graphic, Evoked 11-614 Cystometers - -
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Potential
Recorders, Graphic, Evoked 16-303 Cystometers 11-111 - -
Potential, Auditory
Recorders, Graphic, Evoked 18-335 Dermatoscopes - -
Potential, Somatosensory
65
66
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Recorders, Graphic, Evoked 18-334 Dermatoscopes 18-021 - -

Potential, Visual
Recorders, Graphic, Physiologic, 18-342 Digestion Systems - -
Anesthesia
Recorders, Graphic, Trend, Heart 12-387 Digestion Systems, Laboratory, 20-001 - -
Rate Microwave
Recorders, Graphic, Trend, 17-572 ECG Monitors - -
Temperature
Recorders, Tape, Data, Blood 12-386 ECG Monitors 12-599 - -
Pressure
Recorders, Tape, Data, 12-388 ECG Monitors, Arrhythmia 12-601 - -
Electrocardiography
Recorders, Tape, Data, 16-008 ECG Monitors, Telemetric 13-988 - -
Physiologic
Recorders, Tape, Video 13-274 EEG Monitors 12-602 - -
Recorders,Graphic, Trend, Blood 16-271 Electrocardiographs - -
Pressure
Sphygmomanometers Electrocardiographs 11-407 - -
Sphygmomanometers 13-106 Electrocardiographs, Multichannel 11-411 - -
Sphygmomanometers, Aneroid 16-156 Electrocardiographs, 16-231 - -
Multichannel, Interpretative
Sphygmomanometers, Electronic 16-157 Electrocardiographs, 18-329 - -
Multichannel, Non-Interpretative
Sphygmomanometers, Electronic, 16-173 Electrocardiographs, Single- 11-413 - -
Automatic Channel
Sphygmomanometers, Electronic, 16-174 Electroencephalographs - -
Manual
Sphygmomanometers, Mercury 16-158 Electroencephalographs 11-467 - -
Description (UMDNS) (UMDNS) Description (UMDNS) (UMDNS) Description (UMDNS)

(UMDNS)
Thermometers Electromyographs - -
Thermometers, Electronic, Infrared, 17-887 Smoke Evacuation Systems, 16-262 - -
Ear Surgical
Thermometers, Electronic, Infrared, 17-888 EMG Monitors, Telemetric - -
Skin
Transilluminators EMG Monitors, Telemetric 15-720 - -
Transilluminators 14-130 Endoscopy - -
Treadmills Anoscopes 10-156 - -
Treadmills 14-141 Bronchoscopes 10-491 - -
Uroflowmeters Bronchoscopes, Flexible 15-073 - -
Uroflowmeters 14-308 Bronchoscopes, Flexible, Video 17-662 - -
Vacuum Electrode System Bronchoscopes, Rigid 15-074 - -
Vacuum Electrode System Cameras, Endoscopic 15-748 - -
- - Cameras, Video, Endoscope 17-002 - -
- - Choledochoscopes 10-831 - -
- - Colonoscopes 10-950 - -
- - Colonoscopes, Video 17-665 - -
- - Colposcopes 10-960 - -
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- - Cystoscopes, Flexible 17-144 - -
- - Cystoscopes, Rigid 17-145 - -
- - Cystourethroscopes 11-114 - -
67
68
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- - Duodenoscopes 11-359 - -
- - Duodenoscopes, Video 17-654 - -
- - Gastroduodenoscopes 11-853 - -
- - Gastroscopes, Flexible 11-857 - -
- - Gastroscopes, Flexible, Video 17-663 - -
- - Gastroscopes, Rigid 11-858 - -
- - Hysteroscopes 12-081 - -
- - Laparoscopes, Video 18-087 - -
- - Laryngoscopes, Flexible 15-075 - -
- - Laryngoscopes, Rigid, Video 23-532 - -
- - Laryngostroboscope 12-294 - -
- - Nasopharyngoscopes 12-709 - -
- - Nephroscopes 15-591 - -
- - Proctoscopes 13-126 - -
- - Rhinoscopes 13-396 - -
- - Sigmoidoscopes 13-594 - -
- - Sigmoidoscopes, Flexible 15-057 - -
- - Sigmoidoscopes, Flexible, Video 17-664 - -
- - Sigmoidoscopes, Rigid 15-058 - -
- - Ureteroscopes 15-788 - -
- - Video Image Processors 18-037 - -
- - Eye Equipment - -
- - Cameras, Fundus 10-551 - -
- - Corneal Topography Systems 18-038 - -
- - Coronary Optical Coherence - -
Tomography System
- - Eye Movement Monitors 12-609 - -
- - Keratomes 12-222 - -
- - Keratoscopes 16-347 - -
- - Lensometers 12-326 - -
- - Microscopes, Light, Examination, 12-537 - -
Ophthalmology
- - Ophthalmometers 12-811 - -
- - Ophthalmometroscopes 12-813 - -
- - Perimeters, Ophthalmic, Manual 16-919 - -
- - Retinoscopes 13-372 - -
- - Slit Lamps 12-281 - -
- - Synoptophores 17-535 - -
- - Tonometers, Ophthalmic 16-809 - -
15R001R2
- - Flowmeters - -
- - Flowmeters, Pulmonary Function 15-965 - -
- - Laboratary - -
- - Oximeters, in Vitro, Laboratory 16-618 - -
69
70
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- - Microscopes, Light, Operating - -

- - Microscopes, Light, Operating 12-539 - -
- - Oximeters - -
- - Oximeters, Cerebral 17-942 - -
- - Oximeters, Pulse 17-148 - -
- - Patient Monitors - -
- - Apnea Monitors 12-575 - -
- - Blood Gas Monitors, Carbon 12-588 - -
Dioxide
- - Blood Gas Monitors, Oxygen 12-590 - -

- - Monitors, Bedside, Intracranial 16-763 - -
Pressure
- - Monitors, Bedside, Physiologic 24-097 - -
Oximetry Tissue
- - Monitors, Personal 20-183 - -
- - Monitors, Physiologic, Vital Signs 25-209 - -
- - Multiple Medical Gas Monitors 17-443 - -
- - Multiple Medical Gas Monitors, 17-445 - -
Respired/Anesthetic
- - Nerve Function Monitors 17-582 - -
- - Physiologic Monitoring Systems, 12-647 - -
Acute Care

Cardiac Catheterisation
Cardiac Electrophysiology
Neonatal
Stress Exercise
Stress Exercise, Cardiac
Telemetric
- - Physiologic Recording Systems 16-306 - -
- - Respiration Monitors 12-662 - -
- - Simulators - -
- - Simulators 15-059 - -
- - Simulators, Cardiac, 11-381 - -
Electrocardiography
- - Simulators, Invasive Blood 18-106 - -
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Pressure
- - Simulators, Multiparameter 19-030 - -
- - Simulators, Non-invasive Blood 18-107 - -
Pressure
71
- - Simulators, Respiration, Lung 12-408 - -

72
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Table A.7. Diagnostic equipment specialisation classification (sample) (concluded)
- - Simulators, Sthethoscope - -
- - Spirometers - -
- - Spirometers 13-674 - -
- - Spirometers, Diagnostic 13-680 - -
- - Spirometers, Monitoring 13-679 - -
- - Television Systems - -
- - Television Systems, Slow-Scan 16-239 - -

- - Ureterorenoscopes - -
- - Ureterorenoscopes 17-690 - -
- - Urethrotomes - -
- - Urethrotomes 17-633 - -
Table A.8. Therapeutic equipment specialisation classification (sample)
Airway Clearance Units,

Aerosol Generators Cataract Extraction Units
Insufflation/Exsufflation
Airway Clearance Units, Cataract Extraction Units,
Aerosol Generators 10-046 20-459 17-596
Insufflation/Exsufflation Phacoemulsification
Analgesia units Analgesia units Circulatory Assist Units
Circulatory Assist Units,
Analgesia Units 15-014 Analgesia Units, Cryogenic 17-140 10-846
Intra-Aortic Balloon
Circulatory Assist Units,
Analgesia Units, Inhalation 16-953 Anesthesia Units 10-849
Venous Return
Aspirators Anesthesia Units 10-134 Eye Equipment
Aspirators 10-208 Anesthesia Units, Dental 17-842 Lasers, Argon, Ophthalmic 16-945
Aspirators, Dental 10-212 Anesthesimeters Lasers, Diode, Ophthalmic 17-808
Lasers, Excimer,
Aspirators, Emergency 15-016 Anesthesimeters 10-148 17-702
Ophthalmic
Lasers, Nd:YAG,
Aspirators, Infant 10-214 Apheresis Units 16-947
Ophthalmic
Aspirators, Liposuction 17-103 Apheresis Units 16-405 Heart-Lung Bypass Units
Aspirators, Low Volume 10-215 Autotransfusion Units Heart-Lung Bypass Units 11-969
Irrigation/Distention
Aspirators, Surgical 10-217 Autotransfusion Units 10-239
Systems
15R001R2
Autotransfusion Units, Blood Irrigation/Distention
Aspirators, Thoracic 10-218 17-537 17-676
Processing Systems
Irrigation/Distention
Aspirators, ultrasonic 15-756 Baths 17-233
Systems, Arthoscopic
- - Baths, Burn Lasers
73
- - Baths, Whirlpool 14-450 Lasers 12-296

Table A.8. Therapeutic equipment specialisation classification (sample) (continued)
74
15R001R2
Baths Cryosurgical Units Lasers, Argon, Surgical 16-941

Lasers, Carbon Dioxide,
Baths, Portable 13-088 Cryosurgical Units 18-051 18-204
Dental
Baths, Paraffin, Physical Cryosurgical Units, General- Lasers, Carbon Dioxide,
11-067 16-942
Therapy Purpose Surgical/Dermatologic
Baths, Paraffin, Physical
12-956 Defibrillator/ Pacemaker Lasers, Diode 18-220
Therapy
Pacemakers, Breath, Lasers, Diode,
Baths, water 16-060 18-222
Diaphragmatic/Phrenic Nerve Biostimulation
Lasers, Dye, Photodynamic
Bath, Water, Plasma-Thawing 16-795 Pacemakers, Cardiac 12-911 18-207
Therapy
Baths, Water, Molded Plastic Pacemakers, Cardiac, External,
17-526 12-912 Lasers, Ho:YAG, Surgical 17-769
Splint Invasive Electrodes, Transvenous
Pacemakers, Cardiac, External, Lasers, Nd:YAG,

Baths, Water, Shaker 16-772 16-516 18-216
Noninvasive Electrodes Frequency-Doubled
Battery Chargers Defibrillator/Pacemakers, External 17-882 Lasers, Nd:YAG, Surgical 16-943
Battery Chargers 17-115 Defibrillators Lithotripters
Bilirubinometers, Cutaneous Defibrillators 11-132 Lithotripters, Extracorporeal 16-758
Lithotripters, Extracorporeal,
Bilirubinometers, Cutaneous 16-166 Defibrillators, External, Automated 17-116 18-415
Electromechanical
Lithotripters, Extracorporeal,
Cast cutters Defibrillators, External, Manual 11-134 18-417
Spark-Gap
Defibrillators, External, Manual,
Cast cutters 10-655 11-137 Lithotripters, Intracorporeal 18-418
Line-Powered-Only
Defibrillators, External, Lithotripters, Intracorporeal,
Cast Cutter Vacuums 10-656 18-500 16-229
Semiautomated Electrohydraulic
Lithotripters, Intracorporeal,
Cast Cutters, Electric 16-340 Defibrillators, External, Telephonic 17-579 16-230
Impact, Ultrasonic
Microwave Therapy
Compression Units Dental Equipment
Systems
Microwave Therapy Systems,
Compression Units, Intermittent 10-969 Apex Locators, Endodontic 16-355 18-818
Tissue Ablation, Endometrial
Compression Units, Intermittent, Chairs, Examination/Treatment,
17-226 10-792 Surgical Instruments
Cryotherapy Dentistry
Dental Equipment Dental Delivery Units 11-165 Lavage Units, Surgical 12-306
Acrylic Curing Units, Dental 16-353 Dental Engines 11-156 Thyroid Uptake Systems
Amalgamators 10-082 Dental Hand Instruments 11-160 Thyroid Uptake Systems 16-567
Carriers, Dental, Cement/Paste, Dental Hand Instruments, Eye Equipment
21-400 16-662
Root Canal, Powered Endodontic
Dental Hand Instruments, Microscopes, Scanning 17-923
Carvers, Dental 21-012 16-666
Surgical Laser, Optical
Casting Furnaces, Dental 17-796 Handpieces, Dental 11-161 Stereotactic Systems
Stereotactic Systems, 18-177
Casting Units, Dental 10-662 Implant Unit,Dental
Neurosurgical
Stereotactic Systems, 18-181
Compressors, Medical-Air 10-972 Dialysis
Orthopedic, Surgery
Dental Handpiece Maintenance Stereotactic Systems, 20-387
Dialyser Reprocessing Units 16-018
Unit Otorhinolaryngology
Hemodialysis Unit Conductivity Stereotactic Systems, 18-053
Fume Evacuators, Dental 11-814 11-222
15R001R2
Monitors Radiosurgical
Micromotor, Dental Hemodialysis Units 11-218 - -
Modular Medical Facilities,
17-955 Hemofiltration Units 15-039 - -
Mobile, Dental
Perimeters 12-993 Peritoneal Dialysis Units 11-226 - -
75
Water Purification Systems,

Polishing Unit, Dental 14-437 - -
Reverse Osmosis
76
15R001R2

Polymer Applicator, Dental 99-903 Reverse Osmosis, Hemodialysis, 20-683 - -
Portable
Presses, Flask, Dental 99-901 Dialators - -
Sandblaster, Dental 99-900 Dilators, Esophageal 11-257 - -
Scalers, Dental, Ultrasonic 17-497 Dilators, Tracheal 11-263 - -
Testers, Pulp 13-187 Drills - -
Trimmers, Model, Dental 20-000 Drills 11-329 - -
Vacuum-Mixing Devices, Dental 16-365 Drills, Biopsy 11-330 - -
Welding Units, Orthodontic 17-465 Drills, Bone 11-331 - -
Dialysis Drills, Fingernail 11-337 - -
Baths, Dialysate Warming 15-825 Drills, Middle Ear Surgery 11-339 - -
Dynamometers Drivers - -
Dynamometers 15-577 Drivers 16-868 - -
ENT Equipment Drivers, Bone Staple 10-458 - -
Trainers, Auditory 14-113 Drivers, syringe 18-092 - -
Ergometres Dynamometer - -
Dynamometer Exercise Systems,
Ergometers 11-592 17-681 - -
Computerised
Ergometers, Bicycle 10-383 Ear, Irrigator - -
Exercisers, continuous
Ear, Irrigator - -
passive motion
Exercisers, Continuous Passive
11-631 Electrosurgical Units - -
Motion
Exercisers, Continuous Passive

17-138 Electrocautery Units 11-418 - -
Motion, Lower Limb
Electrocautery Units, Line-
Eye Equipment 11-422 - -
Powered
Chairs, Examination/Treatment,
15-723 Electrosurgical Units 11-490 - -
Ophthalmology
Pressure Reducers, Intraocular 15-048 Electrosurgical Units, Bipolar 18-230 - -
Flowmeters Electrosurgical Units, Monopolar 18-229 - -
Electrosurgical Units, Monopolar,
Flowmeters 11-746 17-739 - -
Argon-Enhanced Coagulation
Electrosurgical Units,
Flowmeters, Gas 11-748 18-231 - -
Monopolar/Bipolar
Electrosurgical Units,
Heating Units Monopolar/Bipolar, Argon- 18-232 - -
Enhanced Coagulation
Heating Blocks 15-105 Endoscopy - -
Heating Pads 11-985 Arthroscopes 10-198 - -
Heating Units 17-849 Arthroscopic Shaver Systems 17-918 - -
Endoscopes, Gastrointestinal
Heating Units, Hot-Pack 16-509 Tract, Upper Tract, Double 23-999 - -
15R001R2
Balloon
Heating Units, Thermal Probe 17-181 Esophagoscopes 11-603 - -
Heating Units, Wax Scalding
Morcellators, Endoscopic 19-322 - -
Unit
77
78
15R001R2
Moist Heat Therapy Pack

12-565 Washers, Flexible Endoscope 15-999 - -
Conditioners
Infusion Devices ENT Equipment - -
Ear/Nose/Throat Treatment
Intraosseous Infusion Kits 18-009 11-585 - -
Units
Pressure Infusors 13-100 Exercisers, Breathing - -
Exercisers, Breathing,
Pumps, Enteral Feeding 13-209 11-634 - -
Spirometry
Pumps, Extracorporeal
13-203 Eye Equipment - -
Perfusion
Injectors, Medication/Vaccine Cryosurgical Units, Ophthalmic 11-068 - -
Examination/Treatment Stands,
Injectors, Medication/Vaccine 12-504 18-014 - -

Ophthalmic
Injectors, Medication/Vaccine,
18-069 Exophthalmometers 16-345 - -
Needleless
Lights Flowmeters - -
Headlights 11-963 Flowmeters, Blood 10-430 - -
Lights, Dental Flowmeters, Blood, Ultrasonic 10-432 - -
Lights, Dental 12-351 Flowmeters, Intravenous 12-171 - -
Lights, Dental, Intraoral 12-352 Hand Drills, Surgical - -
- - Hand Drills, Surgical 17-954 - -
- - Handpieces - -
- - Handpieces 17-953 - -
Lights, Infrared Handpieces, Surgical 17-949 - -

Lights, Infrared 12-278 Hearing Aids - -
Lights, Surgical Hearing Aids 11-967 - -
Lights, Surgical 12-282 Humidifiers - -
Lights, Ultraviolet Humidifiers 12-047 - -
Lights, Ultraviolet 12-283 Humidifiers, Heated 12-050 - -
Lights, Ultraviolet, Germicidal 12-284 Incubators, Infant - -
Massage Machines, Physical - -
Incubators, Infant 12-113
Therapy
Massage Machines, Physical - -
15-662 Incubators, Infant, Mobile 17-432
Therapy
Mattress Systems Incubators, Infant, Transport 12-114 - -
Mattress Systems, Low-Air-Loss 17-757 Infusion Devices - -
Mattress Systems, Alternating- - -
18-147 Infusion Pumps 16-495
Pressure
Infusion Pumps, General- - -
Nebulisers 13-215
Purpose
Nebulisers 12-712 Infusion Pumps, Micro 16-722 - -
Infusion Pumps, Patient- - -
Nebulisers, Heated 12-716 16-924
Controlled Analgesic
15R001R2
Nebulisers, Nonheated 15-045 Infusion Pumps, Syringe 13-217 - -
Infusion/Monitoring Line - -
Nebulisers, Ultrasonic 12-719 17-793
Organiser System
Photometers Injectors, Medication/Vaccine - -
79
Photometers 15-165 Injectors, Pigmentation 17-660 - -

80
15R001R2
Phototherapy Units Instruments, Surgical - -

Phototherapy Units 13-037 Instruments, Surgical 90-000 - -
Phototherapy Units, Ultraviolet 15-731 Insufflators - -
Phototherapy Units, Visible
17-515 Insufflators 12-144 - -
Light, Hyperbilirubinemia
Pumps, Alternating-Pressure
Insufflators, Laparoscopic 16-849 - -
Pad
Pumps, Alternating-Pressure Microwave Therapy Systems,
16-076 - -
Pad Diathermy
Microwave Therapy Systems,
Pumps, Breast 11-245 - -
Diathermy
Pumps, Breast 10-485 Oxygen Concentrators - -
Resuscitators Oxygen Concentrators 12-873 - -

Resuscitators 13-360 Pressure Measuring Units - -
Pressure Measuring Units,
Resuscitators, Pulmonary 17-196 - -
Compartmental
Resuscitators, Pulmonary, Pressure Measuring Units,
17-141 13-108 - -
Exhaled Air Esophageal
Resuscitators, Pulmonary, Radiofrequency Therapy
13-367 - -
Manual Systems
Resuscitators, Pulmonary, Radiofrequency Therapy Systems,
17-591 11-246 - -
Manual, Reusable Diathermy
Resuscitators, Pulmonary, Radiofrequency Therapy Systems,
13-366 15-874 - -
Pneumatic Tissue Ablation, Opthalmic
Saws Stimulators, Electrical, Brain - -

Saws, Autopsy 15-174 Stimulators, Electrical, Brain 18-467 - -
Stimulators, Electrical, Brain,
Saws, Bone 13-449 11-484 - -
Convulsive Therapy
Stimulators, Electrical, Carotid
Saws, Bone, Electrical 13-450 - -
Sinus Nerve, Blood Pressure
Stimulators, Electrical, Carotid
Saws, Bone, Pneumatic 13-452 13-768 - -
Sinus Nerve, Blood Pressure
Stimulators, Electrical,
Stimulator Analysers - -
Neuromuscular
Stimulator Analysers, Stimulators, Electrical,
15-631 13-775 - -
Transcutaneous Nerve Neuromuscular
Stimulators, Electrical,
Stimulators, Caloric 16-263 - -
Neuromuscular, Diagnostic
Stimulators, Caloric, Physical Stimulators, Electrical,
16-982 17-240 - -
Therapy, Fluidised Medium Neuromuscular, Scoliosis
Stimulators, Caloric, Vestibular Stimulators, Electrical,
10-548 - -
Function Peripheral Nerve
Stimulators, Electrical, Peripheral
Tables/ Beds 13-763 - -
Nerve, Acupuncture
15R001R2
Tables, Operating 13-961 Nerve, Analgesic, 13-782 - -
Transcutaneous
- - 16-252 - -
Nerve, Block Monitoring
81
82
15R001R2
Tourniquets Stimulators, Electrical, Soft Tissue - -

Tourniquets 14-072 Stimulators, Electrical, Soft Tissue 11-503 - -
Tourniquets, Pneumatic 14-074 Surgical Instruments - -
Tourniquets, Pneumatic,
10-234 Microsurgical Instruments 15-621 - -
Automatic Rotating
Ultrasonic Surgical Aspiration
Traction Units - -
System
Ultrasonic Surgical Aspiration
Traction Units 14-105 - -
System
Traction Units, Intermittent 14-106 Ultrasound Surgical Units - -
Traction Units, Static, Bed 14-110 Ultrasound Surgical Units 18-049 - -
Training Aids Ultrasound Therapy Systems - -

Training Aids 16-294 Ultrasound Therapy Systems 18-823 - -
Ultrasound Therapy Systems,
Training Manikins 11-248 - -
Physical Therapy
Ultrasound Therapy/Neuromuscular
Training Manikins,
15-309 Stimulation Systems, Physical 17-908 - -
Cardiopulmonary Resuscitation
Therapy
Ultrasound Cleaning Systems Vaporisers - -
Ultrasound Cleaning Systems 14-263 Anesthesia Unit Vaporisers 10-144 - -
Vacuum Extractors Ventilators - -
Continuous Positive Airway Pressure
Vacuum Extractors, Obstetrical 14-317 11-001 - -
Units
- - Ventilators 15-613 - -
Table A.8. Therapeutic equipment specialisation classification (sample) (concluded)
Vibrators Ventilators, Anesthesia 10-145 - -

Vibrators 14-369 Ventilators, Intensive Care 17-429 - -
Warming Units Ventilators, Intensive Care, Adult 18-792 - -
Ventilators, Intensive Care,
Warming Units 15-610 15-783 - -
Adult, High-Frequency
Warming Units, Blanket 10-414 14-361 - -
Neonatal/Pediatric
Warming Units, Blood/Solution 10-447 Neonatal/Pediatric, High- 18-793 - -
Frequency
Warming Units, Contrast Media 18-848 Ventilators, Portable/Home Care 17-423 - -
Warming Units, Microscope Slide 16-292 Ventilators, Transport 18-098 - -
Warming Units, Patient Vitrectomy Units - -
Warming Units, Patient 17-570 Vitrectomy Units 14-386 - -
Warming Units, Patient, Circulating- Warming/Cooling Units,
17-648 - -
Fluid Patient
Warming Units, Patient, Forced-Air 17-950 Warming/Cooling Units, Patient 12-068 - -
Warming Units, Patient, Radiant 13-248 - - - -
Warming Units, Patient, Radiant, Adult 13-249 - - - -
15R001R2
Warming Units, Patient, Radiant,
17-956 - - - -
Infant
Warming Units, Patient, Radiant,
17-433 - - - -
Infant, Mobile
Washers - - - -
83
Washers, Cell 15-114 - - - -

Table A.9. Laboratory equipment specialisation classification (sample)
84
15R001R2
Description (UMDNS) Description (UMDNS) (UMDNS) Description (UMDNS) (UMDNS)

(UMDNS)
Air Samplers Analysers, Laboratory Analysers, Laboratory

Analysers, Laboratory,
Air Samplers 10-051 Analyser, Laboratory, Dietry Fibre 15-301
Radioimmunoassay
Automated Synthesis
Balances Analysers, Environmental/Gas Systems 18-959
Module, FDG Tracer
Analysers, Laboratory, Biomolecular Automated Synthesis Module,
Balances 10-261
Interactions, Food Products FDG Tracer
Baths, Water Analysers, Laboratory, Blood Gas/pH 15-709 Chambers
Analysers, Laboratory, Blood
Baths 15-555 18-618 Chambers, In-Vitro Fertilisation
Gas/pH/Electrolyte
Analysers, Laboratory, Blood, Glycated
Baths, Water 15-108 17-109 DNA Sequencing Systems
Hemoglobin
Baths, Water, Analysers, Laboratory, Blood, Urea

16-861 15-092 DNA Sequencing Systems 18-236
Laboratory Nitrogen
Water Bath Immunology, Tissue Typing
14-429 Analysers, Laboratory, Body Fluids 18-613
Circulators (HLA) Automated
Analysers, Laboratory, Body Fluids, Immunology, Tissue Typing
Bilirubinometers 16-940
Calcium (HLA) Automated
Analysers, Laboratory, Body Fluids, Samplers, Laboratory,
Bilirubinometers 15-109 15-118
Chloride Automated
Analysers, Laboratory, Body Fluids, Samplers, Laboratory,
Bone Mills 17-182 20-536
Creatinine Automated
Analysers, Laboratory, Body Fluids,
Bone Mills 18-129 15-100 Synthesisers, DNA/RNA
Electrolyte
Bunsen Burners 16-819 Synthesisers, DNA/RNA 18-062
Electrolyte, Coulometric
Bunsen Burners 17-691 16-530 - -
Electrolyte, Flame Photometer
Table A.9. Laboratory equipment specialisation classification (sample) (continued)

Calibrators 16-818 - -
Electrolyte, Ion-Selective
Calibrators 15-563 15-101 - -
Enzyme
Centrifuges 15-102 - -
Glucose
Analysers, Laboratory, Breath, Carbon
Centrifuges 10-778 10-588 - -
Dioxide
Centrifuges, Floor 15-116 Analysers, Laboratory, Breath, Oxygen 15-015 - -
Analysers, Laboratory, Clinical
Centrifuges, Tabletop 10-780 15-551 - -
Chemistry
Centrifuges, Tabletop, High- Analysers, Laboratory, Clinical
10-779 16-298 - -
Speed, Microhematocrit Chemistry, Automated
Centrifuges, Tabletop, High- Analysers, Laboratory, Clinical
17-452 16-301 - -
Speed, Micro-Sample Chemistry, Automated, Continuous-Flow
Chambers, Anaerobic 16-299 - -
Chemistry, Automated, Discrete
Chambers, Anaerobic 16-335 16-302 - -
Chemistry, Manual
Concentrators, Specimen Analysers, Laboratory, Hematology 17-740 - -
Analysers, Laboratory, Hematology,
15R001R2
Concentrators, Specimen 16-456 16-014 - -
Blood Grouping
Diluters 16-817 - -
Blood Grouping, Automated
Analysers, Laboratory, Hematology, Cell
Diluters 15-133 18-620 - -
Counting
85

Diluters, Blood Cell 16-404 17-741 - -
Counting, Automated
86
15R001R2

Dispensers 11-996 - -
Counting, Manual
Dispensers 11-283 17-742 - -
Counting, Semiautomated
Dispensers, Fluid 11-285 15-552 - -
Coagulation
Dispensers, Liquid, Analysers, Laboratory, Hematology,
16-274 15-098 - -
Laboratory Coagulation, Automated
Dispensers, Paraffin 15-134 17-483 - -
Erythrocyte Aggregation
Dryers, Slide 15-146 - -
Hemoglobin
Dryers, Slide 17-134 15-104 - -
Platelet Aggregation
Analysers, Laboratory, Immunoassay,
Evaporators 17-916 - -
Chemiluminescent
Evaporators 15-139 16-218 - -
Fluorimetric
Fluorometers 18-626 - -
Photometric
Fluorometers 15-141 16-217 - -
Photometric, Enzyme (EIA)
Hot Plates 16-979 - -
Photometric, Microplate Reading
Hot Plates 16-287 19-939 - -
Rapid Test, Cardiac Marker
Hygrometers Analysers, Laboratory, Melting Point - -
Hygrometers 12-059 Analysers, Laboratory, Microbiology 16-608 - -
Description (UMDNS) (UMDNS) Description (UMDNS) (UMDNS) Description (UMDNS)

(UMDNS)
Analysers, Laboratory, Microbiology,
Incubators, Laboratory 15-973 - -
Blood Culture, Automated
Incubators, Laboratory, Analysers, Laboratory, Microbiology,
23-431 18-630 - -
Shaker/Rotator, Platelet Blood Culture, Mycobacteria
Analysers, Laboratory, Microbiology,
Incubators, Test Tube 15-327 15-306 - -
Susceptibility, Automated
Incubators, Test Tube, Analysers, Laboratory, Microbiology,
15-272 16-813 - -
Portable Urine Bacteriuria
Analysers, Laboratory, Molecular
Mixers 20-668 - -
Diagnostic
Mixers 15-590 Analysers, Laboratory, Semen 16-984 - -
Mixers, Blood Bank, Donor Analysers, Laboratory, Trace Level
15-305 - -
Blood Mercury
Analysers, Laboratory, Urine,
Mixers, Blood Tube 16-384 16-378 - -
Automated
Analysers, Laboratory, Urine,
Mixers, Clinical Laboratory 15-161 16-887 - -
Semiautomated
pH Meters Balances, Electronic - -
pH Meters 15-164 Balances, Electronic 10-263 - -
pH Monitors Balances, Electronic, Analytical 18-449 - -
pH Monitors 12-634 Balances, Electronic, Precision 18-450 - -
15R001R2
Pipetters Baths, Water - -
Pipetters 15-663 Baths, Freezing 15-106 - -
Pumps, Laboratory Baths, Tissue Flotation 15-107 - -
Pumps, Laboratory 15-168 Blood Cell Processors - -
87
Rotators Blood Cell Processors 16-857 - -

Rotators 15-173 Calibrators - -
88
15R001R2
Sedimentation Rate Units Calibrators, Mass Spectrometer 16-930 - -

Sedimentation Rate Units 15-177 Cell Disrupters - -
Separators Cell Disrupters, Ultrasonic 17-123 - -
Separators 13-540 Centrifuges - -
Centrifuges, Floor, Low-Speed,
Separators, Plasma 16-901 15-115 - -
Nonrefrigerated, Blood Bank
Centrifuges, Floor, Low-Speed,
Shakers 15-117 - -
Refrigerated
Centrifuges, Tabletop, Low-
Shakers 15-598 Speed, Nonrefrigerated, Cell 16-815 - -
Washing
Shakers, Laboratory 15-178 Speed, Nonrefrigerated, 16-765 - -

Cytological
Slide Stainers 18-265 - -
Speed, Refrigerated
Slide Stainers 15-599 Chambers - -
Slide Stainers, Histology 15-183 Chambers, Electrophoresis 18-548 - -
Stirrers Chromatography Systems - -
Hot Plate/Stirrers 23-462 Chromatography Systems, Gas 15-120 - -
Chromatography Systems,
Stirrers 15-651 18-274 - -
Liquid
Strippers, Donor Tube Liquid, Packed Column, High- 15-121 - -
Pressure
Strippers, Donor Tube 13-825 Liquid, Packed Column, High- 18-278 - -
Pressure, Bonded-Phase
Containers, Cryobiological
Timers, Other 15-312 16-534 - -
Storage
Slide Stainers 15-599 Chambers - -
View Boxes Chambers, Electrophoresis 18-548 - -
View Boxes, Microtiter 17-208 Counters - -
View Boxes, Ultraviolet 16-281 Counters, Colony 15-126 - -
Water Purification Systems Culture Media Preparators - -
Water Purification Systems 15-612 Culture Media Preparators 17-829 - -
14-435 Cytometers - -
Deionisation
14-438 Cytometers, Automated 16-582 - -
Ultraviolet
- - Cytometers, Automated, Flow 16-867 - -
Cytometers, Automated, Flow,
- - 16-503 - -
Sorting
- - Cytometers, Manual 15-112 - -
- - Cytometers, Manual, Differential 15-132 - -
- - Densitometers, Laboratory - -
Densitometers, Laboratory,
- - 15-310 - -
Liquid, Urine
15R001R2
Densitometers, Laboratory,
- - 16-905 - -
Scanning Light
- - Dermatomes - -
- - Dermatomes 11-179 - -
- - Electrophoresis Systems - -
89
- - Electrophoresis Systems 15-138 - -

90
15R001R2
Electrophoresis Systems,
- - 18-547 - -
Capillary
- - Extractor System, Solid Phase - -
- - Extractor System, Solid Phase 15-580 - -
- - Extractors - -
- - Extractors, Plasma 15-167 - -
- - Homogenisers - -
- - Homogenisers 17-124 - -
- - Homogensers, Tissue 15-304 - -
- - Homogenisers, Ultrasonic 17-125 - -
- - Incinerators - -
- - Incinerators, Pathology 16-320 - -
- - Incubators - -
- - Incubators, Aerobic 15-151 - -
- - Incubators, Anaerobic 15-152 - -
Incubators, Laboratory,
- - 18-013 - -
Thermocycling
- - Iontophoresis Units - -
- - Iontophoresis Units 12-185 - -
- - Iontophoresis Units, Sweat Test 15-128 - -
- - Laboratory Equipment - -
Laboratory Cutting Mill,
- - - -
Computer-Optimized
- - Laboratory, Manifolds 15-587 - -
- - Microscope - -
- - Cameras, Video, Microscope 15-815 - -
- - Microscopes 12-536 - -
- - Microscopes, Light - -
- - Microscopes, Light, Laboratory 15-156 - -
Microscopes, Light, Laboratory,
- - 18-284 - -
Brightfield
- - 16-439 - -
Fluorescence
- - 17-440 - -
Inverted Stage
- - 16-288 - -
Phase Contrast
- - 17-439 - -
Stereo
- - Microtomes - -
- - Microtomes 15-589 - -
- - Microtomes, Cryostat 15-157 - -
- - Microtomes, Rotary 15-158 - -
- - Nephelometers - -
15R001R2
- - Nephelometers 15-163 - -
- - Osmometers - -
- - Osmometers 12-842 - -
91
92
15R001R2
- - Photometers, Filter - -
- - Photometers, Filter, Automated 18-257 - -
- - Photometers, Filter, Manual 18-258 - -
- - Photometers, Filter, Reflectance 16-531 - -
- - Refractometers - -
- - Refractometers 15-169 - -
- - Refractometers, Laboratory 18-633 - -
- - Sharpeners - -
- - Sharpeners, Knife 13-551 - -
- - Sharpeners, Microtome Knife 15-179 - -
- - Spectrofluorometers - -
- - Spectrofluorometers 15-080 - -
- - Spectrometers - -
- - Spectrometers, Mass 15-062 - -
- - Spectrometers, Mass, Laboratory 17-199 - -
Spectrometers, Mass,
- - Respiratory/Anesthetic Gas 17-416 - -
Monitoring
- - Spectrophotometers - -
- - Spectrophotometers 15-601 - -
Spectrophotometers, Atomic
- - 15-079 - -
Absorption
- - Spectrophotometers, Infrared 15-081 - -
Table A.9. Laboratory equipment specialisation classification (sample) (concluded)

- - Spectrophotometers, Ultraviolet 15-082 - -
Spectrophotometers,
- - 15-083 - -
Ultraviolet/Visible
- - Spectrum Analysers - -
- - Spectrum Analysers 16-770 - -
- - Spectrum Analysers, Doppler 16-015 - -
Sterilising units (For the
- - purpose of medical device 13-737 - -
sterilisation)
- - Tissue Embedding Equipment - -
- - Tissue Embedding Equipment 15-189 - -
- - Tissue Processors - -
- - Tissue Processors 15-190 - -
Tissue Reconstructive Materials,
- - 17-876 - -
Fluid
- - Titrators - -
- - Titrators 15-191 - -
Urodynamic Measurement
- - - -
Systems
15R001R2
Urodynamic Measurement
- - 14-307 - -
Systems
- - Automatic, Cover Slippers - -
- - Automatic, Cover Slippers 17-409 - -
93
94
15R001R2
Table A.10. Radiology and imaging equipment specialisation classification (sample)
Cameras Analysers Calibrators

Cameras, Identification 10-552 Densitometers, X-Ray Film 16-548 Calibrators, Radioisotope 13-275
Calibrators,
Chromoradiometers Biopsy Guns 18-971
Radiopharmaceutical
Chromoradiometers 10-832 Biopsy Guns 17-848 Cameras, Gamma
Film Processor Brachytherapy Systems Cameras, Gamma 15-944
Reader/Digitisers, Image Plate, Brachytherapy Systems, Remote
20-794 17-517 Cobalt Therapy
Radiography Afterloading
X-ray Film Labelers 14-477 Cameras Radiotherapy Units, Cobalt 16-972
X-ray Film Manual Processing
15-945 Cameras, Multi-Image 15-823 Computed Tomography
Equipment
X-ray Film Processors, Scanning Systems,
15-939 Cameras, Video 17-001 13-469

Automatic, Dental Computed Tomography
Computerised Cutters,
X-ray Film Processors,
15-949 Capillaroscopes, Video Radiotherapy Shielding
Automatic, Sheet-Film
Blocks
Computerised Cutters,
Positioning Aids Capillaroscopes, Video Radiotherapy Shielding
Blocks
Computers, Radiotherapy
Positioning Aids 16-223 Densitometers, Bone
Planning System
Positioning Aids, Computers, Radiotherapy
13-260 Densitometers, Bone 17-152 13-281
Radiographic/Radiotherapeutic Planning System
Computers, Radiotherapy
- - Dental Equipment
Record/Verify
Cameras, Video, Dental, Computers, Radiotherapy
- - 17-532
Intraoral/Extraoral Record/Verify
Table A.10. Radiology and imaging equipment specialisation classification (sample) (continued)

- - Film Digitisers Cyclotrons

- - Film Digitisers 16-910 Cyclotrons 15-818
- - Film Processor Fluoroscopic Systems
Image Digitisation Systems, Radiographic/Fluoroscopic Systems,
- - 17-904 16-597
Computed Radiography Angiographic/Interventional
Radiographic/Fluoroscopic Systems,
- - Laser Imagers 17-679 16-885
General-Purpose
X-ray Film Handling Equipment, Radiographic/Fluoroscopic Systems,
- - 16-246 16-212
Automatic, Daylight Urologic
- - 15-938 Radiographic/Fluoroscopic Units 15-952
Automatic
X-ray Film Processors, Radiographic/Fluoroscopic Units,
- - 15-948 11-758
Automatic, Cine Mobile
- - 17-963 Linear Accelerators
Automatic, Floor
- - 15-950 Linear Accelerators 12-364
Automatic, Tabletop
- - Radiographic Systems Magnetic Resonance Imaging
Scanning Systems, Magnetic
- - Radiographic Systems, Film 17-174 16-260
Resonance Imaging
Scanning Systems, Magnetic
- - Injectors, Contrast Media 18-108
Resonance Imaging, Full-Body
- - Injectors, Contrast Media 17-968 Mammographic
15R001R2
Injectors, Contrast Media,
- - 15-284 Radiographic Units, Mammographic 12-425
Angiography
Injectors, Contrast Media,
- - 17-969 Positron Emission Tomography
Computed Tomography
Scanning Systems, Computed
95
- - - - Tomography/Positron Emission 20-161

Tomography
96
15R001R2
Table A.10. Radiology and imaging equipment specialisation classification (sample) (concluded)
Scanning Systems, Positron

- - Printers 16-375
Emission Tomography
- - Printers, Dry-Processing 18-859 Radiographic Unit
- - Radiographic Units Radiographic Systems 18-429
Radiographic/Tomographic
- - Radiographic Units 13-267 16-884
Systems, Linear
- - Radiographic Units, Chest 10-822 - -
- - Radiographic Units, Dental 13-269 - -
- - Radiographic Units, Dental Extraoral 18-427 - -
- - Radiographic Units, Dental Intraoral 18-426 - -
- - Radiographic Units, Mobile 13-272 - -
- - Scanning Systems, Ultrasonic - -
- - Scanning Systems, Ultrasonic 14-278 - -

Scanning Systems, Ultrasonic,
- - 16-241 - -
Abdominal
- - 17-422 - -
Cardiac
- - 20-378 - -
Endoscopic
- - 15-976 - -
General-Purpose
- - 15-657 - -
Obstetric/Gynecologic
- - 11-389 - -
Ophthalmic
15R001R2
Annex B
(informative)
Examples of active medical device tags
Figure B.1. Asset label number
Figure B.2. Maintenance status

15R001R2
Figure B.3. Equipment under warranty
Proposed for Decommissioning

/Disposal
Proposal Reference No
Submission Date
Decommissioning Cert. No
Figure B.4. Equipment proposed for disposal/exemption

15R001R2
DANGER !
EQUIPMENT IS OUT
OF ORDER
Figure B.5. Danger tag
EQUIPMENT
UNDER
OBSERVATION
DO NOT USE ON
PATIENT
From: …….(date, time)
To: ………. (date, time)
Figure B.6. Equipment under observation

15R001R2
Figure B.7. Electrical safety test status
Figure B.8. Calibration status

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Annex C
(informative)
Maintenance consumables and user related consumables
Table C.1. Example of maintenance consumables and user related consumables
Maintenance
User related
Item/ Component considered related
consumables
consumables
Light bulbs, fuses ✓ -
All type of batteries ✓ -
Suction bottles ✓ -
Probes, cables, lead wires for

✓ -
electrodes (except single-use)
Vacuum tubes ✓ -
Filters ✓ -
Reusable electrodes ✓ -
Toner, printer cartridges - ✓
X-ray film, digitising cassette - ✓
Single-use item such as

electrodes, probes, cables and - ✓
lead wires
Patient tubes and circuits - ✓
Calibration gases, QC control

solution, reagent, cleaning - ✓
solution
Single-use item - ✓

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Annex D
(informative)
PPM checklist based on manufacturer’s service manual
Figure D.1. Example of PPM checklist based on manufacturer’s service manual

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(continued)

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(continued)
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(continued)

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(continued)
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(concluded)
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Annex E
(informative)
Routine Inspection (RI) checklist
Figure E.1. Example of RI checklist

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Annex F
(informative)
Work order form
Figure F.1. Example of work order form

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Annex G
(informative)
Example of Electrical Safety Test (EST) printed report

Table G.1. Example of electrical safety test (EST) printed report
IEC60601 - CLASS2 (Defibrillator)

Equipment Information.
EST Model : vPadES Rugged Control Number: ABCD0123
Cal.Due Date:18.06.2017 Description: Defibrillator
File: ABCD0123_201702XX_133550_P.txt Manufacturer: Welchallyn
Date: 2017 Feb XX Model: PIC 40
Time: 13:35:50 Serial Number: ABCD1234
vPad ID: VPR15020002 Location: SISB
Facility: BEMS
Technician ID: Mr MEAM

Signature:_______________Date:_______________ Tech Time (hrs): 0.5
Overall Result: PASS
MultiSequence Title: IEC60601, Class II, 3xCF 1xB (1-6)xBF

MultiSequence Run Time: 13 minutes ________________________________________________
________________________________________________ TEST STEP #2
TEST STEP #1
Elec. Safety Standard: IEC60601
Elec. Safety Standard: IEC60601 Lead Leakage Limits (B): Maximum 100 μA NC; 500 μA SFC
Chassis Leakage Limits: Maximum 100 μA NC; 500 μA SFC EUT power switch "ON".
Ground Leakage Limits: Maximum 5000 μA NC;10000 μA
SFC Lead-Ld RL/AP4 (POL-R;NEU-O;GND-N): 0.5 μA - PASS
Lead Leakage Limit (CF): Maximum 10 μA NC; 50 μA SFC Lead-Ld RL/AP4 (POL-R;NEU-N;GND-O): 2.0 μA - PASS
Lead-Ld RL/AP4 (POL-R;NEU-N;GND-N): 0.5 μA - PASS
Line Voltage L1-L2: 249.2 V Lead-Ld RL/AP4 (POL-N;NEU-O;GND-N):0.5 μA - PASS
Line Voltage L1-GND: 249.1 V Lead-Ld RL/AP4 (POL-N;NEU-N;GND-O): 2.0 μA - PASS
Line Voltage L2-GND: 3.7 V Lead-Ld RL/AP4 (POL-N;NEU-N;GND-N): 0.5 μA - PASS
________________________________________________
EUT power switch "ON". TEST STEP #3...
Chassis Leakage (POL-R;NEU-O;GND-N): 1.5 μA - PASS
Lead-Ld LA/AP1 (POL-R;NEU-O;GND-N): 0.5 μA - PASS Elec. Safety Standard: IEC60601
Lead-Ld RA/AP2 (POL-R;NEU-O;GND-N): 0.5 μA - PASS Lead Leakage Limit (BF): Maximum 100 μA NC; 500 μA
Lead-Ld LL/AP3 (POL-R;NEU-O;GND-N): 0.5 μA - PASS SFC; 5000 μA MAP
Chassis Leakage (POL-R;NEU-N;GND-O): 56.0 μA - PASS EUT power switch "ON".
Lead-Ld LA/AP1 (POL-R;NEU-N;GND-O): 0.5 μA - PASS
Lead-Ld RA/AP2 (POL-R;NEU-N;GND-O): 0.5 μA - PASS Lead-Ld V1-V6 (POL-R;NEU-O;GND-N): 0.5 μA - PASS
Lead-Ld LL/AP3 (POL-R;NEU-N;GND-O): 0.5 μA - PASS Lead-Ld V1-V6 (POL-R;NEU-N;GND-O): 0.5 μA - PASS
Chassis Leakage (POL-R;NEU-N;GND-N): 1.2 μA - PASS Lead-Ld V1-V6 (POL-R;NEU-N;GND-N): 0.4 μA - PASS
Lead-Ld LA/AP1 (POL-R;NEU-N;GND-N): 0.4 μA - PASS Iso Test V1-V6 (POL-R;NEU-N;GND-N): 17.0 μA - PASS
Lead-Ld RA/AP2 (POL-R;NEU-N;GND-N): 0.4 μA - PASS Lead-Ld V1-V6 (POL-N;NEU-O;GND-N): 0.5 μA - PASS
Lead-Ld LL/AP3 (POL-R;NEU-N;GND-N): 0.4 μA - PASS Lead-Ld V1-V6 (POL-N;NEU-N;GND-O): 0.4 μA - PASS
Iso Test LA/AP1 (POL-R;NEU-N;GND-N): 17.5 μA - PASS Lead-Ld V1-V6 (POL-N;NEU-N;GND-N): 0.4 μA - PASS
Iso Test RA/AP2 (POL-R;NEU-N;GND-N): 17.5 μA - PASS Iso Test V1-V6 (POL-N;NEU-N;GND-N): 16.9 μA - PASS
Iso Test LL/AP3 (POL-R;NEU-N;GND-N): 17.5 μA - PASS ________________________________________________
Chassis Leakage (POL-N;NEU-O;GND-N): 1.5 μA - PASS
Lead-Ld LA/AP1 (POL-N;NEU-O;GND-N): 0.5 μA - PASS Comment: Spo2 sensor casing crack, recommend to
Lead-Ld RA/AP2 (POL-N;NEU-O;GND-N): 0.5 μA - PASS replace.
Lead-Ld LL/AP3 (POL-N;NEU-O;GND-N): 0.5 μA - PASS
Chassis Leakage (POL-N;NEU-N;GND-O): 52.0 μA - PASS END OF RECORD
Lead-Ld LA/AP1 (POL-N;NEU-N;GND-O): 0.5 μA - PASS
Lead-Ld RA/AP2 (POL-N;NEU-N;GND-O): 0.5 μA - PASS
Lead-Ld LL/AP3 (POL-N;NEU-N;GND-O): 0.5 μA - PASS

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Table G.1. Example of electrical safety test (EST) printed report (continued)
Chassis Leakage (POL-N;NEU-N;GND-N): 1.2 μA - PASS

Lead-Ld LA/AP1 (POL-N;NEU-N;GND-N): 0.5 μA - PASS
Lead-Ld RA/AP2 (POL-N;NEU-N;GND-N): 0.5 μA - PASS
Lead-Ld LL/AP3 (POL-N;NEU-N;GND-N): 0.5 μA - PASS
Iso Test LA/AP1 (POL-N;NEU-N;GND-N): 17.6 μA - PASS
Iso Test RA/AP2 (POL-N;NEU-N;GND-N): 17.6 μA - PASS
Iso Test LL/AP3 (POL-N;NEU-N;GND-N): 17.6 μA - PASS
Load Current: 0.044 A

Equipment Power: 11 W
IEC61010 no GND (Blood Analyzer) IEC61010 with GND (Centrifuge)
EST Model : vPadES Rugged EST Model : vPadES Rugged

Cal.Due Date:18.06.2017 Cal.Due Date:18.06.2017
File: ABCD0123_201702XX_122438_P.txt File: ABCD-0123_201702XX_121544_P.txt

Date: 2017 Feb XX Date: 2017 Feb XX
Time: 12:24:38 Time: 12:15:44
vPad-ES: VPR15020002 vPad-ES: VPR15020002
Equipment Information. Equipment Information.

Control Number: ABCD0123 Control Number: ABCD-0123
Description: Portable Blood Analyzer (ABG) Description: Centrifuge
Manufacturer: Alere Manufacturer: Harvest
Model: Epoc Model: SMP-2
Serial Number: #ABC0123 Serial Number: ABCD1234
Location: Hospital Location: Hospital
Facility: I.C.U Facility: Laboratory
Technician ID: Mr MEAM Technician ID: Mr MEAM

Tech Time (hrs): 0.3 Tech Time (hrs): 0.4
Overall Result: PASS Overall Result: PASS
Signature:____________________Date:_______________ Signature:______________________Date:______________
Detailed Test Data. Detailed Test Data.
AutoSequence Filename: vpad_as_47.asq AutoSequence Filename: vpad_as_46.asq

Title of AutoSequence: IEC61010 Class 2 Title of AutoSequence: IEC61010 Class 1
AutoSequence Run Time: 7 minutes AutoSequence Run Time: 5 minutes
Elec. Safety Standard: Elec. Safety Standard:

Ground Resistance Limit: Maximum 0.200 ohms Ground Resistance Limit: Maximum 0.200 ohms
Chassis Leakage Limits: Maximum 500 μA NC;3500 μA Chassis Leakage Limits: Maximum 500 μA NC;
SFC 3500 μA SFC
Line Voltage L1-L2: 250.5 V Line Cord Resistance: 0.082 ohm - PASS
Line Voltage L1-GND: 252.0 V External Resistance: 0.112 ohm - PASS
Line Voltage L2-GND: 3.5 V
EUT power switch "ON". Line Voltage L1-L2: 250.0 V
Chassis Leakage (POL-R;NEU-O;GND-N): 0.7 μA - PASS Line Voltage L1-GND: 251.0 V
Chassis Leakage (POL-R;NEU-N;GND-O): 0.8 μA - PASS Line Voltage L2-GND: 3.4 V
Chassis Leakage (POL-R;NEU-N;GND-N): 0.6 μA - PASS
Chassis Leakage (POL-N;NEU-O;GND-N): 0.7 μA - PASS EUT power switch "ON".
Chassis Leakage (POL-N;NEU-N;GND-O): 1.0 μA - PASS Chassis Leakage (POL-R;NEU-O;GND-N): 1.5 μA - PASS
Chassis Leakage (POL-N;NEU-N;GND-N): Chassis Leakage (POL-R;NEU-N;GND-O): 57.9 μA - PASS
0.6 μA - PASS Chassis Leakage (POL-R;NEU-N;GND-N): 1.2 μA - PASS
Load Current: 0.026 A Chassis Leakage (POL-N;NEU-O;GND-N): 1.5 μA - PASS
Equipment Power: 6 W Chassis Leakage (POL-N;NEU-N;GND-O): 54.1 μA - PASS
Chassis Leakage (POL-N;NEU-N;GND-N): 1.2 μA - PASS
Comment: Battery is weak. Recommend to replace. Load Current: 0.046 A
Equipment Power: 11 W
END OF RECORD
Comment: Loud sound due to vibration. Need to check
further on mechanical parts.
END OF RECORD
15R001R2
Table G.1. Example of electrical safety test (EST) printed report (concluded)
IEC62353 - CLASS 2 (Vital Sign) IEC62353 - CLASS 1 (Defibrillator)
Model : vPadES Rugged Model : vPadES Rugged

Cal.Due Date:18.06.2017 Cal.Due Date:18.06.2017
File: ABCD0123_201702XX_125447_P.txt File: ABCD0123_201702XX_165552_P.txt

Date: 2017 Feb XX Date: 2017 Feb XX
Time: 12:54:47 Time: 16:55:52
vPad-353: VPR15020002 vPad ID: VPR15020002
Equipment Information. Equipment Information.

Control Number: ABCD0123 Control Number: ABCD0123
Description: Vital Sign Monitor Description: Defibrillator
Manufacturer: GE Manufacturer: Hewlett Packard
Model: Carescape V100 Model: Codemaster
Serial Number: ABCD1234 Serial Number: ABCD1234
Location: Hospital Location: Hospital
Facility: Ward A Facility: Ward A
Technician ID: Mr MEAM Technician ID: Mr MEAM

Tech Time (hrs): 0.5 Tech Time (hrs): 0.8
Overall Result: PASS Overall Result: PASS
Signature:_____________________Date:_______________ Signature:_________________________Date:_______________
Detailed Test Data. MultiSequence Title: IEC62353, Class I, 3xCF (1-6)xBF

MultiSequence Run Time: 10 minutes
AutoSequence Filename: vpad_a3_40.asq _____________________________________________________
Title of AutoSequence: IEC62353 CLASS 2 TEST STEP #1.
AutoSequence Run Time: 9 minutes
Elec. Safety Standard: IEC62353 Earth Resistance Limit: Maximum 0.300 ohms
Equipment Leakage Limit: Maximum 100.0 μA (Class II) Equipment Leakage Limit: Maximum 500.0 μA (Class I)
Applied Part Lkg Limit: Maximum 5000 μA (Type BF) Applied Part Lkg Limit: Maximum 50 μA (Type CF)
Mains Voltage L1-L2: 246.9 V Prot. Earth Resistance: 0.248 ohm - PASS
Mains Voltage L1-PE: 247.8 V Mains Voltage L1-L2: 246.3 V
Mains Voltage L2-PE: 3.2 V Mains Voltage L1-PE: 247.9 V
Mains Voltage L2-PE: 3.3 V
EUT power switch "ON".
Equipment Leakage (RP): 3.5 μA - PASS Insulation Resistance, L1+L2 to PE: 999.9 Megohm
Applied Part Lkg ALL AP (RP): 15.2 μA - PASS Insulation Resistance, AP to PE: 110.7 Megohm
Equipment Leakage (NP): 3.5 μA - PASS
Applied Part Lkg ALL AP (NP): 15.1 μA - PASS EUT power switch "ON".
Load Current: 0.046 A Equipment Leakage (RP): 126.8 μA - PASS
Equipment Power: 11 W Applied Part Lkg AP1-3 (RP): 8.3 μA - PASS
Equipment Leakage (NP): 132.5 μA - PASS
Comment: Temperature probe missing. Applied Part Lkg AP1-3 (NP): 8.2 μA - PASS
Load Current: 0.177 A
END OF RECORD Equipment Power: 44 W
_____________________________________________________
TEST STEP #2.

Applied Part Lkg Limit: Maximum 5000 μA (Type BF)
EUT power switch "ON".

Applied Part Lkg AP5-10 (RP): 69.1 μA - PASS
Applied Part Lkg AP5-10 (NP): 69.0 μA - PASS
_____________________________________________________
Comment: ECG lead got gel. Already cleaned before test.
END OF RECORD

15R001R2
Annex H
(informative)
Recommended uptime target for active medical device
Table H.1. Recommended uptime target for active medical device
1. Therapeutic Group Operating Operating Uptime Uptime

equipments hours hours/week equipment equipment
(Days) < 5 years 5 to 10
years
Anaesthesia units and C 24 7 99 % 95 %
vaporisers
Anaesthesia ventilator C 24 7 99 % 95 %
Aspirators C 24 7 99 % 95 %
Alternating pressure P 12 6 96 % 92 %
mattress
Defibrillators C 24 7 99 % 95 %
Diathermy unit C 24 7 99 % 95 %
Dental Equipment P 24 7 96 % 92 %
Electrosurgical units C 24 7 99 % 95 %
Haemodialysis units C 24 7 99 % 95 %
Humidifiers C 24 7 99 % 95 %
Hypo/hyperthermia units C 24 7 99 % 95 %
Incubators C 24 7 99 % 95 %
Infusion C 24 7 99 % 95 %
controllers/pumps
Lasers C 24 7 99 % 95 %
Lithotripters C 12 6 99 % 95 %
Pacemakers C 24 7 99 % 95 %
Peritoneal dialysis unit C 24 7 99 % 95 %
Phototheraphy units C 24 7 99 % 95 %
Radiant warmers P 24 7 96 % 92 %
Radiographic dye C 24 7 99 % 95 %
injection
Resuscitators C 24 7 99 % 95 %
Radiotheraphy P 12 6 96 % 92 %
equipments
Surgical drills and saws C 24 7 99 % 95 %
Stimulators P 12 6 96 % 92 %
Surgical tables C 24 7 99 % 95 %
Traction units P 12 6 96 % 92 %
Ventilators C 24 7 99 % 95 %
Ultrasonic nebulisers P 12 7 96 % 92 %
Ultrasonic therapy P 12 6 96 % 92 %

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Table H.1. Recommended uptime target for active medical device (continued)
.
2. Diagnostic Group Operating Operating Uptime Uptime
(Days) < 5 years 5 to10
years
Apnoea monitors C 24 7 99 % 95 %
Ambulatory ECG P 24 7 96 % 92 %
recorded and scanners
Blood pressure units C 12 6 96 % 92 %
(non-invasive inversive
electronic units)
Capnographs C 24 7 99 % 95 %
Cardiac output units P 24 7 96 % 92 %
Diagnostic radiologic C 24 7 99 % 95 %
imaging units
Electrocardiographs P 12 6 96 % 92 %
Electroencephalographs P 12 6 96 % 92 %
Electromyographs P 12 6 96 % 92 %
Endoscopes/ C 24 7 96 % 92 %
Bronscopes (fiber optic)
Evoked potential units P 12 6 96 % 92 %
Electronic thermometer P 12 6 96 % 92 %
Foetal monitors C 24 7 99 % 95 %
Nuclear medicine P 24 7 96 % 92 %
equipments
Oximetres C 24 7 99 % 95 %
Oxygen monitors and C 24 7 99 % 95 %
analysers
Phonocardiographs P 12 6 96 % 92 %
Physiologic monitoring C 24 7 99 % 95 %
systems ad monitors
Pulmonary function P 12 6 99 % 92 %
analysers
Surgical lights C 12 6 99 % 95 %
Surgical microscopes C 24 7 99 % 95 %
Transcutaneous O2 and C 24 7 99 % 95 %
CO2 monitors
Treadmills P 12 6 96 % 92 %
Ultrasound imaging P 12 6 96 % 92 %
units/systems
Vectorcardiographs P 12 6 96 % 92 %

15R001R2
Table H.1. Recommended uptime target for active medical device (continued)
3. Laboratory Group Operating Operating Uptime Uptime

(Days) < 5 years 5 to10
years
Analysers P 12 6 96 % 92 %
Amino acid P 12 6 96 % 92 %
Bilirubinometres P 12 6 96 % 92 %
Blood gas P 12 6 96 % 92 %
Calcium P 12 6 96 % 92 %
Clinical chemistry P 12 6 96 % 92 %
Coagulation P 12 6 96 % 92 %
Counter, gamma P 12 6 96 % 92 %
Electrolyte P 12 6 96 % 92 %
Immunoassay P 12 6 96 % 92 %
Glucose P 12 6 96 % 92 %
Haematology P 12 6 96 % 92 %
Platelet aggregation P 12 6 96 % 92 %
Spectrophotometres P 12 6 96 % 92 %
Atomic absorption P 12 6 96 % 92 %
Atomic absorption units P 12 6 96 % 92 %
Automatic blood P 12 6 96 % 92 %
grouping systems
Automatic P 12 6 96 % 92 %
microbiological systems
Blood bank centrifuges P 12 6 96 % 92 %
Centrifuges P 12 6 96 % 92 %
Cytometres P 12 6 96 % 92 %
Chromatographs P 12 6 96 % 92 %
gas/liquid
Electrophonesis P 12 6 96 % 92 %
equipment
Flame photometres P 12 6 96 % 92 %
Microscopes P 12 6 96 % 92 %
pH metres P 12 6 96 % 92 %
C = Critical equipment (including life support)

P = Patient support equipment
NOTE. Operating hours and operating days are indicative only. Medical services at healthcare
institutions are provided at all times and the equipments may be used/operated at any time of the
day or available for use at any time.

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Annex J
(normative)
Calculation of uptime
Uptime
Uptime target = x 100 %
Uptime + Downtime
where
Uptime is total time equipment normally required to be in clinical use; and
Downtime is the time the equipment is unavailable for clinical use due to failure or out
of calibration.
NOTES:
1. Upgrading time is the time during which equipment is undergoing upgrading or replacement or when
the equipment is out of service for renovations or upgrading.
2. For equipment that is required only during normal office working hours, the Uptime Targets are
based on a maximum uptime of 2 340 h (i.e. 52 weeks X 45 h/week) per year.
3. For equipment that is required 24 hr every day, the Uptime Targets are based on a maximum uptime
of 8 760 h (i.e. 365 days X 24 h/day) per year.
4. For other requirements, the maximum uptime per year is determined based on the same principle.
Figure J.1. Calculation of uptime

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Annex K
(informative)
MMIS for Biomedical Engineering Services
Table K.1. MMIS for Biomedical Engineering Services
No. Report title Content

1. Asset listing  Asset number
 Asset description
 Department
 Section/division
 Location code
 Location description
 Category
 Type
 Brand and model
 Manufacturers serial no.
 Cost
 Date received/purchased
 Supplier name
 File reference number
 Accessories
 Signature of responsible officer
 Date of signature
 Location
 Location changed to XX
 Date of location change
 Signature of location change
 Checked
 Date checked
 Signature for checking
 Number of XX
 Description
 Quantity
 Manufacturer
 Service agent
 Responsibility
 Area/department serviced
 Warranty start date
 Warranty completion date
 Commissioning parameters
 Membership of functional group
 Functional group dependant
 Registration certificate number
 Disposal reference
 Date disposed
 Signature for disposal
 Notes
 Service history

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Table K.1. MMIS for Biomedical Engineering Services (continued)

2. Asset summary listing  Asset number
 Department
 Section/division
 Asset number
 Type
 Cost
 Date received/purchased
 Area/department serviced
 Membership of functional group
 Functional groups dependant
 Scheduled preventive maintenance reference
 Registration of certificate number
 Disposal reference
 Date disposed
 Beyond economical repair tag
3. Work requests  Requisition number

 Requested by name
 Requested by position
 Requested by department
 Requested by telephone no.
 Date of request
 Time of request
 Location of fault
 Asset number
 Work requested
 Work requests received by name
 Work requests received by date
 Work requests received by time
 Work requests completion verification by name
 Work requests completion verification by date
 Work requests completion verification by time
 Work requests assessment cause code
 Work requests assessment by name
 Work requests assessment by date
 Work requests assessment by time
 Work requests type code
4. Work orders  Requisition number

 Requested by name
 Requested by position
 Requested by department
 Requested by telephone no.
 Date of request
 Time of request
 Asset number
 Work requested
 Work requests received by name
 Work requests received by date
 Work requests received by time

15R001R2

 Spare parts used part number
 Spare parts used number used
 Spare parts used cost
 Works order number
 Works carried out by name
 Works carried out start date
 Works carried out start time
 Works carried out finish date
 Works carried out finish time
 Works carried out manhours
 Response time
 Down time
 Up time
 Request entered date
 Request entered time
 Priority code

summary  Requested by department
 Date of request
 Asset number
 Works requested
 Works carried out man hours
 Response time
 Down time
 Up time
 Number of work orders

summary in progress  Requested by department
 Date of request
 Asset number
 Works requested
 Response time

completed summary  Requested by department
 Date of request
 Asset number
 Works requested
 Response time
 Down time
 Up time
 Number of work orders

15R001R2

outstanding summary  Requested by department
 Date of request
 Asset number
 Works requested
 Response time
 Down time
9. Common functions  CFU reference

unit (CFU) register  CFU description
 CFU causal assets listing
 CFU total number of causal assets in CFU
 CFU uptime target year 1, < 5 years old
 CFU uptime target year 1, 5 to 10 years old
 CFU uptime target year 2, < 5 years old
 CFU uptime target year 2, 5 to 10 years old
 CFU uptime target year 2, > 10 years old
 CFU uptime target year 3 to 15, < 5 years old
 CFU uptime target year 3 to 15, 5 to 10 years old
 CFU uptime target year 3 to 15, > 10 years old
 CFU status
 CFU current uptime
10. Common functions  CFU membership listing

unit (CFU) status  CFU disrupted from date
 CFU disrupted from time
 CFU disrupted to date
 CFU disrupted to time
 CFU target uptime
 CFU uptime
 CFU status
11. Stock register  Stock number

 Stock description
 Stock type
 Minimum stock
 Maximum stock
 Stock balance
 Normal suppliers
12. Planned preventive  PPM reference

maintenance  Planner name
schedules  Task name
 Task description
 Tools required
 Parts required
 Access restrictions
 Safety instructions
 Estimated hours
 Scheduled interval
 Scheduled start date
 Contractor
15R001R2
Table K.1. MMIS for Biomedical Engineering Services (concluded)

13. Contract out register  Contract out service reference
 Contractor
 Contract description
 Contract start date
 Contract expiry date

15R001R2
Annex L
(informative)
Key performance indicator (KPI)
Table L.1. Activities and requirements for KPI
Activities Requirements KPI

1a) To carry out scheduled a) Compliance to relevant a) Total preventive
and unscheduled Malaysian statutory regulations. maintenance schedule
maintenance for all (monthly).
medical devices. b) All recommendations from
manufacturers are to be b) Outstanding preventive
1b) To provide effective followed. maintenance (backlog).
and responsive repair
on all equipment and c) Compliance to all safety c) Response time.
provision of on-call and requirements as stated in the
emergency services. IEC 60601 and collaterals, d) Number of emergency
MS 838 for radiological calls attended.
1c) To carry out equipment and relevant
acceptance testing as standards for nuclear and e) Number of safety and
well as safety and radiotherapy equipment. functional checks
performance performed.
characteristics on all d) At least 2 h on-site response
incoming new time for repair calls, and shall not f) Number of safety tests and
equipment. exceed 15 min on site response safety checks performed
time for emergency calls. per year.
e) 24 h on-call basis.
f) Calibration, performance,
functional and safety checks to
the manufacturer's
recommendation shall be
conducted after each repair
work.
g) Guidelines on acceptance
testing and in service testing of
equipment, Ministry of Health,
Malaysia.
h) Compliance to guidelines on
Biomedical Engineering
maintenance competency and
career development.
2) To provide Implement mechanism to avoid a) % uptime

mechanisms to avoid failure or breakdown during use.
failure or breakdown b) Number of occurrence or
during diagnosis or breakdown during
therapy. procedure or use.

15R001R2
Table L.1. Activities and requirements for KPI (continued)

3) To carry out all works a) Critical (including life support): a) % uptime
necessary to provide
uptime guarantee on  99 % equipment uptime b) Uptime guarantee.
maintenance uptime. < 5 years.
 95 % equipment uptime
5 to 10 years.
 90 % service uptime for
common functional units.
b) Patient support machines:
< 5 years.
5 to 10 years.
 80 % service uptime for
common functional unit.
4) To implement the a) Quality assurance programme. a) Implementation of the

Hospital Engineering programme.
Quality Assurance b) Attain relevant MS/ISO quality
plan. management standards b) MS/ISO certification.
certification.
5a) To establish a Associated basic modules for a) Equipment inventory

computerised maintenance management work, i.e. updated every six months.
documentation system. work order, equipment register, stock
control, budgetary control and b) Number of equipment
5b) To provide quarterly preventive maintenance. tagged and entered in
reports on inventory.
maintenance activities.
c) Number of warranty
5c) To notify departments notifications.
of warranty
expirations.
6) To dispose/remove Compliance to national/international Number of equipment disposed

unwanted equipment. standard and regulation on disposal according to guidelines.
of medical devices.
7) To implement Relevant MS/International Standards. Number of hazardous work

procedures for dealing carried out according to
with hazardous matter procedures.
and handling
contaminated
equipment.
8) To cooperate in the Produce report on the status of the Number of reported equipment
investigation of related maintenance history of the related incident.
incidents. equipment.

15R001R2
Table L.1. Activities and requirements for KPI (concluded)

9) To train users on daily Identify the need for training on Number of user training
user maintenance specific equipment and action taken. conducted.
procedure (excludes
clinical procedure
related to the
equipment).
10) To maintain a stock of a) To assist in maintaining the Availability of critical and

genuine spares. uptime targets. recommended spares.
b) Adequate supplies of
maintenance kits.
11) Establish a library of All equipment engineering workshop Number of service manuals not
user and service shall have a documented list of available for critical care
manuals. service manuals. equipment.

15R001R2
Annex M
(informative)
Spare parts management
M.1 Introduction
Management of equipment is sustained by proper management of spare parts. Spare parts
are essential for maintaining and repairing active medical device. Accessories and
consumable components that have been described so far are necessary for maintenance and
inspection. The spare parts are classified into various categories as shown in Figure M.1
according to lifespan and purpose for use.
M.2 Terms and definitions

M.2.1 Inventory
A detailed itemised list of assets held by an organisation or institution which must be

continually maintained and updated to reflect the current status of each asset.
M.2.2 Spare parts
Components including accessories and consumables that are used for maintenance and
repair.

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Usage Lifespan Examples
Figure M.1. Classification of spare parts according to usage and lifespan

15R001R2
M.3 Spare parts cycle management

Stocked and newly procured spare parts should be registered. Based on this, an inventory
list, which shows the current balance of each spare part is made. Stock control is carried out
to ensure inventory accuracy which encompasses the process covering the delivery,
registration, use and stocktaking. Stocktaking (or inventory check) is carried out to ensure
accurate stock confirmation comparing between the numbers of use and inventory figures.
Stock-shortage or newly required spare parts found during the stocktaking are to be
estimated for procurement. Acquired spare parts are stocked and added to registration and
the inventory afresh. The typical flow of the spare parts management is shown in Figure M.2.
Figure M.2. Typical flow of the spare parts management
M.4 Registration and inventory list

The following information is necessary for spare parts registration:
a) Name of spare part.
b) Manufacturer’s code number: Number of the equipment or spare parts manufacturer

gives to equipment spare parts. It is necessary to indicate this number for easy
procurement.
c) Specification: E.g. type, size, weight, voltage, name, serial number and application.
d) Number of contents: Plural quantities might be contained in one package. This may be
included in item specification.

15R001R2
e) Name of manufacturer: Name of manufacturer producing the spare parts. It does not
necessarily conform to the equipment manufacturer.
f) Unit price.
g) Name of equipment: Name of equipment that requires spare parts.
h) Model number.
M.5 Stock control

To manage stock efficiently, an inventory check to confirm correct stock figures (stocktaking)
should be carried out on a regular basis. It is necessary to take inventory of the spare parts at
least once a year to ensure accurate stock confirmation. Records are compared with the
existing spare parts stock, and the result is entered in the database.
M.6 Estimation
The following procedures are required to be followed when estimating necessary spare parts
in large hospitals.
a) Carry out the survey for utilisation of individual equipment and inventory check for spare
parts.
b) Ensure that the survey report and equipment list are the same as above.
c) Evaluate the utilisation of individual equipment items, e.g. fully utilised, partly utilised, not
utilised, malfunctioning, not working and not used (with some reasons).
d) Choose an active medical device item concerned.
e) Based on the utilisation, make a list of necessary spare parts for the concerned
equipment referring to the instruction manual, experience, knowledge of material
engineering and so on.
f) Determine the lifespan of the listed necessary spare parts.
g) Carry out the inventory check.
h) Report the result of the inventory check.
i) Compare the two reports and determine the kind and amount of the spare parts.
j) Apply procedures to all active medical device.

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M.7 Procurement
To procure necessary spare parts, the following should be taken into account – consumption
report, selection of suppliers, contract conditions, payment and stock up to distribution. The
procurement process and limits of authority shall be based on the Medical Device Act 2012
and regulations as well as each organisations procurement policies and procedures.
M.8 Storage
The spare parts should be stored according to manufacturer’s recommendation. Spare parts
should also be easily retrievable and labeled accordingly. Spare parts should be used on first
in first out (FIFO) basis.

15R001R2
Annex N
(informative)
Examples of workshop setup
Dimensions in feet and inches
Figure N.1. Examples of workshop layout for a maximum of two personnel

Library Shower Hazardous working

area
Fume hood
Training room Test equipment storage
Spare parts store Storage areas
Active medical
device out
Repair work bench
Meeting room
Active medical
device under
repair/ waiting
for part
Small meeting room
Active medical
Offices device in
Storage/Packaging
Manager area
Vendor repair
Administrator
Legend
Cleaning PPE Decontamination
Visitor
15R001R2
area room
Reception area
Staff and Helpdesk
131
Figure N.2. Flowchart of workshop layout for a maximum of seven technical personnel
15R001R2
NOTE. Workbench location can be adjustable.
Figure N.3. Example of workshop layout for a maximum of seven technical personnel

Annex P
(informative)
Job designation
Table P.1. shows the requirements of minimum designation based on category of healthcare facilities and establishment in Malaysia.
Table P.1. Requirement of minimum designation based on category of healthcare facilities and establishment
A B C D E F G
AR/
Major Minor Non Hospital/
No. Biomedical Technical Personnel HKL & state Teaching Manufacturer/
specialist specialist specialist special
hospitals hospitals Importer/
hospital hospital hospital institution
Distributor
Appointed Biomedical Engineering
1 # # # # #  
Representative (ABR)
2 Specialist 
#* #* #* #* * ***
3 Junior specialist 
4 Senior BTP 
 ** ** ** ** ** ***
5 Junior BTP
Total designation 5JD(1S) 3JD(2S) 2JD(2S) 2JD(2S) 2JD(2S) 3JD 3JD
Key
JD = Job Description
S = Sharing
# Sharing designation - State/Major Hospitals

* Either Specialist or Junior Specialist
15R001R2
** Either Senior Technician or Technician
*** Manufacturer training or manufacturer authorised training
133
15R001R2
P.1 Category of healthcare facilities

The definition of each category of healthcare facilities according to Garis Panduan dan
Peraturan bagi Perancangan Bangunan oleh Jawatankuasa Standard dan Kos Unit
Perancang Ekonomi, Jabatan Perdana Menteri, Edisi Tahun 2008 are as follows.
a) HKL and State Hospitals
Provides 15 specialist services and designated specific sub-specialist based on the

region of the hospital. The 15 medical specialist services are – (1) General Medicine, (2)
General Surgery, (3) Paediatrics, (4) Orthopaedic, (5) Obstetrics & Gynaecology, (6)
Anaesthesiology, (7) Diagnostic Imaging, (8) Pathology & Mortuary, (9) Ophthalmology,
(10) ENT (Otorhinolaryngology), (11) Emergency Medicine, (12) Psychiatry, (13) Dental
(Oro-Maxillo-Facial) including Paediatric Dental, (14) Dermatology (sub specialities), and
(15) Nephrology (sub-specialities).
Examples of sub-specialities includes cardiology, cardiothoracic surgery, neurosurgery,

plastic surgery, urology, haematology, vascular surgery, oncology & radiotherapy, nuclear
medicine and others.
b) Major specialist hospital
Hospitals other than HKL and State Hospitals providing the 15 medical specialist services
as stated above and specific sub-specialities. Examples in this category include Hospital
Serdang, Hospital Sungai Buloh, Hospital Ampang, Hospital Putrajaya, Hospital Sungai
Petani, Hospital Taiping and Hospital Sultan Ismail Johor Bahru.
c) Minor specialist hospital
Hospitals providing limited medical specialist services from 5 to 6 core medical specialist
services such as General Medicine, General Surgery, Paediatrics, Orthopaedic,
Obstetrics & Gynaecology and Anaesthesiology.
d) Non specialist hospital
Hospitals providing out-patient and in-patient services by the Medical Officers. The
services may include periodic visiting specialist from nearby Specialist Hospital.
e) Hospital/Special institution
Special hospital/Special institution providing in and out-patient services in specialised

medical services such as Psychiatric Hospital, Rehabilitation Hospital, Women & Child
Hospital and National Cancer Institute.
f) Teaching hospital
Teaching hospital providing the core business of medical training and associated medical
services. The facilities should match the teaching requirements of the clinical specialities
offered by the hospital.

15R001R2
Annex Q
(informative)
Example of an active medical device replacement plan
Q.1 Methodology
Hospital A has decided for 10 criteria as in Table Q.1 to be used to derive prioritisation of
equipment replacement. Each of the equipment in the hospital shall be assessed based on
these 10 identified criteria and for each of the criteria assessed, a weightage score was
assigned. The findings shall be based on maintenance records (through their MMIS) and
input obtained from the user. Tables Q.2 and Q.3 give guidance on the weightage and
scoring.
Table Q.1. Criteria and weightage for replacement prioritisation
Replacement factor Description Weightage

Good -1
Request for BER 0.5
Asset condition
Request for exemption 0
BER certification approved 1
Functioning -0.5
Asset status Not functioning 0.5
Not in use 1
Low -1
Asset usage Medium 0.5
High 1
0-2 0
Frequency of breakdowns
3-4 0.5
(average per annum)
>4 1
> 15 years 1
Asset age 10 - 15 years 0.5
< 10 years 0
Yes 1
Obsolescene
No 0
Available 1
Safety alert
Not available 0
Maintenance cost Yes 1
(>20 % of purchase cost) No 0
Availability of back up Yes -1
equipment No 0.5
To replace 1
User recommendation Not to replace -1
No comment 0
15R001R2
Table Q.2. Weightage representing the need for replacement
Individual weightage factor Comments

-1 Likely to be continued/to be used
-0.5 Less likely to be replaced
0 No recommendations
0.5 Recommended to be replaced
1 Highly recommended to be replaced
Table Q.3. Total score of the weightage vs period for replacement
Total score Priority Replacement phase Description

Phase 3 Replacement Replacement to be done in
-3.5 to 0 Low
Programme 7 - 9 years
0.5 to 1.5 Medium
2.0 to 3.0 High
Immediate Replacement Replacement to be done in 1
> 3.5 Absolute
Programme year
Q.2 Example of calculation
Assessment on Equipment A as Table Q.4 below.
Table Q.4. Total score of the weightage vs period for replacement
Replacement criteria Findings Source Weightage score

Asset condition Good Actual physical -1
Asset status Functioning Actual -0.5
Asset usage High User input 1
Frequency of breakdown
0-2 MMIS 0
(average per annum)
Asset age 10 - 15 Based on purchase date 0.5
Obsolete No Obsolete letter 0
ECRI, MMDA,
Safety alert/Recall No 0
manufacture
Maintenance cost > 20 %
No MMIS 0
of equipment price
Availability of backup
No MMIS, user input 0.5
equipment
User recommendations No comment User input 0
Total score 0.5
Based on Table Q.3, Equipment A is suggested to be considered for replacement in Phase 2.

15R001R2
Bibliography
[1] MS 2219, General testing procedures for medical electrical equipment
[2] MS 2366, Guidance on the application of MS IEC 60364-7-710 for Group 2: Medical
locations
[3] MS 2582, Guidance on the setting up of haemodialysis facilities and installation and
maintenance of haemodialysis units (HDU) and system
[4] MS ISO 13485, Medical devices - Quality management systems - Requirements for
regulatory purposes
[5] MS ISO/IEC 17020, Conformity assessment - Requirements for the operation of various
type of bodies performing inspection
[6] MS ISO/IEC 17025, General requirements for the competence of testing and calibration
laboratories
[7] Private Healthcare Facilities and Services Act 1998 (Act 586)
[8] GHTF Document N15:2005, Principles of Medical Devices Classification

Acknowledgements
Members of Technical Committee on Code of Practice of Active Medical Devices and

Low-Voltage Electrical Equipment/System for Healthcare Facilities
Ir Dr Syed Mustafa Kamal Syed Aman Ministry of Health Malaysia

(Chairman)
Ms Zulaikah Zulkifely (Secretary) SIRIM Berhad
Ir Shamila Ariaratnam Association of Private Hospitals of Malaysia
Mr Mohammad Zahid Zamaludin Biomedical Engineering Association Malaysia
Ms Haslin Ismail Edgenta Mediserve Sdn Bhd
Ir Gnana Sakaran R Independent
Ir Haizan Hussein/ Jabatan Kerja Raya Malaysia (Cawangan
Mr Muhammad Syukri Khasim Kejuruteraan Elektrik)
Mr Maznan Muhammad KPJ Healthcare Berhad
Mr Lee Chor On Malaysia Medical Device Association
Dr Hajah Selasawati Haji Ghazali Malaysian Medical Association
Ir Sasikaladevi Tangavelu/ Medical Device Authority, Ministry of Health
Mr Muhammad Hazman Mohd Zaini Malaysia
Mr Azrulazhar Jamaludin/ Medical Electronic Engineering Association
Ms Norantanum Abu Bakar Malaysia
Ms Fatimah Mohamad Nor/ Medivest Sdn Bhd
Ms Siti Ainol Khabtiah Mohd Jamil
Mr Mohd Azrin Roselan Radicare (M) Sdn Bhd
Ir K.T. Lim/Ir Eng Ho Shin The Institution of Engineers, Malaysia
Assoc Prof Dr Ahmad Nazlim Haji Yusoff Universiti Kebangsaan Malaysia (Faculty of
Health Sciences)
Ms Siti Farah Md Noor/ Universiti Kebangsaan Malaysia Medical
Mr Zamri Nordin Centre
Prof Ir Dr Fatimah Ibrahim/ Universiti Malaya (Department of Biomedical
Dr Mohd Yazed Ahmad Engineering)
Ms Nor Haliza Yusof/ Universiti Malaya Medical Centre
Ms Mas Syamsiah Noor Mazlan
Mr Mohd Rosdi Zakaria Universiti Sains Malaysia (Department of
Development)
Prof Dr Jasmy Yunus/ Universiti Teknologi Malaysia (Faculty of
Assoc Prof Dr Azli Yahya Biosciences and Medical Engineering)

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DRAFT

Code of practice for good engineering

Committee representation .........................................................................................................iv

2 Normative references ................................................................................................... 1

3 Terms and definitions ................................................................................................... 2

6 Testing & commissioning and acceptance ................................................................. 10

7 User maintenance ...................................................................................................... 11

8 Scheduled maintenance ............................................................................................. 12

9 Unscheduled maintenance ......................................................................................... 17

10 Mechanisms to avoid failure or breakdown during use .............................................. 18

12 Quality assurance programme (QAP) ........................................................................ 19

13 Maintenance management information system (MMIS) ............................................. 21

14 Management of warranties ......................................................................................... 21

15 Decommissioned of active medical device ................................................................. 22

16 Disposal of active medical device .............................................................................. 22

17 Processes for handling hazardous/contaminated active medical device ................... 23

18 Incidents investigation and reporting .......................................................................... 23

19 Alerts, safety, field corrective action and recall notices .............................................. 24

20 User training ............................................................................................................... 24

21 Genuine parts ............................................................................................................. 25

© STANDARDS MALAYSIA 2017 - All rights reserved i

22 On-site library ............................................................................................................. 25

23 Workshop setup .......................................................................................................... 26

24 Safety, health and environment .................................................................................. 28

25 Advisory service ......................................................................................................... 29

26 Procurement of active medical device ........................................................................ 30

27 Risk management ....................................................................................................... 31

28 Technical audit ........................................................................................................... 33

30 Technical training ....................................................................................................... 36

31 Active medical device replacement plan .................................................................... 37

Annex A Biomedical Technical Personnel (BTP) competency and career development

Annex B Examples of active medical device tags .............................................................. 97

Annex C Maintenance consumables and user related consumables ............................... 101

Annex D PPM checklist based on manufacturer’s service manual .................................. 102

Annex E Routine Inspection (RI) checklist ....................................................................... 108

Annex F Work order form ................................................................................................. 109

Annex J Calculation of uptime.......................................................................................... 116

Annex K MMIS for Biomedical Engineering Services ....................................................... 117

Annex L Key performance indicator (KPI) ........................................................................ 122

Annex M Spare parts management .................................................................................. 125

Annex N Examples of workshop setup ............................................................................. 130

ii © STANDARDS MALAYSIA 2017 - All rights reserved

Annex P Job designation .................................................................................................. 133

Annex Q Example of an active medical device replacement plan .................................... 135

Bibliography ........................................................................................................................... 137

© STANDARDS MALAYSIA 2017 - All rights reserved iii

Association of Malaysian Medical Industries

Association of Private Hospitals of Malaysia

iv © STANDARDS MALAYSIA 2017 - All rights reserved

Major modifications in this revision are as follows:

a) New clauses have been added;

i) Clause 6, Testing & commissioning and acceptance;

ii) Clause 18, Incident investigation and reporting;

iv) Clause 21, Genuine parts;

v) Clause 24, Safety, health and environment;

vi) Clause 27, Risk management;

vii) Clause 28, Technical audit;

viii) Clause 29, Manpower;

ix) Clause 30, Technical training; and

x) Clause 31, Active medical device replacement plan.

b) Addition of subclause on Routine Inspection (RI) in scheduled maintenance.

c) Annex A on Biomedical Technical Personnel (BTP) competency and career development

d) New annexes have been added;

i) Annex C, Maintenance consumables and user related consumables;