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737-1:1998
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Medical gas pipeline |
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systems Ð |
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Part 1: Terminal units for compressed |
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medical gases and vacuum |
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The European Standard EN 737-1:1998 has the status of a |
British Standard |
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ICS 11.040.10; 23.040.60 |
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NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
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BS EN 737-1:1998

National foreword
This British Standard is the English language version of EN 737-1:1998 and covers
terminal units for compressed medical gases and vacuum. Together with
BS EN 739:1998, which covers hose assemblies and non-interchangeable
screw-threaded (NIST) connectors, it partially supersedes BS 5682:1984
(as amended by AMD 5419:1987) which covered hose assemblies, terminal units and
their connectors. The remainder of the content of BS 5682:1984, i.e. ªquick connectº
probes, is the subject of EN 737-6, currently in preparation.
When published, EN 737-6 is expected to have a lengthy transitional period, the date
of withdrawal of conflicting national standards (DOW) being set several years in the
future. BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new
edition (BS 5682:1998) which will retain only the requirements for quick connect
probes given in the amended 1984 edition. This new edition is expected to co-exist
with the forthcoming BS EN 737-6 until the expiry of the DOW of EN 737-6, at which
time BS 5682:1998 will be withdrawn.
The UK participation in its preparation was entrusted to Technical Committee
CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems
and hose assemblies, to Subcommittee CH/44/2, Medical gas supply systems, which
has the responsibility to:

Ð aid enquirers to understand the text;


Ð present to the responsible European committee any enquiries on the
interpretation, or proposals for change, and keep the UK interests informed;
Ð monitor related international and European developments and promulgate
them in the UK.

A list of organizations represented on this committee can be obtained on request to


its secretary.
Cross-references
The British Standards which implement international or European publications
referred to in this document may be found in the BSI Standards Catalogue under the
section entitled ªInternational Standards Correspondence Indexº, or by using the
ªFindº facility of the BSI Standards Electronic Catalogue.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

Summary of pages
This document comprises a front cover, an inside front cover, the EN title page,
pages 2 to 15 and a back cover.

This British Standard, having Amendments issued since publication


been prepared under the
direction of the Health and Amd. No. Date Text affected
Environment Sector Board, was
published under the authority of
the Standards Board and comes
into effect on 15 June 1998

 BSI 1998

ISBN 0 580 29706 3


EUROPEAN STANDARD EN 737-1
NORME EUROPEÂENNE
EUROPAÈISCHE NORM January 1998

ICS 11.040.10; 23.040.60; 23.060.01

Descriptors: Gas distribution, medical gases, compressed gas, junctions, definitions, design, equipment specifications, mechanical
properties, tests, marking, colour codes, packing

English version

Medical gas pipeline systems Ð


Part 1: Terminal units for compressed medical gases and vacuum

SysteÁmes de distribution de gaz meÂdicaux Ð Rohrleitungssysteme fuÈr medizinische Gase Ð


Partie 1: Prises murales pour gaz meÂdicaux Teil 1: Entnahmestellen fuÈr medizinische Druckgase
comprimeÂs et pour le vide (aspiration) und Vakum

This European Standard was approved by CEN on 5 July 1997.


CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a
national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to
the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German).
A version in any other language made by translation under the responsibility of a
CEN member into its own language and notified to the Central Secretariat has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
United Kingdom.

CEN
European Committee for Standardization
Comite EuropeÂen de Normalisation
EuropaÈisches Komitee fuÈr Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national
Members.
Ref. No. EN 737-1:1998 E
Page 2
EN 737-1:1998

Foreword Contents
This European Standard has been prepared by Page
Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, the secretariat of which is held Foreword 2
by BSI. Introduction 3
This European Standard shall be given the status of a 1 Scope 3
national standard, either by publication of an identical 2 Normative references 3
text or by endorsement, at the latest by July 1998, and
conflicting national standards shall be withdrawn at 3 Definitions 3
the latest by July 1998. 4 Terminology 4
This European Standard has been prepared under a 5 General requirements 5
mandate given to CEN by the European Commission
6 Test methods 7
and the European Free Trade Association, and
supports essential requirements of EU Directive(s). 7 Marking, colour coding and packaging 8
For special national conditions and transition periods 8 Information to be supplied by the
for clause 7.2.1, see annex C. manufacturer 9
EN 737 consists of the following parts under the Annex A (informative) Bibliography 13
general title Medical gas pipeline systems: Annex B (informative) Rationale 13
Part 1: Terminal units for compressed medical gases
Annex C (normative) Special national conditions 13
and vacuum;
Part 2: Anaesthetic gas scavenging disposal systems; Annex ZA (informative) Clauses of this European
Standard addressing essential requirements or other
Part 3: Pipelines for compressed medical gases and provisions of EU Directives 14
vacuum;
Part 4: Terminal units for anaesthetic gas scavenging
systems;
Part 5: Oxygen concentrators;
Part 6: Dimensions of probes for terminal units for
compressed medical gases and vacuum.
Dimensions of probes are specified in prEN 737-6,
which has a Date of Withdrawal (DoW) of
(DOP + 15 years).
Until this time, products complying with national
standards may continue to be used for the
maintenance and repair of probes.
Annex C forms a normative part of this part of this
European Standard. Annexes A and B are informative.
For relationship with EU Directive(s), see informative
annex ZA, which is an integral part of this standard.
According to the CEN/CENELEC Internal Regulations,
the national standards organizations of the following
countries are bound to implement this European
Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.

 BSI 1998
Page 3
EN 737-1:1998

Introduction It is intended especially to ensure the gas-specific


assembly of terminal units and to prevent their
Terminal units are the points on a medical gas pipeline
interchange between different gases.
system where the operator makes connections and
disconnections for the supply of specified medical 1.2 This part of this European Standard also specifies
gases to anaesthetic machines, lung ventilators or other requirements for:
items of medical equipment, and where a wrong Ð terminal units for the supply and disposal of air
connection may create a hazard to the life of a patient. for driving surgical tools;
It is important that terminal units and their Ð probes intended to be connected to the
components are designed, manufactured, installed and gas-specific connection point which is part of a
maintained in such a way as to meet the basic terminal unit;
requirements specified in this part of this European
Standard. This part of this European Standard pays 1.3 This part of this European Standard does not
particular attention to: specify:
Ð suitability of materials; Ð the dimensions of probes and of the gas-specific
Ð gas-specificity; connection points of the terminal unit
(see prEN 737-6);
Ð cleanliness;
Ð the dimensions of NIST connectors (see EN 739);
Ð testing;
Ð requirements for terminal units for anaesthetic
Ð identification; gas scavenging systems (see EN 737-4).
Ð information supplied.
In any health care facility, it is strongly recommended
that terminal units of only one type (i.e. with the same
2 Normative references
set of dimensions for probe and socket) are used for This part of this European Standard incorporates by
any particular gas. During hospital renovation it may dated or undated reference, provisions from other
be desirable to upgrade existing medical gas publications. These normative references are cited at
installations rather than renew them completely. the appropriate places in the text and the publications
It is recognized that with modified terminal units it are listed hereafter. For dated references, subsequent
may not be possible to achieve the flow and pressure amendments to or revisions of any of these
drop requirements of this part of this European publications apply to this European Standard only
Standard, due to limitations imposed by the pipeline when incorporated in it by amendment or revision. For
system itself or by those components of the original undated references the latest edition of the publication
terminal units that remain in the pipeline system. referred to applies.
This part of this European Standard specifies the prEN 737-3, Medical gas pipeline systems Ð
provision of information for the installation and testing Part 3: Pipelines for compressed medical gases and
of terminal units. Testing after installation is critical to vacuum Ð Basic requirements.
patient safety and it is essential that terminal units are EN 739, Low-pressure hose assemblies for use with
not used until full testing in accordance with medical gases.
prEN 737-3 has been completed. prEN 1441, Medical devices Ð Risk analysis.
Rationales for some of the requirements of this part of ISO 32, Gas cylinders for medical use Ð Marking for
this European Standard are given in annex B. These identification of content.
requirements are indicated by the letter ªRº after the ISO 554, Standard atmospheres for conditioning
clause number. and/or testing Ð Specifications.

1 Scope 3 Definitions
1.1 This part of this European Standard specifies For the purposes of this part of this European
requirements for terminal units intended for use in Standard, the following definitions apply.
medical gas pipeline systems specified in
prEN 737-3 for use with the following medical gases: 3.1
Ð oxygen; gas-specific
Ð nitrous oxide; having characteristics which prevent interchangeability
and thereby allow assignment to one gas or vacuum
Ð air for breathing;
service only
Ð carbon dioxide;
Ð oxygen/nitrous oxide mixture [50 %/50 % (V/V)]; 3.2
Ð air for driving surgical tools; gas-specific connection point
Ð nitrogen for driving surgical tools; that part of the socket which is the receptor for a
gas-specific probe
Ð vacuum.

 BSI 1998
Page 4
EN 737-1:1998

3.3 3.11
gas-specific connector quick connector
NIST (non-interchangeable screw-threaded) connector pair of non-threaded gas-specific components which
(see EN 739) or a probe (see prEN 737-6) can be easily and rapidly joined together by a single
action of one or both hands without the use of tools
3.4
low-pressure hose assembly 3.12
assembly which consists of a flexible hose with single fault condition
permanently-attached gas-specific inlet and outlet condition in which a single means for protection
connectors which is designed to conduct a medical gas against a safety hazard in equipment is defective or a
at pressures between 300 kPa and 1 400 kPa and for use single external abnormal condition is present
with a vacuum service at pressures above 10 kPa
3.13
absolute (see EN 739)
socket
3.5
that part of a terminal unit which is either integral or
medical gas attached to the base block by a gas-specific interface
any gas or mixture of gases intended to be and which contains the gas-specific connection point
administered to patients for therapeutic, diagnostic or
3.14
prophylactic purposes or for surgical tool application
terminal unit
3.6
outlet assembly (inlet for vacuum) in a medical gas
medical gas pipeline system supply system at which the operator makes
central supply system with control equipment, a connections and disconnections
pipeline distribution system and terminal units at the
3.15
points where medical gases or vacuum are required
terminal unit base block
3.7
that part of a terminal unit which is attached to the
medical gas supply system pipeline distribution system
either:
3.16
a) a medical gas pipeline system; or
terminal unit check valve
b) any other installation having no permanent
valve which remains closed until opened by insertion
pipeline system but employing a medical gas supply
of an appropriate probe and which then permits flow
source complete with pressure regulators
in either direction
3.8
3.17
NIST connectors; non-interchangeable
terminal unit for supply and disposal of air for
screw-threaded connectors
driving tools
range of male and female components intended to
combination of an outlet assembly (for the supply) and
maintain gas-specificity by the allocation of a set of
an inlet assembly (for disposal) which are connected
different diameters and a left or right hand screw
to a supply system and to a disposal system
thread to the mating components for each particular
respectively and at which the operator makes
gas
connections and disconnections by means of a
3.9 combined probe
nominal distribution pressure 3.18
pressure which the pipeline distribution system is terminal unit maintenance valve
intended to deliver at the terminal units
valve which permits maintenance of the terminal unit
3.10 without shutting down the pipeline system to other
probe terminal units
non-interchangeable male component designed for
acceptance by and retention in the socket 4 Terminology
A diagram of a typical terminal unit with examples of
terminology is given in Figure 1.

 BSI 1998
Page 5
EN 737-1:1998

5 General requirements 5.4.1.2 R Terminal units for oxygen, nitrous oxide, air
for breathing, carbon dioxide and oxygen/nitrous oxide
5.1 Safety mixture 50 %/50 % (V/V) shall not create a hazard to the
Terminal units shall, when transported, stored, patient or operator at an inlet pressure of 1 000 kPa.
installed, operated in normal use and maintained Evidence shall be provided by the manufacturer.
according to the instructions of the manufacturer,
cause no safety hazard which could be foreseen using 5.4.1.3 R Terminal units for oxygen, nitrous oxide, air
risk analysis procedures in accordance with for breathing, carbon dioxide and oxygen/nitrous oxide
prEN 1441 and which is connected with their intended mixture 50 %/50 % (V/V) shall meet the requirements
application, in normal condition and in single fault of 5.4.1.1 following exposure to an inlet pressure
condition. of 1 000 kPa for 10 min.
5.2 R Alternative construction 5.4.1.4 R Terminal units for air for driving surgical
tools and nitrogen for driving surgical tools shall
Terminal units and components or parts thereof, using
operate and meet the requirements of this part of this
materials or having forms of construction different
European Standard for a medical gas supply having a
from those detailed in clause 5 of this part of this
pressure range from 640 kPa to 1 200 kPa.
standard shall be accepted if it can be demonstrated
that an equivalent degree of safety is obtained. 5.4.1.5 R Terminal units for air for driving surgical
Such evidence shall be provided by the manufacturer. tools and nitrogen for driving surgical tools shall not
create a hazard to the patient or operator at an inlet
See annex C for special national conditions and
pressure of 2 000 kPa.
transition periods.
Evidence shall be provided by the manufacturer.
5.3 Materials
5.4.1.6 R Terminal units for air for driving surgical
5.3.1 The materials in contact with the gas shall be tools and nitrogen for driving surgical tools shall meet
compatible with oxygen, the other medical gases and the requirements of 5.4.1.4 following exposure to an
their mixtures in the temperature range specified inlet pressure of 2 000 kPa for 10 min.
in 5.3.2.
NOTE 1 Corrosion resistance includes resistance against
5.4.1.7 R Terminal units for vacuum shall operate and
moisture and surrounding materials. meet the requirements of this part of this European
NOTE 2 Compatibility with oxygen involves both combustibility Standard for a vacuum supply having a minimum
and ease of ignition. Materials which burn in air will burn violently absolute pressure of 10 kPa.
in pure oxygen. Many materials which do not burn in air will do
so in pure oxygen, particularly under pressure. Similarly, materials 5.4.2 Terminal units for different pressures
which can be ignited in air require lower ignition energies for Terminal units for the same gas at different nominal
ignition in oxygen. Many such materials may be ignited by
adiabatic compression produced when oxygen at high pressure is
operating pressures shall have gas-specific connection
rapidly introduced into a system initially at low pressure. points for each pressure (e.g. the supply of air for
NOTE 3 A standard, Compatibility of medical equipment with driving surgical tools and air for breathing).
oxygen, is in preparation by ISO/TC 121/SC6.
5.4.3 Incomplete assembly
5.3.2 The materials shall permit the terminal units and If any gas-specific component is removed from the
their components to meet the requirements of 5.4 in terminal unit, either the terminal unit shall be rendered
the temperature range of 220 ÊC to +60 ÊC. inoperable or the gas-specificity of the terminal unit
5.3.3 Terminal units shall be capable, while packed shall be maintained.
for transport and storage, of being exposed to If the terminal unit can be dismantled, the components
environmental conditions as stated by the shall not be capable of being reassembled in such a
manufacturer. way that the fully-assembled terminal unit is no longer
gas-specific.
5.3.4 R Evidence of conformity with the requirements
of 5.3.1, 5.3.2 and 5.3.3 shall be provided by the 5.4.4 Gas-specific connection point
manufacturer. Each terminal unit shall include a gas-specific
5.4 Design requirements connection point which shall accept the appropriate
gas-specific probe only. This connection point shall be
5.4.1 Medical gas supply pressure included in a socket.
5.4.1.1 R Terminal units for oxygen, nitrous oxide, air 5.4.5 Terminal unit check valve
for breathing, carbon dioxide and oxygen/nitrous oxide Each terminal unit shall include a check valve which
mixture 50 %/50 % (V/V) shall operate and meet the shall open the gas supply when the probe is connected
requirements of this part of this European Standard for and which shall shut off automatically when the probe
a medical gas supply having a pressure range is disconnected. The check valve shall be a separate
from 320 kPa to 600 kPa. component or assembly from the maintenance valve
specified in 5.4.6.

 BSI 1998
Page 6
EN 737-1:1998

5.4.6 Terminal unit maintenance valve 5.4.11 R Pressure drop


Except for vacuum services, each terminal unit shall The pressure drop across the terminal unit and its
be equipped with a maintenance valve, which can be probe shall not exceed the values given in Table 1.
manual or automatic. The maintenance valve shall be a For terminal units for supply and disposal of air for
separate component or assembly from the check valve driving surgical tools, the pressure drop across the
specified in 5.4.5. outlet assembly shall not exceed the value given in
5.4.7 Connection of terminal units to the pipeline Table 1; the pressure drop across the inlet assembly
shall not exceed 25 kPa with a back pressure not
NOTE See also 8.2.
exceeding 15 kPa.
5.4.7.1 The base block of a terminal unit shall be The test for pressure drop is given in 6.3.
designed and manufactured for either permanent or
gas-specific connection to a pipeline. 5.4.12 Connection force and torque
The force and the torque required to insert the probe
5.4.7.2 Except for connection to a disposal system,
into the terminal unit shall be:
connection to a pipeline distribution system shall be by
brazing, welding or by means of a NIST body and shall a) an axial force not exceeding 100 N and/or
comply with prEN 737-3. b) a torque not exceeding 1 N´m.
5.4.7.3 Connection to a low-pressure flexible The test for connection force and torque is given
connecting assembly shall be either by direct ferruling in 6.4.
or by means of a NIST body and shall comply 5.4.13 Disconnection force and torque
with EN 739.
The force and the torque required to release the
5.4.8 Socket locking mechanism shall be:
The arrangement for attaching a socket to its base a) a push or pull of not more than 110 N and not less
block for a particular service shall be of a design than 20 N and/or
which prevents interchangeability with the base block b) a torque of not more than 1 N´m and not less
of any other service. than 0,1 N´m.
5.4.9 Testing When all locking provisions have been released,
Compliance with clauses 5.4.2 to 5.4.8 shall be tested according to the manufacturer's instructions,
by visual inspection. disconnection of the probe from the terminal unit shall
require a force of not more than 100 N.
5.4.10 Endurance (connection/release)
The test for disconnection force and torque is given
5.4.10.1 Socket in 6.5.
The socket shall meet the requirements given NOTE Danger to personnel can occur as a result of the rapid
expulsion of probes from terminal units. The design should
in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 prevent this from occurring.
and 5.4.17 after testing in accordance with
clause 6.2.1. 5.4.14 Mechanical strength
5.4.10.2 Probe The terminal unit shall withstand the application of a
steady axial tensile force of not less than 500 N.
The probe shall meet the requirements given
in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16 The test for mechanical strength is given in 6.6.
and 5.4.17 after testing in accordance with 6.2.2.

Table 1 Ð Requirements for flow and pressure drop across terminal units with probe inserted
Terminal unit nominal Test pressure Test flow Maximum pressure drop
distribution pressure across a terminal unit
(see prEN 737-3)
kPa kPa l/min kPa
400 to 500 320 60 15
400 to 500 320 200 70
800 to 1 000 640 300 70
Vacuum 401) 40 15
1) Absolute pressure.

 BSI 1998
Page 7
EN 737-1:1998

5.4.15 Leakage 6.1.3 Reference conditions


The leakage from a terminal unit with and without the Correct flows to 23 ÊC and 101,3 kPa.
probe inserted shall not exceed 0,296 ml/min
(0,03 kPa l/min). The test for leakage is given in 6.7.1 6.2 Test method for endurance
and 6.7.2. 6.2.1 Socket
The leakage from a terminal unit with the probe Fix the terminal unit to a horizontal or vertical surface,
inserted and with side force applied shall not as appropriate, using the procedure recommended by
exceed 0,296 ml/min (0,03 kPa l/min). the manufacturer.
The test for leakage with side force applied is given Apply a test pressure at the inlet to the base block of
in 6.7.3. the terminal unit. Use a test pressure of 1 200 kPa for
5.4.16 Gas-specificity terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure
The terminal unit shall only accept the probe for the of 600 kPa for all other terminal units. Using a test
medical gas for which it is intended. probe made of corrosion-resistant steel of minimum
The test for gas specificity is given in 6.8. chromium content 17 % and a surface Brinell hardness
of 210 HB 1/30, connect and release the
5.4.17 Effective connection of probes
probe 10 000 times, at a frequency of not more than
A tactile or audible indication of locking shall be 10 operations per minute, changing the seals every
perceived on retention of the gas-specific probe. 1 000 operations or according to the manufacturer's
The test for effective connection of probes is given instructions, whichever is the greater interval.
in 6.9. Test the socket for compliance with 5.4.11, 5.4.12,
5.5 Constructional requirements 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.

5.5.1 R Cleaning 6.2.2 Probe


The components of terminal units for all services shall Fix a terminal unit complying with this part of this
be supplied clean and free from oil, grease and European Standard to a horizontal or vertical surface,
particulate matter. as appropriate, using the procedure recommended by
the manufacturer.
Evidence shall be provided by the manufacturer.
Apply a test pressure at the inlet to the base block of
NOTE 1 Any method of cleaning and degreasing can be used
which effectively removes all surface dirt and hydrocarbons, and the terminal unit. Use a test pressure of 1 200 kPa for
which leaves no residue itself. Chemical cleaning methods will terminal units for air for driving surgical tools and for
normally require a subsequent washing and drying process to nitrogen for driving surgical tools, or a test pressure
remove residues. of 600 kPa for all other terminal units. Connect and
NOTE 2 Examples of cleaning procedures will be described in a release the probe 10 000 times, at a frequency of not
standard, Compatibility of medical equipment with oxygen, more than 10 operations per minute, changing the seals
which is in preparation by ISO/TC 121/SC6.
every 1 000 operations or according to the
5.5.2 R Lubricants manufacturer's instructions, whichever is the greater
If lubricants are used, they shall be compatible with interval.
oxygen, the other medical gases and their mixtures in Test the probe for compliance with 5.4.11, 5.4.12,
the temperature range specified in 5.3.2. 5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.
Evidence shall be provided by the manufacturer. 6.3 Test method for pressure drop
Using an apparatus of typical configuration shown in
6 Test methods Figure 2 for terminal units for compressed medical
gases, Figure 3 for terminal units for vacuum or
6.1 General Figure 4 for terminal units for supply and disposal of
6.1.1 Ambient conditions air for driving surgical tools, set the test pressure and
Except if otherwise stated, carry out tests at flow at the inlet of the terminal unit to the appropriate
(23 ± 2) ÊC. values given in Table 1 and in 5.4.11.
Measure the pressure drop across the terminal unit
6.1.2 Test gas with the probe inserted.
Carry out tests in accordance with ISO 554 with clean, For terminal units for the supply and disposal of air for
oil-free dry air or nitrogen. driving surgical tools, measure the pressure drops
In all cases, carry out tests with dry gas with a across the outlet and inlet assemblies simultaneously.
maximum moisture content of 50 ppm (parts per
million = 1026) corresponding to a dew point
of 248 ÊC at atmospheric pressure.

 BSI 1998
Page 8
EN 737-1:1998

6.4 Test method for connection force and torque 6.7 Test methods for leakage
Adapt a probe to accommodate a suitable measuring 6.7.1 Fix the terminal unit to a horizontal or vertical
device. surface, as appropriate, using the procedure
Fix the terminal unit to a horizontal or vertical surface, recommended by the manufacturer.
as appropriate, using the procedure recommended by Apply a test pressure at the inlet of the base block of
the manufacturer. the terminal unit. Use the following test pressures.
Apply a test pressure at the inlet to the base block of a) 320 kPa and 600 kPa for terminal units for
the terminal unit. Use a test pressure of 1 200 kPa for compressed medical gases;
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure b) 640 kPa and 1 200 kPa for terminal units for air
of 600 kPa for all other terminal units. for driving surgical tools and nitrogen for driving
surgical tools;
In accordance with the manufacturer's instructions,
insert the adapted probe into the terminal unit and c) 40 kPa absolute pressure for terminal units for
record the force and/or torque required to insert and vacuum.
engage the probe fully. Measure the leakage under the conditions of maximum
and minimum test pressure.
6.5 Test method for disconnection force and
torque 6.7.2 Keep the terminal unit pressurized as described
Adapt a probe to accommodate a suitable measuring in 6.7.1 and insert a gas-specific blanked probe.
device. Measure the leakage under the conditions of maximum
and minimum test pressure.
Fix the terminal unit to a horizontal or vertical surface,
as appropriate, using the procedure recommended by 6.7.3 Apply a force of 20 N perpendicular to the long
the manufacturer. axis of the probe, 50 mm from the outermost surface of
Apply a test pressure at the inlet to the base block of the terminal unit. Measure the leakage whilst the force
the terminal unit. Use a test pressure of 640 kPa for is applied to the probe under the conditions of
terminal units for driving surgical tools and for maximum and minimum test pressure.
nitrogen for driving surgical tools, or a test pressure of 6.8 Test method for gas-specificity
320 kPa for all other terminal units. Carry out the test by attempting to connect all
Insert the adapted probe into the terminal unit in gas-specific test probes in turn to the gas-specific
accordance with the manufacturer's instructions and connection point of each socket.
ensure that it is fully engaged.
6.9 Test method for effective connection of
Disconnect the probe in accordance with the probes
manufacturer's instructions and record the force and/or
torque required to release the locking mechanism. Carry out the test by inserting the gas-specific probe
and checking that a tactile or audible indication of
If the recommended disconnection method involves locking is given.
applying, for example, compressive force to the probe
to reduce the effort required to disengage the locking 6.10 Test method for durability of markings and
mechanism, measure each separate force/torque colour coding
involved. Rub markings and colour coding by hand, without
6.6 Test method for mechanical strength undue pressure, first for 15 s with a cloth rag soaked
with distilled water, then for 15 s with a cloth rag
Adapt a blanked probe in order to apply tensile force. soaked with methylated spirit and then for 15 s with a
Fix the terminal unit to a suitable surface using the cloth rag soaked with isopropyl alcohol. Carry out this
procedure recommended by the manufacturer. test at ambient temperature.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for 7 Marking, colour coding and packaging
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure 7.1 Marking
of 600 kPa for all other terminal units.
7.1.1 Terminal units, probes and their gas-specific
Insert the adapted probe. components shall be durably and legibly marked with
Apply a tensile force of 500 N and hold it for 1 min. the symbol of the relevant gas in accordance
Remove the tensile force, check that the terminal unit with Table 2.
is completely functional and the leakage is according NOTE In addition to the symbol, the name of the gas can be
to 5.4.15. used.

Dismantle the terminal unit and check that no damage The test for the durability of markings is given in 6.10.
or distortion has occurred to either the terminal unit 7.1.2 The height of the lettering shall be at
components or the probe. least 2,5 mm.

 BSI 1998
Page 9
EN 737-1:1998

Table 2 Ð Symbols and colour coding for medical gases


Medical gas or mixture Symbol Colour coding
Oxygen O2 White1)
Nitrous oxide N2O Blue1)
Air for breathing Air3) Black±white1)
Air for driving surgical tools Air: 800 Black±white1)
Air for driving surgical tools (with disposal) Air: motor Black±white1)
Nitrogen for driving surgical tools N2: 800 Black1)
Carbon dioxide CO2 Grey1)
Mixture of oxygen/nitrous oxide [50 %/50 % (V/V)] O2/N2O White±blue1)
Vacuum Vac3) Yellow2)
1) In accordance with ISO 32.
2) An example of yellow is NCS 0060Y in SS 01 91 02.
3) National languages may be used for air and vacuum.

7.1.3 Terminal units and probes shall be marked with 8 Information to be supplied by the
the manufacturer's name or identification mark and, if
applicable, with additional means to ensure traceability
manufacturer
such as type, batch or serial number or year of 8.1 Terminal units shall be accompanied by
manufacture. documents containing at least a technical description,
instructions for use and an address to which the
7.2 Colour coding
operator can refer. The accompanying documents shall
7.2.1 If colour coding is used, it shall be in be regarded as a component part of terminal units.
accordance with Table 2.
8.2 The manufacturer shall provide instructions for
See annex C for special national conditions and installation and a reference to the testing procedures
transition periods. for terminal units given in prEN 737-3.
7.2.2 Colour coding shall be durable. The test for the 8.3 Instructions for use shall include all information
durability of colour coding is given in clause 6.10. necessary for the operation of the terminal unit in
7.3 Packaging accordance with its specification and shall include a
description of the procedure for connection and
7.3.1 Terminal units, gas-specific probes and spare disconnection of probes.
parts shall be sealed to protect against particulate Instructions for use shall give detailed instructions for
contamination and packaged to prevent damage during the safe performance of cleaning, inspection and
storage and transportation. preventive maintenance to be performed by the
7.3.2 Packages shall provide a means of identification operator or by authorized persons and shall indicate
of the contents. the frequency of such activities.
Particular attention shall be given to the following
safety-related items:
± the danger of fire or explosion due to the use of
lubricants not recommended by the manufacturer;
± the range of operating pressures;
± the hazard due to the use of improper probes.
A list of recommended spare parts shall be provided.

 BSI 1998
Page 10
EN 737-1:1998

1) NIST body 6) Check valve


2) Hose insert 7) Gas-specific interface
3) Point for brazed connection 8) Socket
4) Base block 9) Gas-specific connection point
5) Maintenance valve 10) Probe

Figure 1 Ð Diagram showing the typical components of a terminal unit

 BSI 1998
Page 11
EN 737-1:1998

1) Pressure differential measuring device 5) Terminal unit with probe inserted


2) Pressure gauge 6) Flow control valve
3) Pressure regulator 7) Pressure supply
4) Flowmeter

Figure 2 Ð Typical apparatus for measuring pressure drop across


terminal units for compressed medical gases

1) Pressure differential measuring device 5) Terminal unit with probe inserted


2) Pressure gauge 6) Flow control valve
3) Vacuum regulator 7) Vacuum supply
4) Flowmeter

Figure 3 Ð Typical apparatus for measuring pressure drop across terminal


units for vacuum

 BSI 1998
Page 12
EN 737-1:1998

1) Pressure differential measuring device 6) Flow control valve


2) Pressure gauge 7) Pressure supply
3) Pressure regulator 8) Disposal assembly of the terminal unit with the probe inserted
4) Flowmeter 9) Connection between the supply and the probe disposal sides of
5) Supply assembly of the terminal unit with the the probe
probe inserted

Figure 4 Ð Typical apparatus for measuring pressure drop across terminal units for
supply and disposal of air for driving surgical tools

 BSI 1998
Page 13
EN 737-1:1998

Annex A (informative) B.5.4.1.5 The value of 2 000 kPa is equal to 2 times


the maximum nominal distribution pressure of
Bibliography
EN 737-4, Medical gas pipeline systems Ð
( )
800 +200
0 kPa (see prEN 737-3). This pressure can be
applied to the terminal units by the supply system in
Part 4: Terminal units for anaesthetic gas scavenging single fault condition.
systems.
Evidence will be provided e.g. to a Notified Body
prEN 737-6, Medical gas pipeline systems Ð during CE conformity assessment and Competent
Part 6: Dimensions of probes for terminal units for Authority upon request.
compressed medical gases and vacuum.
B.5.4.1.6 See B.5.4.1.5.
EN 1089, Transportable gas cylinders Ð Gas cylinder
identification (excluding LPG). B.5.4.1.7 The value of 10 kPa is the lower limit of the
possible absolute pressure supplied by vacuum pumps.
SS 01 91 02, Colour atlas.
B.5.4.11 Lung ventilators can require peak flows
of 200 l/min for up to 3 s. Experience shows that such
Annex B (informative) ventilators can be supplied by terminal units which
Rationale meet the requirements of 5.4.11.
B.5.2 Evidence will be provided to e.g. a Notified B.5.5.1 Evidence of such compatibility will be
Body during CE conformity assessment and upon provided e.g. to a Notified Body during CE conformity
request to the Competent Authority. Attention is drawn assessment and Competent Authority upon request.
to prEN 1441 on risk analysis and to the standards B.5.5.2 Evidence of such compatibility will be
under development by ISO/TC 210 on risk evaluation provided e.g. to a Notified Body during CE conformity
and risk control. assessment and Competent Authority upon request.
B.5.3.4 Evidence of such compatibility will be
provided e.g. to a Notified Body during CE conformity Annex C (normative)
assessment and Competent Authority upon request.
Special national conditions
B.5.4.1.1 The values of 320 kPa and 600 kPa are
derived from the range of nominal operating pressure Special national condition: National characteristic or
( +100
)
of 400 0 kPa and from the maximum allowable
practice that cannot be changed even over a long
period, e.g. climatic conditions, electrical earthing
deviation of ± 20 % of the nominal distribution pressure conditions. If it affects harmonization, it forms part of
(see prEN 737-3). the European Standard. In the countries in which the
B.5.4.1.2 The value of 1 000 kPa is equal to 2 times the relevant national condition applies these provisions are
(
maximum nominal operating pressure of 400 0 kPa )
+100 normative; for other countries they are informative.
Clause 7.2.1 and Table 2: special national condition for
(see prEN 737-3). This pressure can be applied to the
terminal units by the supply system in single fault Austria, Germany, Switzerland.
condition. The requirement to comply with Table 2 does not apply
Evidence will be provided e.g. to a Notified Body until the latest date of withdrawal of the special
during CE conformity assessment and Competent national conditions (2006-07-01) subject to review
Authority upon request. taking into account e.g. the results of a forthcoming
European study and the ongoing European
B.5.4.1.3 See B.5.4.1.2. standardization activities of the EN 1089 series.
B.5.4.1.4 The values of 640 kPa and 1 200 kPa are
derived from the range of nominal operating pressure
( +200
)
of 800 0 kPa and from the maximum allowable
deviation of ± 20 % of the nominal distribution pressure
(see prEN 737-3).

 BSI 1998
Page 14
EN 737-1:1998

Annex ZA (informative)
Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association and supports essential requirements of EU Directive 93/42/EEC.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
The following clauses of this standard (see Table ZA.1) are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the specific essential
requirements of the Directive concerned and associated EFTA regulations.

Table ZA.1 Ð Correspondence between this European Standard and EU Directives


Clause/subclause/annex of this Corresponding essential requirement Comments
European Standard of Directive 93/42/EEC
Section 5 1
Section 6 1
5.1 6
5.2 2
5.3 2
5.3.1 7.1, 7.2, 7.3, 9.3
5.3.2 4, 7.1, 9.2
5.3.3 3, 5
5.3.4 2, 3, 4, 5, 7.1, 7.3, 9.2, 9.3
5.4 2, 3, 4
5.4.1 9.1, 9.2
5.4.1.2 12.7.1
5.4.1.5 12.7.1
5.4.2 9.1, 12.7.4
5.4.3 12.7.4
5.4.4 9.1, 12.7.4
5.4.5 12.8.2
5.4.6 12.8.2
5.4.7 9.1, 12.7.4
5.4.8 12.7.4
5.4.9 12.7.4
5.4.10 12.7.4
5.4.11 12.7.4
5.4.12 9.2, 12.7.4
5.4.13 9.2, 12.7.4
5.4.14 12.7.1, 12.7.4
5.4.15 7.5, 12.7.4
5.4.16 12.7.4
5.4.17 12.7.4
5.5.1 9.3
5.5.2 9.3

 BSI 1998
Page 15
EN 737-1:1998

Table ZA.1 Ð Correspondence between this European Standard and EU Directives (continued)
Clause/subclause/annex of this Corresponding essential requirement Comments
European Standard of Directive 93/42/EEC
6 12.7.4
6.2 2, 3, 4
6.3 2, 3, 4
6.4 2, 3, 4, 9.2
6.5 2, 3, 4, 9.2
6.6 2, 3, 4, 12.7.1
6.7 2, 3, 4, 7.5
6.8 2, 3, 4
6.9 2, 3, 4
6.10 13.2
7.1 13.2
7.1.3 13.1, 13.3a), 13.3d), 13.5
7.2 13.2
7.3 3
7.3.1 5, 7.2, 7.6
7.3.2 13.1, 13.3b)
8.1 13.1, 13.3a), 13.4, 13.6a)
8.2 7.6, 9.1, 12.7.4, 13.6c), d)
8.3 2, 13.1
8.3 1st dash 9.3
8.3 2nd dash 9.2
8.3 3rd dash 9.1, 12.7.4, 13.6c)

 BSI 1998
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