Академический Документы
Профессиональный Документы
Культура Документы
| BS EN
|
|
|
737-1:1998
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical gas pipeline |
|
|
|
|
|
systems Ð |
|
|
|
|
|
|
|
|
Part 1: Terminal units for compressed |
|
|
medical gases and vacuum |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The European Standard EN 737-1:1998 has the status of a |
British Standard |
|
|
|
|
|
|
|
|
ICS 11.040.10; 23.040.60 |
|
|
|
|
|
|
|
|
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
|
|
|
|
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 BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new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time BS 5682:1998 will be withdrawn.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:
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.
BSI 1998
Descriptors: Gas distribution, medical gases, compressed gas, junctions, definitions, design, equipment specifications, mechanical
properties, tests, marking, colour codes, packing
English version
CEN
European Committee for Standardization
Comite EuropeÂen de Normalisation
EuropaÈisches Komitee fuÈr Normung
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
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
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
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
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
BSI 1998
Page 11
EN 737-1:1998
BSI 1998
Page 12
EN 737-1:1998
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
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.
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
|
|
|
|
|
|
|
|
|
BSI Ð British Standards Institution
|
|
|
|
|
|
| BSI is the independent national body responsible for preparing British Standards. It
|
| presents the UK view on standards in Europe and at the international level. It is
| incorporated by Royal Charter.
|
|
| Revisions
|
|
| British Standards are updated by amendment or revision. Users of British Standards
|
| should make sure that they possess the latest amendments or editions.
|
|
| It is the constant aim of BSI to improve the quality of our products and services. We
|
| would be grateful if anyone finding an inaccuracy or ambiguity while using this
| British Standard would inform the Secretary of the technical committee responsible,
|
| the identity of which can be found on the inside front cover. Tel: 020 8996 9000.
|
| Fax: 020 8996 7400.
|
|
| BSI offers members an individual updating service called PLUS which ensures that
|
| subscribers automatically receive the latest editions of standards.
|
|
| Buying standards
|
| Orders for all BSI, international and foreign standards publications should be
|
| addressed to Customer Services. Tel: 020 8996 9001. Fax: 020 8996 7001.
|
|
| In response to orders for international standards, it is BSI policy to supply the BSI
|
| implementation of those that have been published as British Standards, unless
|
| otherwise requested.
|
|
| Information on standards
|
| BSI provides a wide range of information on national, European and international
|
| standards through its Library and its Technical Help to Exporters Service. Various
|
| BSI electronic information services are also available which give details on all its
|
| products and services. Contact the Information Centre. Tel: 020 8996 7111.
|
| Fax: 020 8996 7048.
|
|
| Subscribing members of BSI are kept up to date with standards developments and
| receive substantial discounts on the purchase price of standards. For details of
|
| these and other benefits contact Membership Administration. Tel: 020 8996 7002.
|
| Fax: 020 8996 7001.
|
|
| Copyright
|
|
| Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of
|
| the publications of the international standardization bodies. Except as permitted
| under the Copyright, Designs and Patents Act 1988 no extract may be reproduced,
|
| stored in a retrieval system or transmitted in any form or by any means ± electronic,
|
| photocopying, recording or otherwise ± without prior written permission from BSI.
|
|
| This does not preclude the free use, in the course of implementing the standard, of
|
| necessary details such as symbols, and size, type or grade designations. If these
|
| details are to be used for any other purpose than implementation then the prior
| written permission of BSI must be obtained.
|
|
| If permission is granted, the terms may include royalty payments or a licensing
|
| agreement. Details and advice can be obtained from the Copyright Manager.
|
| Tel: 020 8996 7070.
|
|
|
|
|
|
|
|
|
BSI |
|
389 Chiswick High Road |
|
London |
|
W4 4AL |
|
|
|
|
|
|