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BRITISH STANDARD

Medical gas pipeline


systems
Part 1: Terminal units for compressed
medical gases and vacuum
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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

Copyright British Standards Institution


Provided by IHS under license with BSI
No reproduction or networking permitted without license from IHS

Not for Resale

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BS EN
737-1:1998

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. quick connect
probes, is the subject of EN 737-6, currently in preparation.

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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 BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new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time BS 5682:1998 will be withdrawn.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:
aid enquirers to understand the text;
present to the responsible European committee any enquiries on the
interpretation, or proposals for change, and keep the UK interests informed;
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 International Standards Correspondence Index, or by using the
Find 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


been prepared under the
direction of the Health and
Environment Sector Board, was
published under the authority of
the Standards Board and comes
into effect on 15 June 1998

Amendments issued since publication


Amd. No.

Date

Text affected

BSI 1998

ISBN 0 580 29706 3


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EN 737-1

EUROPEAN STANDARD
NORME EUROPEENNE
EUROPAISCHE 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


Part 1: Terminal units for compressed medical gases and vacuum

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Systemes de distribution de gaz medicaux


Partie 1: Prises murales pour gaz medicaux
comprimes et pour le vide (aspiration)

Rohrleitungssysteme fur medizinische Gase


Teil 1: Entnahmestellen fur medizinische Druckgase
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 Europeen de Normalisation
Europaisches Komitee fur 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
Copyright British Standards Institution
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Page 2
EN 737-1:1998

Foreword

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This European Standard has been prepared by


Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, the secretariat of which is held
by BSI.
This European Standard shall be given the status of a
national standard, either by publication of an identical
text or by endorsement, at the latest by July 1998, and
conflicting national standards shall be withdrawn at
the latest by July 1998.
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(s).
For special national conditions and transition periods
for clause 7.2.1, see annex C.
EN 737 consists of the following parts under the
general title Medical gas pipeline systems:
Part 1: Terminal units for compressed medical gases
and vacuum;
Part 2: Anaesthetic gas scavenging disposal systems;
Part 3: Pipelines for compressed medical gases and
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.

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Contents
Page
2
3
3
3
3
4
5
7
8

Foreword
Introduction
1
Scope
2
Normative references
3
Definitions
4
Terminology
5
General requirements
6
Test methods
7
Marking, colour coding and packaging
8
Information to be supplied by the
manufacturer
Annex A (informative) Bibliography
Annex B (informative) Rationale
Annex C (normative) Special national conditions
Annex ZA (informative) Clauses of this European
Standard addressing essential requirements or other
provisions of EU Directives

9
13
13
13

14

BSI 1998
Not for Resale

Page 3
EN 737-1:1998

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Introduction

It is intended especially to ensure the gas-specific


assembly of terminal units and to prevent their
interchange between different gases.

Terminal units are the points on a medical gas pipeline


system where the operator makes connections and
disconnections for the supply of specified medical
gases to anaesthetic machines, lung ventilators or other
items of medical equipment, and where a wrong
connection may create a hazard to the life of a patient.
It is important that terminal units and their
components are designed, manufactured, installed and
maintained in such a way as to meet the basic
requirements specified in this part of this European
Standard. This part of this European Standard pays
particular attention to:
suitability of materials;
gas-specificity;
cleanliness;
testing;
identification;
information supplied.
In any health care facility, it is strongly recommended
that terminal units of only one type (i.e. with the same
set of dimensions for probe and socket) are used for
any particular gas. During hospital renovation it may
be desirable to upgrade existing medical gas
installations rather than renew them completely.
It is recognized that with modified terminal units it
may not be possible to achieve the flow and pressure
drop requirements of this part of this European
Standard, due to limitations imposed by the pipeline
system itself or by those components of the original
terminal units that remain in the pipeline system.
This part of this European Standard specifies the
provision of information for the installation and testing
of terminal units. Testing after installation is critical to
patient safety and it is essential that terminal units are
not used until full testing in accordance with
prEN 737-3 has been completed.
Rationales for some of the requirements of this part of
this European Standard are given in annex B. These
requirements are indicated by the letter R after the
clause number.

This part of this European Standard incorporates by


dated or undated reference, provisions from other
publications. These normative references are cited at
the appropriate places in the text and the publications
are listed hereafter. For dated references, subsequent
amendments to or revisions of any of these
publications apply to this European Standard only
when incorporated in it by amendment or revision. For
undated references the latest edition of the publication
referred to applies.
prEN 737-3, Medical gas pipeline systems
Part 3: Pipelines for compressed medical gases and
vacuum Basic requirements.
EN 739, Low-pressure hose assemblies for use with
medical gases.
prEN 1441, Medical devices Risk analysis.
ISO 32, Gas cylinders for medical use Marking for
identification of content.
ISO 554, Standard atmospheres for conditioning
and/or testing Specifications.

1 Scope

3 Definitions

1.1 This part of this European Standard specifies


requirements for terminal units intended for use in
medical gas pipeline systems specified in
prEN 737-3 for use with the following medical gases:
oxygen;
nitrous oxide;
air for breathing;
carbon dioxide;
oxygen/nitrous oxide mixture [50 %/50 % (V/V)];
air for driving surgical tools;
nitrogen for driving surgical tools;
vacuum.

For the purposes of this part of this European


Standard, the following definitions apply.

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1.2 This part of this European Standard also specifies


requirements for:
terminal units for the supply and disposal of air
for driving surgical tools;
probes intended to be connected to the
gas-specific connection point which is part of a
terminal unit;
1.3 This part of this European Standard does not
specify:
the dimensions of probes and of the gas-specific
connection points of the terminal unit
(see prEN 737-6);
the dimensions of NIST connectors (see EN 739);
requirements for terminal units for anaesthetic
gas scavenging systems (see EN 737-4).

2 Normative references

3.1
gas-specific
having characteristics which prevent interchangeability
and thereby allow assignment to one gas or vacuum
service only
3.2
gas-specific connection point
that part of the socket which is the receptor for a
gas-specific probe

Page 4
EN 737-1:1998

3.4
low-pressure hose assembly
assembly which consists of a flexible hose with
permanently-attached gas-specific inlet and outlet
connectors which is designed to conduct a medical gas
at pressures between 300 kPa and 1 400 kPa and for use
with a vacuum service at pressures above 10 kPa
absolute (see EN 739)
3.5
medical gas
any gas or mixture of gases intended to be
administered to patients for therapeutic, diagnostic or
prophylactic purposes or for surgical tool application
3.6
medical gas pipeline system
central supply system with control equipment, a
pipeline distribution system and terminal units at the
points where medical gases or vacuum are required
3.7
medical gas supply system
either:
a) a medical gas pipeline system; or
b) any other installation having no permanent
pipeline system but employing a medical gas supply
source complete with pressure regulators
3.8
NIST connectors; non-interchangeable
screw-threaded connectors
range of male and female components intended to
maintain gas-specificity by the allocation of a set of
different diameters and a left or right hand screw
thread to the mating components for each particular
gas
3.9
nominal distribution pressure
pressure which the pipeline distribution system is
intended to deliver at the terminal units
3.10
probe
non-interchangeable male component designed for
acceptance by and retention in the socket

3.11
quick connector
pair of non-threaded gas-specific components which
can be easily and rapidly joined together by a single
action of one or both hands without the use of tools
3.12
single fault condition
condition in which a single means for protection
against a safety hazard in equipment is defective or a
single external abnormal condition is present
3.13
socket
that part of a terminal unit which is either integral or
attached to the base block by a gas-specific interface
and which contains the gas-specific connection point
3.14
terminal unit
outlet assembly (inlet for vacuum) in a medical gas
supply system at which the operator makes
connections and disconnections
3.15
terminal unit base block
that part of a terminal unit which is attached to the
pipeline distribution system
3.16
terminal unit check valve
valve which remains closed until opened by insertion
of an appropriate probe and which then permits flow
in either direction
3.17
terminal unit for supply and disposal of air for
driving tools
combination of an outlet assembly (for the supply) and
an inlet assembly (for disposal) which are connected
to a supply system and to a disposal system
respectively and at which the operator makes
connections and disconnections by means of a
combined probe
3.18
terminal unit maintenance valve
valve which permits maintenance of the terminal unit
without shutting down the pipeline system to other
terminal units

4 Terminology
A diagram of a typical terminal unit with examples of
terminology is given in Figure 1.

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BSI 1998
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3.3
gas-specific connector
NIST (non-interchangeable screw-threaded) connector
(see EN 739) or a probe (see prEN 737-6)

Page 5
EN 737-1:1998

5 General requirements
5.1 Safety
Terminal units shall, when transported, stored,
installed, operated in normal use and maintained
according to the instructions of the manufacturer,
cause no safety hazard which could be foreseen using
risk analysis procedures in accordance with
prEN 1441 and which is connected with their intended
application, in normal condition and in single fault
condition.
5.2 R Alternative construction
Terminal units and components or parts thereof, using
materials or having forms of construction different
from those detailed in clause 5 of this part of this
standard shall be accepted if it can be demonstrated
that an equivalent degree of safety is obtained.
Such evidence shall be provided by the manufacturer.
See annex C for special national conditions and
transition periods.
5.3 Materials
5.3.1 The materials in contact with the gas shall be
compatible with oxygen, the other medical gases and
their mixtures in the temperature range specified
in 5.3.2.
NOTE 1 Corrosion resistance includes resistance against
moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility
and ease of ignition. Materials which burn in air will burn violently
in pure oxygen. Many materials which do not burn in air will do
so in pure oxygen, particularly under pressure. Similarly, materials
which can be ignited in air require lower ignition energies for
ignition in oxygen. Many such materials may be ignited by
adiabatic compression produced when oxygen at high pressure is
rapidly introduced into a system initially at low pressure.
NOTE 3 A standard, Compatibility of medical equipment with
oxygen, is in preparation by ISO/TC 121/SC6.

5.3.2 The materials shall permit the terminal units and


their components to meet the requirements of 5.4 in
the temperature range of 220 C to +60 C.
5.3.3 Terminal units shall be capable, while packed
for transport and storage, of being exposed to
environmental conditions as stated by the
manufacturer.
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
manufacturer.
5.4 Design requirements
5.4.1 Medical gas supply pressure
5.4.1.1 R Terminal units for oxygen, nitrous oxide, air
for breathing, carbon dioxide and oxygen/nitrous oxide
mixture 50 %/50 % (V/V) shall operate and meet the
requirements of this part of this European Standard for
a medical gas supply having a pressure range
from 320 kPa to 600 kPa.

--`,``-`-`,,`,,`,`,,`---

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5.4.1.2 R Terminal units for oxygen, nitrous oxide, air


for breathing, carbon dioxide and oxygen/nitrous oxide
mixture 50 %/50 % (V/V) shall not create a hazard to the
patient or operator at an inlet pressure of 1 000 kPa.
Evidence shall be provided by the manufacturer.
5.4.1.3 R Terminal units for oxygen, nitrous oxide, air
for breathing, carbon dioxide and oxygen/nitrous oxide
mixture 50 %/50 % (V/V) shall meet the requirements
of 5.4.1.1 following exposure to an inlet pressure
of 1 000 kPa for 10 min.
5.4.1.4 R Terminal units for air for driving surgical
tools and nitrogen for driving surgical tools shall
operate and meet the requirements of this part of this
European Standard for a medical gas supply having a
pressure range from 640 kPa to 1 200 kPa.
5.4.1.5 R Terminal units for air for driving surgical
tools and nitrogen for driving surgical tools shall not
create a hazard to the patient or operator at an inlet
pressure of 2 000 kPa.
Evidence shall be provided by the manufacturer.
5.4.1.6 R Terminal units for air for driving surgical
tools and nitrogen for driving surgical tools shall meet
the requirements of 5.4.1.4 following exposure to an
inlet pressure of 2 000 kPa for 10 min.
5.4.1.7 R Terminal units for vacuum shall operate and
meet the requirements of this part of this European
Standard for a vacuum supply having a minimum
absolute pressure of 10 kPa.
5.4.2 Terminal units for different pressures
Terminal units for the same gas at different nominal
operating pressures shall have gas-specific connection
points for each pressure (e.g. the supply of air for
driving surgical tools and air for breathing).
5.4.3 Incomplete assembly
If any gas-specific component is removed from the
terminal unit, either the terminal unit shall be rendered
inoperable or the gas-specificity of the terminal unit
shall be maintained.
If the terminal unit can be dismantled, the components
shall not be capable of being reassembled in such a
way that the fully-assembled terminal unit is no longer
gas-specific.
5.4.4 Gas-specific connection point
Each terminal unit shall include a gas-specific
connection point which shall accept the appropriate
gas-specific probe only. This connection point shall be
included in a socket.
5.4.5 Terminal unit check valve
Each terminal unit shall include a check valve which
shall open the gas supply when the probe is connected
and which shall shut off automatically when the probe
is disconnected. The check valve shall be a separate
component or assembly from the maintenance valve
specified in 5.4.6.

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Page 6
EN 737-1:1998

5.4.6 Terminal unit maintenance valve


Except for vacuum services, each terminal unit shall
be equipped with a maintenance valve, which can be
manual or automatic. The maintenance valve shall be a
separate component or assembly from the check valve
specified in 5.4.5.
5.4.7 Connection of terminal units to the pipeline
NOTE See also 8.2.

5.4.7.1 The base block of a terminal unit shall be


designed and manufactured for either permanent or
gas-specific connection to a pipeline.
5.4.7.2 Except for connection to a disposal system,
connection to a pipeline distribution system shall be by
brazing, welding or by means of a NIST body and shall
comply with prEN 737-3.
5.4.7.3 Connection to a low-pressure flexible
connecting assembly shall be either by direct ferruling
or by means of a NIST body and shall comply
with EN 739.
5.4.8 Socket
The arrangement for attaching a socket to its base
block for a particular service shall be of a design
which prevents interchangeability with the base block
of any other service.
5.4.9 Testing
Compliance with clauses 5.4.2 to 5.4.8 shall be tested
by visual inspection.
5.4.10 Endurance (connection/release)
5.4.10.1 Socket
The socket shall meet the requirements given
in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16
and 5.4.17 after testing in accordance with
clause 6.2.1.
5.4.10.2 Probe
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
and 5.4.17 after testing in accordance with 6.2.2.

5.4.11 R Pressure drop


The pressure drop across the terminal unit and its
probe shall not exceed the values given in Table 1.
For terminal units for supply and disposal of air for
driving surgical tools, the pressure drop across the
outlet assembly shall not exceed the value given in
Table 1; the pressure drop across the inlet assembly
shall not exceed 25 kPa with a back pressure not
exceeding 15 kPa.
The test for pressure drop is given in 6.3.
5.4.12 Connection force and torque
The force and the torque required to insert the probe
into the terminal unit shall be:
a) an axial force not exceeding 100 N and/or
b) a torque not exceeding 1 Nm.
The test for connection force and torque is given
in 6.4.
5.4.13 Disconnection force and torque
The force and the torque required to release the
locking mechanism shall be:
a) a push or pull of not more than 110 N and not less
than 20 N and/or
b) a torque of not more than 1 Nm and not less
than 0,1 Nm.
When all locking provisions have been released,
according to the manufacturer's instructions,
disconnection of the probe from the terminal unit shall
require a force of not more than 100 N.
The test for disconnection force and torque is given
in 6.5.
NOTE Danger to personnel can occur as a result of the rapid
expulsion of probes from terminal units. The design should
prevent this from occurring.

5.4.14 Mechanical strength


The terminal unit shall withstand the application of a
steady axial tensile force of not less than 500 N.
The test for mechanical strength is given in 6.6.

Table 1 Requirements for flow and pressure drop across terminal units with probe inserted
Terminal unit nominal
distribution pressure
(see prEN 737-3)

Test pressure

Test flow

Maximum pressure drop


across a terminal unit

kPa

kPa

l/min

kPa

400 to 500
400 to 500
800 to 1 000
Vacuum
1)

320
320
640
401)

60
200
300
40

15
70
70
15

Absolute pressure.

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Page 7
EN 737-1:1998

5.4.15 Leakage
The leakage from a terminal unit with and without the
probe inserted shall not exceed 0,296 ml/min
(0,03 kPa l/min). The test for leakage is given in 6.7.1
and 6.7.2.
The leakage from a terminal unit with the probe
inserted and with side force applied shall not
exceed 0,296 ml/min (0,03 kPa l/min).
The test for leakage with side force applied is given
in 6.7.3.
5.4.16 Gas-specificity
The terminal unit shall only accept the probe for the
medical gas for which it is intended.
The test for gas specificity is given in 6.8.
5.4.17 Effective connection of probes
A tactile or audible indication of locking shall be
perceived on retention of the gas-specific probe.
The test for effective connection of probes is given
in 6.9.
5.5 Constructional requirements
5.5.1 R Cleaning
The components of terminal units for all services shall
be supplied clean and free from oil, grease and
particulate matter.
Evidence shall be provided by the manufacturer.
NOTE 1 Any method of cleaning and degreasing can be used
which effectively removes all surface dirt and hydrocarbons, and
which leaves no residue itself. Chemical cleaning methods will
normally require a subsequent washing and drying process to
remove residues.
NOTE 2 Examples of cleaning procedures will be described in a
standard, Compatibility of medical equipment with oxygen,
which is in preparation by ISO/TC 121/SC6.

5.5.2 R Lubricants
If lubricants are used, they shall be compatible with
oxygen, the other medical gases and their mixtures in
the temperature range specified in 5.3.2.
Evidence shall be provided by the manufacturer.

6 Test methods
6.1 General
6.1.1 Ambient conditions
Except if otherwise stated, carry out tests at
(23 2) C.
6.1.2 Test gas
Carry out tests in accordance with ISO 554 with clean,
oil-free dry air or nitrogen.
In all cases, carry out tests with dry gas with a
maximum moisture content of 50 ppm (parts per
million = 1026) corresponding to a dew point
of 248 C at atmospheric pressure.

--`,``-`-`,,`,,`,`,,`---

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6.1.3 Reference conditions


Correct flows to 23 C and 101,3 kPa.
6.2 Test method for endurance
6.2.1 Socket
Fix the terminal unit to a horizontal or vertical surface,
as appropriate, using the procedure recommended by
the manufacturer.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure
of 600 kPa for all other terminal units. Using a test
probe made of corrosion-resistant steel of minimum
chromium content 17 % and a surface Brinell hardness
of 210 HB 1/30, connect and release the
probe 10 000 times, at a frequency of not more than
10 operations per minute, changing the seals every
1 000 operations or according to the manufacturer's
instructions, whichever is the greater interval.
Test the socket for compliance with 5.4.11, 5.4.12,
5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.
6.2.2 Probe
Fix a terminal unit complying with this part of this
European Standard to a horizontal or vertical surface,
as appropriate, using the procedure recommended by
the manufacturer.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure
of 600 kPa for all other terminal units. Connect and
release the probe 10 000 times, at a frequency of not
more than 10 operations per minute, changing the seals
every 1 000 operations or according to the
manufacturer's instructions, whichever is the greater
interval.
Test the probe for compliance with 5.4.11, 5.4.12,
5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.
6.3 Test method for pressure drop
Using an apparatus of typical configuration shown in
Figure 2 for terminal units for compressed medical
gases, Figure 3 for terminal units for vacuum or
Figure 4 for terminal units for supply and disposal of
air for driving surgical tools, set the test pressure and
flow at the inlet of the terminal unit to the appropriate
values given in Table 1 and in 5.4.11.
Measure the pressure drop across the terminal unit
with the probe inserted.
For terminal units for the supply and disposal of air for
driving surgical tools, measure the pressure drops
across the outlet and inlet assemblies simultaneously.

Page 8
EN 737-1:1998

6.4 Test method for connection force and torque


Adapt a probe to accommodate a suitable measuring
device.
Fix the terminal unit to a horizontal or vertical surface,
as appropriate, using the procedure recommended by
the manufacturer.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure
of 600 kPa for all other terminal units.
In accordance with the manufacturer's instructions,
insert the adapted probe into the terminal unit and
record the force and/or torque required to insert and
engage the probe fully.
6.5 Test method for disconnection force and
torque
Adapt a probe to accommodate a suitable measuring
device.
Fix the terminal unit to a horizontal or vertical surface,
as appropriate, using the procedure recommended by
the manufacturer.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 640 kPa for
terminal units for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure of
320 kPa for all other terminal units.
Insert the adapted probe into the terminal unit in
accordance with the manufacturer's instructions and
ensure that it is fully engaged.
Disconnect the probe in accordance with the
manufacturer's instructions and record the force and/or
torque required to release the locking mechanism.
If the recommended disconnection method involves
applying, for example, compressive force to the probe
to reduce the effort required to disengage the locking
mechanism, measure each separate force/torque
involved.
6.6 Test method for mechanical strength
Adapt a blanked probe in order to apply tensile force.
Fix the terminal unit to a suitable surface using the
procedure recommended by the manufacturer.
Apply a test pressure at the inlet to the base block of
the terminal unit. Use a test pressure of 1 200 kPa for
terminal units for air for driving surgical tools and for
nitrogen for driving surgical tools, or a test pressure
of 600 kPa for all other terminal units.
Insert the adapted probe.
Apply a tensile force of 500 N and hold it for 1 min.
Remove the tensile force, check that the terminal unit
is completely functional and the leakage is according
to 5.4.15.
Dismantle the terminal unit and check that no damage
or distortion has occurred to either the terminal unit
components or the probe.

6.7 Test methods for leakage


6.7.1 Fix the terminal unit to a horizontal or vertical
surface, as appropriate, using the procedure
recommended by the manufacturer.
Apply a test pressure at the inlet of the base block of
the terminal unit. Use the following test pressures.
a) 320 kPa and 600 kPa for terminal units for
compressed medical gases;
b) 640 kPa and 1 200 kPa for terminal units for air
for driving surgical tools and nitrogen for driving
surgical tools;
c) 40 kPa absolute pressure for terminal units for
vacuum.
Measure the leakage under the conditions of maximum
and minimum test pressure.
6.7.2 Keep the terminal unit pressurized as described
in 6.7.1 and insert a gas-specific blanked probe.
Measure the leakage under the conditions of maximum
and minimum test pressure.
6.7.3 Apply a force of 20 N perpendicular to the long
axis of the probe, 50 mm from the outermost surface of
the terminal unit. Measure the leakage whilst the force
is applied to the probe under the conditions of
maximum and minimum test pressure.
6.8 Test method for gas-specificity
Carry out the test by attempting to connect all
gas-specific test probes in turn to the gas-specific
connection point of each socket.
6.9 Test method for effective connection of
probes
Carry out the test by inserting the gas-specific probe
and checking that a tactile or audible indication of
locking is given.
6.10 Test method for durability of markings and
colour coding
Rub markings and colour coding by hand, without
undue pressure, first for 15 s with a cloth rag soaked
with distilled water, then for 15 s with a cloth rag
soaked with methylated spirit and then for 15 s with a
cloth rag soaked with isopropyl alcohol. Carry out this
test at ambient temperature.

7 Marking, colour coding and packaging


7.1 Marking
7.1.1 Terminal units, probes and their gas-specific
components shall be durably and legibly marked with
the symbol of the relevant gas in accordance
with Table 2.
NOTE In addition to the symbol, the name of the gas can be
used.

The test for the durability of markings is given in 6.10.


7.1.2 The height of the lettering shall be at
least 2,5 mm.

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Page 9
EN 737-1:1998

Table 2 Symbols and colour coding for medical gases


Medical gas or mixture

Symbol

Oxygen
Nitrous oxide
Air for breathing
Air for driving surgical tools
Air for driving surgical tools (with disposal)
Nitrogen for driving surgical tools
Carbon dioxide
Mixture of oxygen/nitrous oxide [50 %/50 % (V/V)]
Vacuum
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.

O2
N2O
Air3)
Air: 800
Air: motor
N2: 800
CO2
O2/N2O
Vac3)

7.1.3 Terminal units and probes shall be marked with


the manufacturer's name or identification mark and, if
applicable, with additional means to ensure traceability
such as type, batch or serial number or year of
manufacture.
7.2 Colour coding
7.2.1 If colour coding is used, it shall be in
accordance with Table 2.
See annex C for special national conditions and
transition periods.

Blue1)
Blackwhite1)
Blackwhite1)
Blackwhite1)
Black1)
Grey1)
Whiteblue1)
Yellow2)

8 Information to be supplied by the


manufacturer
8.1 Terminal units shall be accompanied by
documents containing at least a technical description,
instructions for use and an address to which the
operator can refer. The accompanying documents shall
be regarded as a component part of terminal units.
8.2 The manufacturer shall provide instructions for
installation and a reference to the testing procedures
for terminal units given in prEN 737-3.

7.2.2 Colour coding shall be durable. The test for the


durability of colour coding is given in clause 6.10.
7.3 Packaging
7.3.1 Terminal units, gas-specific probes and spare
parts shall be sealed to protect against particulate
contamination and packaged to prevent damage during
storage and transportation.
7.3.2 Packages shall provide a means of identification
of the contents.

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Colour coding

White1)

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8.3 Instructions for use shall include all information


necessary for the operation of the terminal unit in
accordance with its specification and shall include a
description of the procedure for connection and
disconnection of probes.
Instructions for use shall give detailed instructions for
the safe performance of cleaning, inspection and
preventive maintenance to be performed by the
operator or by authorized persons and shall indicate
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.

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 Diagram showing the typical components of a terminal unit

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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 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 Typical apparatus for measuring pressure drop across terminal


units for vacuum

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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


the probe

5) Supply assembly of the terminal unit with the


probe inserted

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

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Page 13
EN 737-1:1998

Annex A (informative)
Bibliography
EN 737-4, Medical gas pipeline systems
Part 4: Terminal units for anaesthetic gas scavenging
systems.
prEN 737-6, Medical gas pipeline systems
Part 6: Dimensions of probes for terminal units for
compressed medical gases and vacuum.
EN 1089, Transportable gas cylinders Gas cylinder
identification (excluding LPG).
SS 01 91 02, Colour atlas.

Annex B (informative)
Rationale

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B.5.2 Evidence will be provided to e.g. a Notified


Body during CE conformity assessment and upon
request to the Competent Authority. Attention is drawn
to prEN 1441 on risk analysis and to the standards
under development by ISO/TC 210 on risk evaluation
and risk control.
B.5.3.4 Evidence of such compatibility will be
provided e.g. to a Notified Body during CE conformity
assessment and Competent Authority upon request.
B.5.4.1.1 The values of 320 kPa and 600 kPa are
derived from the range of nominal operating pressure
+100
of 400 0 kPa and from the maximum allowable
deviation of 20 % of the nominal distribution pressure
(see prEN 737-3).
B.5.4.1.2 The value of 1 000 kPa is equal to 2 times the
+100
maximum nominal operating pressure of 400 0 kPa
(see prEN 737-3). This pressure can be applied to the
terminal units by the supply system in single fault
condition.
Evidence will be provided e.g. to a Notified Body
during CE conformity assessment and Competent
Authority upon request.
B.5.4.1.3 See B.5.4.1.2.
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).

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B.5.4.1.5 The value of 2 000 kPa is equal to 2 times


the maximum nominal distribution pressure of
800 +200
kPa (see prEN 737-3). This pressure can be
0
applied to the terminal units by the supply system in
single fault condition.
Evidence will be provided e.g. to a Notified Body
during CE conformity assessment and Competent
Authority upon request.
B.5.4.1.6 See B.5.4.1.5.
B.5.4.1.7 The value of 10 kPa is the lower limit of the
possible absolute pressure supplied by vacuum pumps.
B.5.4.11 Lung ventilators can require peak flows
of 200 l/min for up to 3 s. Experience shows that such
ventilators can be supplied by terminal units which
meet the requirements of 5.4.11.
B.5.5.1 Evidence of such compatibility will be
provided e.g. to a Notified Body during CE conformity
assessment and Competent Authority upon request.
B.5.5.2 Evidence of such compatibility will be
provided e.g. to a Notified Body during CE conformity
assessment and Competent Authority upon request.

Annex C (normative)
Special national conditions
Special national condition: National characteristic or
practice that cannot be changed even over a long
period, e.g. climatic conditions, electrical earthing
conditions. If it affects harmonization, it forms part of
the European Standard. In the countries in which the
relevant national condition applies these provisions are
normative; for other countries they are informative.
Clause 7.2.1 and Table 2: special national condition for
Austria, Germany, Switzerland.
The requirement to comply with Table 2 does not apply
until the latest date of withdrawal of the special
national conditions (2006-07-01) subject to review
taking into account e.g. the results of a forthcoming
European study and the ongoing European
standardization activities of the EN 1089 series.

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 Correspondence between this European Standard and EU Directives


Clause/subclause/annex of this
European Standard

Section 5
Section 6
5.1
5.2
5.3
5.3.1
5.3.2
5.3.3
5.3.4
5.4
5.4.1
5.4.1.2
5.4.1.5
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
5.4.9
5.4.10
5.4.11
5.4.12
5.4.13
5.4.14
5.4.15
5.4.16
5.4.17
5.5.1
5.5.2

Corresponding essential requirement


of Directive 93/42/EEC

1
1
6
2
2
7.1, 7.2, 7.3, 9.3
4, 7.1, 9.2
3, 5
2, 3, 4, 5, 7.1, 7.3, 9.2, 9.3
2, 3, 4
9.1, 9.2
12.7.1
12.7.1
9.1, 12.7.4
12.7.4
9.1, 12.7.4
12.8.2
12.8.2
9.1, 12.7.4
12.7.4
12.7.4
12.7.4
12.7.4
9.2, 12.7.4
9.2, 12.7.4
12.7.1, 12.7.4
7.5, 12.7.4
12.7.4
12.7.4
9.3
9.3

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Page 15
EN 737-1:1998

Table ZA.1 Correspondence between this European Standard and EU Directives (continued)

6
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
7.1
7.1.3
7.2
7.3
7.3.1
7.3.2
8.1
8.2
8.3
8.3 1st dash
8.3 2nd dash
8.3 3rd dash

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Corresponding essential requirement


of Directive 93/42/EEC

12.7.4
2, 3, 4
2, 3, 4
2, 3, 4, 9.2
2, 3, 4, 9.2
2, 3, 4, 12.7.1
2, 3, 4, 7.5
2, 3, 4
2, 3, 4
13.2
13.2
13.1, 13.3a), 13.3d), 13.5
13.2
3
5, 7.2, 7.6
13.1, 13.3b)
13.1, 13.3a), 13.4, 13.6a)
7.6, 9.1, 12.7.4, 13.6c), d)
2, 13.1
9.3
9.2
9.1, 12.7.4, 13.6c)

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Comments

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Clause/subclause/annex of this
European Standard

BSI
389 Chiswick High Road
London
W4 4AL

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