SIST EN ISO 10524-4:2008

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

This part of ISO 10524 applies to the types of low-pressure regulators listed in 1.2 and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients: - oxygen; - nitrous oxide; - medical air; - helium; - carbon dioxide; - xenon; - specified mixtures of the gases listed above; - air for driving surgical tools; - nitrogen for driving surgical tools; - oxygen-enriched air. The types of low-pressure regulators covered by this part of ISO 10524 are as follows: a) low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; b) low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of complying with ISO 7396-1; b) low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1; c) low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3; d) operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 4: Niederdruckminderer (ISO 10524-4:2008)

1.1   Dieser Teil von ISO 10524 gilt für die unter 1.2 aufgeführten Arten von Niederdruckminderern und ist für die Anwendung der folgenden medizinischen Gase bei Behandlung, Management, Diagnosebewertung und Pflege von Patienten bestimmt:
-   Sauerstoff;
-   Distickstoffoxid (Lachgas);
-   medizinische Luft;
-   Helium;
-   Kohlendioxid;
-   Xenon;
-   festgelegte Gemische der oben genannten Gase;
-   Luft zum Antrieb chirurgischer Instrumente;
-   Stickstoff zum Antrieb chirurgischer Instrumente;
-   mit Sauerstoff angereicherte Luft.
1.2   In diesem Teil von ISO 10524 werden folgende Arten von Niederdruckminderern behandelt:
a)   Niederdruckminderer, die an Entnahmestellen von Rohrverteilersystemen für medizinische Gase nach EN ISO 7396 1 angeschlossen werden sollen;
b)   Niederdruckminderer mit eingebauten Durchflussmessgeräten, die an Entnahmestellen von Rohrverteiler¬systemen für medizinische Gase nach ISO 7396 1 angeschlossen werden sollen;
c)   Niederdruckminderer, die an Entnahmestellen angeschlossen werden sollen, die an Druckminderern nach ISO 10524-1 oder ISO 10524-3 angebracht sind;
d)   vom Anwender einstellbare Niederdruckminderer für Luft oder Stickstoff zum Antrieb chirurgischer Instrumente, die ein untrennbarer Bestandteil eines Rohrverteilersystems für medizinische Gase nach ISO 7396 1 sind.
1.3   Diese Norm gilt nicht für Niederdruckminderer, die fester Bestandteil von Anästhesie  und Beatmungsgeräten sind.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 4: Détendeurs a basse pression (ISO 10524-4:2008)

L'ISO 10524-4:2008 s'applique aux types de détendeurs basse pression indiqués ci-dessous et destinés à administrer les gaz médicaux suivants dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et du soin des patients:
oxygène;
protoxyde d'azote;
air médical;
hélium;
dioxyde de carbone;
xénon;
mélanges des gaz cités ci-dessus;
air pour les instruments chirurgicaux;
azote pour les instruments chirurgicaux;
air enrichi en oxygène.
Les types de détendeurs à basse pression couverts par l'ISO 10524-4:2008 sont
les détendeurs basse pression, destinés à être branchés à des prises murales de systèmes de distribution de gaz médicaux, conformes à l'ISO 7396-1,
les détendeurs basse pression, avec débitmètres intégrés, destinés à être branchés à des prises murales de systèmes de distribution de gaz médicaux, conformes à l'ISO 7396-1,
les détendeurs basse pression, destinés à être branchés à des prises murales reliées à des détendeurs de pression conformes à l'ISO 10524-1 ou à l'ISO 10524-3,
les détendeurs basse pression, réglables par un opérateur, pour l'air ou l'azote pour les instruments chirurgicaux, et qui font partie intégrante d'un système de distribution de gaz médicaux, conforme à l'ISO 7396-1.

Tlačni regulatorji za medicinske pline - 4. del: Nizkotlačni regulatorji (ISO 10524-4:2008)

General Information

• Status: Published
• Publication Date: 11-Aug-2008
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 23.060.40 - Pressure regulators
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jul-2008
• Due Date: 05-Sep-2008
• Completion Date: 12-Aug-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10524-4:2008 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

Relations

• Replaces: SIST EN 738-4:2000 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
• Effective Date: 01-Sep-2008
• Replaces: SIST EN 738-4:2000/A1:2002 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
• Effective Date: 22-Dec-2008
• Parent: SIST EN ISO 10524-1:2006 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10524-4:2008
01-september-2008
1DGRPHãþD
SIST EN 738-4:2000
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO1L]NRWODþQLUHJXODWRUML,62

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO
10524-4:2008)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 4: Niederdruckminderer
(ISO 10524-4:2008)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 4: Détendeurs a basse
pression (ISO 10524-4:2008)
Ta slovenski standard je istoveten z: EN ISO 10524-4:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN ISO 10524-4:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10524-4:2008

---------------------- Page: 2 ----------------------

SIST EN ISO 10524-4:2008
EUROPEAN STANDARD
EN ISO 10524-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2008
ICS 11.040.10 Supersedes EN 738-4:1998
English Version
Pressure regulators for use with medical gases - Part 4: Low-
pressure regulators (ISO 10524-4:2008)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
4: Détendeurs basse pression (ISO 10524-4:2008) Teil 4: Niederdruckminderer (ISO 10524-4:2008)
This European Standard was approved by CEN on 29 May 2008.
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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-4:2008: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 10524-4:2008
EN ISO 10524-4:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 10524-4:2008
EN ISO 10524-4:2008 (E)
Foreword
This document (EN ISO 10524-4:2008) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic
and respiratory equipment" in collaboration with 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 December 2008, and conflicting national standards shall be withdrawn
at the latest by June 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 738-4:1998.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10524-4:2008 has been approved by CEN as a EN ISO 10524-4:2008 without any
modification.
3

---------------------- Page: 5 ----------------------

SIST EN ISO 10524-4:2008
EN ISO 10524-4:2008 (E)
Annex ZA
(informative)

Correspondence between this International Standard and Directive
93/42/EEC

This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC on Medical devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC, Medical
devices

Essential Requirements (ERs) of EU Qualifying remarks/Notes
Clause(s)/Subclause(s) of
Directive 93/42/EEC
this International Standard
5 1
5.1 2 - 6
5.1.2 9.1 - 12.7.4
5.2 2
5.3 2
5.3.1 7.1 – 7.3 – 9.3
5.3.2 7.3 – 9.3
5.3.3 4 – 7.1 – 9.2
5.3.4 3 – 5
5.3.5 7.1 – 7.2
5.4 2 – 3 – 4
5.4.1 9.2
5.4.2.1 10.2 – 10.3
5.4.2.3 10.2
5.4.3 9.1 – 12.7.4
5.4.4 9.1 – 12.7.4
5.4.6 12.7.1
5.4.7 7.2 – 7.6
5.4.8 7.5
5.4.9 7.5 – 9.2 – 12.7.1
5.4.10.1 12.8.1 – 12.8.2
5.4.10.2 10.2
4

---------------------- Page: 6 ----------------------

SIST EN ISO 10524-4:2008
EN ISO 10524-4:2008 (E)

Clause(s)/Subclause(s) of this Essential Requirements (ERs) of EU Qualifying remarks/Notes
International Standard Directive 93/42/EEC
5.4.10.3 10.1 – 12.8.1 – 12.8.2
5.4.10.4 10.1 – 12.8.1 – 12.8.2
5.4.10.5 12.8.1 – 12.8.2
5.4.11.1 10.1 – 10.3 – 12.8.1 – 12.8.2
5.4.11.2 10.1 – 12.8.1 – 12.8.2
5.4.11.3 10.1 – 12.8.1 – 12.8.2
5.4.12 10.1 – 12.8.1 – 12.8.2
5.5.1 7.2 – 9.3
5.5.2 9.3
6 7.5 – 9.2 –– 9.3 – 12.8.1 – 12.8.2
7.1 13.1 – 13.2

st
13.1
7.1.2, 1 dash
nd
13.1
7.1.2, 2 dash
rd
13.3 d)
7.1.2, 3 dash
st
13.1
7.1.4, 1 dash
7.1.6 12.9
7.2 13.2
7.3 3 - 5
7.3.1 5 – 7.2 – 7.6
7.3.3 13.1 – 13.3 b)
8.1 and 8.2 13.1 – 13.3 a) – 13.4 – 13.6 a)
8.3 9.1 – 9.3 – 13.6 l)

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.


5

---------------------- Page: 7 ----------------------

SIST EN ISO 10524-4:2008

---------------------- Page: 8 ----------------------

SIST EN ISO 10524-4:2008

INTERNATIONAL ISO
STANDARD 10524-4
First edition
2008-06-01

Pressure regulators for use with medical
gases —
Part 4:
Low-pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 4: Détendeurs basse pression




Reference number
ISO 10524-4:2008(E)
©
ISO 2008

---------------------- Page: 9 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.


COPYRIGHT PROTECTED DOCUMENT


©  ISO 2008
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2008 – All rights reserved

---------------------- Page: 10 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 * Normative references.2
3 Terms and definitions .2
4 Nomenclature.4
5 General requirements.4
5.1 Safety .4
5.2 Alternative construction .4
5.3 Materials .5
5.4 Design requirements .5
5.5 Constructional requirements.12
6 Test methods.13
6.1 General.13
6.2 Test conditions .13
6.3 Test method for outlet pressure.13
6.4 Test methods for leakage .14
6.5 Test method for mechanical strength.15
6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges .15
6.7 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges .15
6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices .15
6.9 Test method for loosening torque .15
6.10 Test method for durability of markings and colour coding .15
7 Marking, colour coding, packaging .16
7.1 Marking .16
7.2 Colour coding.17
7.3 Packaging .17
8 Information to be supplied by the manufacturer.17
Annex A (informative) Typical examples of low-pressure regulators.19
Annex B (informative) Rationale .24
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases.26
Annex D (informative) Environmental aspects.28
Bibliography .30

© ISO 2008 – All rights reserved iii

---------------------- Page: 11 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10524-4 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
ISO 10524 consists of the following parts, under the general title Pressure regulators for use with medical
gases:
⎯ Part 1: Pressure regulators and pressure regulators with flow-metering devices
⎯ Part 2: Manifold and line pressure regulators
⎯ Part 3: Pressure regulators integrated with cylinder valves
⎯ Part 4: Low-pressure regulators
iv © ISO 2008 – All rights reserved

---------------------- Page: 12 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
Introduction
A low-pressure regulator is used to reduce the pressure in a medical gas pipeline system to a lower pressure
suitable for use with medical equipment or for delivery of gas directly to a patient.
These functions cover a range of inlet and outlet pressures and flows which require specific design
characteristics. It is important that the operating characteristics of low-pressure regulators are appropriately
specified for their intended use and then tested in a defined manner.
A low-pressure regulator may be coupled to a device that controls the flow, such as a flow control valve or a
fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge.
It is essential that regular inspection and maintenance are undertaken to ensure that low-pressure regulators
continue to meet the requirements of this part of ISO 10524.
This part of ISO 10524 pays particular attention to:
⎯ safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition);
⎯ suitability of materials;
⎯ gas specificity;
⎯ accuracy;
⎯ cleanliness;
⎯ testing;
⎯ marking;
⎯ information supplied by the manufacturer.
Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The clauses
and subclauses marked with an asterisk (*) after their number have corresponding rationale contained in
Annex B, included to provide additional insight into the reasoning that led to the requirements and
recommendations that have been incorporated in this document. It is considered that knowledge of the
reasons for the requirements will not only facilitate the proper application of this part of ISO 10524, but will
expedite any subsequent revisions.

© ISO 2008 – All rights reserved v

---------------------- Page: 13 ----------------------

SIST EN ISO 10524-4:2008

---------------------- Page: 14 ----------------------

SIST EN ISO 10524-4:2008
INTERNATIONAL STANDARD ISO 10524-4:2008(E)

Pressure regulators for use with medical gases —
Part 4:
Low-pressure regulators
1 Scope
1.1 This part of ISO 10524 applies to the types of low-pressure regulators listed in 1.2 and intended to be
used with the following medical gases in the treatment, management, diagnostic evaluation and care of
patients:
⎯ oxygen;
⎯ nitrous oxide;
⎯ medical air;
⎯ helium;
⎯ carbon dioxide;
⎯ xenon;
⎯ specified mixtures of the gases listed above;
⎯ air for driving surgical tools;
⎯ nitrogen for driving surgical tools;
⎯ oxygen-enriched air.
1.2 The types of low-pressure regulators covered by this part of ISO 10524 are as follows:
a) low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems
complying with ISO 7396-1;
b) low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of
medical gas pipeline systems complying with ISO 7396-1;
c) low-pressure regulators intended to be connected to terminal units attached to pressure regulators
complying with ISO 10524-1 or ISO 10524-3;
d) operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral
part of a medical gas pipeline system complying with ISO 7396-1.
1.3 This part of ISO 10524 does not apply to low-pressure regulators integrated within anaesthetic and
respiratory equipment.
© ISO 2008 – All rights reserved 1

---------------------- Page: 15 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
2 * Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and
vacuum
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure
regulators with flow-metering devices
ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with
cylinder valves
ISO 11114-3:1997, Transportable gas cylinders — Compatibility of cylinder and valve materials with gas
contents — Part 3: Autogenous ignition test in oxygen atmosphere
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 837-1, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
EN 1089-3:2004, Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour
coding
EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accuracy of flow
difference between the indicated value and the actual value of the flow expressed in percent
3.2
adjustable pressure regulator
pressure regulator that is provided with a means of operator adjustment of the outlet pressure
3.3
flow outlet
outlet intended to deliver a controlled flow of gas
3.4
flowgauge
device that measures pressure and that is calibrated in units of flow
NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice.
2 © ISO 2008 – All rights reserved

---------------------- Page: 16 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
3.5
flowmeter
device that measures and indicates the flow of a specific gas or gas mixture
3.6
flow-metering device
device fitted with an inlet connector and an outlet connector and that incorporates one of the following:
a) a flowmeter with a flow control valve;
b) a flowgauge and a fixed orifice with a flow control valve;
c) one or more fixed orifices with a means of selection
3.7
gas-specific
having characteristics that prevent connection between different gas services
3.8
gas-specific connection point
that part of the terminal unit that is the receptor for a gas-specific probe
3.9
low pressure
pressure of 2 000 kPa or less
3.10
maximum inlet pressure
p
m
maximum upstream pressure specified by the manufacturer for which the pressure regulator is intended to be
used
3.11
nominal outlet pressure
p
2
nominal downstream pressure
NOTE p is specified by the manufacturer in the instructions for use for a pressure regulator with pressure outlet(s).
2
3.12
medical gas pipeline system
complete system that comprises a supply system, a monitoring and alarm system and a distribution system
with terminal units at the points where medical gases or vacuum may be required
3.13
nipple
that portion of a connector that is pushed into and secured within the bore (lumen) of a hose
3.14
orifice
restriction of known cross section that delivers a constant flow of gas when supplied with gas at a constant
upstream pressure
NOTE An orifice does not provide an indication of flow.
3.15
pipeline distribution system
that portion of a medical gas or vacuum pipeline system linking the sources of supply of the supply system to
the terminal units
© ISO 2008 – All rights reserved 3

---------------------- Page: 17 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
3.16
preset pressure regulator
pressure regulator that is not provided with a means of operator adjustment of the outlet pressure
3.17
pressure gauge
device that measures and indicates pressure
3.18
pressure outlet
outlet intended to deliver gas at a controlled pressure
3.19
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.20
single-fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is present
[IEC 60601-1:2005, definition 3.116]
4 Nomenclature
Examples of low-pressure regulators with terminology are given in Annex A.
5 General requirements
5.1 Safety
5.1.1 Low-pressure regulators shall, when transported, stored, installed, operated in normal use and
maintained according to the instructions of the manufacturer, present no risks that are not reduced to an
acceptable level using risk management procedures in accordance with ISO 14971 and which is connected
with their intended application, in normal condition and in single fault condition.
5.1.2 Following exposure for 5 min to the maximum pressure under single-fault condition allowed by
ISO 7396-1, a low-pressure regulator shall meet the requirements of this part of ISO 10524 when the pressure
is reduced to maximum inlet pressure, p . These pressures are 1 000 kPa for gases other than air or nitrogen
m
for driving surgical tools and 2 000 kPa for air or nitrogen for driving surgical tools.
5.2 Alternative construction
Low-pressure regulators and components or parts thereof, using materials or having forms of construction
different from those detailed in 5.3 shall be presumed to be in compliance with the safety objectives of this
part of ISO 10524 if it can be demonstrated that an equivalent degree of safety is obtained (i.e. compliance
with requirements presumes that risks have been mitigated to acceptable levels) unless objective evidence to
the contrary becomes available. Evidence of an equivalent degree of safety shall be provided by the
manufacturer upon request. Objective evidence may be obtained by postmarket surveillance.
NOTE 1 Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.
NOTE 2 Attention is drawn to ISO 14971 on risk management and to the International Standards, under development
by ISO/TC 210, on risk evaluation and risk control.
4 © ISO 2008 – All rights reserved

---------------------- Page: 18 ----------------------

SIST EN ISO 10524-4:2008
ISO 10524-4:2008(E)
5.3 Materials
5.3.1* The materials in contact with the medical gases listed in 1.1, during normal use, shall be resistant to
corrosion and compatible with oxygen, the other medical gases and their mixtures in the temperature range
specified in 5.3.3.
NOTE 1 Corrosion resistance includes resistance to moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air burn
violently in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure.
Similarly, materials that can be ignited in air require lower ignition energies in oxygen. Many such materials can be ignited
by friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a
system initially at low pressure. For low-pressure regulators the risk of ignition by adiabatic compression is reduced in
comparison with pressure regulators covered in other parts of ISO 10524 because of the lower pressures involved.
NOTE 3 ISO 15001 contains information on selection of metallic and non-metallic materials and other aspects of
compatibility of equipment with oxygen.
5.3.2* For low-pressure regulators for all gases, the auto-ignition temperature of the non-metallic
components in contact with the gas, including the sealing materials and lubricants (if used), shall not be lower
than 160 °C.
Evidence of conformity with this requirement shall be provided by the manufacturer upon request.
NOTE 1 Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.
The determination of the auto-ignition temperature shall be carried out in accordance with ISO 11114-3.
NOTE 2 The maximum permitted operating temperature of tested material is 100 °C lower than the auto-ignition
temperature at the corresponding oxygen pressure. This safety margin is necessary because it covers both an unforeseen
increase in the operating temperature and the fact that the auto-ignition temperature is not a constant. Values of the auto-
ignition temperature always depend on the test method used, which does not exactly simulate all possible operating
conditions.
5.3.3 The materials shall permit the low-pressure regulator and its components to meet the req
...