SIST EN ISO 10524-1:2019

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)

This document specifies the design, construction, type testing, and marking requirements for pressure
regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures
in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving
surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators,
resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable
or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up
to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the
medical gas delivered.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2018)

Dieses Dokument definiert die Anforderungen an die Ausführung, die Konstruktion, die Typprüfung und die Kennzeichnung von DRUCKMINDERERN (wie in 3.18 definiert), die für die Verabreichung medizinischer Gase und ihrer Gemische bei der Behandlung, Führung, diagnostischen Beurteilung und Pflege von Patienten oder für Gase zum Antrieb chirurgischer Instrumente vorgesehen sind.
Beispiele für Gase umfassen Sauerstoff, medizinische Luft und Sauerstoff /Distickstoffoxid Gemische.
Dieses Dokument gilt für DRUCKMINDERER,
a)   die vom Anwender an Gasflaschen angeschlossen werden sollen,
b)   mit fest verbundenen Durchflussmesseinrichtungen, die vom Anwender an Gasflaschen angeschlossen werden sollen,
c)   die fester Bestandteil medizinischer Geräte (z. B. Anästhesie Arbeitsplätze, Beatmungsgeräte, Wiederbelebungsgeräte) sind.
Ein DRUCKMINDERER kann mit einem DRUCKAUSGANG oder DURCHFLUSSAUSGANG ausgestattet und einstellbar oder voreingestellt sein.
DRUCKMINDERER sind für den Anschluss an wiederauffüllbare Gasflaschen mit BETRIEBSDRÜCKEN bis 30 000 kPa (300 bar) vorgesehen und können mit Geräten geliefert werden, die den Durchfluss des abgegebenen medizinischen Gases steuern und messen.

Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-débitmètres (ISO 10524-1:2018)

ISO 10524-1:2018 spécifie la conception, la construction, les essais de type et les exigences de marquage s'appliquant aux détendeurs (tels que définis en 3.18), destinés à l'administration de gaz médicaux et de leurs mélanges dans le cadre du traitement, de la prise en charge, de l'évaluation diagnostique et des soins portés aux patients, ou de gaz destinés aux instruments chirurgicaux.
De tels gaz sont par exemple l'oxygène, l'air médical et les mélanges d'oxygène et de protoxyde d'azote.
ISO 10524-1:2018 s'applique aux détendeurs:
a)    destinés à être branchés sur les bouteilles par l'opérateur;
b)    à débitmètre intégré destinés à être branchés sur les bouteilles par l'opérateur;
c)    qui font partie intégrante d'un matériel médical (par exemple les stations d'anesthésie, les ventilateurs pulmonaires, les appareils de réanimation).
Un détendeur peut être réglable ou préréglé et muni d'une sortie de pression et/ou d'une sortie de débit.
Les détendeurs sont destinés à être connectés sur des bouteilles à gaz rechargeables dont la pression de service peut atteindre 30 000 kPa (300 bar) et peuvent comporter des dispositifs de régulation et de mesure du débit des gaz médicaux délivrés.

Tlačni regulatorji za medicinske pline - 1. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki (ISO 10524-1:2018)

Ta dokument določa projektiranje, konstrukcijo, tipsko preskušanje in zahteve za označevanje tlačnih regulatorjev (kot je določeno v točki 3.18), namenjenih za dovajanje medicinskih plinov in njihovih zmesi pri zdravljenju, upravljanju, diagnostičnem vrednotenju ter oskrbi bolnikov, ali za pline, ki omogočajo uporabo kirurških instrumentov.
Primeri plinov: kisik, medicinski zrak in mešanice kisika/dušikovega oksida.
Ta dokument se uporablja za tlačne regulatorje:
a) namenjene, da jih na cilindre priključi upravljavec;
b) z vgrajenimi pretočnimi merilniki, namenjene, da jih na cilindre priključi upravljavec;
c) ki so del medicinske opreme (npr. delovnih postaj za anestezijo, pljučnih ventilatorjev, naprav za oživljanje).
Tlačni regulator lahko vključujejo izhodno odprtino za tlak ali z odprtino za pretok, lahko pa so prilagodljivi ali predhodno nastavljeni.
Tlačni regulatorji so namenjeni namestitvi na jeklenke, ki jih je mogoče polniti, z delovnim tlakom do 30.000 kPa (300 barov) in lahko vključujejo naprave, ki nadzorujejo in merijo pretok dovajanega medicinskega plina.

General Information

• Status: Published
• Public Enquiry End Date: 09-May-2017
• Publication Date: 18-Mar-2019
• 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: 18-Feb-2019
• Due Date: 25-Apr-2019
• Completion Date: 19-Mar-2019
• 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 10524-1:2019 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)

Relations

• Replaces: 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: 01-Apr-2019
• Amended By: SIST EN ISO 10524-1:2019/oprA1:2023 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1 (ISO 10524-1:2018/DAM 1:2023)
• Effective Date: 07-Dec-2022
• Replaces: 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10524-1:2019
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-1:2006
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL,62
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO 10524-1:2018)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-
débitmètres (ISO 10524-1:2018)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN ISO 10524-1:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10524-1:2019

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SIST EN ISO 10524-1:2019


EN ISO 10524-1
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-1:2006
English Version

Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow-
metering devices (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Druckminderer zur Verwendung mit medizinischen
Partie 1: Détendeurs et détendeurs-débitmètres (ISO Gasen - Teil 1: Druckminderer und Druckminderer mit
10524-1:2018) Durchflussmessgeräten (ISO 10524-1:2018)
This European Standard was approved by CEN on 13 December 2018.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-1:2019 E
worldwide for CEN national Members.

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SIST EN ISO 10524-1:2019
EN ISO 10524-1:2019 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 10524-1:2019
EN ISO 10524-1:2019 (E)
European foreword
This document (EN ISO 10524-1:2019) 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 July 2019, and conflicting national standards shall be
withdrawn at the latest by July 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10524-1:2006.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10524-1:2018 has been approved by CEN as EN ISO 10524-1:2019 without any
modification.

3

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SIST EN ISO 10524-1:2019

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SIST EN ISO 10524-1:2019
INTERNATIONAL ISO
STANDARD 10524-1
Second edition
2018-01
Pressure regulators for use with
medical gases —
Part 1:
Pressure regulators and pressure
regulators with flow-metering devices
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs-débitmètres
Reference number
ISO 10524-1:2018(E)
©
ISO 2018

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SIST EN ISO 10524-1:2019
ISO 10524-1:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2018 – All rights reserved

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SIST EN ISO 10524-1:2019
ISO 10524-1:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 4
5 General requirements . 4
5.1 Safety . 4
5.2 Usability . 4
5.3 Alternative construction . 4
5.4 Materials . 4
6 Design requirements . 5
6.1 General . 5
6.2 Indicator for cylinder pressure or cylinder content . 6
6.2.1 General. 6
6.2.2 Pressure gauges, pressure indicators, and flowgauges . 6
6.3 Integrated electronic device . 6
6.4 Connections . 6
6.4.1 Inlet connector. 6
6.4.2 Outlet connectors . 7
6.5 * Requirements for outlet pressure . 7
6.5.1 Pressure outlet . 7
6.5.2 Flow outlet . 8
6.6 Flow-metering device . 8
6.7 Flow control and indication . 8
6.8 Pressure-adjusting device . 8
6.9 * Filtration . 9
6.10 * Pressure-relief device . 9
6.11 Leakage . 9
6.12 Mechanical strength .10
6.12.1 Resistance of the high-pressure side .10
6.12.2 Resistance of the low-pressure side to pneumatic pressure .10
6.12.3 Resistance of the low-pressure side to inlet pressure, P .10
1
6.13 * Resistance to ignition .10
6.14 Requirements for pressure regulators with flowmeters .10
6.14.1 Calibration .10
6.14.2 Accuracy of flow .10
6.14.3 Stability of flow .11
6.14.4 Legibility .11
6.14.5 Flow control device .11
6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges.11
6.15.1 Calibration .11
6.15.2 Accuracy of flow .11
6.15.3 Stability of flow .11
6.16 Requirements for pressure regulators fitted with fixed orifices .12
6.16.1 Stability and accuracy of flow .12
6.16.2 * Flow setting torque .12
6.16.3 Removal of a fixed orifice .12
6.16.4 Legibility .12
6.17 Endurance .12
6.17.1 Flow selector .12
6.17.2 Pressure regulator .13
© ISO 2018 – All rights reserved iii

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SIST EN ISO 10524-1:2019
ISO 10524-1:2018(E)

7 Construction requirements .13
7.1 * Cleanliness .13
7.2 Lubricants .13
7.3 Loosening torques .13
8 Test methods for type tests .14
8.1 General conditions .14
8.1.1 General.14
8.1.2 Ambient conditions .14
8.1.3 Test gas .14
8.1.4 Reference conditions .14
8.2 Test schedule .14
8.3 Test methods for outlet pressure .16
8.3.1 Test equipment .16
8.3.2 Test methods for determining outlet pressure limits for a pressure
regulator fitted with a pressure outlet .17
8.3.3 Test method for determining the outlet pressure limit for a pressure
regulator fitted with a flow outlet .18
8.4 Test method for a pressure-relief device .18
8.5 Test methods for leakage .18
8.5.1 External leakage .18
8.5.2 Internal leakage .19
8.6 Test method for mechanical strength .19
8.6.1 Test method for the high-pressure side .19
8.6.2 Test method for resistance of the low-pressure side to pneumatic pressure .19
8.6.3 Test method for the resistance of the low pressure side to P .19
1
8.7 Test method for resistance to ignition .20
8.7.1 General.20
8.7.2 Test procedure for adjustable and pre-set pressure regulators .20
8.8 Test method for accuracy of flow of pressure regulators fitted with
flowmeters or flowgauges .20
8.9 Test method for the stability of flow of pressure regulator fitted with
flowmeters or flowgauges .20
8.10 Test method for stability and accuracy of flow of pressure regulators fitted
with fixed orifices .21
8.11 Test method for flow setting and loosening torques .21
8.11.1 General.21
8.11.2 Test method for verifying no stable position between two settings .21
8.12 Test method for durability of markings and colour coding .21
8.13 *Flow selector endurance test.21
8.14 Pressure regulator endurance test .22
9 Marking, colour coding, and packaging .22
9.1 Marking .22
9.2 Colour coding .24
9.3 Packaging .24
10 Information to be supplied by the manufacturer .24
Annex A (informative) Rationale .26
Annex B (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .31
Bibliography .33
iv © ISO 2018 – All rights reserved

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SIST EN ISO 10524-1:2019
ISO 10524-1:2018(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 10524-1:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the common requirements have been aligned with ISO 10524-2 and ISO 10524-3;
— this document has been restructured according to the new ISO template and associated renumbering;
— a complete schedule has been introduced;
— all type tests have been reviewed.
A list of all parts in the ISO 10524 series can be found on the ISO website.
© ISO 2018 – All rights reserved v

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SIST EN ISO 10524-1:2019
ISO 10524-1:2018(E)

Introduction
Pressure regulators are used to reduce high cylinder pressure to a lower pressure suitable for use
with medical equipment or for delivery of gas directly to a patient.
These functions cover a wide range of inlet and outlet pressures and flows which require specific
design characteristics. It is important that the operating characteristics of pressure regulators are
specified and tested in a defined manner.
A pressure regulator normally has coupled to it a device which controls the flow, such as a flow
control device or a fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge.
It is essential that regular inspection and maintenance be undertaken to ensure that the pressure
regulator continues to meet the requirements of this document.
This document pays particular attention to
— use of suitable materials,
— safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition),
— gas specificity,
— cleanliness,
— type testing,
— marking, and
— information supplied by the manufacturer.
Annex A contains rationale statements for some of the requirements of this document. The clauses and
subclauses marked with an asterisk (*) after their number have corresponding rationale included to
provide additional insight into the reasoning that led to the requirements and recommendations that
have been incorporated into this document. It is considered that knowledge of the reasons for the
requirements will not only facilitate the proper application of this document, but will expedite any
subsequent revisions.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
In this document, the following print types are used:
— requirements and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type;
— test specifications: italic type;
— terms defined in clause 3 of this document or as noted: small capitals type.
vi © ISO 2018 – All rights reserved

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SIST EN ISO 10524-1:2019
INTERNATIONAL STANDARD ISO 10524-1:2018(E)
Pressure regulators for use with medical gases —
Part 1:
Pressure regulators and pressure regulators with flow-
metering devices
1 Scope
This document specifies the design, construction, type testing, and marking requirements for pressure
regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures
in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving
surgical tools.
Examples of gases i
...

SLOVENSKI STANDARD
oSIST prEN ISO 10524-1:2017
01-maj-2017
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL,62',6
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO/DIS 10524-1:2017)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO/DIS 10524-1:2017)
Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-
débitmètres (ISO/DIS 10524-1:2017)
Ta slovenski standard je istoveten z: prEN ISO 10524-1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
oSIST prEN ISO 10524-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 10524-1:2017

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oSIST prEN ISO 10524-1:2017
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10524-1
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-02-17 2017-05-11
Pressure regulators for use with medical gases —
Part 1:
Pressure regulators and pressure regulators with flow-
metering devices
Détendeurs pour l’utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs-débitmètres
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10524-1:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017

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oSIST prEN ISO 10524-1:2017
ISO/DIS 10524-1:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 10524-1:2017
ISO/DIS 10524-1:2017(E)
1 Contents
2 Foreword. 7
3 Introduction . 9
4 1 Scope .10
5 2 Normative references .10
6 3 Terms and Definitions .11
7 4 Nomenclature .13
8 5 General Requirements.13
9 5.1 Safety . 13
10 5.2 Usability. 14
11 5.3 Alternative construction. 14
12 5.4 Materials . 14
13 6 Design Requirements .15
14 6.1 General . 15
15 6.2 PRESSURE GAUGES and FLOW GAUGES. 15
16 6.3 Integrated digital gauges. 16
17 6.4 Connections. 16
18 6.5 * Requirements for Outlet pressure. 18
19 6.6 Indicator for cylinder pressure or cylinder content . 18
20 6.7 Flow-metering device. 19
21 6.8 Flow Control and Indication . 19
22 6.9 Pressure-adjusting device. 19
23 6.10 * Filtration . 19
24 6.11 * Pressure relief valve . 20
25 6.12 Leakage . 20
26 6.13 Mechanical strength . 21
27 6.14 * Resistance to ignition . 21
28 6.15 Requirements for PRESSURE REGULATORS with flow-metering device . 21
29 6.16 Requirements for PRESSURE REGULATORS fitted with FLOW GAUGEs. 22
30 6.17 Requirements for PRESSURE REGULATORS fitted with fixed ORIFICEs. 23
31 6.18 Endurance . 23
32 7 Construction Requirements .24
33 7.1 * Cleanliness . 24
34 7.2 Lubricants. 24
35 7.3 Loosening torques . 25
36 8 Test methods for type tests .25

Reference number
Error! Reference source not found.

© ISO 2017

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oSIST prEN ISO 10524-1:2017
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37 8.1 General Conditions . 25
38 8.2 Test Schedule . 26
39 8.3 Test Methods for Outlet Pressure . 27
40 8.4 Test method for PRESSURE RELIEF VALVE . 28
41 8.5 Test methods for leakage . 29
42 8.6 Test method for mechanical strength . 30
43 8.7 Test method for resistance to ignition. 30
44 8.8 Test method for ACCURACY OF FLOW of PRESSURE REGULATORS fitted with FLOW METERs
45 or FLOW GAUGEs. 31
46 8.9 Test method for the stability of flow of PRESSURE REGULATORS fitted with FLOW METERs
47 or FLOW GAUGEs. 31
48 8.10 Test method for stability and ACCURACY OF FLOW of PRESSURE REGULATORS fitted with fixed
49 ORIFICEs. 31
50 8.11 Test method for flow setting and loosening torques . 32
51 8.12 Test method for durability of markings and colour coding. 32
52 8.13 Flow selection mechanism endurance test . 32
53 8.14 PRESSURE REGULATOR endurance test . 33
54 9 Marking, Colour Coding, and Packaging .33
55 9.1 Marking. 33
56 9.2 Colour coding . 35
57 9.3 Packaging . 35
58 10 Information to be supplied by the manufacturer.35
59 10.1 In order to provide the necessary information for safe use, the manufacturer of the VIPR
60 shall make available to his customer(s) the following information: . 35
61 10.2 For a PRESSURE REGULATOR fitted with a PRESSURE OUTLET, the technical description
62 provided shall include evidence (e.g., a table or curve) giving the values of the maximum
63 flow as a function of the inlet pressure and outlet pressure in a range between 1500 kPa
64 and P . 35
1(15)
65 10.3 For a PRESSURE REGULATOR fitted with a FLOW OUTLET, the technical description provided
66 shall include values of the NOMINAL INLET PRESSURE (P ) and the range of flow settings. . 35
1(15)
67 10.4 Instructions for operating the PRESSURE REGULATOR shall include the specification of the
68 PRESSURE REGULATOR inlet connector. . 36
69 10.5 Instructions for operating the PRESSURE REGULATOR shall give detailed information needed
70 for the safe performance including: . 36
71 Annex A (informative) .37
72 Annex B.38
73 Annex C (normative) Reported regional and national deviations of colour coding and
74 nomenclature for medical gases .40
75 Annex D (informative) Terminology-Alphabetized index of defined terms .42
76 Annex ZA (informative) Relationship between this Document and the Essential Requirements of
77 EU Directive 93/42/EEC.43
78 Bibliography .44
79
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80 Foreword
81 ISO (the International Organization for Standardization) is a worldwide federation of national
82 standards bodies (ISO member bodies). The work of preparing International Standards is normally
83 carried out through ISO technical committees. Each member body interested in a subject for which a
84 technical committee has been established has the right to be represented on that committee.
85 International organizations, governmental and non-governmental, in liaison with ISO, also take part in
86 the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
87 matters of electrotechnical standardization.
88 The procedures used to develop this document and those intended for its further maintenance are
89 described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
90 different types of ISO documents should be noted. This document was drafted in accordance with the
91 editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
92 The main task of technical committees is to prepare International Standards. Draft International
93 Standards adopted by the technical committees are circulated to the member bodies for voting.
94 Publication as an International Standard requires approval by at least 75 % of the member bodies
95 casting a vote.
96 Attention is drawn to the possibility that some of the elements of this document may be the subject of
97 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
98 any patent rights identified during the development of the document will be in the Introduction and/or
99 on the ISO list of patent declarations received. www.iso.org/patents
100 Any trade name used in this document is information given for the convenience of users and does not
101 constitute an endorsement.
102 For an explanation on the meaning of ISO specific terms and expressions related to conformity
103 assessment, as well as information about ISO's adherence to the WTO principles in the Technical
104 Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
105 ISO 10524-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
106 Subcommittee SC 6, Medical gas systems.
107 This is the second edition of ISO 10524-1, and should be read in conjunction with ISO 10524-2, 10524-
108 3, and 10524-4.
109 ISO 10524 consists of the following parts, under the general title PRESSURE REGULATORS for use with
110 medical gases:
111  Part 1: PRESSURE REGULATORS and PRESSURE REGULATORS with flow-metering devices
112  Part 2: Manifold and line PRESSURE REGULATORS
113  Part 3: PRESSURE REGULATORS integrated with cylinder valves (VIPRs)
114  Part 4: Low-PRESSURE REGULATORS
115 This edition includes the following significant changes with respect to the previous edition:
116 a) Alignment of common requirements with ISO 10524-2 and ISO 10524-3.
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117 b) Restructuring with the new ISO template and associated renumbering.
118 c) Introduction of a complete test schedule.
119 d) Review of all type tests.
120 In this standard, the following print types are used:
121  Requirements and definitions: roman type.
122  Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
123 Normative text of tables is also in a smaller type.
124  Test specifications: italic type
125  TERMS DEFINED IN CLAUSE 3 OF THIS STANDARD OR AS NOTED: SMALL CAPITALS TYPE.
126 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
127 combination of the conditions is true.
128 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
129 Directives, Part 2. For the purposes of this standard, the auxiliary verb:
130  “shall” means that compliance with a requirement or a test is mandatory for compliance with this
131 standard;
132  “should” means that compliance with a requirement or a test is recommended but is not mandatory
133 for compliance with this standard;
134  “may” is used to describe a permissible way to achieve compliance with a requirement or test.
135 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
136 that there is guidance or rationale related to that item in Annex A.
137 The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing
138 organizations may need a transitional period following publication of a new, amended or revised ISO
139 publication in which to make products in accordance with the new requirements and to equip
140 themselves for conducting new or revised tests. It is the recommendation of the committee that the
141 content of this publication be adopted for implementation nationally not earlier than 3 years from the
142 date of publication for equipment newly designed and not earlier than 5 years from the date of
143 publication for equipment already in production.
144
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145 Introduction
146 PRESSURE REGULATORS are used to reduce high cylinder pressure to a lower pressure suitable for use with
147 medical equipment or for delivery of gas directly to a patient.
148 These functions cover a wide range of inlet and outlet pressures and flows which require specific design
149 characteristics. It is important that the operating characteristics of PRESSURE REGULATORS are specified
150 and tested in a defined manner.
151 A PRESSURE REGULATOR normally has coupled to it a device which controls the flow, such as a flow control
152 device or a fixed ORIFICE. The flow can be indicated by a FLOW METER or by a FLOW GAUGE.
153 It is essential that regular inspection and maintenance be undertaken to ensure that the PRESSURE
154 REGULATOR continues to meet the requirements of this part of ISO 10524.
155 This part of ISO 10524 pays particular attention to:
156  use of suitable materials;
157  safety (mechanical strength, leakage, safe relief of excess pressure and resistance to ignition);
158  GAS SPECIFICity;
159  cleanliness;
160  type testing;
161  marking;
162  information supplied by the manufacturer.
163 Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The
164 clauses and subclauses marked with an asterisk (*) after their number have corresponding rationale
165 included to provide additional insight into the reasoning t hat led to the requirements and
166 recommendations that have been incorporated into this part of ISO 10524. It is considered that
167 knowledge of the reasons for the requirements will not only facilitate the proper application of this part
168 of ISO 10524, but will expedite any subsequent revisions.
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169 PRESSURE REGULATORS for use with medical gases — Part 1: PRESSURE
170 REGULATORS and PRESSURE REGULATORS with flow-metering devices
171 1 Scope
172 This International Standard specifies design, type testing, and marking requirements for PRESSURE
173 REGULATORS (as defined in 3.17) intended for the administration of medical gases in the treatment,
174 management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
175 Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
176 This standard applies to PRESSURE REGULATORS
177 e) intended to be connected to cylinders by the operator;
178 f) with integral flow-metering devices intended to be connected to cylinders by the operator;
179 g) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators,
180 resuscitators).
181 A PRESSURE REGULATOR can be provided with PRESSURE OUTLET or flow outlet, and can be adjustable or
182 pre-set.
183 PRESSURE REGULATORS are intended to be fitted to refillable cylinders with a WORKING PRESSURE up to
184 25 000 kPa (250 bar) and can be provided with devices which control and measure the flow of the
185 medical gas delivered.
186 2 Normative references
187 The following documents, in whole or in part, are normatively referenced in this document and are
188 indispensable for its application. For dated references, only the edition cited applies. For undated
189 references, the latest edition of the referenced document (including any amendments) applies.
190 ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
191 ISO 407:2004, Small medical gas cylinders — Pin-index yoke-type valve connections
192 ISO 5145:2014, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
193 ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols
194 ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and
195 vacuum (new edition)
196 ISO TR 7470:1988, Valve outlets for gas cylinders — List of provisions which are either standardized or in
197 use
198 ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
199 compressed medical gases and vacuum
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200 ISO 10156:2010, Gases and gas mixtures — Determination of fire potential and oxidizing ability for the
201 selection of cylinder valve outlets
202 ISO 10297:—1), Transportable gas cylinders — Cylinder valves — Specification and type testing
203 ISO 14971:2007, Medical devices — Application of risk management to medical devices
204 ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
205 EN 837-1:1996, PRESSURE GAUGEs — Part 1: Bourdon tube PRESSURE GAUGEs — Dimensions, metrology,
206 requirements and testing
207 EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
208 IEC 60529:2013, Degrees of protection provided by enclosures (IP Code)
209 IEC 62366-1:2015, Usability of medical devices
210 3 Terms and Definitions
211 For the purposes of this document, the following terms and definitions apply.
212 3.1
213 ACCURACY OF FLOW
214 Difference between the indicated value and the actual value of the flow, expressed in percent
215 3.2
216 ADJUSTABLE PRESSURE REGULATOR
217 PRESSURE REGULATOR that is provided with a means of operator adjustment of the outlet pressure
218 3.3
219 CONTENT INDICATOR
220 Device that displays the amount gas remaining in the cylinder.
221 Note 1 to entry: the content can be expressed either in percentage of content , volume of gas or cylinder
222 pressure.
223 3.4
224 FLOW GAUGE
225 Device that measures pressure and which is calibrated in units of flow
226 NOTE The FLOW GAUGE does not measure flow. It indicates flow by measuring the pressure upstream of a
227 fixed ORIFICE.
228 3.5
229 FLOW METER
230 Device that measures and indicates the flow of a specific gas or gas mixture
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231 3.6
232 FLOW OUTLET
233 Outlet intended to deliver a controlled flow of gas
234
235 3.7
236 GAS SPECIFIC
237 Having characteristics that prevent connection between different gas services
238
239 3.8
240 GAS SPECIFIC CONNECTION POINT
241 That part of the terminal unit which is the receptor for a GAS SPECIFIC probe
242 3.9
243 NOMINAL INLET PRESSURE
244 P
1(15)
245 Upstream WORKING PRESSURE specified by the manufacturer for which the pressure regulator is
246 intended to be used
247 3.10
248 NIPPLE
249 That portion of a connector which is pushed into and secured within the bore (lumen) of a hose
250 3.11
251 NOMINAL OUTLET PRESSURE
252 P2
253 Nominal downstream pressure under flow conditions specified by the manufacturer
254 3.12
255 ORIFICE
256 Restriction of known cross-section that delivers a constant flow of gas when supplied with gas at a
257 constant upstream pressure
258 3.13
259 OXIDISING GAS
260 Any gas or gas mixture more oxidizing than air, i.e. any gas or gas mixture that is able, at atmospheric
261 pressure, to support the combustion more than a reference oxidizer consisting of 23,5 % oxygen in
262 nitrogen
263 [derived from ISO 10156:2010 ]
264 3.14
265 PRE-SET PRESSURE REGULATOR
266 PRESSURE REGULATOR that is not provided with a means of operator adjustment of the outlet pressure
267 3.15
268 PRESSURE GAUGE
269 Device that measures and indicates pressure
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270 3.16
271 PRESSURE OUTLET
272 Outlet intended to deliver gas at a controlled pressure
273 3.17
274 PRESSURE REGULATOR
275 Device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
276 3.18
277 PRESSURE RELIEF VALVE
278 Device intended to relieve excess pressure at a pre-set value
279 3.19
280 SINGLE FAULT CONDITION
281 Condition in which a single means for protection against a safety hazard in equipment is defective or a
282 single external abnormal condition is present
283 3.20
284 WORKING PRESSURE
285 Settled pressure of a compressed gas at a uniform reference temperature of 15°C in a ful l gas cylinder
286 Note 1 to entry: This definition does not apply to liquefied gases (e.g. carbon dioxide) or dissolved gases (e.g.
287 acetylene).
288 4 Nomenclature
289 Examples of PRESSURE REGULATORS with terminology are given in Annex A.
290 5 General Requirements
291 5.1 Safety
292 PRESSURE REGULATORS shall, when transported, stored, installed, operated in normal use and maintained
293 according to the instructions of the manufacturer, present no risks with an unacceptable level, under
294 normal condition or SINGLE FAULT CONDITION, identified using risk management procedures in accordance
295 with ISO 14971.
296 The risks associated with the ignition of metallic and non-metallic materials, including the potential
297 release of toxic products in an oxygen-enriched environment, shall be assessed according to the
298 principles defined in ISO 15001.
299 The design of the PRESSURE REGULATOR should be such that in the event of internal ignition, the
300 consequences of the ignition are contained and the gas vented safely by the VIPR.
301 Check compliance by inspection of the risk management file.
302 NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
303 situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In
304 that case, a fault condition subsequently detected needs to be considered as a SINGLE FAULT CONDITION. Specific risk
305 control measures to deal with such situations need to be determined within the risk management process.
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306 5.2 Usability
307 The manufacturer shall address, in a usability engineering process, any risks resulting from poor
308 usability.
309 Check compliance by inspection of the usability engineer
...