SIST EN ISO 10524-2:2019

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

This document specifies design, construction, type testing, and marking requirements for manifold
pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended
for use in medical gas pipeline systems.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to manifold pressure regulators and line pressure regulators supplied
as individual units or to the relevant components incorporated within an assembly.
Manifold pressure regulators are intended to be connected to a manifold system which has a
nominal inlet pressure, P1 of up to 30 000 kPa (300 bar).
Line pressure regulators are intended to be connected downstream of the manifold pressure
regulator with a supply pressure up to 3 000 kPa (30 bar).
This document does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in
ISO 10079-3.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2018)

Diese Internationale Norm definiert die Konstruktion, die Typprüfung und die Kennzeichnungsanforderungen für HAUPTSTELLENDRUCKREGLER (wie in 3.6 definiert) und LEISTUNGSDRUCKMINDERER (wie in 3.4 definiert) zur Verwendung in ROHRLEITUNGSSYSTEMEN FÜR MEDIZINISCHE GASE.
Beispiele für Gase umfassen Sauerstoff, medizinische Luft und Sauerstoff-/Distickstoffoxid-Gemische.  
Dieser Teil von ISO 10524 gilt für HAUPTSTELLENDRUCKREGLER und LEITUNGSDRUCKMINDERER, die als individuelle Einheiten geliefert werden oder für die entsprechenden Bestandteile innerhalb eines zusammengebauten Geräts.
HAUPTSTELLENDRUCKREGLER sind für den Anschluss an ein Sammelstellensystem mit einem Nennbetriebsdruck von bis zu 30 000 kPa (300 bar) vorgesehen.
LEITUNGSDRUCKMINDERER sind für den Anschluss hinter dem HAUPTSTELLENDRUCKREGLER mit einem Versorgungsdruck von bis zu 3 000 kPa (30 bar) vorgesehen.
Dieser Teil von ISO 10524 gilt nicht für DRUCKMINDERER zur Verwendung mit Vakuum-Rohrleitungssystemen.
ANMERKUNG   Anforderungen an DRUCKMINDERER zur Verwendung mit Vakuum-Rohrleitungssystemen sind in ISO 10079-3 erfasst.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et de canalisations (ISO 10524-2:2018)

ISO 10524-2:2018 spécifie la conception, la construction, les essais de type et les exigences de marquage s'appliquant aux détendeurs de rampes (tels que définis en 3.7) et aux détendeurs de canalisations (tels que définis en 3.5), destinés aux réseaux de distribution de gaz médicaux.
De tels gaz sont par exemple l'oxygène, l'air médical et les mélanges d'oxygène et de protoxyde d'azote.
ISO 10524-2:2018 s'applique aux détendeurs de rampes et aux détendeurs de canalisations fournis sous la forme d'unités individuelles ou faisant partie d'éléments à assembler.
Les détendeurs de rampes sont destinés à être raccordés à un système de rampe dont la pression nominale d'alimentation, P1 peut atteindre 30 000 kPa (300 bar).
Les détendeurs de canalisations sont destinés à être raccordés en aval du détendeur de rampe d'une pression d'alimentation maximale de 3 000 kPa (30 bar).
ISO 10524-2:2018 ne s'applique pas aux détendeurs utilisés avec les systèmes d'aspiration.
NOTE       Les exigences relatives aux détendeurs utilisés avec les systèmes d'aspiration sont décrites dans l'ISO 10079‑3.

Tlačni regulatorji za medicinske pline - 2. del: Tlačni regulatorji v razdelilnikih in ceveh (ISO 10524-2:2018)

Ta dokument določa projektiranje, konstrukcijo, tipsko preskušanje in zahteve za označevanje tlačnih regulatorjev v razdelilnikih (kot je določeno v točki 3.7) ter tlačnih regulatorjev v ceveh (kot je določeno v točki 3.5), namenjenih za uporabo v sistemih napeljav za medicinske pline.
Primeri plinov: kisik, medicinski zrak in mešanice kisika/dušikovega oksida.
Ta dokument se uporablja za tlačne regulatorje v razdelilnikih in tlačne regulatorje v ceveh, dobavljene kot posamezne enote ali kot ustrezne komponente, vgrajene znotraj sestava.
Tlačni regulatorji v razdelilnikih so namenjeni za priključitev na razdelilni sistem z nazivnim vhodnim tlakom P1 30.000 kPa (300 barov).
Tlačni regulatorji v ceveh so namenjeni za priključitev na izhodni strani tlačnega regulatorja v razdelilniku z vhodnim tlakom do 3000 kPa (30 barov).
Ta dokument se ne uporablja za tlačne regulatorje, namenjene za uporabo z vakuumskimi cevnimi sistemi.
OPOMBA: Zahteve za tlačne regulatorje, namenjene za uporabo z vakuumskimi cevnimi sistemi, so zajete v standardu ISO 10079-3.

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 10524-2:2019 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)

Relations

• Replaces: SIST EN ISO 10524-2:2006 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
• Effective Date: 01-Apr-2019
• Replaces: SIST EN ISO 10524-2:2006 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10524-2:2019
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-2:2006
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYUD]GHOLOQLNLKLQ
FHYHK,62
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure
regulators (ISO 10524-2:2018)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2:
Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2018)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et
de canalisations (ISO 10524-2:2018)
Ta slovenski standard je istoveten z: EN ISO 10524-2:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
SIST EN ISO 10524-2:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN ISO 10524-2:2019

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

SIST EN ISO 10524-2:2019


EN ISO 10524-2
EUROPEAN STANDARD

NORME EUROPÉENNE

January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-2:2006
English Version

Pressure regulators for use with medical gases - Part 2:
Manifold and line pressure regulators (ISO 10524-2:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Druckminderer zur Verwendung mit medizinischen
Partie 2: Détendeurs de rampes et de canalisations Gasen - Teil 2: Hauptstellendruckregler und
(ISO 10524-2:2019) Leitungsdruckminderer (ISO 10524-2:2019)
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 10524-2:2019 E
worldwide for CEN national Members.

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

SIST EN ISO 10524-2:2019
EN ISO 10524-2:2019 (E)
Contents Page
European foreword . 3

2

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

SIST EN ISO 10524-2:2019
EN ISO 10524-2:2019 (E)
European foreword
This document (EN ISO 10524-2:2019) 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 10524-2:2006.
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 10524-2:2018 has been approved by CEN as EN ISO 10524-2:2019 without any
modification.

3

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

SIST EN ISO 10524-2:2019

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

SIST EN ISO 10524-2:2019
INTERNATIONAL ISO
STANDARD 10524-2
Second edition
2018-01
Pressure regulators for use with
medical gases —
Part 2:
Manifold and line pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 2: Détendeurs de rampes et de canalisations
Reference number
ISO 10524-2:2018(E)
©
ISO 2018

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

Contents Page
Foreword .v
Introduction .vi
1 * Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Nomenclature . 4
5 General requirements . 4
5.1 Safety . 4
5.2 Usability . 4
5.3 Alternative construction . 4
5.4 Materials . 5
6 Design requirements . 6
6.1 General . 6
6.2 Pressure gauges. 6
6.3 Integrated digital gauges . 6
6.4 Pressure-adjusting device . 6
6.5 Filtration . 7
6.6 Mechanical strength . 7
6.6.1 Resistance of the high-pressure side . 7
6.6.2 Resistance of the low-pressure side to pneumatic pressure . 7
6.6.3 Resistance of the low pressure side to P .
1 7
6.7 Endurance . 7
6.8 Manifold pressure regulators . 8
6.8.1 * Inlet connector . 8
6.8.2 Outlet connector . . . 8
6.8.3 Leakage . 8
6.8.4 Functional and flow characteristics . 8
6.8.5 Pressure-relief device. 9
6.8.6 * Resistance to ignition . 9
6.8.7 Nominal inlet pressure . 9
6.9 Line pressure regulators. 9
6.9.1 * Inlet connector . 9
6.9.2 Outlet connector . . . 9
6.9.3 Leakage . 9
6.9.4 Outlet pressure variation limits .10
6.9.5 * Resistance to ignition of sealing materials and lubricants .10
6.9.6 Nominal inlet pressure .10
7 Construction requirements .10
7.1 * Cleanliness .10
7.2 Lubricants .10
8 Test methods for type tests .11
8.1 General conditions .11
8.1.1 General.11
8.1.2 Ambient conditions .11
8.1.3 Test gas .11
8.1.4 Reference conditions .11
8.2 Test schedule .11
8.3 Test methods for manifold pressure regulators .13
8.3.1 Test equipment for functional and flow characteristics .13
8.3.2 Test method for determining standard discharge, Q .
1 13
8.3.3 Test method for determining the coefficient of pressure increase upon closure .14
© ISO 2018 – All rights reserved iii

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

8.3.4 Test method for determining the irregularity coefficient .15
8.3.5 Test method for pressure-relief device .17
8.3.6 Test methods for leakage .17
8.3.7 Test method for mechanical strength .18
8.3.8 Test method for resistance to ignition .18
8.4 Test method for line pressure regulators .19
8.4.1 Test method for measuring the variation of the outlet pressure .19
8.4.2 Test methods for leakage .19
8.4.3 Test method for mechanical strength .20
8.4.4 Test method for determination of the auto-ignition temperature of sealing
materials and lubricants .20
8.5 Endurance test .22
8.6 Test method for durability of markings and colour coding .23
9 Marking, colour coding, and packaging .23
9.1 Marking .23
9.2 Colour coding .24
9.3 Packaging .24
10 Information to be supplied by the manufacturer .24
Annex A (informative) Examples of pressure regulators .26
Annex B (informative) Rationale .27
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .29
Bibliography .31
iv © ISO 2018 – All rights reserved

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(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 10524-2:2005), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the scope has been extended to include 30 000 kPa (300 bar) manifold pressure regulators;
— this document has been restructured according to the new ISO template and associated renumbering;
— the common requirements have been aligned with ISO 10524-1 and ISO 10524-3;
— all type tests have been reviewed;
— a complete schedule has been introduced;
— a pressure retention test of the low-pressure side for the line pressure regulators has been
introduced.
A list of all parts in the ISO 10524 series can be found on the ISO website.
© ISO 2018 – All rights reserved v

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

Introduction
Manifold pressure regulators are used within the supply systems of medical gas pipeline systems
to reduce high cylinder pressure to a lower pressure suitable for the supply of medical gases to the inlet
of line pressure regulators.
Line pressure regulators are used to reduce the pressure supplied by manifold pressure
regulators or by cryogenic vessels to the lower pressure required at the terminal units of medical
gas pipeline systems.
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 manifold and line pressure
regulators are specified and tested in a defined manner.
It is essential that regular inspection and maintenance be undertaken to ensure that the pressure
regulators continue 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),
— cleanliness,
— type testing,
— marking, and
— information supplied by the manufacturer.
Annex B 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 B.
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

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

SIST EN ISO 10524-2:2019
INTERNATIONAL STANDARD ISO 10524-2:2018(E)
Pressure regulators for use with medical gases —
Part 2:
Manifold and line pressure regulators
1 * Scope
This document specifies design, construction, type testing, and marking requirements for manifold
pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5) intended
for use in medical gas pipeline systems.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to manifold pressure regulators and line pressure regulators supplied
as individual units or to the relevant components incorporated within an assembly.
Manifold pressure regulators are intended to be connected to a manifold system which has a
nominal inlet pressure, P of up to 30 000 kPa (300 bar).
1
Line pressure regulators are intended to be connected downstream of the manifold pressure
regulator with a supply pressure up to 3 000 kPa (30 bar).
This document does not apply to pressure regulators for use with vacuum pipeline systems.
NOTE Requirements for pressure regulators for use with vacuum pipeline systems are covered in
ISO 10079-3.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 32, Gas cylinders for medical use — Marking for identification of content
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 10297:2014, Gas cylinders — Cylinder valves — Specification and type testing
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 837-1, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology, requirements
and testing
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2018 – All rights reserved 1

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
closure pressure
P
4
stabilized outlet pressure, after cessation of the flow, from a pressure regulator (3.15) when the flow
has been set to standard discharge (3.20)
3.2
double-stage pipeline distribution system
pipeline distribution system in which gas is initially distributed from the supply system (3.21) at a
higher pressure than the nominal distribution pressure (3.8), and is then reduced to the nominal
distribution pressure by line pressure regulator(s) (3.4)
3.3
flow characteristic
variation of outlet pressure in relation to flow with the inlet pressure remaining constant
3.4
line pressure regulator
pressure regulator (3.15) used in a double stage pipeline distribution system (3.2) to reduce the
nominal supply system pressure to the nominal distribution pressure (3.8)
3.5
manifold
device for connecting the outlet(s) of one or more cylinders or cylinder bundles of the same medical gas
to a medical gas pipeline system (3.7)
3.6
manifold pressure regulator
pressure regulator (3.15) intended to be installed within source of supply (3.19) containing cylinders
or cylinder bundles, or high pressure storage vessel(s)
3.7
medical gas pipeline system
complete system which comprises a supply system (3.21), a monitoring and alarm system, a pipeline
distribution system with terminal units at the points where medical gases or vacuum may be required
3.8
nominal distribution pressure
pressure of gas which the medical gas pipeline system (3.7) is intended to deliver at the terminal units
3.9
nominal inlet pressure
P
1
upstream working pressure (3.24) specified by the manufacturer for which the pressure regulator
(3.15) is intended to be used
3.10
nominal outlet pressure
P
2
pressure downstream of the pressure regulator (3.15) under flow conditions specified by the
manufacturer
2 © ISO 2018 – All rights reserved

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

SIST EN ISO 10524-2:2019
ISO 10524-2:2018(E)

3.11
oxidizing gas
any gas or gas mixture more oxidizing than air, i.e. any gas or gas mixture that is able, at atmospheric
pressure, to support the combusti
...