SIST EN ISO 10524-3:2019

SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-3:2006
SIST EN ISO 10524-3:2006/A1:2013
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FLOLQGULþQLKYHQWLORYMHNOHQN,62
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (VIPRs) (ISO 10524-3:2019)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (VIPR) (ISO 10524-3:2019)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2019
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
23.060.40 7ODþQLUHJXODWRUML Pressure regulators
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10524-3
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-3:2006
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves
(VIPRs) (ISO 10524-3:2019)
Détendeurs pour l'utilisation avec les gaz médicaux - Druckminderer zur Verwendung mit medizinischen
Partie 3: Détendeurs intégrés dans les robinets des Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO
bouteilles de gaz (VIPR) (ISO 10524-3:2019) 10524-3:2019)
This European Standard was approved by CEN on 3 October 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 10524-3:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10524-3:2019) 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 10524-3:2006.
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 10524-3:2019 has been approved by CEN as EN ISO 10524-3:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 10524-3
Second edition
2019-01
Pressure regulators for use with
medical gases —
Part 3:
Pressure regulators integrated with
cylinder valves (VIPRs)
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés dans les robinets des bouteilles à gaz
(VIPR)
Reference number
ISO 10524-3:2019(E)
©
ISO 2019
ISO 10524-3:2019(E)
© ISO 2019
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.
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 10524-3:2019(E)
Contents Page
Foreword .vi
Introduction .viii
1 *Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 4
5 General requirements . 5
5.1 Safety . 5
5.2 Usability . 5
5.3 Materials . 5
5.4 Alternative construction . 6
6 Design requirements . 6
6.1 *General . 6
6.2 Integrated electronic device . 7
6.3 Filling port . 7
6.4 Connections . 8
6.4.1 valve inlet connection . 8
6.4.2 Outlet connectors . 8
6.5 *Requirements for outlet pressure . 8
6.5.1 Pressure outlet . 8
6.5.2 Flow outlet . 9
6.6 Cylinder pressure or cylinder content indicator . 9
6.6.1 Pressure gauges and cylinder content indicators . 9
6.7 Flow selector .10
6.8 Filtration .10
6.9 Main shut-off .10
6.10 Residual pressure device .10
6.11 *Pressure-relief device .10
6.12 Leakage .11
6.13 Mechanical strength .11
6.13.1 Resistance of the high-pressure side .11
6.13.2 Resistance of the low-pressure side to excessive pressure .12
6.13.3 Resistance of the low-pressure side to P .12
6.13.4 Impact and drop tests .12
6.14 *Resistance to ignition .12
6.15 Requirements for VIPR fitted with fixed orifices .12
6.15.1 Stability and accuracy of flow .12
6.15.2 *Flow setting torque .13
6.15.3 Removal of a fixed orifice .13
6.15.4 Legibility .13
6.16 Endurance .13
6.16.1 flow selector .13
6.16.2 Non-return valve fitted to the filling port .13
6.16.3 Pressure regulator .13
7 Construction requirements .14
7.1 *Cleanliness .14
7.2 Lubricants .14
7.3 Loosening torques .14
8 Test methods for non-gas specific type tests .15
8.1 General conditions .15
8.1.1 Ambient conditions .15
ISO 10524-3:2019(E)
8.1.2 Test gas .15
8.1.3 Reference conditions .15
8.2 Test schedule .15
8.3 Test methods for outlet pressure .17
8.3.1 Purpose .17
8.3.2 Test equipment .17
8.3.3 Test methods for determining outlet pressure limits for VIPRs fitted
with a pressure outlet .18
8.3.4 Test method for determining outlet pressure limits for a VIPR fitted
with a flow outlet .19
8.4 Test method for pressure-relief device .19
8.4.1 Purpose .19
8.4.2 Test procedure .19
8.5 Test methods for leakage .20
8.5.1 Purpose .20
8.5.2 Test procedure .20
8.6 Test method for mechanical strength .20
8.6.1 Purpose .20
8.6.2 Test procedure .20
8.7 Test method for resistance to ignition .21
8.7.1 Purpose .21
8.7.2 General.21
8.7.3 Test procedure .21
8.8 Test methods for the stability and accuracy of flow of VIPRs fitted with fixed orifices .23
8.8.1 Purpose .23
8.8.2 Test procedure .23
8.9 Test method for flow setting and loosening torques .23
8.9.1 Purpose .23
8.9.2 Test procedure .24
8.10 Test for integrity of the filling port non-return valve under high flow condition .24
8.10.1 Purpose .24
8.10.2 Test procedure .24
8.11 Test method for durability of markings and colour coding .25
8.11.1 Purpose .25
8.11.2 Test procedure .25
8.12 Flow selector endurance test .26
8.12.1 Purpose .26
8.12.2 Test procedure .26
8.13 filling port non-return valve endurance test .26
8.13.1 Purpose .26
8.13.2 Test procedure .26
8.14 pressure regulator endurance test .27
8.14.1 Purpose .27
8.14.2 Test procedure .27
9 *Gas-specific type tests .28
9.1 Purpose .28
9.2 Apparatus .28
9.3 General test conditions .29
9.3.1 Test conditions.30
9.4 Test procedure .30
9.4.1 Test method for determining outlet pressure limits for a VIPR fitted
with a pressure outlet .30
9.4.2 Test method for stability and accuracy of flow of a VIPR fitted with
fixed orifices .30
9.4.3 Test method for residual pressure device.31
10 Marking, colour coding and packaging .31
10.1 Marking .31
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ISO 10524-3:2019(E)
10.2 Colour coding .32
10.3 Packaging .33
11 *Information to be supplied by the manufacturer .33
Annex A (informative) Example of VIPRs .35
Annex B (informative) Rationale .36
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .39
Bibliography .41
ISO 10524-3:2019(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 of 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 www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 10524-3:2005), which has been
technically revised. It also incorporates the Amendment ISO 10524-3:2005/Amd 1:2013.
The main changes compared to the previous edition are as follows:
a) introduction of the acronym VIPR for designating the valve with integrated pressure regulator as
[9]
in ISO 10297 and ISO 22435 ;
b) extension of the scope to include VIPRs with a nominal inlet pressure up to 30 000 kPa (300 bar);
c) restructuring of the document to the new ISO template and associated renumbering;
d) removal of the requirements for VIPRs fitted with flow-metering devices, flow gauges and
adjustable pressure regulators;
e) alignment with the common requirements of ISO 10524-1 and ISO 10524-2;
f) addition of cross-reference to ISO 10297 for all requirements concerning the main shut-off;
g) rationalization of impact test requirements to comply with ISO 10297 and requirements for drop
testing in alignment with ISO 11117;
h) introduction of endurance testing on the flow selector, non-return valve and pressure regulator;
i) introduction of type testing with the intended gas;
j) introduction of a complete test schedule;
k) review of all type tests;
l) reference to ISO 15996 for residual pressure device (RPD);
vi © ISO 2019 – All rights reserved

ISO 10524-3:2019(E)
m) introduction of requirements for usability;
n) consideration of avoidance of stainless steel for parts in contact with oxygen.
A list of all parts in the ISO 10524 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
ISO 10524-3:2019(E)
Introduction
Valves with integrated pressure regulators (VIPRs) are used to reduce high cylinder pressure to
a lower pressure suitable for use with medical equipment or for delivery of gas 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 VIPRs are specified and tested in a
defined manner.
A VIPR is normally coupled to a device which controls the gas flow, such as a flow control device or a
fixed orifice.
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;
— information supplied by the manufacturer.
This document should be read in conjunction with ISO 10524-1, ISO 10524-2 and ISO 10524-4.
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: smaller type.
Normative text of tables are also in a smaller type.
— Test specifications: italic type.
— terms defined in Clause 3 or as noted: small capitals type.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2:2016,
Annex H. For the purposes of this document, the auxiliary verb:
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
document;
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this document;
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
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. Annex B contains rationale statements
for some of the requirements of this document. It provides 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.
viii © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 10524-3:2019(E)
Pressure regulators for use with medical gases —
Part 3:
Pressure regulators integrated with cylinder valves (VIPRs)
1 *Scope
This document specifies design, type testing, and marking requirements for cylinder valves with
integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with
integrated pressure regulators (VIPRs)] intended for the administration of medical gases 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 VIPRs mounted on refillable cylinders with a working pressure up to
30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used
in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or
pre-set flow outlet(s).
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 5145, Gas cylinders — Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO/TR 7470, Valve outlets for gas cylinders — List of provisions which are either standardized or in use
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 10297:2014, Gas cylinders — Cylinder valves — Specification and type testing
ISO 10297:2014/Amd1: 2017, Pressure drums and tubes
ISO 11117, Gas cylinders — Valve protection caps and valve guards — Design, construction and tests
ISO 11363-1, Gas cylinders — 17E and 25E taper threads for connection of valves to gas cylinders — Part 1:
Specifications
ISO 13341, Gas cylinders — Fitting of valves to gas cylinders
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15245-1, Gas cylinders — Parallel threads for connection of valves to gas cylinders — Part 1:
Specification
ISO 10524-3:2019(E)
ISO 15996, Gas cylinders — Residual pressure valves — Specification and type testing of cylinder valves
incorporating residual pressure devices
EN 837-1, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology, requirements
and testing
EN 13544-2:2002+ A1: 2009, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 60601-1+ A1: 2012, Medical electrical equipment — Part 1: General requirements for safety
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 http: //www .electropedia .org/
3.1
accuracy of flow
difference between the indicated flow and the measured flow
Note 1 to entry: Expressed as a percentage.
3.2
content indicator
device that displays the amount of gas remaining in the cylinder
Note 1 to entry: The content can be expressed either in percentage of content, volume of gas or cylinder pressure.
3.3
filling adaptor
means of connecting the VIPR filling port to the filling system allowing a cylinder fitted with a VIPR
(3.26) to be filled or vented
Note 1 to entry: This is not part of the VIPR.
Note 2 to entry: It may also be referred to as a filling tool.
3.4
filling port
connector on the VIPR (3.26) through which the cylinder is filled
3.5
filling port non-return valve
valve which remains closed in normal use thus preventing the flow out of the VIPR's filling port (3.4)
until opened by insertion of an appropriate means and which then permits flow in either direction
Note 1 to entry: Some filling port non-return valves may also be opened by the pressure of the incoming gas.
3.6
flow outlet
outlet intended to deliver a controlled flow of gas
3.7
flow selector
means for selecting the flow and indicating the flow selected
2 © ISO 2019 – All rights reserved

ISO 10524-3:2019(E)
3.8
gas-specific
having characteristics that prevent connection between different gas services
3.9
gas-specific connection point
part of the pressure outlet (3.19) which is the receptor for a gas-specific (3.8) probe
3.10
main shut-off
primary mechanism which closes and opens the valve orifice (3.14) and which includes the internal and
external sealing systems
Note 1 to entry: In ISO 10297, the main shut-off is called valve operating mechanism.
Note 2 to entry: For some VIPR (3.26) designs, the pressure regulating valve acts as the shut-off mechanism.
3.11
nipple
portion of a connector which is pushed into and secured within the bore (lumen) of a hose
3.12
nominal inlet pressure
P
working pressure (3.27) of the cylinder specified by the manufacturer of the VIPR (3.26) for which the
VIPRs is intended to be used
3.13
nominal outlet pressure
P
pressure downstream of the pressure regulator (3.20) under flow conditions specified by the
manufacturer
3.14
orifice
restriction of known cross-section that delivers a constant flow of gas when supplied with gas at a
constant upstream pressure
3.15
outlet pressure
pressure supplied by the VIPR (3.26) at the outlet
3.16
oxidizing gas
gas or gas mixture more oxidizing than air
EXAMPLE Any gas or gas mixture that is able, at atmospheric pressure, to support the combustion greater
than or equal to a reference oxidizer consisting of 23,5 % oxygen in nitrogen
Note 1 to entry: Derived from ISO 10156.
3.17
pre-set pressure regulator
pressure regulator (3.20) that is not provided with a means of operator adjustment of the outlet
pressure (3.15)
3.18
pressure gauge
device that measures and indicates pressure
ISO 10524-3:2019(E)
3.19
pressure outlet
outlet intended to deliver gas at a controlled pressure
3.20
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure (3.15) within specified limits
3.21
pressure-relief device
device intended to relieve excess pressure at a pre-set value
3.22
residual pressure device
device that is designed to prevent ingress of contaminants by maintaining a positive pressure within
the cylinder relative to atmosphere by closing off its internal gas passages in the discharging direction
[SOURCE: ISO 15996:2017, 3.2]
3.23
service life
time period during which a VIPR (3.26) can be used to refill a cylinder
Note 1 to entry: The VIPR can be used after its service life up to the expiry date of the filled medical gas.
3.24
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a
single external abnormal condition is present
3.25
valve inlet connection
threaded connection of the VIPR (3.26) which connects it to the cylinder
Note 1 to entry: It can also be referred to as the valve stem.
3.26
valve with integrated pressure regulator
VIPR
combination of a pressure regulator (3.20) and cylinder valve intended to be fitted to a medical gas
cylinder
3.27
working pressure
settled pressure of a compressed gas at a uniform reference temperature of 15 °C in a full gas cylinder
Note 1 to entry: This definition does not apply to liquefied gases (e.g. carbon dioxide) or dissolved gases (e.g.
acetylene) (from ISO 10297).
4 Nomenclature
The terminology used in this document for components of VIPRs is given in a labelled diagram in
Annex A.
4 © ISO 2019 – All rights reserved

ISO 10524-3:2019(E)
5 General requirements
5.1 Safety
VIPRs shall, when transported, stored, installed, operated in normal use and maintained according
to the instructions of the manufacturer, present no risks with an unacceptable level, under normal
condition or single fault condition, identified using risk management procedures in accordance with
ISO 14971.
The risks associated with the ignition of metallic and non-metallic materials, including the potential
release of toxic products in an oxygen-enriched environment, shall be assessed according to the
principles defined in ISO 15001.
The design of the VIPR should be such that in the event of internal ignition, the consequences of the
ignition are contained and the gas vented safely by the VIPR.
Check compliance by inspection of the risk management file.
A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
situations can remain undetected over a period of time and as a consequence can lead to an unacceptable
risk. In that case, a fault condition subsequently detected needs to be considered as a single fault
condition. Specific risk control measures to deal with such situations need to be determined within
the risk management process.
5.2 Usability
The manufacturer shall address, in a usability engineering process, any risks resulting from poor
usability.
Check compliance by inspection of the usability engineering file.
[6]
NOTE For information related to usability, see other standards, for example IEC 62366-1 and IEC/
[7]
TR 62366-2 .
5.3 Materials
5.3.1 *The materials which come in contact with the medical gas in normal condition shall be resistant
to corrosion and compatible with the intended medical gas and oxygen, in the temperature range
specified in 6.1.
Check compliance by inspection of the list of materials in contact with the gas in normal and single fault
condition and associated rationale for compatibility.
NOTE 1 Corrosion resistance includes resistance ag
...