SIST EN ISO 10524-2:2019

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 10524-2:2018(E)
© 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
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CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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 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

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 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

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).
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 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
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
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
pressure downstream of the pressure regulator (3.15) under flow conditions specified by the
manufacturer
2 © ISO 2018 – All rights reserved

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 combustion more than a reference oxidizer consisting of 23,5 % oxygen in
nitrogen
[SOURCE: ISO 10156:2017, 3.1.5, modified]
3.12
pre-set pressure regulator
pressure regulator (3.15) that is not provided with a means of operator adjustment of the outlet
pressure
3.13
pressure characteristic
variation of the outlet pressure in relation to inlet pressure under constant flow conditions
3.14
pressure gauge
device that measures and indicates pressure
3.15
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.16
pressure-relief device
device intended to relieve excess pressure at a pre-set value
3.17
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
3.18
single-stage pipeline distribution system
pipeline distribution system in which gas is distributed from the supply system (3.19) at the nominal
distribution pressure (3.8)
3.19
source of supply
portion of the supply system (3.19) with associated control equipment, which supplies the pipeline
distribution system
3.20
standard discharge
Q
flow for which the pressure regulator (3.15) is designed to maintain a nominal outlet pressure, P
(3.10), at test inlet pressure, P (3.22)
3.21
supply system
system that supplies the pipeline distribution system and which includes two or more sources of
supply (3.19)
3.22
test inlet pressure
P
minimum inlet test pressure
ISO 10524-2:2018(E)
3.23
test outlet pressure
P
highest or lowest value of the outlet pressure resulting from a variation in the inlet pressure between
P (3.9) and P (3.22) at previously adjusted conditions P , P (3.10), Q (3.20)
1 3 1 2 1
3.24
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).
4 Nomenclature
Examples of a line pressure regulator and a manifold pressure regulator with terminology are
given in Annex A.
5 General requirements
5.1 Safety
Manifold and line pressure regulators 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 manifold and line pressure regulators should be such that in the event of an internal
ignition, the consequences of the ignition are contained and the gas vented safely.
Check compliance by inspection of the risk management file.
NOTE 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.
NOTE For information related to usability, see other documents; for example, IEC 62366-1 and
IEC/TR 62366-2.
5.3 Alternative construction
Manifold and line pressure regulators and components, or parts thereof, using materials or
having forms of construction different from those detailed in this document, shall be presumed to be
in compliance with the safety objectives of this document if it can be demonstrated that at least an
equivalent degree of safety is obtained (i.e. compliance with requirements presumes that risks have
been mitigated to acceptable levels) unless objective evidence to the contrary becomes available.
4 © ISO 2018 – All rights reserved

ISO 10524-2:2018(E)
Objective evidence may be obtained by post-market surveillance.
Evidence of at least an equivalent degree of safety shall be provided by the manufacturer.
NOTE Regional or national regulations can require the provision of evidence to a competent authority or a
conformity assessment body, e.g. to a notified body in the European Economic Area (EEA) upon request.
5.4 Materials
5.4.1 * The materials which come in contact with the medical gas in normal condition shall be resistant
to corrosion and compatible with oxygen, the other medical gases and their mixtures in the temperature
range specified in 6.1.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Oxygen compatibility is usually defined as the ability of a material to coexist with oxygen and a
moderate ignition source. The aim of using oxygen-compatible materials is to develop a system design which
has a low probability of ignition and minimizes consequences based on the use of materials exhibiting good
compatibility and low energy release if ignited or by minimizing the quantities of non-metallic components.
NOTE 3 Many materials which do not burn in air will do so in an oxygen-enriched atmosphere, particularly
under pressure. Similarly, materials which can be ignited in air require lower ignition energies to ignite in an
oxygen-enriched atmosphere. Many such materials can be ignited by friction at a valve seat or by adiabatic
compression when an oxygen-enriched gas at high pressure is rapidly introduced into a system initially at low
pressure.
NOTE 4 Halogenated polymers such as polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PTCFE)
and fluoroelastomers (FKM) can release highly toxic products during thermal decomposition.
NOTE 5 Design considerations and criteria for the selection of metallic and non-metallic materials are given in
ISO 15001.
5.4.2 Materials that are liable to shed particles which can come in contact with the medical gas in
normal condition or single fault condition shall not be used for highly strained components and parts
liable to wear.
EXAMPLE Springs.
NOTE See ISO 15001:2010, Annex C.
5.4.3 * Aluminium, aluminium alloys or alloys with aluminium content greater than 2,5 % shall not be
used for components whose surfaces come into contact with oxidizing gases or gas mixtures at cylinder
pressure in normal or single fault condition.
5.4.4 Consideration should be given to the avoidance of stainless steel and other ferrous alloys for
components whose surfaces come into contact with oxidizing gases or gas mixtures at cylinder pressure
in normal or single fault condition.
5.4.5 The materials shall permit the manifold and line pressure regulators and their components
to meet the requirements of Clause 6 in the temperature range of −20 °C to +60 °C.
NOTE Regional or national environmental conditions can require deviation from this range of temperatures.
5.4.6 Manifold and line pressure regulators shall meet the requirements of this document after
being packed for transport and storage and being exposed to environmental conditions, as stated by the
manufacturer.
Evidence of conformity with the requirements of Clause 6 shall be provided by the manufacturer upon
request.
ISO 10524-2:2018(E)
6 Design requirements
6.1 General
The operation of the manifold and line pressure regulators shall comply with the requirements of
this document between −20 °C and +60 °C.
NOTE Regional or national regulations can specify additional design requirements and certifications or
approval.
6.2 Pressure gauges
6.2.1 If a Bourdon tube pressure gauge is used, it shall conform to EN 837-1 (except for the minimum
nominal size).
NOTE EN 837-1 is a standard for Bourdon tube pressure gauges but not all of its requirements are
applicable to other types of gauges, e.g. direct drive gauges.
6.2.2 Pressure gauges should be designed to resist moisture ingress (e.g. IP 44 of IEC 60529).
6.2.3 The casings of pressure gauges should be designed such that the pressure is safely relieved to
prevent a hazardous overpressure that could lead to a rupture in the event of a leak within the gauge.
6.2.4 If the gauge connector is threaded, it shall comply with EN 837-1 or a regional or national
standard.
6.2.5 The pressure or content indication shall be legible to an operator having a visual acuity of 1
(corrected if necessary) 1 m from the gauge with an illuminance of 215 lx.
6.2.6 The scale of the cylinder pressure gauge shall extend to at least 133 % of P .
NOTE In addition to the scale ranges in EN 837-1, a pressure gauge with a scale range of 0 kPa to 31 500 kPa
(315 bar) can also be used.
6.2.7 Pressure gauges shall be class 2.5 or better, in accordance with EN 837-1.
6.2.8 The inlet connection of a pressure gauge, with a scale range greater than 4 000 kPa, shall be
fitted with an orifice with an area no greater than 0,1 mm .
Check compliance with the requirements of 6.2 by visual inspection or measurement as required.
6.3 Integrated digital gauges
Where the risk management process demonstrates that the risk to patient safety is impacted by the use
of electrical equipment, IEC 60601-1 shall be used as a normative reference.
6.4 Pressure-adjusting device
6.4.1 Manifold and line pressure regulators shall be provided with a pressure-adjusting device.
6.4.2 The pressure-adjusting device shall be designed so that it can be locked into position and
adjusted only with the use of a tool.
Check compliance by attempting to adjust the pressure without the use of a tool.
6 © ISO 2018 – All rights reserved

ISO 10524-2:2018(E)
6.4.3 The pressure-adjusting device shall be captive.
Check compliance by attempting to remove the pressure adjusting device
6.4.4 The pressure regulator shall be designed so that the pressure regulator valve cannot be
held in the open position as a consequence of the pressure regulator spring being compressed to its
solid length.
Check compliance by inspection.
6.4.5 Using the pressure-adjusting device it shall not be possible to set a pressure at which the
pressure-relief device opens.
Check compliance by inspection.
6.5 Filtration
Means shall be provided to prevent particles greater than 100 μm in diameter from entering the high-
pressure side of the pressure regulator.
If a filter is removable without the use of a tool, or it is a separate item, the test for resistance to ignition
shall be carried out with and without the filter.
Check compliance by inspection of the risk management file.
NOTE The filter can be a separate item.
6.6 Mechanical strength
6.6.1 Resistance of the high-pressure side
The inlet side of a manifold or line pressure regulator shall be capable of withstanding 2,25× its
nominal inlet pressure [P ] for 5 min without rupturing.
The test is given in 8.4.3.1.
6.6.2 Resistance of the low-pressure side to pneumatic pressure
The outlet side of a manifold or line pressure regulator shall be capable of withstanding 4× its
nominal outlet pressure (P ) without rupturing.
The test is given in 8.4.3.2.
6.6.3 Resistance of the low pressure side to P
Components of the manifold pressure regulator shall not be ejected if the low-pressure chamber
of the pressure regulator is exposed to nominal inlet pressure, P (for instance, if the pressure
regulator valve is held in the open position and the outlet connector is closed).
The high-pressure gas shall either be safely retained or vented.
The test is given in 8.4.3.2.
6.7 Endurance
The pressure regulating mechanism shall be able to withstand 10 000 operational cycles without
impairment of operation, mechanical failure, or the development of leakage in excess of the rates
described in 8.5.
ISO 10524-2:2018(E)
The device shall maintain flow accuracy.
6.8 Manifold pressure regulators
6.8.1 * Inlet connector
The dimensions of the inlet connector shall be at the discretion of the manufacturer.
A cylinder valve connector shall not be used as an inlet connector.
6.8.2 Outlet connector
The dimensions of the outlet connector shall be at the discretion of the manufacturer.
6.8.3 Leakage
6.8.3.1 The total external leakage to atmosphere shall not exceed 0,2 ml/min (equivalent to a pressure
decay of 0,020 2 kPa⋅l/min) at nominal pressure, P , and closure pressure, P .
1 4
The test for total external leakage is given in 8.3.6.1
6.8.3.2 The internal leakage through the pressure regulator valve shall not exceed 1 ml/min
(equivalent to a pressure decay of 0,101 0 kPa⋅l/min) at nominal inlet pressure, P , and test inlet
pressure, P .
The test for internal leakage is given in 8.3.6.2.
6.8.4 Functional and flow characteristics
6.8.4.1 Standard discharge, Q
The standard discharge, Q , shall be in accordance with the value(s) stated by the manufacturer.
If the manifold pressure regulator is designed for a range of nominal outlet pressures, P s, the
manufacturer shall specify values of standard discharge, Q , for the upper and lower limits of the
nominal outlet pressure.
The test to demonstrate compliance to the manufacturer’s declared value(s) of Q is given in 8.3.2.
6.8.4.2 Coefficient of pressure increase upon closure
The coefficient of pressure increase upon closure, R, is calculated using Formula (1):
PP−
R= (1)
P
The coefficient, R, shall be less than 0,3.
The test for determining the coefficient of pressure increase upon closure, R, is given in 8.3.3.
6.8.4.3 Irregularity coefficient, i
The irregularity coefficient (i) is calculated using Formula (2):
PP−
i = (2)
P
The irregularity coefficient, i, shall fall within the limit ±0,3.
8 © ISO 2018 – All rights reserved

ISO 10524-2:2018(E)
The test for determining the irregularity coefficient, i, is given in 8.3.4.
6.8.5 Pressure-relief device
Each manifold pressure regulator shall be provided with a pressure-relief device which may be
integral with or separate from the manifold pressure regulator. Bursting discs shall not be used.
Means shall be provided to limit the outlet pre
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