SIST EN ISO 10524-3:2006

Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as defined in 3.16) intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients for use with the following medical gases:
- oxygen;
- nitrous oxide;
- air for breathing;
- helium;
- carbon dioxide;
- xenon;
- specified mixtures of the gases listed above;
- air for driving surgical tools;
- nitrogen for driving surgical tools.
1.2 These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and measure the flow of the medical gas delivered.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in Flaschenventilen (ISO 10524-3:2005)

1.1   Dieser Teil von ISO 10524 gilt für Druckminderer in Flaschenventilen (wie in 3.16 definiert), die für die Verabreichung medizinischer Gase bei der Behandlung, Führung, diagnostischen Beurteilung und Pflege von Patienten zur Verwendung mit folgenden medizinischen Gasen vorgesehen sind:
-   Sauerstoff;
-   Distickstoffoxid;
-   Luft für Beatmungszwecke;
-   Helium;
-   Kohlendioxid;
-   Xenon;
-   festgelegte Gemische der oben genannten Gase;
-   Luft zum Antrieb chirurgischer Werkzeuge;
-   Stickstoff zum Antrieb chirurgischer Werkzeuge.
1.2 *   Diese Druckminderer in Flaschenventilen sind für den Anschluss an Gasflaschen mit Nennfülldrücken bis zu 25 000 kPa bei 15 °C vorgesehen und können mit Geräten geliefert werden, die den Durchfluss des abgegebenen medizinischen Gases regeln und messen.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans les robinets des bouteilles de gaz (ISO 10524-3:2005)

L'ISO 10524-3:2005 s'applique aux détendeurs intégrés dans les robinets de bouteilles, destinés à administrer des gaz médicaux dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et du soin aux patients, et utilisés avec les gaz médicaux suivants:
l'oxygène;
le protoxyde d'azote;
l'air respirable;
l'hélium;
le dioxyde de carbone;
le xénon;
les mélanges spécifiés des gaz mentionnés ci-dessus;
l'air pour les instruments chirurgicaux;
l'azote pour les instruments chirurgicaux.
Ces détendeurs intégrés dans les robinets des bouteilles de gaz sont prévus pour être fixés sur des bouteilles avec des pressions de remplissage nominales atteignant 25 000 kPa à 15 °C et peuvent être équipés de dispositifs permettant de réguler et de mesurer le débit du gaz médical fourni au patient.

Tlačni regulatorji za medicinske pline - 3. del: Tlačni regulatorji v sklopu ventilov jeklenk (ISO 10524-3:2005)

1.1 Ta del standarda ISO 10524 velja za tlačne regulatorje v sklopu ventilov jeklenk (kot je opredeljeno v točki 3.16), namenjene doziranju medicinskih plinov pri zdravljenju, diagnostičnem ocenjevanju, oskrbi bolnikov in ravnanju z njimi, za naslednje medicinske pline:
– kisik,
– dušikov oksid,
– zrak za dihanje,
– helij,
– ogljikov dioksid,
– ksenon,
– določene zmesi zgoraj navedenih plinov,
– zrak za delovanje kirurških instrumentov,
– dušik za delovanje kirurških instrumentov.
1.2 Ti tlačni regulatorji v sklopu ventilov jeklenk so namenjeni namestitvi v jeklenke z nazivnim polnilnim tlakom do 25000 kPa pri 15 °C in jih je mogoče uporabljati skupaj z napravami, ki nadzorujejo in merijo tok dovajanega medicinskega plina.

General Information

• Status: Withdrawn
• Publication Date: 30-Jun-2006
• Withdrawal Date: 14-Mar-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• ICS: 23.060.40 - Pressure regulators
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 14-Mar-2019
• Due Date: 06-Apr-2019
• Completion Date: 15-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 10524-3:2006 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)

Relations

• Replaced By: SIST EN ISO 10524-3:2019 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO 10524-3:2019)
• Effective Date: 01-Apr-2019
• Amended By: SIST EN ISO 10524-3:2006/A1:2013 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 738-3:2000/A1:2002 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves
• Effective Date: 01-Jul-2006
• Replaces: SIST EN 738-3:2000 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves
• Effective Date: 01-Jul-2006
• Amended By: SIST EN ISO 10524-3:2006/A1:2013 - Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves - Amendment 1: Filtration and information to be supplied by the manufacturer (ISO 10524-3:2005/Amd 1:2013)
• Effective Date: 01-Jun-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10524-3:2006
01-julij-2006
1DGRPHãþD
SIST EN 738-3:2000
SIST EN 738-3:2000/A1:2002
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYVNORSXYHQWLORY
MHNOHQN,62
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated
with cylinder valves (ISO 10524-3:2005)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 3: Druckminderer in
Flaschenventilen (ISO 10524-3:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 3: Détendeurs intégrés dans
les robinets des bouteilles de gaz (ISO 10524-3:2005)
Ta slovenski standard je istoveten z: EN ISO 10524-3:2006
ICS:
11.040.10
23.060.40
SIST EN ISO 10524-3:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 10524-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.040.10 Supersedes EN 738-3:1998
English Version
Pressure regulators for use with medical gases - Part 3:
Pressure regulators integrated with cylinder valves (ISO 10524-
3:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
3: Détendeurs intégrés dans les robinets des bouteilles de Teil 3: Druckminderer in Flaschenventilen (ISO 10524-
gaz (ISO 10524-3:2005) 3:2005)
This European Standard was approved by CEN on 20 March 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-3:2006: E
worldwide for CEN national Members.

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EN ISO 10524-3:2006 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices.4

2

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EN ISO 10524-3:2006 (E)
Foreword
The text of ISO 10524-3:2005 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 10524-3:2006 by 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 October 2006, and conflicting national standards shall be withdrawn at
the latest by October 2006.
This document supersedes EN 738-3:1998.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

Endorsement notice
The text of ISO 10524-3:2005 has been approved by CEN as EN ISO 10524-3:2006 without any modifications.

3

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EN ISO 10524-3:2006 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC Medical
devices
Essential requirements (ERs) of EU
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 9.3
5.3.2 4, 7.1, 9.2
5.3.3 3, 5
5.3.4 7.1, 7.2
5.4 2, 3, 4
5.4.1.1 10
5.4.1.3 10.2
5.4.1.4 10.1
5.4.2 9.1, 12.7.4
5.4.3 9.1, 12.7.4
5.4.4 9.1, 12.7.4
5.4.5 12.2
5.4.6 12.8.1
5.4.7 12.8.1
5.4.8 12.7.1
5.4.9 7.2, 7.6
5.4.12 7.5, 9.2, 12.7.1
5.4.13 7.5
5.4.14 9.2
4

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EN ISO 10524-3:2006 (E)
Essential requirements (ERs) of EU
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5.4.15 7.3, 9.3
5.4.16.1 10.3, 12.8.2
5.4.16.2 10.2
5.4.16.3 10.1, 12.8.1, 12.8.2
5.4.16.4 10.1, 12.8.1, 12.8.2
5.4.17.1 12.8.1, 12.8.2
5.4.17.2 10.1, 12.8.1, 12.8.2
5.4.17.3 10.1, 12.8.1, 12.8.2
5.4.18.1 10.1, 12.8.1, 12.8.2
5.4.18.2 10.2
5.5.1 7.2, 9.3
5.5.2 7.3, 9.3
6 3, 7.5, 9.2, 9.3, 12.7.1, 12.8.1, 12.8.2
7.1 13.1, 13.2
7.1.2 a) 13.1, 13.3 a)
7.1.2 b) 13.3 b)
7.1.2 c) 13.3 d), 13.5
7.1.2 d) 9.1, 12.7.4
7.1.4, a) 13.1, 13.3 a)
7.1.5 12.9
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13. 13.3 b)
8.1 13.1, 13.3 a), 13.4, 13.6 a)
8.2 13.6 b)
8.3 13.6 b)
8.5 13.6 c), 13.6 d)
8.6 9.1, 9.3, 13.1, 13.6 c), 13.6 d)

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

5

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INTERNATIONAL ISO
STANDARD 10524-3
First edition
2005-05-01


Pressure regulators for use with medical
gases —
Part 3:
Pressure regulators integrated with
cylinder valves
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 3: Détendeurs intégrés aux valves des bouteilles de gaz





Reference number
ISO 10524-3:2005(E)
©
ISO 2005

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ISO 10524-3:2005(E)
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ii © ISO 2005 – All rights reserved

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ISO 10524-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Symbols . 4
5 General requirements . 4
5.1 Safety. 4
5.2 Alternative construction. 4
5.3 Materials. 4
5.4 Design requirements . 5
5.5 Constructional requirements. 12
6 Test methods. 13
6.1 Conditions. 13
6.2 Test methods for outlet pressure. 14
6.3 Test method for pressure-relief valve. 15
6.4 Test methods for leakage. 15
6.5 Test method for mechanical strength. 16
6.6 Test method for resistance to ignition. 17
6.7 Test method for accuracy of flow of pressure regulators integrated with cylinder valves
fitted with flowmeters or flowgauges. 20
6.8 Test method for the stability of flow of pressure regulators integrated with cylinder valves
fitted with flowmeters or flowgauges. 20
6.9 Test method for stability and accuracy of flow of pressure regulators integrated with
cylinder valves fitted with fixed orifices . 20
6.10 Test method for flow setting and loosening torques . 20
6.11 Drop test. 21
6.12 Impact test . 21
6.13 Test method for means of gas shut-off . 22
6.14 Test method for non-return valve of filling port. 22
6.15 Test method for durability of markings and colour coding. 22
7 Marking, colour coding, packaging. 22
7.1 Marking. 22
7.2 Colour coding. 23
7.3 Packaging . 23
8 * Information to be supplied by the manufacturer. 24
Annex A (informative) Examples of pressure regulators integrated with cylinder valves . 26
Annex B (normative) Rationale . 29
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases . 31
Bibliography . 33

© ISO 2005 – All rights reserved iii

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ISO 10524-3:2005(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10524-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
ISO 10524 consists of the following parts, under the general title Pressure regulators for use with medical
gases:
 Part 1: Pressure regulators and pressure regulators with flow-metering devices
 Part 2: Manifold and line pressure regulators
 Part 3: Pressure regulators integrated with cylinder valves
 Part 4: Low-pressure regulators
iv © ISO 2005 – All rights reserved

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ISO 10524-3:2005(E)
Introduction
Pressure regulators integrated with cylinder valves 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 integrated with cylinder
valves be 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 valve
or a fixed orifice. The flow can be indicated by a flowmeter or by a flowgauge.
It is essential that regular inspection and maintenance be undertaken to ensure that the pressure regulators
continue to meet the requirements of this part of ISO 10524.
This part of ISO 10524 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.
Annex B contains rationale statements for some of the requirements of this part of ISO 10524. The clauses
and subclauses marked with an asterisk (*) after their number have corresponding rationale included to
provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated into this part of ISO 10524. It is considered that knowledge of the reasons for the requirements
will not only facilitate the proper application of this part of ISO 10524, but will expedite any subsequent
revisions.
© ISO 2005 – All rights reserved v

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INTERNATIONAL STANDARD ISO 10524-3:2005(E)

Pressure regulators for use with medical gases —
Part 3:
Pressure regulators integrated with cylinder valves
1 Scope
1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as defined
in 3.16) intended for the administration of medical gases in the treatment, management, diagnostic evaluation
and care of patients for use with the following medical gases:
 oxygen;
 nitrous oxide;
 air for breathing;
 helium;
 carbon dioxide;
 xenon;
 specified mixtures of the gases listed above;
 air for driving surgical tools;
 nitrogen for driving surgical tools.
1.2 * These pressure regulators integrated with cylinder valves are intended to be fitted to cylinders with
nominal filling pressures up to 25 000 kPa at 15 °C and can be provided with devices that control and
measure the flow of the medical gas delivered.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 407:2004, Small medical gas cylinders — Pin-index yoke-type valve connections
ISO 5145, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO 5359:2000, Low-pressure hose assemblies for use with medical gases
ISO 7396-1:2002, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and
vacuum
© ISO 2005 – All rights reserved 1

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ISO 10524-3:2005(E)
ISO/TR 7470:1988, Valve outlets for gas cylinders — List of provisions which are either standardized or in use
ISO 9170-1:1999, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
1)
ISO 10297:— , Transportable gas cylinders — Cylinder valves — Specification and type testing
ISO 10920:1997, Gas cylinders — 25E taper thread for connection of valves to gas cylinders — Specification
EN ISO 11116-1:1999, Gas cylinders — 17E taper thread for connection of valves to gas cylinders — Part 1:
Specifications
ISO 11117:1998, Gas cylinders — Valve protection caps and valve guards for industrial and medical gas
cylinders — Design, construction and tests
ISO 13341:1997, Transportable gas cylinders — Fitting of valves to gas cylinders
ISO 14971:2000, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 15245-1:2001, Gas cylinders — Parallel threads for connection of valves to gas cylinders — Part 1:
Specification
EN 837-1:1996, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
EN 13544-2:2002, Respiratory therapy equipment — Part 2: Tubing and connectors
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
SS 01 91 02, Colour Atlas
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accuracy of flow
difference between the indicated value and the actual value of the flow, expressed in percent
3.2
adjustable pressure regulator
pressure regulator that is provided with a means of operator adjustment of the outlet pressure
3.3
filling port
connector on the pressure regulator through which the cylinder is filled
3.4
flow outlet
outlet intended to deliver a controlled flow of gas

1) To be published. (Revision of ISO 10297:1999)
2 © ISO 2005 – All rights reserved

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ISO 10524-3:2005(E)
3.5
flowgauge
device that measures pressure and which is calibrated in units of flow
NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice.
3.6
flowmeter
device that measures and indicates the flow of a specific gas or gas mixture
3.7
gas-specific
having characteristics that prevent connection between different gas services
3.8
gas-specific connection point
that part of the terminal unit which is the receptor for a gas-specific probe
3.9
nipple
that portion of a connector which is pushed into and secured within the bore (lumen) of a hose
3.10
nominal inlet pressure
P
1
upstream pressure (specified as a single value by the manufacturer) for which the pressure regulator is
intended to be used
3.11
nominal outlet pressure
P
2
nominal downstream pressure
NOTE P is specified by the manufacturer in the instructions for use.
2
3.12
pre-set pressure regulator
pressure regulator that is not provided with a means of operator adjustment of the outlet pressure
3.13
pressure gauge
device that measures and indicates pressure
3.14
pressure outlet
outlet intended to deliver gas at a controlled pressure
3.15
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.16
pressure regulator integrated with cylinder valve
combination of a pressure regulator and cylinder valve intended to be permanently fitted to a medical gas
cylinder
3.17
pressure-relief valve
device intended to relieve excess pressure at a pre-set value
© ISO 2005 – All rights reserved 3

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ISO 10524-3:2005(E)
3.18
residual pressure valve
means for retaining a minimum pressure within a cylinder
3.19
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
[IEC 60601-1:1988, 2.10.11]
4 Symbols
P Nominal inlet pressure;

1
P Nominal outlet pressure.

2
Examples of pressure regulators integrated with cylinder valves with terminology are given in Annex A.
5 General requirements
5.1 Safety
Pressure regulators integrated with cylinder valves shall, when transported, stored, installed, operated in
normal use and maintained according to the instructions of the manufacturer, cause no safety hazard that
could be foreseen using risk management procedures in accordance with ISO 14971 and that is connected
with their intended application, in normal condition and in single fault condition.
5.2 Alternative construction
Pressure regulators integrated with cylinder valves and components or parts thereof, using materials or having
forms of construction different from those detailed in 5.3 to 5.5 shall be accepted if it can be demonstrated that
an equivalent degree of safety is obtained.
Such evidence shall be provided by the manufacturer upon request.
5.3 Materials
5.3.1 * The materials in contact with the medical gases listed in 1.1, during normal use shall be resistant to
corrosion and compatible with oxygen, the other medical gases and their mixtures in the temperature range
specified in 5.3.2.
Criteria for the selection of metallic and non-metallic materials are given in ISO 15001.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air burn
violently in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure.
Similarly, materials that can be ignited in air, in oxygen require lower ignition energies. Many such materials can be ignited
by friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a
system initially at low pressure.
5.3.2 The materials shall permit the pressure regulator, integrated with cylinder valve and its components,
to meet the requirements of 5.4 in the temperature range of − 20 °C to + 60 °C.
NOTE Regional or national environmental conditions may require deviation from this range of temperatures.
4 © ISO 2005 – All rights reserved

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ISO 10524-3:2005(E)
5.3.3 Pressure regulators integrated with cylinder valves shall meet the requirements of this part of
ISO 10524 after being packed for transport and storage and being exposed to environmental conditions as
stated by the manufacturer.
5.3.4 Springs, highly strained components and parts liable to wear which come in contact with the medical
gas shall not be plated.
NOTE Any plating could detach from the component surface.
5.3.5 * Aluminium or aluminium alloys shall not be used for components whose surfaces come into contact
with gas at cylinder pressure in normal or single-fault condition.
5.3.6 Evidence of conformity with the requirements of 5.3.1, 5.3.2, 5.3.3, 5.3.4 and 5.3.5 shall be provided
by the manufacturer upon request.
5.4 Design requirements
5.4.1 Pressure gauges and flowgauges
5.4.1.1 If a Bourdon tube pressure gauge or flowgauge is used, it shall conform to EN 837-1, except for
the minimum nominal size.
The requirements in 5.4.1.2 to 5.4.1.7 shall apply to all types of pressure gauges and flowgauges.
5.4.1.2 The connector shall be a thread complying to EN 837-1 or a proprietary connector.
5.4.1.3 The indicated value of a pressure gauge or flowgauge shall be legible to any operator having a
visual acuity of 1 (corrected if necessary) 1 m from the gauge with an illuminance of 215 lx.
5.4.1.4 The scale of the cylinder pressure gauge shall extend to a pressure at least 33 % greater than
nominal inlet pressure, P .
1
NOTE In addition to the scale ranges in EN 837-1, a pressure gauge with a scale range of 0 to 31 500 kPa (315 bar)
can also be used.
5.4.1.5 The cylinder pressure gauge, outlet pressure gauge or flowgauge shall be class 2,5 or better in
accordance with EN 837-1.
5.4.1.6 The connector for a pressure gauge with a scale range greater than 4 000 kPa shall be fitted with
2
an orifice with an area no greater than 0,1 mm .
5.4.1.7 Evidence of conformity with the requirements of 5.4.1.1 and 5.4.1.5 shall be provided by the
manufacturer upon request. Compliance with the requirements of 5.4.1.2, 5.4.1.3, 5.4.1.4 and 5.4.1.6 shall be
checked by visual inspection or measurement as required.
5.4.2 Filling port
5.4.2.1 * The filling port shall be gas-specific for the medical gas for which the pressure regulator is
intended to be used.
5.4.2.2 The filling port shall either:
a) comply with either ISO 407, ISO 5145 or the relevant regional or national standard (see ISO/TR 7470 for
information) or
b) be a proprietary connector.
© ISO 2005 – All rights reserved 5

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