EN ISO 10524-3:2006

SLOVENSKI STANDARD
01-julij-2006
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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
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.

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

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 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

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.
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 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

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
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
nominal downstream pressure
NOTE P is specified by the manufacturer in the instructions for use.
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 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;
P Nominal outlet pressure.
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

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 .
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
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 10524-3:2005(E)
5.4.2.3 The filling port shall be fitted with a means (e.g. non-return valve and/or plug or cap) that allows
the pressure regulator integrated with cylinder valve to meet the external leakage requirement in 5.4.13.1.
Pressure-tight caps and plugs shall be designed to require the use of a proprietary tool for removal.
5.4.2.4 The non-return valve, if fitted, shall comply with the requirement of 5.4.13.1 after 1 000 opening
and closing cycles.
The test is described in 6.14
5.4.2.5 Means shall be provided to reduce the likelihood of the filling port becoming contaminated.
NOTE Such means may include a filter or a removable cap.
Evidence shall be provided by the manufacturer upon request.
5.4.2.6 Means shall be provided to reduce the likelihood of the filling port being used for other than its
intended purpose.
Evidence shall be provided by the manufacturer upon request.
5.4.3 Connectors
5.4.3.1 Valve stem
If a taper thread is used for the valve stem, it shall be in accordance with ISO 10920 or ISO 11116-1 or
regional or national standards. If a parallel thread is used for the valve stem, it shall be in accordance with
ISO 15245-1 or regional or national standards.
Evidence shall be provided by the manufacturer upon request.
5.4.3.2 Outlet connector
5.4.3.2.1 General
The outlet connector shall be in accordance with 5.4.3.2.2 and/or 5.4.3.2.3.
NOTE A pressure regulator integrated with cylinder valve can have multiple outlets and can have both a pressure
outlet and a flow outlet.
5.4.3.2.2 * Flow outlet
A flow outlet shall be fitted with a fixed nipple or a threaded connector.
Nipples, if used, shall be in accordance with EN 13544-2.
Threaded connectors used for oxygen or air for breathing shall be in accordance with EN 13544-2. Threaded
connectors used for other gases shall be in accordance with regional or national standards or shall be
proprietary connectors.
A flow outlet shall not be fitted on a pressure regulator integrated with cylinder valve intended for use with air
or nitrogen for driving surgical tools.
5.4.3.2.3 Pressure outlet
A pressure outlet shall be fitted with one of the following:
a) a terminal unit or a gas-specific connection point in accordance with ISO 9170-1, for the following medical
gases:
 oxygen;
6 © ISO 2005 – All rights reserved

ISO 10524-3:2005(E)
 nitrous oxide;
 air for breathing;
 carbon dioxide;
 oxygen/nitrous oxide mixture 50/50 % (volume fraction);
 air for driving surgical tools;
 nitrogen for driving surgical tools;
 other gases for which terminal units in regional or national standards exist.
NOTE The connection of the terminal unit or the gas-specific connection point to the pressure regulator body need
not be gas-specific.
b) an NIST or DISS body in accordance with ISO 5359, unless a regional or national standard exists for
terminal units, for the following medical gases:
 helium;
 xenon;
 mixtures of oxygen and nitrous oxide (except 50/50 % (volume fraction);
 mixtures of oxygen and helium;
 mixtures of oxygen and carbon dioxide;
c) a connector in accordance with regional or national standards.
5.4.4 * Outlet pressure
5.4.4.1 General
The pressure requirements for a pressure outlet are given in 5.4.4.2.2 and 5.4.4.2.3.
The pressure requirement for a flow outlet is given in 5.4.4.3.
5.4.4.2 Pressure outlet
5.4.4.2.1 General
If a pressure regulator integrated with cylinder valve is fitted with a pressure outlet, the pressure regulator
shall be pre-set.
5.4.4.2.2 Nominal outlet pressure, P
The nominal outlet pressure, P , shall be either:
 400 kPa for medical gases except for air or nitrogen for driving surgical tools or
 800 kPa for air or nitrogen for driving surgical tools.
ISO 10524-3:2005(E)
5.4.4.2.3 * Outlet pressure limits
The outlet pressure from a pressure regulator integrated with cylinder valve fitted with a pressure outlet
(except for air or nitrogen for driving surgical tools) shall be not less than 360 kPa and no greater than
550 kPa at any flow between zero and 40 l/min for all inlet pressures between P and 1 000 kPa.
The outlet pressure for a pressure regulator integrated with cylinder valve fitted with a pressure outlet for air or
nitrogen for driving surgical tools shall be not less than 595 kPa and no greater than 1 150 kPa at any flow
between zero and 350 l/min for all inlet pressures between P and 2 000 kPa.
On a pressure regulator integrated with cylinder valve fitted with multiple pressure outlets, each pressure
outlet shall be capable of meeting these requirements whilst all outlets are operating simultaneously.
The test for outlet pressure limits is described in 6.2.2.
5.4.4.3 Flow outlet
The pressure immediately upstream of a flow control device shall be no greater than 550 kPa for inlet
pressures between P and 1 000 kPa for all flow settings including zero flow.
The test for the flow outlet pressure limit is described in 6.2.3.
5.4.5 Cylinder pressure or content indicator
The pressure regulator integrated with cylinder valve shall be fitted with a cylinder pressure gauge or with an
equivalent means of indicating the cylinder gas pressure or content.
NOTE In a cylinder with liquefiable gas (e.g. nitrous oxide) the pressure might not indicate the content.
5.4.6 Flow control and indication
If the pressure regulator integrated with cylinder valve is fitted with a flow outlet(s) in accordance with 5.4.3.2.2,
it shall also be fitted with a means of controlling the flow and means of indicating either the flow or the flow
control setting (see 5.4.16, 5.4.17 and 5.4.18).
5.4.7 Flow control valve
5.4.7.1 If a flow control valve is fitted, the flow control knob and the valve spindle shall be captive such
that they cannot be disengaged without the use of a tool.
Compliance shall be tested by attempting to remove the knob and spindle without the use of a tool.
5.4.7.2 The flow control valve shall be designed so that the flow increases when the knob is turned
anticlockwise.
Compliance shall be checked by visual inspection.
5.4.8 Pressure-adjusting device
5.4.8.1 If a pressure-adjusting device is fitted, it shall be captive such that it cannot be disengaged
without the use of a tool.
Compliance shall be tested by attempting to remove the pressure adjusting device without the use of a tool.
5.4.8.2 The pressure regulator integrated with cylinder valve 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.
8 © ISO 2005 – All rights reserved

ISO 10524-3:2005(E)
Evidence of compliance shall be provided by the manufacturer upon request.
5.4.8.3 Using the pressure-adjusting device, it shall not be possible to set a pressure at which the pressure-
relief valve opens.
Evidence of compliance shall be provided by the manufacturer upon request.
5.4.9 Filtration
The pressure regulator integrated with cylinder valve shall be fitted on the inlet side with a filter that prevents
particles greater than 100 µm from entering the pressure regulator.
Evidence of conformity shall be provided by the manufacturer upon request.
5.4.10 Means of gas shut-off
Means shall be provided to shut off the flow of gas from the cylinder during normal operation and under single
fault condition.
NOTE This requirement can be met e.g., by a means of gas shut-off upstream of the pressure regulator valve.
The means of gas shut-off shall meet the requirements in 5.4.13.1 and 5.4.13.3 after 2 000 opening and
closing cycles. The test method is described in 6.13.
If the means of gas shut-off is a handwheel-operated device, the relevant leakage requirements given in
ISO 10297 apply.
5.4.11 Residual pressure valve
If a residual pressure valve is fitted, it shall be designed to retain a gas pressure of at least 300 kPa within the
cylinder, after use.
Means shall be provided so that it is possible to vent the retained residual gas by use of a proprietary tool and
allow the cylinder to be purged or evacuated before filling.
Compliance shall be tested by inspection.
NOTE ISO 15996 contains further information on the residual pressure valve.
5.4.12 * Pressure-relief valve
A pressure-relief valve shall be provided as a component part of the pressure regulator integrated with
cylinder valve. The pressure-relief valve shall be either pre-set or not adjustable without the use of a
proprietary tool.
The leakage from the pressure-relief valve shall comply with the requirement of 5.4.13.1 up to a pressure of
550 kPa for medical gases (except for air or nitrogen for driving surgical tools) and 1 150 kPa for air or
nitrogen for driving surgical tools.
The pressure-relief valve shall lift automatically to relieve excess pressure and shall reset at a pressure
W 550 kPa for medical gases (except for air or nitrogen for driving surgical tools) and 1 150 kPa for air or
nitrogen for driving surgical tools.
The discharge from the pressure-relief valve shall be equal to or greater than the maximum predicted flow
through the pressure regulator valve in single fault condition at an outlet pressure of 1 000 kPa for medical
gases (except for air or nitrogen for driving surgical tools) and 2 000 kPa for air or nitrogen for driving surgical
tools.
ISO 10524-3:2005(E)
The pressure-relief valve shall be fitted in such a way that gas will be discharged safely.
The maximum predicted flow through the pressure regulator valve in single fault condition shall be determined
by the manufacturer and made available upon request.
NOTE Typical single fault conditions are particles on the valve seat and damage to, or loss of, the valve seat material.
The test for the pressure-relief valve is given in 6.3.
5.4.13 Leakage
5.4.13.1 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).
The test for total external leakage is described in 6.4.1.
5.4.13.2 The internal leakage through the pressure regulator valve shall not exceed 0,2 ml/min (equivalent
.
to a pressure decay of 0,020 2 kPa l/min).
The test for internal leakage is described in 6.4.2.
5.4.13.3 The internal leakage through the means of gas shut-off shall not exceed 0,1 ml/min (equivalent to
.
a pressure decay of 0,010 1 kPa l/min) when closed in accordance with the manufacturer’s instructions.
The test for internal leakage through the means of gas shut-off is described in 6.4.3.
5.4.14 Mechanical strength
5.4.14.1 The high-pressure side of the pressure regulator integrated with cylinder valve shall be capable of
withstanding × 2,25 its nominal inlet pressure, P , for 5 min without rupturing.
The test is described in 6.5.1.
5.4.14.2 The low-pressure side of the pressure regulator integrated with cylinder valve including any
integral flow control device (except for air or nitrogen for driving surgical tools) shall be capable of
withstanding a pressure of 2 200 kPa for 5 min without rupturing.
The test is described in 6.5.2.1.
NOTE 2 200 kPa is × 4 the maximum permissible outlet pressure of 550 kPa (see 5.4.4.2.3).
5.4.14.3 The low-pressure side of the pressure regulator integrated with cylinder valve for air or nitrogen
for driving surgical tools, shall be capable of withstanding a pressure of 4 600 kPa for 5 min without rupturing.
The test is described in 6.5.2.1.
NOTE 4 600 kPa is × 4 the maximum permissible outlet pressure of 1 150 kPa (see 5.4.4.2.3).
5.4.14.4 Components of the pressure regulator integrated with cylinder valve shall not be ejected if the
low-pressure chamber of the pressure regulator is exposed to nominal inlet pressure, P (e.g. if the 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 described in 6.5.2.2.
5.4.14.5 A pressure regulator integrated with cylinder valve intended to be fitted to a cylinder with a
protection cap or guard complying with ISO 11117 shall not rupture when subjected to the drop test with the
means of gas shut-off fully open. After the drop test, the means of gas shut-off shall be closed with the closure
10 © ISO 2005 – All rights reserved

ISO 10524-3:2005(E)
torque specified by the manufacturer and the pressure regulator integrated with cylinder valve shall comply with
5.4.13. After the drop test, the non-return valve, if fitted, shall comply with 5.4.13.1.
NOTE Distortion of the pressure regulator integrated with cylinder valve is not a failure of the drop test.
The drop test is described in 6.11.
5.4.14.6 If the pressure regulator integrated with cylinder valve is intended to be fitted to a cylinder without
a protection cap or guard complying with ISO 11117, it shall be subjected to the impact test with the means of
gas shut-off fully open. After the impact test, it shall be possible to close the means of gas shut-off in
accordance with the manufacturer’s instructions and there shall be no safety hazard (e.g. by release of gas or
ejection of components) when the device is pressurized.
NOTE Loss of function or distortion of the pressure regulator integrated with cylinder valve is not a failure of the
impact test.
The impact test is described in 6.12.
5.4.15 * Resistance to ignition
Pressure regulators integrated with cylinder valves for all medical gases shall not ignite or show internal
scorching when subjected to oxygen pressure shocks.
The tests for resistance to ignition are described in 6.6.
5.4.16 Requirements for pressure regulators integrated with cylinder valves fitted with flowmeters
5.4.16.1 Scales and indicators of flowmeters
Flowmeters shall be graduated in units of litres per minute (l/min) or for flows equal to or less than 1 l/min in
units of millilitres per minute (ml/min).
Compliance shall be checked by visual inspection.
5.4.16.2 Legibility
The indicated value of the flowmeter shall be legible to an operator having visual acuity of 1 (corrected if
necessary), 1 m from the flowmeter with an illuminance of 215 lx.
5.4.16.3 Accuracy of flow
The accuracy of flow at any graduation of a flowmeter shall be within ± 10 % of the indicated value for flows
between 10 % and 100 % of full scale or ± 0,5 l/min, whichever is greater, when the flow is discharged into
ambient atmosphere and corrected to reference conditions (see 6.1.3).
The accuracy of the flow at any flow graduation of a fl
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