SIST EN ISO 10524-1:2019

SLOVENSKI STANDARD
01-april-2019
1DGRPHãþD
SIST EN ISO 10524-1:2006
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL,62
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO 10524-1:2018)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Partie 1: Détendeurs et détendeurs-
débitmètres (ISO 10524-1:2018)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2019
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 10524-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10524-1:2006
English Version
Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow-
metering devices (ISO 10524-1:2018)
Détendeurs pour l'utilisation avec les gaz médicaux- Druckminderer zur Verwendung mit medizinischen
Partie 1: Détendeurs et détendeurs-débitmètres (ISO Gasen - Teil 1: Druckminderer und Druckminderer mit
10524-1:2018) Durchflussmessgeräten (ISO 10524-1:2018)
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 10524-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10524-1:2019) 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 10524-1:2006.
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 10524-1:2018 has been approved by CEN as EN ISO 10524-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 10524-1
Second edition
2018-01
Pressure regulators for use with
medical gases —
Part 1:
Pressure regulators and pressure
regulators with flow-metering devices
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 1: Détendeurs et détendeurs-débitmètres
Reference number
ISO 10524-1:2018(E)
©
ISO 2018
ISO 10524-1:2018(E)
© ISO 2018, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2018 – All rights reserved

ISO 10524-1:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Nomenclature . 4
5 General requirements . 4
5.1 Safety . 4
5.2 Usability . 4
5.3 Alternative construction . 4
5.4 Materials . 4
6 Design requirements . 5
6.1 General . 5
6.2 Indicator for cylinder pressure or cylinder content . 6
6.2.1 General. 6
6.2.2 Pressure gauges, pressure indicators, and flowgauges . 6
6.3 Integrated electronic device . 6
6.4 Connections . 6
6.4.1 Inlet connector. 6
6.4.2 Outlet connectors . 7
6.5 * Requirements for outlet pressure . 7
6.5.1 Pressure outlet . 7
6.5.2 Flow outlet . 8
6.6 Flow-metering device . 8
6.7 Flow control and indication . 8
6.8 Pressure-adjusting device . 8
6.9 * Filtration . 9
6.10 * Pressure-relief device . 9
6.11 Leakage . 9
6.12 Mechanical strength .10
6.12.1 Resistance of the high-pressure side .10
6.12.2 Resistance of the low-pressure side to pneumatic pressure .10
6.12.3 Resistance of the low-pressure side to inlet pressure, P .10
6.13 * Resistance to ignition .10
6.14 Requirements for pressure regulators with flowmeters .10
6.14.1 Calibration .10
6.14.2 Accuracy of flow .10
6.14.3 Stability of flow .11
6.14.4 Legibility .11
6.14.5 Flow control device .11
6.15 Requirements for PRESSURE REGULATORS fitted with flowgauges.11
6.15.1 Calibration .11
6.15.2 Accuracy of flow .11
6.15.3 Stability of flow .11
6.16 Requirements for pressure regulators fitted with fixed orifices .12
6.16.1 Stability and accuracy of flow .12
6.16.2 * Flow setting torque .12
6.16.3 Removal of a fixed orifice .12
6.16.4 Legibility .12
6.17 Endurance .12
6.17.1 Flow selector .12
6.17.2 Pressure regulator .13
ISO 10524-1:2018(E)
7 Construction requirements .13
7.1 * Cleanliness .13
7.2 Lubricants .13
7.3 Loosening torques .13
8 Test methods for type tests .14
8.1 General conditions .14
8.1.1 General.14
8.1.2 Ambient conditions .14
8.1.3 Test gas .14
8.1.4 Reference conditions .14
8.2 Test schedule .14
8.3 Test methods for outlet pressure .16
8.3.1 Test equipment .16
8.3.2 Test methods for determining outlet pressure limits for a pressure
regulator fitted with a pressure outlet .17
8.3.3 Test method for determining the outlet pressure limit for a pressure
regulator fitted with a flow outlet .18
8.4 Test method for a pressure-relief device .18
8.5 Test methods for leakage .18
8.5.1 External leakage .18
8.5.2 Internal leakage .19
8.6 Test method for mechanical strength .19
8.6.1 Test method for the high-pressure side .19
8.6.2 Test method for resistance of the low-pressure side to pneumatic pressure .19
8.6.3 Test method for the resistance of the low pressure side to P .19
8.7 Test method for resistance to ignition .20
8.7.1 General.20
8.7.2 Test procedure for adjustable and pre-set pressure regulators .20
8.8 Test method for accuracy of flow of pressure regulators fitted with
flowmeters or flowgauges .20
8.9 Test method for the stability of flow of pressure regulator fitted with
flowmeters or flowgauges .20
8.10 Test method for stability and accuracy of flow of pressure regulators fitted
with fixed orifices .21
8.11 Test method for flow setting and loosening torques .21
8.11.1 General.21
8.11.2 Test method for verifying no stable position between two settings .21
8.12 Test method for durability of markings and colour coding .21
8.13 *Flow selector endurance test.21
8.14 Pressure regulator endurance test .22
9 Marking, colour coding, and packaging .22
9.1 Marking .22
9.2 Colour coding .24
9.3 Packaging .24
10 Information to be supplied by the manufacturer .24
Annex A (informative) Rationale .26
Annex B (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases .31
Bibliography .33
iv © ISO 2018 – All rights reserved

ISO 10524-1:2018(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 10524-1:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— the common requirements have been aligned with ISO 10524-2 and ISO 10524-3;
— this document has been restructured according to the new ISO template and associated renumbering;
— a complete schedule has been introduced;
— all type tests have been reviewed.
A list of all parts in the ISO 10524 series can be found on the ISO website.
ISO 10524-1:2018(E)
Introduction
Pressure regulators 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 are
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 device 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
regulator continues 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),
— gas specificity,
— cleanliness,
— type testing,
— marking, and
— information supplied by the manufacturer.
Annex A 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 A.
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 10524-1:2018(E)
Pressure regulators for use with medical gases —
Part 1:
Pressure regulators and pressure regulators with flow-
metering devices
1 Scope
This document specifies the design, construction, type testing, and marking requirements for pressure
regulators (as defined in 3.18) intended for the administration of medical gases and their mixtures
in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving
surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to pressure regulators:
a) intended to be connected to cylinders by the operator;
b) with integral flow-metering devices intended to be connected to cylinders by the operator;
c) that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators,
resuscitators).
A pressure regulator can be provided with pressure outlet or flow outlet, and can be adjustable
or pre-set.
pressure regulators are intended to be fitted to refillable cylinders with a working pressure up
to 30 000 kPa ( 300 bar) and can be provided with devices which control and measure the flow of the
medical gas delivered.
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 407, Small medical gas cylinders — Pin-index yoke-type valve connections
ISO 5145, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 10297:2014, Gas cylinders — Cylinder valves — Specification and type testing
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 10524-1:2018(E)
EN 837-1, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors
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 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
accuracy of flow
difference between the indicated value and the actual value of the flow
Note 1 to entry: It is expressed in per cent.
3.2
adjustable pressure regulator
pressure regulator (3.18) that is provided with a means of operator adjustment of the outlet pressure
3.3
content indicator
device that displays the amount of gas remaining in the cylinder
Note 1 to entry: The content can be expressed either in percentage of content or cylinder pressure.
3.4
flowgauge
device that measures pressure and which is calibrated in units of flow
Note 1 to entry: The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of
a fixed orifice (3.13).
3.5
flowmeter
device that measures and indicates the flow of a specific gas or gas mixture
3.6
flow selector
means for selecting the flow and indicating the flow selected
3.7
flow outlet
outlet intended to deliver a controlled flow of gas
3.8
gas-specific
quality of having characteristics that prevent connection between different gas services
3.9
gas-specific connection point
part of the terminal unit which is the receptor for a gas-specific (3.8) probe
2 © ISO 2018 – All rights reserved

ISO 10524-1:2018(E)
3.10
nipple
portion of a connector which is pushed into and secured within the bore (lumen) of a hose
3.11
nominal inlet pressure
P
upstream working pressure (3.21) specified by the manufacturer for which the pressure regulator
(3.18) is intended to be used
3.12
nominal outlet pressure
P
nominal downstream pressure under flow conditions specified by the manufacturer
3.13
orifice
restriction of known cross-section that delivers a constant flow of gas when supplied with gas at a
constant upstream pressure
3.14
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]
3.15
pre-set pressure regulator
pressure regulator (3.18) that is not provided with a means of operator adjustment of the outlet
pressure
3.16
pressure gauge
device that measures and indicates pressure
3.17
pressure outlet
outlet intended to deliver gas at a controlled pressure
3.18
pressure regulator
device that reduces the inlet pressure and maintains the set outlet pressure within specified limits
3.19
pressure-relief device
device intended to relieve excess pressure at a pre-set value
3.20
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
3.21
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).
ISO 10524-1:2018(E)
4 Nomenclature
Examples of pressure regulators (see figures) with terminology are given in Annex A.
5 General requirements
5.1 Safety
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 the pressure regulator should be such that in the event of 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.
[6]
NOTE For information related to usability, see other documents; for example, IEC 62366-1 and
[7]
IEC/TR 62366-2 .
5.3 Alternative construction
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.
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.
4 © ISO 2018 – All rights reserved

ISO 10524-1:2018(E)
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, 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 pressure regulator and its components to meet the requirements
of Clause 5 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 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 5 shall be provided by the manufacturer upon
request.
6 Design requirements
6.1 General
The operation of the pressure regulator shall comply with the requirements of this document
between −20 °C and +60 °C.
NOTE Regional or national regulations can specify additional design requirements.
ISO 10524-1:2018(E)
6.2 Indicator for cylinder pressure or cylinder content
6.2.1 General
The pressure regulator shall be fitted with a pressure gauge or with an equivalent means to
indicate the cylinder pressure or cylinder content.
NOTE In a cylinder with liquefiable gas (e.g. nitrous oxide), the pressure might not indicate the content.
6.2.2 Pressure gauges, pressure indicators, and flowgauges
6.2.2.1 If a Bourdon tube pressure gauge or flowgauge 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 their requirements are
applicable to other types of gauges, e.g. direct drive gauges.
6.2.2.2 Pressure gauges, content indicators, and flowgauges should be designed to resist moisture
ingress (e.g. IP 44 of IEC 60529).
6.2.2.3 The casings of pressure gauges, content indicators and flowgauges 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.
6.2.2.4 If the gauge connector is threaded, it shall comply with EN 837-1 or a regional or national
standard.
6.2.2.5 The pressure, flow 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.
6.2.2.6 The scale of the cylinder pressure gauge and content indicator shall extend to at least
133 % of P .
6.2.2.7 Pressure gauges and flowgauges shall be class 2.5 or better in accordance with EN 837-1.
6.2.2.8 The inlet connection of a pressure gauge and content indicator, 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 electronic device
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 Connections
6.4.1 Inlet connector
The inlet connector for connection to cylinders shall comply with either ISO 407, ISO 5145 or the
relevant regional or national standards. See ISO TR 7470 for information. The inlet connection should
be selected in order to ensure that the pressure regulator will not be subjected to an upstream
pressure higher than the pressure, P , specified.
6 © ISO 2018 – All rights reserved

ISO 10524-1:2018(E)
6.4.2 Outlet connectors
6.4.2.1 General
The outlet connector(s) shall be in accordance with 6.4.2.2 or 6.4.2.3.
NOTE A pressure regulator can have multiple outlets and can have both a pressure outlet and a
flow outlet.
6.4.2.2 * Flow outlet
A flow outlet shall either be:
a) a nipple in accordance with EN 13544-2;
b) a threaded connector in accordance with EN 13544-2:
— thread for oxygen: 9/16-18UNF-2A-RH;
— thread for medical air: 3/4-16UNF-2A-RH.
Threaded connectors, if used for other medical gases, shall be in accordance with regional or national
standards.
A flow outlet shall not be fitted to a pressure regulator intended for use with air or nitrogen for
driving surgical tools.
6.4.2.3 Pressure outlet
A pressure outlet shall be fitted with a gas-specific connection point, in accordance with
IS
...