EN ISO 10524-2:2006

Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

ISO 10524-2:2005 specifies requirements for manifold pressure regulators intended to be connected to cylinders with nominal filling pressures up to 25 000 kPa at 15 °C and for line pressure regulators for inlet pressures up to 3 000 kPa and intended for use in pipeline systems for the following medical gases:
oxygen; nitrous oxide; air for breathing; carbon dioxide; oxygen/nitrous oxide mixtures; air for driving surgical tools; nitrogen for driving surgical tools; oxygen produced by an oxygen concentrator.
ISO 10524-2:2005 applies to manifold pressure regulators and line pressure regulators supplied as individual units or to the relevant components incorporated within an assembly. It does not apply to pressure regulators for use with vacuum pipeline systems.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2: Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2005)

1.1   * Dieser Teil von ISO 10524 legt Anforderungen an Hauptstellendruckregler (wie sie in 3.6 definiert sind), die zum Anschluss an Gasflaschen mit einem Nenn-Fülldruck bis zu 25 000 kPa bei 15 °C vorgesehen sind, sowie für Leitungsdruckminderer (wie sie in 3.4 definiert sind) für Vordrücke bis zu 3 000 kPa fest, die zur Verwendung in Rohrleitungssystemen für folgende medizinische Gase vorgesehen sind:
   Sauerstoff;
   Distickstoffoxid;
   Luft für Beatmungszwecke;
   Kohlendioxid;
   Sauerstoff-/Distickstoffoxidgemisch;
   Luft zum Antrieb chirurgischer Werkzeuge;
   Stickstoff zum Antrieb chirurgischer Werkzeuge;
   Sauerstoff von einem Sauerstoff-Konzentrator.
1.2   * Dieser Teil von ISO 10524 gilt für Hauptstellendruckregler und Leitungsdruckminderer, die als individuelle Einheiten geliefert werden oder für die entsprechenden Bestandteile innerhalb eines zusammen-gebauten Geräts.
1.3   Dieser Teil von ISO 10524 gilt nicht für Druckminderer zur Verwendung mit Rohrleitungssystemen für Vakuum.
ANMERKUNG   Anforderungen an Druckminderer zur Verwendung mit Rohrleitungssystemen für Vakuum sind in ISO 10079 3 erfasst.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et de canalisations (ISO 10524-2:2005)

L'ISO 10524-2:2005 spécifie les exigences relatives aux détendeurs de rampes, tels que définis en 3.6, destinés à être raccordés à des bouteilles dont la pression d'alimentation maximale est de 25 000 kPa à 15 °C, ainsi qu'aux détendeurs de canalisations, tels que définis en 3.4, pour une pression d'alimentation maximale de 3 000 kPa et destinés à alimenter les réseaux de distribution des gaz médicaux suivants:
l'oxygène;
le protoxyde d'azote;
l'air respirable;
le dioxyde de carbone;
les mélanges oxygène/protoxyde d'azote;
l'air pour les instruments chirurgicaux;
l'azote pour les instruments chirurgicaux;
l'oxygène produit par les concentrateurs d'oxygène.
L'ISO 10524-2:2005 s'applique aux détendeurs de rampes et de canalisations fournis sous la forme d'unités individuelles ou faisant partie d'éléments à assembler.
L'ISO 10524-2:2005 ne s'applique pas aux détendeurs utilisés avec les systèmes d'aspiration.

Tlačni regulatorji za medicinske pline - 2. del: Tlačni regulatorji v razdelilnikih in ceveh (ISO 10524-2:2005)

General Information

• Status: Withdrawn
• Publication Date: 25-Apr-2006
• Withdrawal Date: 29-Jan-2019
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Jan-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: SIST EN ISO 10524-2:2006 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

Relations

• Replaces: EN 738-2:1998 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10524-2:2019 - Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2018)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN 738-2:2000
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO7ODþQLUHJXODWRUMLYUD]GHOLOQLNLKLQ
FHYHK,62
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure
regulators (ISO 10524-2:2005)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 2:
Hauptstellendruckregler und Leitungsdruckminderer (ISO 10524-2:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 2: Détendeurs de rampes et
de canalisations (ISO 10524-2:2005)
Ta slovenski standard je istoveten z: EN ISO 10524-2:2006
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 10524-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.040.10 Supersedes EN 738-2:1998
English Version
Pressure regulators for use with medical gases - Part 2:
Manifold and line pressure regulators (ISO 10524-2:2005)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
2: Détendeurs de rampes et de canalisations (ISO 10524- Teil 2: Hauptstellendruckregler und Leitungsdruckminderer
2:2005) (ISO 10524-2:2005)
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 10524-2:2006: 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 10524-2:2005 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 738-2: 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 10524-2:2005 has been approved by CEN as EN ISO 10524-2:2006 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
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
5.4.2. 12.7.1
5.4.3 7.2, 7.6
5.4.4 9.2
5.4.5.1 9.1, 12.7.4
5.4.5.2 9.1, 12.7.4
5.4.5.3 7.5
5.4.5.4 3
5.4.5.5 7.5, 9.2, 12.7.1
5.4.5.6 7.3, 9.3
5.4.6.1 9.1, 12.7.4
5.4.6.2 9.1, 12.7.4
5.4.6.3 7.5
Essential requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
5.4.6.4 3
5.4.6.5 7.3, 9.3
5.5.1 7.2, 9.3
5.5.2 7.2,  9.3
6 3, 7.5, 9.2, 9.3, 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)
7.1.3, a) 13.1, 13.3 a)
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13.1, 13.3 b)
8.1 13.1, 13.3 a, 13.4, 13.6 a)
8.2 9.1, 9.2, 9.3, 13.1, 13.6 c), 13.6 d),
13.6 k)
8.3 13.6 b)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 10524-2
First edition
2005-05-01
Pressure regulators for use with medical
gases —
Part 2:
Manifold and line pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 2: Détendeurs de rampes et de canalisations

Reference number
ISO 10524-2:2005(E)
©
ISO 2005
ISO 10524-2:2005(E)
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ISO 10524-2:2005(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. 9
6 Test methods. 9
6.1 Conditions. 9
6.2 Test methods for manifold pressure regulators. 10
6.3 Test methods for line pressure regulators.16
6.4 Test method for determination of the auto-ignition temperature of sealing materials and
lubricants . 17
6.5 Test method for durability of markings and colour coding. 18
7 Marking, colour coding, packaging. 19
7.1 Marking. 19
7.2 Colour coding. 20
7.3 Packaging . 21
8 Information to be supplied by the manufacturer . 21
Annex A (informative) Examples of pressure regulators . 22
Annex B (informative) Rationale .24
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases . 26
Bibliography . 28

ISO 10524-2:2005(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 10524-2 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
...