EN ISO 10524-1:2006

Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

ISO 10524-1:2006 is applicable to the types of pressure regulators listed and is intended for the administration of the following medical gases in the treatment, management, diagnostic evaluation and care of patients:
oxygen;
nitrous oxide;
air for breathing;
helium;
carbon dioxide;
xenon;
mixtures of the gases listed above;
air for driving surgical tools;
nitrogen for driving surgical tools.
These pressure regulators 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 which control and measure the flow of the medical gas delivered.
The types of pressure regulators covered by ISO 10524-1:2006 are as follows:
pressure regulators intended to be connected to cylinders by the operator;
pressure regulators with integral flow-metering devices intended to be connected to cylinders by the operator;
pressure regulators that are an integral part of medical equipment (e.g. anaesthetic workstations, lung ventilators, resuscitators).

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2006)

1.1   Dieser Teil von ISO 10524 gilt für die in 1.3 aufgeführten Arten von Druckminderern, die für die Verabreichung folgender medizinischer Gase bei Behandlung, Management, Diagnosebewertung und Pflege von Patienten vorgesehen sind:
-   Sauerstoff;
-   Distickstoffoxid (Lachgas);
-   Luft für Beatmungszwecke;
-   Helium;
-   Kohlendioxid;
-   Xenon;
-   Gemische der oben genannten Gase;
-   Luft zum Antrieb chirurgischer Werkzeuge;
-   Stickstoff zum Antrieb chirurgischer Werkzeuge.
1.2 *    Diese Druckminderer sind für den Anschluss an Gasflaschen mit Nennfülldrücken bis 25 000 kPa bei 15 °C vorgesehen und können mit Geräten geliefert werden, die den Durchfluss des abgegebenen medizinischen Gases steuern und messen.
1.3   In diesem Teil von ISO 10524 werden folgende drei Arten von Druckminderern behandelt:
a)   Druckminderer, die vom Anwender an Gasflaschen angeschlossen werden sollen;
b)   Druckminderer mit fest verbundenen Durchflussmessgeräten, die vom Anwender an Gasflaschen angeschlossen werden sollen;
c)   Druckminderer, die fester Bestandteil medizinischer Geräte (z. B. Anästhesie-Arbeitsplätze, Beatmungsgeräte, Wiederbelebungsgeräte) sind.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs-débimètres (ISO 10524-1:2006)

L'ISO 10524-1:2006 s'applique aux types de détendeurs indiqués en 1.3 destinés à administrer les gaz médicaux suivants dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et du soin aux patients:
l'oxygène; le protoxyde d'azote; l'air respirable; l'hélium; le dioxyde de carbone; le xénon; les mélanges spécifiés des gaz cités ci-dessus; l'air pour les instruments chirurgicaux; l'azote pour les instruments chirurgicaux.
Ces détendeurs sont destinés à être branchés sur des bouteilles de gaz dont la pression nominale de remplissage peut atteindre 25 000 kPa à 15 °C, et peuvent comporter des dispositifs de contrôle et de mesure du débit des gaz médicaux délivrés.
Les types de détendeurs couverts par la présente partie de l'ISO 10524-1:2006 sont
les détendeurs destinés à être branchés sur les bouteilles par l'opérateur, les détendeurs à débitmètre intégré destinés à être branchés sur les bouteilles par l'opérateur, les détendeurs qui font partie intégrante d'un matériel médical (par exemple les appareils d'anesthésie, les ventilateurs pulmonaires, les appareils de réanimation).

Tlačni regulatorji za medicinske pline – 1. del: Tlačni regulatorji in tlačni regulatorji s pretočnimi merilniki (ISO 10524-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 31-Jan-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 10524-1:2006 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)

Relations

• Replaces: EN 738-1:1997/A1:2002 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices
• Effective Date: 22-Dec-2008
• Replaces: EN 738-1:1997 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10524-1:2019 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2018)
• Effective Date: 20-Aug-2014
• Revised: prEN ISO 10524-1 - Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
• Effective Date: 19-Jan-2023
• Child: EN ISO 10524-4:2008 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2006
1DGRPHãþD
OSIST prEN ISO 10524-1:2004
SIST EN 738-1:2000
SIST EN 738-1:2000/A1:2002
SIST EN 738-4:2000
SIST EN 738-4:2000/A1:2002
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQH±GHO7ODþQLUHJXODWRUMLLQWODþQLUHJXODWRUML
VSUHWRþQLPLPHULOQLNL,62
Pressure regulators for use with medical gases - Part 1: Pressure regulators and
pressure regulators with flow-metering devices (ISO 10524-1:2006)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 1: Druckminderer und
Druckminderer mit Durchflussmessgeräten (ISO 10524-1:2006)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 1: Détendeurs et détendeurs
-débimetres (ISO 10524-1:2006)
Ta slovenski standard je istoveten z: EN ISO 10524-1:2006
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.

EUROPEAN STANDARD
EN ISO 10524-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2006
ICS 11.040.10 Supersedes EN 738-1:1997
English Version
Pressure regulators for use with medical gases - Part 1:
Pressure regulators and pressure regulators with flow-metering
devices (ISO 10524-1:2006)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
1: Détendeurs et détendeurs à débitmètre intégré (ISO Teil 1: Druckminderer und Druckminderer mit
10524-1:2006) Durchflussmessgeräten (ISO 10524-1:2006)
This European Standard was approved by CEN on 30 November 2005.

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 10524-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 10524-1:2006) 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 August 2006, and conflicting national
standards shall be withdrawn at the latest by August 2006.

This document supersedes EN 738-1:1997.

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 10524-1:2006 has been approved by CEN as EN ISO 10524-1:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC concerning Medical
Devices
This International Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide one 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 normative clauses of this standard given in Table ZA.1 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.1 — Correspondence between this International Standard and Directive
93/42/EEC
Clause(s)/sub-clause(s) of this Essential requirements (ERs) of EU
Qualifying
International standard
Directive 93/42/EEC
remarks/Notes
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 7.9
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 3, 9.1, 12.7.4
5.4.4 12.3
5.4.5 12.8
5.4.6 12.7.1, 12.8.1
5.4.7 7.2, 7.6, 9.3
5.4.8 7.5, 9.2, 12.7.1
5.4.9 7.5
5.4.10 9.2, 12.7.1
5.4.11 7.3, 9.3
5.4.12.1 10.3, 12.8.2
5.4.12.2 10.2
5.4.12.3 10.1, 12.8.1, 12.8.2
5.4.12.4 10.1, 12.8.1, 12.8.2
5.4.13.1 10.3, 12.8.1, 12.8.2
5.4.13.2 10.1, 12.8.1, 12.8.2
5.4.13.3 10.1, 12.8.1, 12.8.2
5.4.14.1 10.1, 12.8.1, 12.8.2
5.4.14.2 12.8.1, 12.8.2
5.4.14.3 12.8.1, 12.8.2
5.4.14.4 10.2
5.5.1 7.2, 9.3
5.5.2 7.1, 9.3
6 3, 7.5, 9.2, 9.3, 12.8.1, 12.8.2
7.1 13, 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
7.1.4 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)
8.4 9.1, 9.2, 9.3, 13.1, 13.6 c), 13.6 d)

WARNING: Other requirements and other EU Directives may be applicable to the products
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 10524-1
First edition
2006-02-01
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 à débitmètre intégré

Reference number
ISO 10524-1:2006(E)
©
ISO 2006
ISO 10524-1:2006(E)
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ISO 10524-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Nomenclature . 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. 12
6.1 General. 12
6.2 Test methods for outlet pressure. 13
6.3 Test method for pressure-relief valve. 14
6.4 Test methods for leakage . 14
6.5 Test method for mechanical strength. 15
6.6 Test method for resistance to ignition . 15
6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges . 16
6.8 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges . 16
6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices . 16
6.10 Test method for flow setting and loosening torques. 16
6.11 Test method for durability of markings and colour coding. 16
7 Marking, colour coding, packaging . 16
7.1 Marking . 16
7.2 Colour coding. 18
7.3 Packaging . 18
8 Information to be supplied by the manufacturer. 18
Annex A (informative) Typical examples of pressure regulators and pressure regulators with flow-
metering devices. 22
Annex B (informative) Rationale . 26
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases. 28
Bibliography . 30

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