EN ISO 10524-4:2008

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

ISO 10524-4:2008 applies to the types of low-pressure regulators listed below and intended to be used with the following medical gases in the treatment, management, diagnostic evaluation and care of patients:
oxygen;
nitrous oxide;
medical air;
helium;
carbon dioxide;
xenon;
specified mixtures of the gases listed above;
air for driving surgical tools;
nitrogen for driving surgical tools;
oxygen-enriched air.
The types of low-pressure regulators covered by ISO 10524-4:2008 are as follows:
low-pressure regulators intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;
low-pressure regulators with integral flow-metering devices intended to be connected to terminal units of medical gas pipeline systems complying with ISO 7396-1;
low-pressure regulators intended to be connected to terminal units attached to pressure regulators complying with ISO 10524-1 or ISO 10524-3;
operator-adjustable low-pressure regulators for air or nitrogen for driving surgical tools that are an integral part of a medical gas pipeline system complying with ISO 7396-1.

Druckminderer zur Verwendung mit medizinischen Gasen - Teil 4: Niederdruckminderer (ISO 10524-4:2008)

1.1   Dieser Teil von ISO 10524 gilt für die unter 1.2 aufgeführten Arten von Niederdruckminderern und ist für die Anwendung der folgenden medizinischen Gase bei Behandlung, Management, Diagnosebewertung und Pflege von Patienten bestimmt:
   Sauerstoff;
   Distickstoffoxid (Lachgas);
   medizinische Luft;
   Helium;
   Kohlendioxid;
   Xenon;
   festgelegte Gemische der oben genannten Gase;
   Luft zum Antrieb chirurgischer Instrumente;
   Stickstoff zum Antrieb chirurgischer Instrumente;
   mit Sauerstoff angereicherte Luft.
1.2   In diesem Teil von ISO 10524 werden folgende Arten von Niederdruckminderern behandelt:
a)   Niederdruckminderer, die an Entnahmestellen von Rohrverteilersystemen für medizinische Gase nach ISO 7396 1 angeschlossen werden sollen;
b)   Niederdruckminderer mit eingebauten Durchflussmessgeräten, die an Entnahmestellen von Rohrverteiler¬systemen für medizinische Gase nach ISO 7396 1 angeschlossen werden sollen;
c)   Niederdruckminderer, die an Entnahmestellen angeschlossen werden sollen, die an Druckminderern nach ISO 10524 1 oder ISO 10524 3 angebracht sind;
d)   vom Anwender einstellbare Niederdruckminderer für Luft oder Stickstoff zum Antrieb chirurgischer Instrumente, die ein untrennbarer Bestandteil eines Rohrverteilersystems für medizinische Gase nach ISO 7396 1 sind.
1.3   Dieser Teil von ISO 10524 gilt nicht für Niederdruckminderer, die fester Bestandteil von Anästhesie  und Beatmungsgeräten sind.

Détendeurs pour l'utilisation avec les gaz médicaux - Partie 4: Détendeurs basse pression (ISO 10524-4:2008)

L'ISO 10524-4:2008 s'applique aux types de détendeurs basse pression indiqués ci-dessous et destinés à administrer les gaz médicaux suivants dans le cadre du traitement, de la gestion, de l'évaluation diagnostique et du soin des patients:
oxygène;
protoxyde d'azote;
air médical;
hélium;
dioxyde de carbone;
xénon;
mélanges des gaz cités ci-dessus;
air pour les instruments chirurgicaux;
azote pour les instruments chirurgicaux;
air enrichi en oxygène.
Les types de détendeurs à basse pression couverts par l'ISO 10524-4:2008 sont
les détendeurs basse pression, destinés à être branchés à des prises murales de systèmes de distribution de gaz médicaux, conformes à l'ISO 7396-1,
les détendeurs basse pression, avec débitmètres intégrés, destinés à être branchés à des prises murales de systèmes de distribution de gaz médicaux, conformes à l'ISO 7396-1,
les détendeurs basse pression, destinés à être branchés à des prises murales reliées à des détendeurs de pression conformes à l'ISO 10524-1 ou à l'ISO 10524-3,
les détendeurs basse pression, réglables par un opérateur, pour l'air ou l'azote pour les instruments chirurgicaux, et qui font partie intégrante d'un système de distribution de gaz médicaux, conforme à l'ISO 7396-1.

Tlačni regulatorji za medicinske pline - 4. del: Nizkotlačni regulatorji (ISO 10524-4:2008)

General Information

• Status: Published
• Publication Date: 31-May-2008
• Withdrawal Date: 29-Jun-2010
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Jun-2008
• Due Date: 07-Apr-2008
• Completion Date: 01-Jun-2008
• 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 10524-4:2008 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)

Relations

• Replaces: EN 738-4:1998/A1:2002 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
• Effective Date: 22-Dec-2008
• Replaces: EN 738-4:1998 - Pressure regulators for use with medical gases - Part 4: Low-pressure regulators intended for incorporation into medical equipment
• Effective Date: 22-Dec-2008
• Parent: 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)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN 738-4:2000
7ODþQLUHJXODWRUML]DPHGLFLQVNHSOLQHGHO1L]NRWODþQLUHJXODWRUML,62

Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO
10524-4:2008)
Druckminderer zur Verwendung mit medizinischen Gasen - Teil 4: Niederdruckminderer
(ISO 10524-4:2008)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie 4: Détendeurs a basse
pression (ISO 10524-4:2008)
Ta slovenski standard je istoveten z: EN ISO 10524-4:2008
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 10524-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2008
ICS 11.040.10 Supersedes EN 738-4:1998
English Version
Pressure regulators for use with medical gases - Part 4: Low-
pressure regulators (ISO 10524-4:2008)
Détendeurs pour l'utilisation avec les gaz médicaux - Partie Druckminderer zur Verwendung mit medizinischen Gasen -
4: Détendeurs basse pression (ISO 10524-4:2008) Teil 4: Niederdruckminderer (ISO 10524-4:2008)
This European Standard was approved by CEN on 29 May 2008.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10524-4:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4

Foreword
This document (EN ISO 10524-4:2008) 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 December 2008, and conflicting national standards shall be withdrawn
at the latest by June 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 738-4:1998.
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 EC Directive(s).
For relationship with EC 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, Bulgaria, 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 the United Kingdom.
Endorsement notice
The text of ISO 10524-4:2008 has been approved by CEN as a EN ISO 10524-4:2008 without any
modification.
Annex ZA
(informative)
Correspondence between this International Standard and Directive
93/42/EEC
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 on 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.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, Medical
devices
Essential Requirements (ERs) of EU Qualifying remarks/Notes
Clause(s)/Subclause(s) of
Directive 93/42/EEC
this International Standard
5 1
5.1 2 - 6
5.1.2 9.1 - 12.7.4
5.2 2
5.3 2
5.3.1 7.1 – 7.3 – 9.3
5.3.2 7.3 – 9.3
5.3.3 4 – 7.1 – 9.2
5.3.4 3 – 5
5.3.5 7.1 – 7.2
5.4 2 – 3 – 4
5.4.1 9.2
5.4.2.1 10.2 – 10.3
5.4.2.3 10.2
5.4.3 9.1 – 12.7.4
5.4.4 9.1 – 12.7.4
5.4.6 12.7.1
5.4.7 7.2 – 7.6
5.4.8 7.5
5.4.9 7.5 – 9.2 – 12.7.1
5.4.10.1 12.8.1 – 12.8.2
5.4.10.2 10.2
Clause(s)/Subclause(s) of this Essential Requirements (ERs) of EU Qualifying remarks/Notes
International Standard Directive 93/42/EEC
5.4.10.3 10.1 – 12.8.1 – 12.8.2
5.4.10.4 10.1 – 12.8.1 – 12.8.2
5.4.10.5 12.8.1 – 12.8.2
5.4.11.1 10.1 – 10.3 – 12.8.1 – 12.8.2
5.4.11.2 10.1 – 12.8.1 – 12.8.2
5.4.11.3 10.1 – 12.8.1 – 12.8.2
5.4.12 10.1 – 12.8.1 – 12.8.2
5.5.1 7.2 – 9.3
5.5.2 9.3
6 7.5 – 9.2 –– 9.3 – 12.8.1 – 12.8.2
7.1 13.1 – 13.2
st
13.1
7.1.2, 1 dash
nd
13.1
7.1.2, 2 dash
rd
13.3 d)
7.1.2, 3 dash
st
13.1
7.1.4, 1 dash
7.1.6 12.9
7.2 13.2
7.3 3 - 5
7.3.1 5 – 7.2 – 7.6
7.3.3 13.1 – 13.3 b)
8.1 and 8.2 13.1 – 13.3 a) – 13.4 – 13.6 a)
8.3 9.1 – 9.3 – 13.6 l)
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 10524-4
First edition
2008-06-01
Pressure regulators for use with medical
gases —
Part 4:
Low-pressure regulators
Détendeurs pour l'utilisation avec les gaz médicaux —
Partie 4: Détendeurs basse pression

Reference number
ISO 10524-4:2008(E)
©
ISO 2008
ISO 10524-4:2008(E)
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ISO 10524-4:2008(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 .5
5.4 Design requirements .5
5.5 Constructional requirements.12
6 Test methods.13
6.1 General.13
6.2 Test conditions .13
6.3 Test method for outlet pressure.13
6.4 Test methods for leakage .14
6.5 Test method for mechanical strength.15
6.6 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges .15
6.7 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges .15
6.8 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices .15
6.9 Test method for loosening torque .15
6.10 Test method for durability of markings and colour coding .15
7 Marking, colour coding, packaging .16
7.1 Marking .16
7.2 Colour coding.17
7.3 Packaging .17
8 Information to be supplied by the manufacturer.17
Annex A (informative) Typical examples of low-pressure regulators.19
Annex B (informative) Rationale .24
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases.26
Annex D (informative) Environmental aspects.
...