EN ISO 15001:2004

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)

This European Standard specifies minimum requirements for the oxygen compatibility of materials which can come in contact with oxygen at pressures greater than 50 kPa in medical devices. Aspects of compatibility that are addressed include: cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. NOTE: It is expected that particular device standards will make reference to this horizontal standard but may, if appropriate, strengthen these minimum requirements.

Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)

Diese Internationale Norm legt Mindestanforderungen an die Sauerstoffverträglichkeit von Werkstoffen, Bauteilen und Geräten für Anwendungen bei der Anästhesie und Beatmung fest, die im Normalzustand oder beim Ersten Fehler mit Sauerstoff bei Drücken über 50 kPa in Berührung kommen können.
Diese Internationale Norm gilt für Anästhesie- und Beatmungsgeräte, die innerhalb des Aufgabenbereichs des ISO/TC 121 liegen, z. B. Rohrleitungssysteme für medizinische Gase, Druckregler, Entnahmestellen, medizinische Versorgungseinheiten, flexible Verbindungsstücke, Durchflussmessgeräte, Anästhesie-Arbeitsplätze und Lungenbeatmungsgeräte.
Zu den in dieser Internationalen Norm behandelten Gesichtspunkten der Sauerstoffverträglichkeit gehören die Sauberkeit, die Widerstandsfähigkeit gegen Zündung und die Toxizität von Verbrennungs- und/oder Zerfallsprodukten.

Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygène (ISO 15001:2003)

Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)

General Information

• Status: Withdrawn
• Publication Date: 25-May-2004
• Withdrawal Date: 31-May-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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 01-Jun-2010
• Completion Date: 01-Jun-2010
• 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 15001:2004 - Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)

Relations

• Replaced By: EN ISO 15001:2010 - Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15001:2004
01-november-2004
Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygene (ISO 15001:2003)
Ta slovenski standard je istoveten z: EN ISO 15001:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 15001:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15001:2004

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SIST EN ISO 15001:2004
EUROPEAN STANDARD
EN ISO 15001
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.10
English version
Anaesthetic and respiratory equipment - Compatibility with
oxygen (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec Anästhesie- und Beatmungsgeräte - Verträglichkeit mit
l'oxygène (ISO 15001:2003) Sauerstoff (ISO 15001:2003-
This European Standard was approved by CEN on 23 April 2004.
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 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 Management Centre 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, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15001:2004 E
worldwide for CEN national Members.

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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
Contents Page
FOREWORD. 3
ANNEX ZA (NORMATIVE) NORMATIVE REFERENCES TO INTERNATIONAL PUBLICATIONS WITH
THEIR RELEVANT EUROPEAN PUBLICATIONS .4
ANNEX ZB (INFORMATIVE) CLAUSES OF THIS EUROPEAN STANDARD ADDRESSING ESSENTIAL
REQUIREMENTS OR OTHER PROVISIONS OF EU DIRECTIVES. 5
2

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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
Foreword
The text of ISO 15001:2003 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
EN ISO 15001:2004 by 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 November 2004, and conflicting national standards shall be withdrawn
at the latest by November 2004.
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 ZB, which is an integral part of this document.
Details of corresponding International and European standards are given in Annex ZA, which is normative.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Endorsement notice
The text of ISO 15001:2003 has been approved by CEN as EN ISO 15001:2004 without any modifications.
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SIST EN ISO 15001:2004
EN ISO 15001:20
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