EN ISO 8359:2009

Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

Based on IEC 601-1. Specifies safety requirements for oxygen concentrators. Does not apply to oxygen concentrators intended to supply gas to several patients via a medical gas pipeline system. Replaces the first edition.

Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen (ISO 8359:1996)

ANMERKUNG Siehe Begründung in Anhang P
ISO 8359 gehört zu einer Reihe von Internationalen Normen, die auf der IEC 601-1 basieren. In IEC 601-1
(der „Allgemeinen Norm“) wird diese Art Internationaler Norm als „Besondere Festlegungen“ bezeichnet. Wie
in 1.3 der IEC 601-1:1988 festgelegt, haben die Anforderungen dieser Internationalen Norm Vorrang vor
denen der IEC 601-1.
Der Anwendungsbereich nach Abschnitt 1 von IEC 601-1:1988 gilt mit der Ausnahme, dass 1.1 durch
Folgendes ersetzt werden muss:
Diese Internationale Norm legt Sicherheitsanforderungen für Sauerstoff-Konzentratoren mit kontinuierlichem
Durchfluss fest, entsprechend der Definition in 3.8 (dieser Internationalen Norm). Diese Internationale Norm
gilt nicht für Sauerstoff-Konzentratoren, die für die Versorgung mehrerer Patienten über eine Zentralversorgungsanlage
für medizinische Gase vorgesehen sind oder zum Einsatz mit entflammbaren Narkoseund/
oder Reinigungsmitteln.
Der Anwendungsbereich dieser Internationalen Norm ist nicht beschränkt auf Membran-Sauerstoff-Konzentratoren
und Druckwechseladsorber (siehe Einleitung), da alternative Verfahren der Sauerstoffanreicherung
entwickelt werden könnten und zukünftige Entwicklungen durch diese Internationale Norm nicht behindert
werden sollten.

Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité (ISO 8359:1996)

L'ISO 8359 fait partie d'une série de Normes internationales basées sur la CEI 601-1. Dans la CEI 601-1 (la «Norme générale»), il est fait référence à ce type de Norme internationale en tant que «Norme particulière». Comme indiqué au paragraphe 1.3 de la CEI 601-1:1988, les prescriptions de la présente Norme internationale ont priorité sur les prescriptions de la CEI 601-1.
Le domaine d'application indiqué à l'article 1 de la CEI 601-1:1988 est applicable, à l'exception du paragraphe 1.1 qui est remplacé par ce qui suit:
La présente Norme internationale prescrit les exigences de sécurité pour les concentrateurs d'oxygène, comme indiqué en 1.3.8 (dans la présente Norme internationale). La présente Norme internationale ne s'applique pas aux concentrateurs d'oxygène prévus pour fournir du gaz à plusieurs patients par l'intermédiaire de conduites de gaz médicaux, ni à ceux prévus pour être utilisés en présence d'anesthésiques et/ou d'agents de nettoyage inflammables.
Le domaine d'application de la présente Norme internationale ne se limite pas aux concentrateurs d'oxygène à membrane et aux appareils à absorption par oscillation (voir Introduction), car il peut exister d'autres méthodes pour concentrer l'oxygène et la présente Norme internationale n'a pas pour but de faire obstacle à des progrès futurs.

Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve (ISO 8359:1996)

Standard ISO 8359 je eden od standardov iz serije mednarodnih standardov, ki temeljijo na standardu IEC 601-I. V standardu IEC 601-I („splošni standard“) se za to vrsto mednarodnega standarda uporablja izraz „poseben standard“. Kot je navedeno v točki 1.3 standarda IEC 601-I:1988, imajo zahteve iz tega mednarodnega standarda prednost pred zahtevami iz standarda IEC 601-I. Veljata področje uporabe in cilj iz točke 1 standarda IEC 601-I:I 988, vendar se točka 1.1 nadomesti z naslednjim: Ta mednarodni standard določa varnostne zahteve za naprave za koncentriranje kisika s stalnim pretokom, kot je opredeljeno v točki 1.3.8 (v tem mednarodnem standardu). Ta mednarodni standard se ne uporablja za naprave za koncentriranje kisika, ki prek medicinskega cevovoda za plin zagotavljajo plin več pacientom ali so namenjene za uporabo v prisotnosti vnetljivih anestetikov in/ali čistilnih sredstev. Področje uporabe tega mednarodnega standarda ni omejeno na membranske naprave za koncentriranje kisika in absorberje nihanja tlaka (glejte Uvod), ker se utegnejo razviti alternativne metode za koncentriranje kisika, pri čemer ta mednarodni standard ne sme ovirati razvoja v prihodnosti.

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 15-Jul-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 16-Jul-2014
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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 8359:2009 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

Relations

• Replaces: EN ISO 8359:1996 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
• Effective Date: 08-Jun-2022
• Replaced By: EN ISO 80601-2-69:2014 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
• Effective Date: 23-Jul-2014
• Amended By: EN ISO 8359:2009/A1:2012 - Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8359:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 8359:2000
Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve (ISO
8359:1996)
Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen (ISO
8359:1996)
Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité (ISO 8359:1996)
Ta slovenski standard je istoveten z: EN ISO 8359:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8359:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8359:2009

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SIST EN ISO 8359:2009
EUROPEAN STANDARD
EN ISO 8359
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 8359:1996
English Version
Oxygen concentrators for medical use - Safety requirements
(ISO 8359:1996)
Concentrateurs d'oxygène à usage médical - Prescriptions Sauerstoff-Konzentratoren für medizinische Zwecke -
de sécurité (ISO 8359:1996) Sicherheitsanforderungen (ISO 8359:1996)
This European Standard was approved by CEN on 21 March 2009.
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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8359:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8359:2009
EN ISO 8359:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 8359:2009
EN ISO 8359:2009 (E)
Foreword
The text of ISO 8359:1996 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 8359:2009 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 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 ISO 8359:1996.
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.
For relationship with EC Directive, 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 8359:1996 has been approved by CEN as a EN ISO 8359:2009 without any modificati
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