SIST EN ISO 8359:2009/A1:2012

Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)

IS0 8359 is one of a series of International Standards based on IEC 601-I. In IEC 601-I (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 601-I :1988, the requirements of this International Standard take precedence over those of IEC 601-I. The scope and object given in clause 1 of IEC 601-I :I 988 apply, except that 1.1 shall be replaced by the following: This International Standard specifies safety requirements for continuous-flow oxygen concentrators, as defined in 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators intended to supply gas to several patients via a piped medical gas installation or to those intended for use in the presence of flammable anaesthetic and/or cleaning agents. The scope of this International Standard is not restricted to membrane oxygen concentrators and pressure swing absorbers (see Introduction), as alternative methods of concentrating oxygen may become available and it is not intended that this International Standard should restrict future developments.

Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen - Änderung 1 (ISO 8359:1996/Amd 1:2012)

Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité - Amendement 1 (ISO 8359:1996/Amd 1:2012)

Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve - Dopolnilo A1 (ISO 8359:1996/Amd 1:2012)

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
• Public Enquiry End Date: 09-Jul-2012
• Publication Date: 25-Sep-2012
• Withdrawal Date: 20-Aug-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 21-Aug-2014
• Due Date: 13-Sep-2014
• Completion Date: 21-Aug-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: EN ISO 8359:2009/A1:2012 - Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)

Relations

• Amends: SIST EN ISO 8359:2009 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
• Effective Date: 01-Oct-2012
• Replaced By: SIST 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: 01-Oct-2014
• Amends: SIST EN ISO 8359:2009 - Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8359:2009/A1:2012
01-oktober-2012
Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve -
Dopolnilo A1 (ISO 8359:1996/Amd 1:2012)
Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO
8359:1996/Amd 1:2012)
Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen -
Änderung 1 (ISO 8359:1996/Amd 1:2012)
Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité - Amendement 1
(ISO 8359:1996/Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 8359:2009/A1:2012
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8359:2009/A1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8359:2009/A1:2012

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SIST EN ISO 8359:2009/A1:2012


EUROPEAN STANDARD
EN ISO 8359:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2012
ICS 11.040.10
English Version
Oxygen concentrators for medical use - Safety requirements -
Amendment 1 (ISO 8359:1996/Amd 1:2012)
Concentrateurs d'oxygène à usage médical - Prescriptions Sauerstoff-Konzentratoren für medizinische Zwecke -
de sécurité - Amendement 1 (ISO 8359:1996/Amd 1:2012) Sicherheitsanforderungen - Änderung 1 (ISO
8359:1996/Amd 1:2012)
This amendment A1 modifies the European Standard EN ISO 8359:2009; it was approved by CEN on 24 July 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This amendment 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-CENELEC Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8359:2009/A1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 8359:2009/A1:2012
EN ISO 8359:2009/A1:2012 (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/A1:2012
EN ISO 8359:2009/A1:2012 (E)
Foreword
This document (EN ISO 8359:2009/A1:2012) 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 January 2013, and conflicting national standards shall be withdrawn at
the latest by January 2013.
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 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.
For relationship with EU 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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 8359:1996/Amd 1:2012 has been approved by CEN as a EN ISO 8359:2009/A1:2012 without
any modification.
3

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SIST EN ISO 8359:2009/A1:2012
EN ISO 8359:2009/A1:2012 (E)
Annex ZA
(informative)

Relationship between this European Standard and
the Essential Requirements of EU Directive 93/42/EEC
This European 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.
Once this standard is cited in the Official Journal of the European Union 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 European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
European Standard Directive 93/42/EEC

Add the following row in Table ZA.1 of EN 8359:2009
10.3 9.3, 12.7.4

Delete the following rows in Table ZA.1 of EN 8359:2009
6.1 to 6.5 9.3
10.3 12.7.4

WARNING: Other requirements and other EU Directives may be applicable to the products falling within t
...

SLOVENSKI STANDARD
SIST EN ISO 8359:2009/kFprA1:2012
01-junij-2012
Naprave za koncentriranje kisika za uporabo v medicini - Varnostne zahteve -
Dopolnilo A1 (ISO 8359:1996/FDAM 1:2012)
Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO
8359:1996/FDAM 1:2012)
Sauerstoff-Konzentratoren für medizinische Zwecke - Sicherheitsanforderungen -
Änderung 1 (ISO 8359:1996/FDAM 1:2012)
Concentrateurs d'oxygène à usage médical - Prescriptions de sécurité - Amendement 1
(ISO 8359:1996/FDAM 1:2012)
Ta slovenski standard je istoveten z: EN ISO 8359:2009/FprA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8359:2009/kFprA1:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8359:2009/kFprA1:2012

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SIST EN ISO 8359:2009/kFprA1:2012


EUROPEAN STANDARD
FINAL DRAFT
EN ISO 8359:2009
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
April 2012
ICS 11.040.10
English Version
Oxygen concentrators for medical use - Safety requirements -
Amendment 1 (ISO 8359:1996/FDAM 1:2012)
Concentrateurs d'oxygène à usage médical - Prescriptions Sauerstoff-Konzentratoren für medizinische Zwecke -
de sécurité - Amendement 1 (ISO 8359:1996/FDAM Sicherheitsanforderungen - Änderung 1 (ISO
1:2012) 8359:1996/FDAM 1:2012)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.

This draft amendment A1, if approved, will modify the European Standard EN ISO 8359:2009. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment was established by CEN 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-CENELEC Management Centre has
the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8359:2009/FprA1:2012: E
worldwide for CEN national Members.

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SIST EN ISO 8359:2009/kFprA1:2012
EN ISO 8359:2009/FprA1:2012 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 8359:2009/kFprA1:2012
EN ISO 8359:2009/FprA1:2012 (E)
Foreword
This document (EN ISO 8359:2009/FprA1:2012) 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 document is currently submitted to the Unique Acceptance Procedure.
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).
Endorsement notice
The text of ISO 8359:2009/FDAM 1:2012 has been approved by CEN as a EN ISO 8359:2009/FprA1:2012
without any modification.

3

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SIST EN ISO 8359:2009/kFprA1:2012

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SIST EN ISO 8359:2009/kFprA1:2012
FINAL
ISO
AMENDMENT
DRAFT 8359:1996
FDAM 1
ISO/TC 121/SC 3
Oxygen concentrators for medical use —
Secretariat: ANSI
Safety requirements
Voting begins on:
2012-04-12
AMENDMENT 1
Voting terminates on:
2012-06-12 Concentrateurs d’oxygène à usage médical — Prescriptions de sécurité
AMENDEMENT 1
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR­
TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO 8359:1996/FDAM 1:2012(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2012

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SIST EN ISO 8359:2009/kFprA1:2012
ISO 8359:1996/FDAM 1:2012(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright­protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced,
stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording
or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E­mail [e-mail]
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved

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SIST EN ISO 8359:2009/kFprA1:2012
ISO 8359:1996/FDAM 1:2012(E)
ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final draft
was established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two­month approval vote in ISO and formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by th
...