EN ISO 8359:2009/A1:2012
(Amendment)Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)
2019-02-19 - JO - TC decision 17/2018 (BT N 11332 - BT C160/2018) to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.
DOR should have been 2012-08-13
2012-01-18 EMA: Draft for // vote received in ISO/CS (see notification of 2012-01-17 in dataservice).
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- Withdrawn
- Publication Date
- 24-Jul-2012
- Withdrawal Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 215 - Respiratory and anaesthetic equipment
- Drafting Committee
- CEN/TC 215/WG 2 - Lung ventilators
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 16-Jul-2014
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 23-Jul-2014
- Effective Date
- 08-Jun-2022
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Frequently Asked Questions
EN ISO 8359:2009/A1:2012 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Oxygen concentrators for medical use - Safety requirements - Amendment 1 (ISO 8359:1996/Amd 1:2012)". This standard covers: 2019-02-19 - JO - TC decision 17/2018 (BT N 11332 - BT C160/2018) to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO. DOR should have been 2012-08-13 2012-01-18 EMA: Draft for // vote received in ISO/CS (see notification of 2012-01-17 in dataservice).
2019-02-19 - JO - TC decision 17/2018 (BT N 11332 - BT C160/2018) to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO. DOR should have been 2012-08-13 2012-01-18 EMA: Draft for // vote received in ISO/CS (see notification of 2012-01-17 in dataservice).
EN ISO 8359:2009/A1:2012 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 8359:2009/A1:2012 has the following relationships with other standards: It is inter standard links to EN ISO 80601-2-69:2014, EN ISO 8359:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 8359:2009/A1:2012 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN ISO 8359:2009/A1:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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.
SIST EN ISO 8359:2009/kFprA1:2012
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.
SIST EN ISO 8359:2009/kFprA1:2012
EN ISO 8359:2009/FprA1:2012 (E)
Contents Page
Foreword .3
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.
SIST EN ISO 8359:2009/kFprA1:2012
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
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
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Fax + 41 22 749 09 47
Email copyright@iso.org
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
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 the r
...
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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.
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
...
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