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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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
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 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 a 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 European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
All 1 (1st paragraph), 2, 3
1.7 13.3 (a): This relevant Essential
Requirement is not fully
addressed in this European
Standard
1.7 13.6 (q) This relevant Essential
Requirement is not addressed in
this European Standard
1.7 1st dash to 4th dash 13.3
1.7 1st dash to 6th dash 13.4
1.7 6th dash to 5.8 dash 9.2
3.1 to 3.8 12.6
4.1 to 4.8 4, 12.7.1, 12.7.2, 12.7.3, 12.7.4
4.1 to 7.8 4
10.1 to 10.6 12.6
1.6 12.6
1.7 12.6, 13.1
1.7 4th dash 7.2
1.7 5th dash 13.2
1.7 6th dash 7.2, 8.1, 9.1, 13.6, (except e) and j))
1.7 7th dash 9.1, 13.6, (except e) and j))
1.7 8th dash 13.6 (except e and j)
1.8 12.6
2.3 4, 5
5.8 12.5
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
6.1 to 6.5 9.3
7.1 7.1, 7.2, 12.7.5
7.2 7.1, 7.3, 9.3
7.2 a) 2) 7.5
- 1 (2nd paragraph, 1st dash) This relevant Essential
Requirement is not specifically
addressed in this European
Standard
- 1 (2nd paragraph, 2nd dash) This relevant Essential
Requirement is not specifically
addressed in this European
Standard
- 6a This relevant Essential
Requirement is not addressed in
this European Standard
7.3 7.6, 8.1
7.3 7.5 (1st paragraph) This relevant Essential
Requirement is not fully
addressed in this European
Standard
- 7.5 (2nd paragraph) This relevant Essential
Requirement is not addressed in
this European Standard
- 7.5 (3rd paragraph) This relevant Essential
Requirement is not addressed in
this European Standard
- 12.1a) This relevant Essential
Requirement is not addressed in
this European Standard.
8.1 9.2, 12.8.1, 12.8.2
8.2 9.2, 12.8.1, 12.8.2
8.2 2nd dash 7.1, 7.2, 8.1
8.2 3rd dash 12.4
9.1 4, 7.5, 9.3, 12.6
9.2 12.6
10.3 12.7.4
10.3 1st dash 12.9
10.3 2nd dash 12.9
10.4 12.7.4
11.2 12.3
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of this EHSR of 2006/42/EC Qualifying remarks/Notes
EN
- 1.1.4 This relevant EHSR is not
addressed in this European
Standard
8 1.2.2 This relevant EHSR is not fully
addressed in this European
Standard
- 1.5.4 This relevant EHSR is not
addressed in this European
Standard
- 1.6.1 This relevant EHSR is not
addressed in this European
Standard
- 1.6.2 This relevant EHSR is not
addressed in this European
Standard
- 1.6.3 This relevant EHSR is not
addressed in this European
Standard
- 3.6.2 This relevant EHSR is not fully
addressed in this European
Standard
INTERNATIONAL
IS0
STANDARD
Second edition
1996-l 2-l 5
Oxygen concentrators for medical use -
Safety requirements
Concentrateurs d’oxyghe 2 usage mgdical - Prescriptions de s6curit6
Reference number
IS0 8359: 1996(E)
IS0 8359: 1996(E)
Contents
Page
Section 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1 .I Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Definitions
................................ ............................. 2
I .4 General requirements
O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
I.5 General requirements for tests
1.6 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Identification, marking and documents . . .*. 2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.8 Power input
. . . .D.‘. 6
Section 2 Safety requirements
2.1 Basic safety categories ~.~.
....................................... ......... 6
2.2 Removable protective means
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Environmental conditions . . . . .
. . . . . . . . . . . . . . . . 7
Protection against electric shock hazards
Section 3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 General
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Requirements related to classification
............ 7
...........................
3.3 Limitation of voltage and/or energy
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Enclosures and protective covers
3.5 Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Protective earthing, functional earthing and potential
equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 7
Continuous leakage currents and patient auxiliary currents
3.7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
3.8 Dielectric strength
. . . . .*. 8
Protection against mechanical hazards
Section 4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Mechanical strength
0 IS0 1996
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
0 IS0
IS0 8359: 1996(E)
4.2 Moving parts . . 8
4.3 Surfaces, corners and edges . . . 8
4.4 Stability in normal use . . . . 8
4.5 Expelled parts .
............................ ...................................... 8
4.6 Vibration and noise
....................................... .......................... 8
Pneumatic and hydraulic power
4.7 . 8
4.8 Suspended masses . . 8
Section 5 Protection against hazards from unwanted or excessive
radiation . .~.” . 9
5.1 X-Radiation . . . . 9
5.2 Alpha, beta, gamma, neutron radiation and other particle
radiation . . . . 9
5.3 Microwave radiation . . 9
5.4 Light radi
...