SIST EN ISO 8359:2009
(Main)Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
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 (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
Relations
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 modification.
3
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SIST EN ISO 8359:2009
EN ISO 8359:2009 (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 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
4
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SIST EN ISO 8359:2009
EN ISO 8359:2009 (E)
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.
5
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SIST EN ISO 8359:2009
EN ISO 8359:2009 (E)
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
6
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SIST EN ISO 8359:2009
INTERNATIONAL
IS0
STANDARD
8359
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)
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SIST EN ISO 8359:2009
IS0 8359: 1996(E)
Contents
Page
1
Section 1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
1 .I Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
1.2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3 Definitions
................................ ............................. 2
I .4 General requirements
O . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
I.5 General requirements for tests
2
1.6 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 Identification, marking and documents . . .*. 2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.8 Power input
. . . .D.‘. 6
Section 2 Safety requirements
6
2.1 Basic safety categories ~.~.
....................................... ......... 6
2.2 Removable protective means
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
2.3 Environmental conditions . . . . .
. . . . . . . . . . . . . . . . 7
Protection against electric shock hazards
Section 3
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.1 General
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.2 Requirements related to classification
............ 7
...........................
3.3 Limitation of voltage and/or energy
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.4 Enclosures and protective covers
7
3.5 Separation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3.6 Protective earthing, functional earthing and potential
7
equalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 7
Continuous leakage currents and patient auxiliary currents
3.7
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
3.8 Dielectric strength
. . . . .*. 8
Protection against mechanical hazards
Section 4
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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
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SIST EN ISO 8359:2009
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 radiation (including visual radiation and lasers) . 9
5.5 Infrared radiation . . . 9
5.6 Ultraviolet radiation . . 9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.7 Acoustical energy (including ultrasonics)
5.8 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Section 6 Protection against hazards of expli osions in medically
used rooms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Locations and basic requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
6.1
10
6.2 Marking, accompanying documents . . . . . . . . . . . . . . D . . . . . . . . . . . . . . . . . . . . .
6.3 Common requirements for category AP and category APG
equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
6.4 Requirements and tests for category AP equipment, parts and
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IO
components thereof
6.5 Requirements and tests for category APG equipment, parts and
components thereof . . . . . . . . . . . . . . . .I. IO
Protection against excessive temperatures and other
Section 7
safety hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
.................................................
7.1 Excessive temperatures . 11
7.2 Fire prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.4 Pressure vessels and parts subject to pressure . . . . . . . . . . . . . . . . . .
12
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SIST EN ISO 8359:2009
0 IS0
IS0 8359:1996(E)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
7.5 Human errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.6 Electrostatic charges
7.7 Materials in applied parts in contact with the body of the
12
patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.8 Interruption of the power supply
Section 8 Accuracy of operating data and protection against
13
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
hazardous output
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
8.1 Accuracy of operating data
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
8.2 Protection against hazardous output
Abnormal operation and fault conditions; environmental
Section 9
16
tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
9.1 Abnormal operation and fault conditions
16
Environmental tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9.2
. . . . . .m.*. 17
Constructional requirements
Section 10
I7
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1
I7
Enclosures and covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
10.3 Components and general assembly
. . . . . . . . . . . . . . . . . . .“. 17
10.4 Mains parts, components and layout
. . . . . . . . . . . 17
10.5 Protective earthing - Terminals and connections
17
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10.6 Construction and layout
18
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Additional clauses
Section 11
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
11 .l Auditory indicators
18
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11.2 Indication of loss of mains power
Annexes
................................................................................ 20
N Test apparatus
21
......................................................................
P Rationale statement.
24
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Q Bibliography
iv
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SIST EN ISO 8359:2009
0 IS0
IS0 8359: 1996(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 8359 was prepared by Technical Committee
lSO/TC 121, Anaesthetic and respiratory equipment, Subcommittee
SC 3, Lung ventilators and related equipment.
This second edition cancels and replaces the first edition
(IS0 8359:1988), which has been technically revised.
Annexes A to N form an integral part of this International Standard. An-
nexes P and Q are for information only.
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SIST EN ISO 8359:2009
0 IS0
IS0 8359: 1996(E)
Introduction
Oxygen concentrators provide a safe source of oxygen-enriched air for
patients in need. These devices raise the level of inspired oxygen by sep-
arating nitrogen or oxygen from ambient air.
Oxygen concentrators fall into two main classes according to the means
whereby gas separation is effected, namely:
a) oxygen concentrators in which oxygen selectively permeates or
transports through a membrane or lattice,
b) pressure swing absorbers (PSA) in which air is exposed at a certain
pressure to molecular sieve material which selectively retains nitrogen
and other components until they are subsequently released when the
pressure is reduced.
Details of the arrangement of test apparatus for carrying out a number of
the tests to check compliance with certain requirements are given in an-
nex N.
A rationale for the most important requirements is given in annex P. It is
considered that a knowledge of the reasons for the requirements will not
only facilitate the proper application of this International Standard, but will
expedite any subsequent revision.
Test methods other than those specified in this International Standard, but
of equal or greater accuracy, may be used to verify compliance with the
given requirements. However, in the event of a dispute, the methods
specified in this International Standard are to be used as the reference
methods.
VI
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SIST EN ISO 8359:2009
INTERNATIONAL STANDARD 0 IS0
IS0 8359: 1996(E)
Oxygen concentrators for medical use
- Safety
requirements
Section I: General
1.1 Scope
NOTE 1 See the rationale in annex P.
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 in-
tended 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.
1.2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the possi-
bility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
- Determination of sound power levels of noise sources using sound pressure - En-
I SO 3744: 1994, Acoustics
gineering method in an essentially free field over a reflecting plane.
IS0 9703-I :I 992, Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals.
IS0 9703-2: 1994, Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals.
- Part 1: General requirements for safety.
I EC 601-I : 1988, Medica/ electrica/ equipment
- Part 1: General requirements for safety. 2. Collateral standard:
I EC 601-I -2: 1993, Medical electrica/ equipment
Electromagnetic compatibility requirements and tests.
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SIST EN ISO 8359:2009
IS0 8359:1996(E)
I EC 651: 1979, Sound level meters.
1.3 Definitions
For the purposes of this International Standard, the definitions given in clause 2 of IEC 601-l :I988 apply, except
that the definition given in 2.1.5 shall be replaced by the following:
2.1.5 applied part: Oxygen concentrator outlet.
For the purposes of this International Standard, the following definitions also apply:
1.3.1 administration accessories: All accessories for conducting the product gas from the oxygen concentrator
outlet to the patient, but excluding any fixed tubing extensions.
1.3.2 oxygen concentrator outlet: Port of the oxygen concentrator from which the product gas flows.
1.3.3 flow control device: Device which controls the flow of the product gas.
1.3.4 flow indicator: Device which shows the volume of product gas passing through the oxygen concentrator
in a specified unit of time.
operator control: Contro I to enable the user, without the need for tools, to cause the oxygen concentrator
1.3.5
t-form its intended fu nction.
to pe
1.3.6 outlet pressure: Gauge pressure at the oxygen concentrator outlet under the test flow conditions.
1.3.7 oxygen analyzer: Device which measures and quantitatively indicates the concentration of oxygen present
in a gaseous mixture.
Device which, by selective removal of constituents of ambient air, increases the
1.3.8 oxygen concentrator:
product gas.
concentration of oxygen in the
1.3.9 product gas: Output from the oxygen concentrator consisting of respirable oxygen-enriched air.
1.3.10 oxygen concentration status indicator (OCSI): Device which indicates when the proportion of oxygen
in the product gas is at an abnormal level.
1.4 General requirements
The requirements given in clause 3 of IEC 601-I :I 988 apply.
1.5 General requirements for tests
The requirements given in clause 4 of IEC 601-I :I 988 apply.
1.6 Classification
The classification given in clause 5 of IEC 601-I :I988 applies, except for the following deletions.
- Delete 5.5.
- In 5.6 delete all except for “continuous operation” and “intermittent operation”.
1 .J Identification, marking and documents
The requirements given in clause 6 of IEC 601-I :I 988 apply, except for the following additions and modifications.
2
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SIST EN ISO 8359:2009
0 IS0
IS0 8359: 1996(E)
- The foilowing additional general requirement also applies.
All markings pertaining to the operation of the oxygen concentrator shall be legible to an operator having
visual acuity, corrected if necessary, of at least I,0 and seated or standing 1 m from the oxygen
concentrator flooded with illuminance of 215 lux.
NOTE 2 All markings should have a luminance contrast of at least 50 % when compared with the surrounding
background material.
- In 6.1 e) add the following.
The oxygen concentrator shall be marked with its country of origin plus the address of the manufacturer.
- Delete 6.1 r)
- To 6.1 add the following additional items.
The marking on the outside shall additionally include the following:
1) a warning against removal of the cover by unauthorized persons;
2) a warning “NO SMOKING OR NAKED FLAMES”;
3) the nominal concentration of oxygen in the product gas, expressed as a percent volume fraction, at a
flowrate of 2 I/min or at the recommended maximum flowrate;
4) the statement “USE NO OIL OR GREASE”;
5) on the flow indicator, the output (e.g. output, gas flow, etc.).
- Replace 6.7 a) by the following.
If visual indicators are used on the oxygen concentrator, with the exception of alphanumeric displays, their
colouring shall conform to IS0 9703-I and the following additional requirements:
1) continuous red shall be used to indicate to the operator that the oxygen concentrator, or a portion of it,
has failed;
2) the function
...
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