SIST EN ISO 80601-2-69:2014
(Main)Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (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)
EN ISO 80601-2-69 specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private and public well as in commerc transportation as ial aircraft.
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO 80601-2-69:2014)
IEC 60601-1:2005+Änderung 1:2012, 1.1 wird ersetzt durch:
Diese besondere Norm legt Anforderungen an die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE eines SAUERSTOFF-KONZENTRATORS zusammen mit dessen ZUBEHÖR fest, nachfolgend als ME-GERÄT bezeichnet, der dafür vorgesehen ist, die Sauerstoffkonzentration des Gases zu erhöhen, das einem einzelnen PATIENTEN zugeführt werden soll. Derartige SAUERSTOFF-KONZENTRATOREN sind typischerweise für den Einsatz bei der MEDIZINISCHEN VERSORGUNG in HÄUSLICHER UMGEBUNG vorgesehen, einschließlich der Verwendung durch einen einzelnen PATIENTEN bei Bewegung (BETRIEBSFÄHIG BEI BEWEGUNG) in verschiedenen Umgebungen, wie privater und öffentlicher Transport, sowie zur Verwendung in Verkehrsflugzeugen.
ANMERKUNG 1 Ein solcher SAUERSTOFF-KONZENTRATOR kann auch in professionellen Einrichtungen zur Gesundheitsfürsorge angewendet werden.
Diese besondere Norm gilt für BEI BEWEGUNG BETRIEBSFÄHIGE und BEI BEWEGUNG nicht BETRIEBSFÄHIGE SAUERSTOFF-KONZENTRATOREN. Diese besondere Norm ist auf einen SAUERSTOFF-KONZENTRATOR anwendbar, der in andere medizinische Geräte, ME-GERÄTE oder in ME-SYSTEME eingebaut ist oder zusammen mit diesen benutzt wird.
BEISPIEL 1 Ein SAUERSTOFF-KONZENTRATOR mit eingebauter SAUERSTOFF-DOSIEREINRICHTUNG [10] oder mit Anfeuchter [4].
BEISPIEL 2 Ein SAUERSTOFF-KONZENTRATOR in Verwendung mit einem Durchflussmesser.
BEISPIEL 3 Ein SAUERSTOFF-KONZENTRATOR als Teil eines Anästhesiesystems zur Verwendung in Gebieten mit eingeschränkter Bereitstellung von Strom und Anästhesiegasen [3].
BEISPIEL 4 Ein SAUERSTOFF-KONZENTRATOR mit eingebautem Flüssigkeitsreservoir oder Gasflaschenfüllsystem.
Diese besondere Norm gilt auch für jenes ZUBEHÖR, das vom HERSTELLER des ZUBEHÖRS für den Anschluss an einen SAUERSTOFF-KONZENTRATOR vorgesehen ist, wenn die Eigenschaften dieses ZUBEHÖRS die BASISSICHERHEIT oder die WESENTLICHEN LEISTUNGSMERKMALE des SAUERSTOFF-KONZENTRATORS beeinträchtigen können.
Diese besondere Norm legt nicht die Anforderungen an SAUERSTOFF-KONZENTRATOREN zur Verwendung mit einem ROHRLEITUNGSSYSTEM FÜR MEDIZINISCHE GASE fest, die ISO 10083 zu entnehmen sind.
Ist ein Abschnitt oder Unterabschnitt nur speziell für die Anwendung auf ME-GERÄTE oder ME-SYSTEME vorgesehen, ist das aus der Überschrift und dem Inhalt des Abschnitts oder Unterabschnitts ersichtlich. Ist das nicht der Fall, trifft gegebenenfalls der Abschnitt oder Unterabschnitt auf das ME-GERÄT und das ME SYSTEM zu.
Die mit der physiologischen Funktion des ME-GERÄTS oder ME-SYSTEMS innerhalb des Anwendungsbereiches dieser Norm direkt verbundenen GEFÄHRDUNGEN werden nicht in spezifischen Anforderungen dieser Norm berücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der allgemeinen Norm.
ANMERKUNG 2 Siehe auch 4.2 der allgemeinen Norm.
Diese Internationale Norm ist eine besondere Norm in der IEC 60601-1-Normenreihe.
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO 80601-2-69:2014)
L'ISO 80601-2-69:2014 spécifie les exigences applicables à la sécurité de base et aux performances essentielles d'un concentrateur d'oxygène en combinaison avec ses accessoires, désigné ci-après sous le terme d'appareil em, visant à augmenter la concentration en oxygène du gaz destiné à être délivré à un patient unique. De tels concentrateurs d'oxygène sont, en général, destinés à être utilisés dans un environnement de soins à domicile, et sont également opérationnels en déplacement pour un patient unique dans divers environnements, dans les transports publics et privés ainsi que dans les transports aériens.
L'ISO 80601-2-69:2014 est applicable aux concentrateurs d'oxygène opérationnels en déplacement et non opérationnels en déplacement. Elle est applicable aux concentrateurs d'oxygène intégrés ou utilisés avec d'autres dispositifs médicaux, appareils em ou systèmes em.
Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za koncentriranje kisika (ISO 80601-2-69:2014)
Standard EN ISO 80601-2-69 določa zahteve za OSNOVNO VARNOST in BISTVENE LASTNOSTI NAPRAV ZA KONCENTRIRANJE KISIKA v kombinaciji s PRIPOMOČKI, v nadaljevanju MEDICINSKI PRIPOMOČKI, ki so namenjeni za povečanje koncentracije kisika v plinu, ki ga prejema PACIENT. Takšne NAPRAVE ZA KONCENTRIRANJE KISIKA se običajno uporabljajo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE, vključno z DELOVANJEM MED NOŠNJO s strani PACIENTA v različnih okoljih, tako v osebnih in javnih prevozih ter komercialnih prevozih, kot so letala.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80601-2-69:2014
01-oktober-2014
1DGRPHãþD
SIST EN ISO 8359:2009
SIST EN ISO 8359:2009/A1:2012
0HGLFLQVNDHOHNWULþQDRSUHPD GHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLQDSUDY]DNRQFHQWULUDQMHNLVLND ,62
Medical electrical equipment - Part 2-69: Particular requirements for basic safety and
essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO
80601-2-69:2014)
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de
base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO
80601-2-69:2014)
Ta slovenski standard je istoveten z: EN ISO 80601-2-69:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-69:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80601-2-69:2014
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SIST EN ISO 80601-2-69:2014
EUROPEAN STANDARD
EN ISO 80601-2-69
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.040.10 Supersedes EN ISO 8359:2009
English Version
Medical electrical equipment - Part 2-69: Particular requirements
for basic safety and essential performance of oxygen
concentrator equipment (ISO 80601-2-69:2014)
Appareils électromédicaux - Partie 2-69: Exigences Medizinische elektrische Geräte - Teil 2-69: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des dispositifs concentrateurs d'oxygène (ISO wesentlichen Leistungsmerkmale für Sauerstoff-
80601-2-69:2014) Konzentratoren (ISO 80601-2-69:2014)
This European Standard was approved by CEN on 28 May 2014.
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-CENELEC 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-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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-69:2014 E
worldwide for CEN national Members.
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SIST EN ISO 80601-2-69:2014
EN ISO 80601-2-69:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this Document and the Essential Requirements of
EU Directive 93/42/EEC .4
2
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SIST EN ISO 80601-2-69:2014
EN ISO 80601-2-69:2014 (E)
Foreword
This document (EN ISO 80601-2-69:2014) 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 2015, and conflicting national standards shall be withdrawn at
the latest by July 2017.
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 8359:2009.
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).
For relationship with EU Directive(s), 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 80601-2-69:2014 has been approved by CEN as EN ISO 80601-2-69:2014 without any
modification.
3
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SIST EN ISO 80601-2-69:2014
EN ISO 80601-2-69:2014 (E)
Annex ZA
(informative)
Relationship between this Document and
the Essential Requirements of EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the New
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the
Member States concerning medical devices” (Medical Device Directive).
Once this document 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 clauses of this
document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.11.6.4, 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the PATIENT are
addressed.
201.11.6.4, 201.11.6.6 7.3 Only the part of the first sentence
of ER 7.3 relating to design is
addressed.
201.11.6.4 7.5
201.11 7.6
201.11.6.6, 201.11.6.7 8.1 The part of ER 8.1 relating to easy
handling is not addressed.
201.11.6.7 8.4 Validated processes for
sterilization are required via the
normative references to
ISO 11135-1, ISO 11137-1 and
ISO 17665-1.
201.4.6, 201.7.2.4.101, 9.1
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.5.101, 201.7.9.2.14.101,
201.12.1.101, 201.12.1.102,
201.12.1.103, 201.16, 201.101,
201.102
201.9, 202, 206, 211 9.2 The 4th indent of ER 9.2 is not
addressed.
201.11 9.3
201.12.1, 201.102 10.1 The part of ER 10.1 relating to
stability is not addressed.
4
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SIST EN ISO 80601-2-69:2014
EN ISO 80601-2-69:2014 (E)
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.7, 201.12.1, 206, 208 10.2
201.7.4.3 10.3
201.14 12.1
201.14 12.1 a)
202 12.5
201.8 12.6
201.9, 211 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.101, 201.15, 201.103 12.7.4
201.11 12.7.5
201.12.1 12.8.1 Only the protection of the PATIENT
is covered.
201.12.4 12.8.2 Only the first sentence of ER
12.8.2 is covered.
201.7, 206 12.9
201.7, 201.11.6.4 13.1
201.7.2.1, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101,
201.8, 201.9, 201.11.6.4
201.7.9.1 13.3 a)
201.7.2.17.101 13.3 b)
201.7, 201.7.2.17.101 a) 13.3 c)
201.7.2.17.101 13.3 d) Is only covered if the batch number
is preceded by the word LOT.
201.7.2.17.101 13.3 f)
201.7.2.101 a), 211 13.3 i)
201.7.2.101 b), 201.7.2.101 d), 211 13.3 j)
201.7.2.101 b) 13.3 k)
201.7, 201.7.2.17.101 a) 13.3 m) Presumption of conformity is only
provided if one of the symbols 5.21
to 5.24 from ISO 15223-1:2012 are
utilized, as applicable.
201.7.9.1, 201.7.9.2, 201.16 13.6 a)
201.7.9.2.5.101 13.6 b)
201.7.9.2.14.101, 201.16, 201.102 13.6 c)
201.7, 201.7.9.2.8.101, 13.6 d)
201.7.9.2.13.101, 201.16
5
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SIST EN ISO 80601-2-69:2014
EN ISO 80601-2-69:2014 (E)
Clause/subclause Corresponding essential Qualifying remarks/notes
of this Document requirement of
Directive 93/42/EEC
201.16 13.6 f)
201.7.9.2.1.101, 201.7.9.2.12, 13.6 h)
201.16, 211
201.7 13.6 i)
211 13.6 k)
211 13.6 k)
211 13.6 l)
211 13.6 n)
201.12.1.103, 211 13.6 p)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this European 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 health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than essential requirements 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) EHSR of 2006/42/EC Qualifying remarks/Notes
of this EN
— 1.1.4 This relevant EHSR is not
covered by this European
Standard.
201.12.1, 201.12.101 1.2.2
201.7.2.101 c), 201.7.2.101 d), 1.5.4
201.101
— 1.6.2 This relevant EHSR is not
covered by this European
Standard.
201.8 1.6.3
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SIST EN ISO 80601-2-69:2014
INTERNATIONAL ISO
STANDARD 80601-2-69
First edition
2014-07-15
Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety
and essential performance of oxygen
concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et
les performances essentielles des dispositifs concentrateurs
d'oxygène
Reference number
ISO 80601-2-69:2014(E)
©
ISO 2014
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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 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
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
Contents Page
Foreword . 5
Introduction . 7
201.1 Scope, object and related standards . 1
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing of ME EQUIPMENT . 6
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
201.7 ME EQUIPMENT identification, marking and documents . 6
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 16
201.13 HAZARDOUS SITUATIONS and fault conditions . 20
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 20
201.15 Construction of ME EQUIPMENT . 20
201.16 ME SYSTEMS . 20
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
201.101 Outlet connector . 21
201.102 Requirements for parts and ACCESSORIES . 21
201.102.1 * General . 21
201.102.2 Labelling . 21
201.102.3 * Fire RISK reduction in ACCESSORIES . 22
201.103 SIGNAL INPUT/OUTPUT PART . 22
201.103.1 General . 22
201.103.2 * Connection to a DISTRIBUTED ALARM SYSTEM . 22
201.103.3 * Connection for remote control . 23
201.104 * Indication of duration of operation . 23
201.105 Integrated CONSERVING EQUIPMENT . 23
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility –
Requirements and tests . 23
202.6.2.1.10 Compliance criteria . 23
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability . 23
208 Medical electrical equipment – Part 1-8: General requirements for basic safety and
essential performance – Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical
systems . 24
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
211 Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance – Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
. 24
211.4.2.2 Environmental operating conditions . 24
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS . 25
Annex D (informative) Symbols on marking . 29
Annex AA (informative) Particular guidance and rationale . 30
Annex BB (informative) Reference to the Essential Principles . 37
Figures
Figure 201.101 – Standard resistance . 13
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives,
Part 2.
The main task of technical committees is to prepare International Standards. 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.
Attention is drawn to the possibility that some of the elements of this document may be the subject
of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/IEC 80601-2-69 was prepared by a joint working group of Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related
equipment and Technical Committee IEC/TC 62, Electrical equipment in medical practice,
Subcommittee SC D, Electrical equipment.
This first edition of ISO 80601-2-69 cancels and replaces the first edition of ISO 8359:1996. This
edition of ISO 80601-2-69 constitutes a major technical revision of ISO 8359:1996 and includes an
alignment with the third edition of IEC 60601-1 and IEC 60601-1-11.
The most significant changes are the following modifications:
– extending the scope to include not only the OXYGEN CONCENTRATOR but also its ACCESSORIES,
where the characteristics of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL
PERFORMANCE of the OXYGEN CONCENTRATOR;
– identification of ESSENTIAL PERFORMANCE for an OXYGEN CONCENTRATOR and its ACCESSORIES;
– and the following additions:
tests for oxygen delivery performance;
new symbols;
new requirement for a means to prevent the propagation of fire into the OXYGEN CONCENTRATOR
and its ACCESSORIES;
tests for cleaning and disinfection PROCEDURES; and
consideration of contamination of the breathing gas delivered to the PATIENT from the gas
pathways.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS TYPE.
In referring to the structure of this standard, the term
– "clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are
all subclauses of Clause 201.7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
indicates that there is guidance or rationale related to that item in Annex A.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a
new, amended or revised ISO or IEC publication in which to make products in accordance with the
new requirements and to equip themselves for conducting new or revised tests. It is the
recommendation of the committee that the content of this publication not be adopted for mandatory
implementation nationally earlier than 3 years from the date of publication for equipment newly
designed and not earlier than 5 years from the date of publication for equipment already in
production.
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
Introduction
Oxygen supplementation can be part of management of PATIENTS with chronic, acute–on-chronic
and acute respiratory disorders. The amount of supplemental oxygen depends on the individual
PATIENT’S needs under various conditions. The managing healthcare team typically prescribes the
endpoint of treatment, for example a target value for oxygen saturation. The amount of
supplemental oxygen can be controlled by the flowrate.
The goal of long term oxygen therapy is to keep the oxygen saturation above 90 % in PATIENTS that
require supplemental oxygen. The flowrate should be adjusted for rest, exertion, and sleep to meet
the individual PATIENT’S needs under these various conditions. Ideally, the resting flowrate is
adjusted to maintain SpO > 90 % as indicated by pulse oximetry.
2
Supplemental oxygen is supplied by various sources: MEDICAL GAS PIPELINE SYSTEMS, OXYGEN
CONCENTRATORS, compressed gas cylinders, and liquid oxygen reservoirs. This standard covers the
particular requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of OXYGEN CONCENTRATORS.
OXYGEN CONCENTRATORS produce oxygen enriched air from room air for delivery to a PATIENT
requiring oxygen therapy. The most common OXYGEN CONCENTRATOR uses molecular sieve beds to
filter and concentrate oxygen molecules from the ambient air, generating oxygen concentrations of
typically 82 % to 96 %. The main component of this type of OXYGEN CONCENTRATOR is the molecular
sieve, which adsorbs nitrogen from air to produce a product gas which is a mixture of typically up to
95 % oxygen and 5 % of other gases. The periodic adsorbing and purging of nitrogen is referred to
as the pressure swing adsorption process.
© ISO 2014 – All rights reserved
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SIST EN ISO 80601-2-69:2014
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SIST EN ISO 80601-2-69:2014
INTERNATIONAL STANDARD ISO 80601-2-69:2014(E)
Medical electrical equipment —
Part 2-69:
Particular requirements for basic safety and essential
performance of oxygen concentrator equipment
201.1 Scope, object and related standards
IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:
201.1.1 Scope
IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:
This particular standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of an
OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT,
intended to increase the oxygen concentration of gas intended to be delivered to a single PATIENT. Such
OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT, including
TRANSIT‐OPERABLE use by a single PATIENT in various environments including any private and public
transportation as well as in commercial aircraft.
NOTE 1 Such an OXYGEN CONCENTRATOR can also be used in professional healthcare facilities.
This particular standard is applicable to a TRANSIT‐OPERABLE and non‐TRANSIT‐OPERABLE OXYGEN
CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or used
with other medical devices, ME EQUIPMENT or ME SYSTEMS.
EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT [10] or humidifier [4].
EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand.
EXAMPLE 3 An OXYGEN CONCENTRATOR as part of an anaesthetic system for use in areas with limited logistical
supplies of electricity and anaesthetic gases. [3]
EXAMPLE 4 An OXYGEN CONCENTRATOR with an integrated liquid reservoir or gas cylinder filling system.
This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can affect the
BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR.
This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a
MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS
only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
© ISO 2014 – All rights reserved
1
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SIST EN ISO 80601-2-69:2014
ISO 80601-2-69:2014(E)
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope
of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of
the general standard.
NOTE 2 See also 4.2 of the General Standard.
This International Standard is a particular standard in the IEC 60601‐1 series of standards.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:
The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for an OXYGEN CONCENTRATOR [as defined in 201.3.203] and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the OXYGEN CONCENTRATOR and the ACCESSORIES
needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE
of an OXYGEN CONCENTRATOR.
201.1.3 Collateral standards
IEC 60601-1:2005+Amendment 1:2012, 1.3 applies with the following addition:
This particular standard refers to those applicable collateral standards that are listed in IEC 60601‐
1:2005+Amendment 1:2012, Clause 2 of the general standard and 201.2 of this particular standard.
IEC 60601‐1‐3:2008+Amendment 1:2013 does not apply.
201.1.4 Particular standards
IEC 60601-1:2005+Amendment 1:2012, 1.4 is replaced by:
In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT
under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard or the collateral
standards
...
SLOVENSKI STANDARD
oSIST prEN ISO 80601-2-69:2013
01-januar-2013
Elektromedicinska oprema - 2-69. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za koncentriranje kisika (ISO/DIS 80601-2-69:2012)
Medical Electrical Equipment - Part 2-69: Particular requirements for basic safety and
essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69:2012)
Medizinische elektrische Geräte - Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren
(ISO/DIS 80601-2-69:2012)
Appareils électromédicaux - Partie 2-63 : exigences particulières pour la sécurité de
base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO/DIS
80601-2-69:2012)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-69 rev
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 80601-2-69:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 80601-2-69:2013
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oSIST prEN ISO 80601-2-69:2013
EUROPEAN STANDARD
DRAFT
prEN ISO 80601-2-69 rev
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.10 Will supersede EN ISO 8359:2009
English Version
Medical Electrical Equipment - Part 2-69: Particular
requirements for basic safety and essential performance of
oxygen concentrator equipment (ISO/DIS 80601-2-69:2012)
Appareils électromédicaux - Partie 2-63 : exigences Medizinische elektrische Geräte - Besondere Festlegungen
particulières pour la sécurité de base et les performances für die Sicherheit einschließlich der wesentlichen
essentielles des dispositifs concentrateurs d'oxygène Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO/DIS
(ISO/DIS 80601-2-69:2012) 80601-2-69:2012)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 215.
If this draft becomes a European Standard, 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.
This draft European Standard 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, 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.
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. prEN ISO 80601-2-69 rev:2012: E
worldwide for CEN national Members.
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oSIST prEN ISO 80601-2-69:2013
prEN ISO 80601-2-69:2012 (E)
Contents Page
Foreword .3
2
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oSIST prEN ISO 80601-2-69:2013
prEN ISO 80601-2-69:2012 (E)
Foreword
This document (prEN ISO 80601-2-69:2012) 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 parallel Enquiry.
This document will supersede EN ISO 8359:2009.
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/DIS 80601-2-69:2012 has been approved by CEN as a prEN ISO 80601-2-69:2012 without
any modification.
3
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oSIST prEN ISO 80601-2-69:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 80601-2-69
ISO/TC 121/SC 3 Secretariat: ANSI
Voting begins on Voting terminates on
2012-10-25 2013-03-25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Medical Electrical Equipment —
Part 2-69:
Particular requirements for basic safety and essential
performance of oxygen concentrator equipment
Appareils électromédicaux —
Partie 2-69: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs
concentrateurs d'oxygène
[Revision of second edition (ISO 8359:1996)]
ICS 11.040.10
ISO/CEN PARALLEL PROCESSING
This 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.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2012
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oSIST prEN ISO 80601-2-69:2013
ISO/DIS 80601-2-69
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected 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
E-mail 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
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oSIST prEN ISO 80601-2-69:2013
ISO/IEC DIS 80601-2-69
1 Contents Page
2 201.1 Scope, object and related standards . 1
3 201.1.1 Scope . 1
4 201.1.2 Object . 2
5 201.1.3 Collateral standards . 2
6 201.1.4 Particular standards . 2
7 201.2 Normative references . 3
8 201.3 Terms and definitions . 4
9 201.4 General requirements. 5
10 201.4.3 ESSENTIAL PERFORMANCE . 5
11 201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 5
12 201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT. 5
13 201.5 General requirements for testing of ME EQUIPMENT . 6
14 201.5.101 Additional requirements for general requirements for testing of
15 ME EQUIPMENT . 6
16 201.5.101.1 Gas flowrate and leakage specifications . 6
17 201.5.101.2 OXYGEN CONCENTRATOR testing errors . 6
18 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 6
19 201.7 ME EQUIPMENT identification, marking and documents . 6
20 201.7.1.2 Legibility of markings . 6
21 201.7.2.4.101 Additional requirements for ACCESSORIES . 6
22 201.7.2.13.101 Additional requirements for physiological effects. 7
23 201.7.2.101 Additional requirements for marking on the outside of
24 ME EQUIPMENT or ME EQUIPMENT parts . 7
25 201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 12
26 201.8.11.3.4.101 Additional requirements for APPLIANCE COUPLERS . 12
27 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 12
28 201.9.6.2.1.101 Additional requirements for audible acoustic energy . 12
29 201.10 Protection against unwanted and excessive radiation HAZARDS. 13
30 201.11 Protection against excessive temperatures and other HAZARDS . 13
31 201.11.1 Maximum temperature during NORMAL USE . 13
32 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT . 14
33 201.11.2.101 Additional requirements for fire prevention . 14
34 201.11.6.4 Leakage . 14
35 201.11.6.6 Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM . 14
36 201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM . 15
37 201.11.8.101 Additional requirements for interruption of the power
38 supply/SUPPLY MAINS to ME EQUIPMENT . 15
39 201.11.8.101.1 TECHNICAL ALARM CONDITION for power supply failure . 15
40 201.11.8.101.2 INTERNAL ELECTRICAL POWER SOURCE . 16
41 201.12 Accuracy of controls and instruments and protection against hazardous outputs
42 . 16
43 201.12.1 Accuracy of controls and instruments. 16
44 201.12.1.101 Accuracy of continuous flowrate . 17
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45 201.12.1.102 Accuracy of triggered flowrate . 17
46 201.12.1.103 Accuracy of concentration . 17
47 201.12.1.104 Outlet pressure . 19
48 201.12.4 Protection against hazardous output . 20
49 201.12.4.4.101 Additional requirements for incorrect output . 20
50 201.12.4.4.101.1 Flowrate control . 20
51 201.12.4.4.101.2 Indication of start-up period . 20
52 201.12.4.102 Low oxygen concentration ALARM CONDITION . 20
53 201.12.4.103 Delivered gas filter . 20
54 201.13 HAZARDOUS SITUATIONS and fault conditions . 21
55 201.13.2.101 Additional specific SINGLE FAULT CONDITIONS . 21
56 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 21
57 201.15 Construction of ME EQUIPMENT . 21
58 201.16 ME SYSTEMS . 21
59 201.16.1.101 Additional general requirements for ME SYSTEMS . 21
60 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 21
61 201.17.101 Additional requirements for electromagnetic compatibility of
62 ME EQUIPMENT and ME SYSTEMS . 21
63 201.101 Outlet connector. 22
64 201.102 Requirements for parts and ACCESSORIES . 22
65 201.102.1 General . 22
66 201.102.2 Labelling . 22
67 201.102.3 Fire RISK reduction in ACCESSORIES . 22
68 201.103 SIGNAL INPUT/OUTPUT PART . 23
69 201.103.1 General . 23
70 201.103.2 Connection to a DISTRIBUTED ALARM SYSTEM . 23
71 201.103.3 Connection for remote control . 23
72 201.104 Indication of duration of operation . 23
73 201.105 Integrated CONSERVING EQUIPMENT . 23
74 202.6.2.1.10 Compliance criteria . 24
75 211.4.2.2 Environmental operating conditions . 25
76 ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
77 ME SYSTEMS . 26
78 Annex D (informative) Symbols on marking . 30
79 Annex AA (informative) Particular guidance and rationale . 31
80 Annex BB (informative) Reference to the Essential Principles . 38
81 Bibliography . 40
82 Alphabetical index of defined terms used in this particular standard . 41
83 Annex ZA (informative) Relationship between this Document and the Essential Requirements
84 of EU Directive 93/42/EEC . 43
85
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86 Foreword
87 ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
88 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
89 technical committees. Each member body interested in a subject for which a technical committee has been
90 established has the right to be represented on that committee. International organizations, governmental and
91 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
92 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
93 International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
94 The main task of technical committees is to prepare International Standards. Draft International Standards
95 adopted by the technical committees are circulated to the member bodies for voting. Publication as an
96 International Standard requires approval by at least 75 % of the member bodies casting a vote.
97 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
98 rights. ISO shall not be held responsible for identifying any or all such patent rights.
99 ISO/IEC 80601-2-69 was prepared by a joint working group of Technical Committee ISO/TC 121, Anaesthetic
100 and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment and Technical
101 Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
102 This first edition of ISO 80601-2-69 cancels and replaces the first edition of ISO 8359:1996. This edition of
103 ISO 80601-2-69 constitutes a major technical revision of ISO 8359:1996 and includes an alignment with third
104 edition of IEC 60601-1 and IEC 60601-1-11.
105 The most significant changes are the following modifications:
106 – extending the scope to include not only the OXYGEN CONCENTRATOR but also its ACCESSORIES,
107 where the characteristics of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL
108 PERFORMANCE of the OXYGEN CONCENTRATOR;
109 – identification of ESSENTIAL PERFORMANCE for an OXYGEN CONCENTRATOR and its ACCESSORIES;
110 – and the following additions:
111 tests for oxygen delivery performance;
112 new symbols;
113 new requirement for a means to prevent the propagation of fire into the OXYGEN CONCENTRATOR
114 and its ACCESSORIES;
115 tests for cleaning and disinfection procedures; and
116 consideration of contamination of the breathing gas delivered to the PATIENT from the gas
117 pathways.
118 In this standard, the following print types are used:
119 – Requirements and definitions: roman type.
120 – Test specifications: italic type.
121 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
122 Normative text of tables is also in a smaller type.
123 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
124 SMALL CAPITALS TYPE.
125 In referring to the structure of this standard, the term
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126 – "clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
127 all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
128 – “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are
129 all subclauses of Clause 201.7).
130 References to clauses within this standard are preceded by the term “Clause” followed by the clause number.
131 References to subclauses within this particular standard are by number only.
132 In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of
133 the conditions is true.
134 The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part
135 2. For the purposes of this standard, the auxiliary verb:
136 – “shall” means that compliance with a requirement or a test is mandatory for compliance with this
137 standard;
138 – “should” means that compliance with a requirement or a test is recommended but is not
139 mandatory for compliance with this standard;
140 – “may” is used to describe a permissible way to achieve compliance with a requirement or test.
141 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
142 there is guidance or rationale related to that item in Annex A.
143 The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers
144 and testing organizations may need a transitional period following publication of a new, amended or revised
145 ISO or IEC publication in which to make products in accordance with the new requirements and to equip
146 themselves for conducting new or revised tests. It is the recommendation of the committee that the content of
147 this publication not be adopted for mandatory implementation nationally earlier than 3 years from the date of
148 publication for equipment newly designed and not earlier than 5 years from the date of publication for
149 equipment already in production.
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150 Introduction
151 Oxygen supplementation can be part of management of PATIENTS with chronic, acute–on-chronic and
152 acute respiratory disorders. The amount of supplemental oxygen depends on the individual PATIENT’S
153 needs under various conditions. The managing healthcare team typically prescribes the endpoint of
154 treatment, for example a target value for oxygen saturation. The amount of supplemental oxygen can
155 be controlled by the flow rate.
156 The goal of long term oxygen therapy is to keep the oxygen saturation above 90 % in PATIENTS that require
157 supplemental oxygen. The flow rate should be adjusted for rest, exertion, and sleep to meet the individual
158 PATIENT’S needs under these various conditions. Ideally, the resting flowrate can be adjusted by monitoring
159 pulse oximetry to Sp0 > 90 %.
2
160 Supplemental oxygen is supplied by three types of sources: OXYGEN CONCENTRATORS, compressed
161 gas cylinders, and liquid oxygen reservoirs. This standard covers the particular requirements for
162 BASIC SAFETY and ESSENTIAL PERFORMANCE of OXYGEN CONCENTRATORS. OXYGEN CONCENTRATORS
163 produce oxygen enriched air from room air for delivery to a PATIENT requiring oxygen therapy. The
164 most common OXYGEN CONCENTRATOR uses molecular sieve beds to filter and concentrate oxygen
165 molecules from the ambient air, generating oxygen concentrations of 82 to 95%. The main
166 component of this type of OXYGEN CONCENTRATOR is the molecular sieve, which adsorbs nitrogen from
167 air to produce a product gas which is a mixture of up to 95% oxygen and 5 % of other gases. The
168 periodic adsorbing and purging of nitrogen is referred to as the pressure swing adsorption process.
169
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IEC ISO/DIS 80601-2-69 ISO:2011 – 1 – ISO TC121/SC3-62D JWG12
170 Medical Electrical Equipment — Part 2-69: Particular
171 requirements for basic safety and essential performance of
172 oxygen concentrator equipment
173 201.1 Scope, object and related standards
174 IEC 60601-1:2005+Amendment 1:2012, Clause 1 applies, except as follows:
175 201.1.1 Scope
176 IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:
177 This particular standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an OXYGEN
178 CONCENTRATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT, intended
179 to increase the oxygen concentration in the gas intended to be delivered to a single PATIENT. Such
180 OXYGEN CONCENTRATORS are typically intended for use in the HOME HEALTHCARE ENVIRONMENT,
181 including TRANSIT-OPERABLE use by a single PATIENT in various environments including any private
182 and public transportation and commercial aircraft.
183 NOTE 1 An OXYGEN CONCENTRATOR can also be used in professional healthcare facilities.
184 This particular standard is applicable to a TRANSIT-OPERABLE or non-TRANSIT-OPERABLE OXYGEN
185 CONCENTRATOR. This particular standard is applicable to an OXYGEN CONCENTRATOR integrated into or
186 used with other ME EQUIPMENT or ME SYSTEMS.
187 EXAMPLE 1 An OXYGEN CONCENTRATOR with integrated oxygen CONSERVING EQUIPMENT or humidifier.
188 EXAMPLE 2 An OXYGEN CONCENTRATOR used with a flowmeter stand.
189 This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to
190 be connected to an OXYGEN CONCENTRATOR, where the characteristics of those ACCESSORIES can
191 affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the OXYGEN CONCENTRATOR.
192 This particular standard does not specify the requirements for OXYGEN CONCENTRATORS for use with a
193 MEDICAL GAS PIPELINE SYSTEM which are given in ISO 10083.
194 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
195 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case,
196 the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
197 HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the
198 scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and
199 8.4.1 of the general standard.
200 NOTE 2 See also 4.2 of the General Standard.
201 This particular standard is a particular standard in the IEC 60601-1 series of standards.
© ISO/IEC 2012 – All rights reserved
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oSIST prEN ISO 80601-2-69:2013
IEC ISO/DIS 80601-2-69 ISO:2011 – 2 – ISO TC121/SC3-62D JWG12
202 201.1.2 Object
203 IEC 60601-1:2005, 1.2 is replaced by:
204 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
205 PERFORMANCE requirements for an OXYGEN CONCENTRATOR [as defined in 201.3.203] and its
206 ACCESSORIES.
207 NOTE ACCESSORIES are included because the combination of the OXYGEN CONCENTRATOR and the
208 ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or
209 ESSENTIAL PERFORMANCE of an OXYGEN CONCENTRATOR.
210 201.1.3 Collateral standards
211 IEC 60601-1:2005+Amendment 1:2012, 1.3 applies with the following addition:
212 This particular standard refers to those applicable collateral standards that are listed in IEC 60601-
213 1:2005+Amendment 1:2012, Clause 2 of the general standard and 201.2 of this particular standard.
214 IEC 60601-1-3:2008 does not apply.
215 201.1.4 Particular standards
216 IEC 60601-1:2005+Amendment 1:2012, 1.4 is replaced by:
217 In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in
218 the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT
219 under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
220 A requirement of a particular standard takes priority over the general standard or the collateral
221 standards.
222 For brevity, IEC 60601-1:2005+Amendment 1:2012 is referred to in this particular standard as the
223 general standard. Collateral standards are referred to by their document number.
224 The numbering of clauses and subclauses of this particular standard corresponds to those of the
225 general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of
226 the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits
227 of the collateral standard document number (e.g. 202.4 in this particular standard addresses the
228 content of Clause 4 of the IEC 60601-1-2 collateral standard, 208.4 in this particular standard
229 addresses the content of Clause 4 of the IEC 60601-1-8 collateral standard, etc.). The changes to the
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