SIST EN ISO 80601-2-69:2021
(Main)Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
This document 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 by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.
This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document 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 function or humidifier function.
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[2].
EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function.
This document 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.
NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment.
This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system.
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.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.
Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO 80601-2-69:2020)
Dieses Dokument 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 Gesundheits-für¬sorge angewendet werden.
Dieses Dokument gilt für bei Bewegung betriebsfähige und bei Bewegung nicht betriebsfähige Sauerstoff-Konzentratoren. Dieses Dokument ist auf einen Sauerstoff Konzentrator anwendbar, der in andere medi-zinische Geräte, ME Geräte oder in ME Systeme eingebaut ist oder zusammen mit diesen benutzt wird.
BEISPIEL 1 Ein Sauerstoff Konzentrator mit eingebauter Sauerstoff Dosiereinrichtung [1] oder mit Anfeuchter.
BEISPIEL 2 Ein Sauerstoff Konzentrator in Verwendung mit einem Durchflussmesser.
BEISPIEL 3 Ein Sauerstoff Konzentrator als Teil eines Anästhesiesystems zur Verwendung in Gebieten mit einge-schränkter Bereitstellung von Strom und Anästhesiegasen [2].
BEISPIEL 4 Ein Sauerstoff Konzentrator mit eingebautem Flüssigkeitsreservoir oder Gasflaschenfüllsystem.
Dieses Dokument gilt auch für Zubehör, für das der Hersteller den Anschluss an einen Sauerstoff-Konzentra-tor vorsieht, bei dem die Merkmale dieses Zubehörs die Basissicherheit und die wesentlichen Leistungsmerk-male des Sauerstoff Konzentrators beeinflussen können.
Dieses Dokument legt nicht die Anforderungen an Sauerstoff Konzentratoren zur Verwendung mit einem Rohrleitungssystem für medizinische Gase fest.
Wenn ein Abschnitt oder Unterabschnitt speziell nur auf ME Geräte oder ME Systeme angewendet werden soll, wird dies aus der Überschrift und dem Inhalt des jeweiligen Abschnitts oder Unterabschnitts deutlich. In den übrigen Fällen gilt der Abschnitt oder Unterabschnitt je nach Zutreffen für sowohl ME Geräte als auch ME Systeme.
Die mit der physiologischen Funktion des ME Geräts oder ME Systems innerhalb des Anwendungsbereiches dieses Dokuments direkt verbundenen Gefährdungen werden nicht in spezifischen Anforderungen dieses Dokuments berücksichtigt, mit Ausnahme von 7.2.13 und 8.4.1 der allgemeinen Norm.
ANMERKUNG 2 Siehe auch 4.2 der allgemeinen Norm.
Dieses Dokument ist eine besondere Norm aus den Normenreihen IEC 60601 und IEC/ISO 80601.
Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO 80601-2-69:2020)
Le présent document 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 pour un patient unique dans divers environnements, dont les transports publics et privés ainsi que dans les transports aériens.
NOTE 1 Ce type de concentrateurs d'oxygène peut également être utilisé dans des établissements de santé.
Le présent document est applicable aux concentrateurs d'oxygène opérationnels en déplacement et non opérationnels en déplacement. Le présent document est applicable aux concentrateurs d'oxygène intégrés ou utilisés avec d'autres dispositifs médicaux, appareils EM ou systèmes EM.
EXEMPLE 1 Un concentrateur d'oxygène doté d'une fonction d'économiseur d'oxygène intégré ou d'humidificateur intégré.
EXEMPLE 2 Un concentrateur d'oxygène utilisé avec un débitmètre.
EXEMPLE 3 Un concentrateur d'oxygène faisant partie d'un système d'anesthésie pour utilisation dans des zones avec équipement logistique limité en électricité et en gaz anesthésiques.[2]
EXEMPLE 4 Un concentrateur d'oxygène doté d'une fonction de réservoir de liquide intégré ou de système de remplissage de bouteilles de gaz intégré.
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un concentrateur d'oxygène, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles du concentrateur d'oxygène.
NOTE 2 Les accessoires peuvent comprendre, entre autres, des masques, des canules, des tubulures d'extension, des humidificateurs, des chariots, des coffrets de transport, des sources d'alimentation externes ou des économiseurs d'oxygène.
Le présent document ne spécifie pas d'exigences applicables à l'utilisation de concentrateurs d'oxygène avec un système de distribution de gaz médicaux.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et 8.4.1 de la norme générale.
NOTE 3 Voir également 4.2 de la norme générale.
Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in bistvene lastnosti naprav za koncentriranje kisika (ISO 80601-2-69:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 80601-2-69:2021
01-januar-2021
Nadomešča:
SIST EN ISO 80601-2-69:2014
Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za koncentriranje kisika (ISO 80601-2-69:2020)
Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and
essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)
Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren (ISO
80601-2-69:2020)
Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO 80601-2-
69:2020)
Ta slovenski standard je istoveten z: EN ISO 80601-2-69:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-69:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 80601-2-69:2021
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SIST EN ISO 80601-2-69:2021
EN ISO 80601-2-69
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-69:2014
English Version
Medical electrical equipment - Part 2-69: Particular
requirements for the basic safety and essential
performance of oxygen concentrator equipment (ISO
80601-2-69:2020)
Appareils électromédicaux - Partie 2-69: Exigences Medizinische elektrische Geräte - Teil 2-69: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des dispositifs wesentlichen Leistungsmerkmale für Sauerstoff-
concentrateurs d'oxygène (ISO 80601-2-69:2020) Konzentratoren (ISO 80601-2-69:2020)
This European Standard was approved by CEN on 15 October 2020.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-69:2020 E
worldwide for CEN national Members.
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SIST EN ISO 80601-2-69:2021
EN ISO 80601-2-69:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 80601-2-69:2021
EN ISO 80601-2-69:2020 (E)
European foreword
This document (EN ISO 80601-2-69:2020) 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80601-2-69:2014.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-69:2020 has been approved by CEN as EN ISO 80601-2-69:2020 without any
modification.
3
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SIST EN ISO 80601-2-69:2021
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SIST EN ISO 80601-2-69:2021
INTERNATIONAL ISO
STANDARD 80601-2-69
Second edition
2020-11
Medical electrical equipment —
Part 2-69:
Particular requirements for the 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 80601-2-69:2020(E)
©
ISO 2020
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
Contents Page
Foreword . v
Introduction . vii
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 . 7
201. 8 Protection against electrical hazards from ME equipment . 14
201. 9 Protection against mechanical hazards of ME equipment and ME systems . 14
201. 10 Protection against unwanted and excessive radiation hazards . 16
201. 11 Protection against excessive temperatures and other hazards . 16
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 20
201. 13 Hazardous situations and fault conditions for ME equipment . 25
201. 14 Programmable electrical medical systems (PEMS) . 25
201. 15 Construction of ME equipment . 25
201. 16 ME systems . 26
201. 17 Electromagnetic compatibility of ME equipment and ME systems . 26
201.101 Outlet connector . 26
201.102 Requirements for parts and accessories . 27
201.103 Functional connection . 28
201.104 * Indication of duration of operation . 28
201.105 Integrated conserving equipment function . 29
202 Electromagnetic disturbances – Requirements and tests . 29
202.4.3.1 * Configurations . 29
206 Usability . 30
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 31
211.4.2.2 Environmental operating conditions . 31
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 32
Annex D (informative) Symbols on marking . 37
© ISO 2020 – All rights reserved iii
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
Annex AA (informative) Particular guidance and rationale . 39
Annex BB (informative) Reference to the IMDRF essential principles and labelling
guidances . 46
Annex CC (informative) Reference to the essential principles . 51
Annex DD (informative) Reference to the general safety and performance requirements . 55
Annex EE (informative) Terminology — alphabetized index of defined terms . 59
Bibliography . 62
iv © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D,
Electromedical equipment, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 80601-2-69:2014), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— changes to the low oxygen concentration alarm condition;
— changes to the gas outlet connector;
— changes to the test method for the filter for the delivered gas;
— reformatting to provide a unique identifier for each requirement;
— harmonization with the ‘A2 project’ of the general standard.
A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.
© ISO 2020 – All rights reserved v
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
Introduction
Oxygen supplementation can be part of management of patients with chronic, acute-on-chronic or 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 a target value 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 greater than the target value 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. 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 90 % 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.
Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and
oxygen from an oxygen concentrator.
In this document, the following print types are used:
— requirements and definitions: roman type;
— test specifications and terms defined in Clause 3 of the general standard, in this particular document
or as noted: italic type; and
— 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.
In referring to the structure of this document, the term.
— “clause” means one of the three numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.); and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all
subclauses of Clause 201).
References to clauses within this document are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular document are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
For the purposes of this document, the auxiliary verb:
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
— “shall” means that conformance with a requirement or a test is mandatory for conformance with
this document;
— "should” means that conformance with a requirement or a test is recommended but is not
mandatory for conformance with this document;
— "may” is used to describe a permission (e.g., permissible way to achieve conformance with a
requirement or test;
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.
Annex C contains a guide to the marking and labelling requirements in this document.
Annex D contains a summary of the symbols referenced in this document.
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 AA.
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SIST EN ISO 80601-2-69:2021
INTERNATIONAL STANDARD ISO 80601-2-69:2020(E)
Medical electrical equipment
Part 2-69:
Particular requirements for the basic safety and
essential performance of oxygen concentrator equipment
201.1 * Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:
This document 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 by a single patient in
various environments including any private and public transportation as well as in commercial aircraft.
NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities.
This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This
document 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 function or humidifier
function.
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
[2]
supplies of electricity and anaesthetic gases .
EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system
function.
This document 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.
NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers,
carts, carrying cases, external power sources and oxygen conserving equipment.
This document does not specify requirements for oxygen concentrators for use with a medical gas
pipeline system.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
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.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the
scope of this document are not covered by specific requirements in this document except in 7.2.13 and
8.4.1 of the general standard.
NOTE 3 See also 4.2 of the general standard.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance
requirements for an oxygen concentrator (as defined in 201.3.202) and its accessories.
NOTE 1 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.
[8] [9]
NOTE 2 This document has been prepared to address the relevant essential principles and labelling
guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance
of ISO 16142-1:2016 as indicated in Annex CC.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements
[7]
of European regulation (EU) 2017/745 as indicated in Annex DD.
201.1.3 Collateral standards
IEC 60601-1:2005+AMD1:2012+AMD2: 2020, 1.3 applies with the following addition:
IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 and
IEC 60601-1-11:2015+AMD1:2020 apply as modified in Clauses 202, 206 and 211 respectively.
IEC 60601-1-3:2008+AMD1:2013 does not apply. All other published collateral standards in the
IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards define basic safety and essential performance requirements,
and may modify, replace or delete requirements contained in the general standard and collateral
standards as appropriate for the particular ME equipment under consideration.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1+AMD1:2012+AMD2:2020 is referred to in this document as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this document corresponds to that of the general standard
with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general
standard) or applicable collateral standard with the prefix “20x”, where x is the final digit(s) of the
2 © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
collateral standard document number (e.g. 202.4 in this document addresses the content of Clause 4 of
the IEC 60601-1-2 collateral standard, 211.4 in this document addresses the content of Clause 4 of the
IEC 60601-1-11collateral standard, etc.). The changes to the text of the general standard are specified
by the use of the following words.
— "Replacement" means that the clause or subclause of the general standard or applicable collateral
standard is replaced completely by the text of this document.
— "Addition" means that the text of this document is additional to the requirements of the general
standard or applicable collateral standard.
— "Amendment" means that the clause or subclause of the general standard or applicable collateral
standard is amended as indicated by the text of this document.
Clauses, subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general standard are
numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from
201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 211 for
IEC 60601-1-11, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this particular document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the
general standard or applicable collateral standard, although possibly not relevant, applies without
modification; where it is intended that any part of the general standard or applicable collateral standard,
although possibly relevant, is not to be applied, a statement to that effect is given in this document.
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005+AMD1:2012+AMD2: 2020, Clause 2 applies, except as follows:
Replacement:
1
ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
1
Under preparation. Stage at the time of publication: ISO/DIS 15223-1:2020.
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SIST EN ISO 80601-2-69:2021
ISO 80601-2-69:2020(E)
ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of
medical devices — Part 1: General essential principles and additional specific essential principles for all
non-IVD medical devices and guidance on the selection of standards
ISO 17664:2017, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices
ISO 18562-1:2017, Biocompat
...
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