EN 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

• Status: Published
• Publication Date: 17-Nov-2020
• Withdrawal Date: 30-May-2021
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Nov-2020
• Completion Date: 18-Nov-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: SIST EN ISO 80601-2-69:2021 - Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2020)

Relations

• Replaces: EN ISO 80601-2-69:2014 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
• Effective Date: 08-Jun-2022
• Revised: prEN ISO 80601-2-69 - Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69:2024)
• Effective Date: 07-Jun-2023

Standards Content (Sample)

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

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.

Contents Page
European foreword . 3

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.
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
ISO 80601-2-69:2020(E)
© 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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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 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

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,
Electrom
...