oSIST prEN ISO 80601-2-69:2024

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)

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/DIS 80601-2-69:2024)

Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO/DIS 80601-2-69:2024)

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/DIS 80601-2-69:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Nov-2024
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 04-Oct-2024
• Due Date: 21-Feb-2025
• 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
• 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: 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)

Relations

• Revises: 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)
• Effective Date: 07-Jun-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-69. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti naprav za koncentriranje kisika (ISO/DIS 80601-2-69:2024)
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)
Medizinische elektrische Geräte - Teil 2-69: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale für Sauerstoff-Konzentratoren
(ISO/DIS 80601-2-69:2024)
Appareils électromédicaux - Partie 2-69: Exigences particulières pour la sécurité de base
et les performances essentielles des dispositifs concentrateurs d'oxygène (ISO/DIS
80601-2-69:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-69
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.

DRAFT
International
Standard
ISO/DIS 80601-2-69
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-69:
Voting begins on:
Particular requirements for 2024-09-16
the basic safety and essential
Voting terminates on:
2024-12-09
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
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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.
Reference number
ISO/DIS 80601-2-69:2024(en)
DRAFT
ISO/DIS 80601-2-69:2024(en)
International
Standard
ISO/DIS 80601-2-69
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-69:
Voting begins on:
Particular requirements for
the basic safety and essential
Voting terminates on:
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
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-69:2024(en)
ii
ISO/DIS 80601-2-69:2024(en)
1 Contents
2 Contents . iii
3 Foreword . v
4 Introduction . vii
5 201. 1 Scope, object and related standards . 1
6 201. 2 Normative references . 3
7 201. 3 Terms and definitions . 5
8 201. 4 General requirements . 17
9 201. 5 General requirements for testing of ME equipment . 18
10 201. 6 Classification of ME equipment and ME systems . 19
11 201. 7 ME equipment identification, marking and documents . 19
12 201. 8 Protection against electrical hazards from ME equipment . 26
13 201. 9 Protection against mechanical hazards of ME equipment and ME systems . 26
14 201. 10 Protection against unwanted and excessive radiation hazards . 29
15 201. 11 Protection against excessive temperatures and other hazards . 29
16 201. 12 Accuracy of controls and instruments and protection against hazardous
17 outputs . 33
18 201. 13 Hazardous situations and fault conditions for ME equipment . 39
19 201. 14 Programmable electrical medical systems (PEMS) . 39
20 201. 15 Construction of ME equipment . 40
21 201. 16 ME systems . 40
22 201. 17 Electromagnetic compatibility of ME equipment and ME systems . 40
23 201.101 Outlet connector . 40
24 201.102 Requirements for parts and accessories . 41
25 201.103 Functional connection . 42
26 201.104 Indication of duration of operation . 43
27 201.105 Integrated conserving equipment function . 43
28 202 Electromagnetic disturbances – Requirements and tests . 43
29 202.4.3.1 Configurations . 44
30 206 Usability . 44
31 211 Requirements for medical electrical equipment and medical electrical systems used
32 in the home healthcare environment . 45
33 211.4.2.2 Environmental operating conditions . 45
34 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
35 ME systems . 46
36 Annex D (informative) Symbols on marking . 51
iii
ISO/DIS 80601-2-69:2024(en)
37 Annex AA (informative) Particular guidance and rationale . 53
38 Annex BB (informative) Reference to the IMDRF essential principles and labelling
39 guidances . 62
40 Annex CC (informative) Terminology — alphabetized index of defined terms . 67
41 Bibliography . 71
42 Table ZA.2 — Applicable Standards to confer presumption of conformity as described in
43 this Annex ZA . 75
iv
ISO/DIS 80601-2-69:2024(en)
45 Foreword
46 ISO (the International Organization for Standardization) is a worldwide federation of national standards
47 bodies (ISO member bodies). The work of preparing International Standards is normally carried out
48 through ISO technical committees. Each member body interested in a subject for which a technical
49 committee has been established has the right to be represented on that committee. International
50 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
51 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
52 electrotechnical standardization.
53 The procedures used to develop this document and those intended for its further maintenance are
54 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
55 different types of ISO documents should be noted. This document was drafted in accordance with the
56 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
57 Attention is drawn to the possibility that some of the elements of this document may be the subject of
58 patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
59 patent rights identified during the development of the document will be in the Introduction and/or on
60 the ISO list of patent declarations received (see www.iso.org/patents).
61 Any trade name used in this document is information given for the convenience of users and does not
62 constitute an endorsement.
63 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
64 expressions related to conformity assessment, as well as information about ISO's adherence to the World
65 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
66 www.iso.org/iso/foreword.html.
67 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
68 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
69 Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular
70 medical equipment, software, and systems, in collaboration with the European Committee for
71 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
72 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
73 This third edition cancels and replaces the second edition (ISO 80601-2-69:2020), which has been
74 technically revised.
75 The main changes compared to the previous edition are as follows:
76 — updated references, where appropriate;
77 — harmonization with ISO 20417, where appropriate;
78 — updated uncertainty of measurement requirements;
79 — added marking requirements for gas intake port, external gas sources and MR compatibility;
80 — requirements for processing of the enclosure;
81 — added cybersecurity recommendations; and
82 — updated connector requirements.
v
ISO/DIS 80601-2-69:2024(en)
83 A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.
84 Any feedback or questions on this document should be directed to the user’s national standards body. A
85 complete listing of these bodies can be found at www.iso.org/members.html.
vi
ISO/DIS 80601-2-69:2024(en)
86 Introduction
87 Oxygen supplementation can be part of
...