prEN ISO 80601-2-67
(Main)Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2024)
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2024)
This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4].
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
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 IEC 60601-1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
Medizinische elektrische Geräte - Teil 2-67: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Sauerstoff-Dosiergeräten (ISO/DIS 80601 2 67:2024)
Appareils électromédicaux - Partie 2-67: Exigences particulières pour la sécurité de base et les performances essentielles des économiseurs d'oxygène (ISO/DIS 80601-2-67:2024)
Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente et synchronisée en suivant le cycle d'inspiration du patient, pour une utilisation dans l'environnement de soins à domicile. L'économiseur d'oxygène est habituellement utilisé par un opérateur non spécialiste.
NOTE 1 Un économiseur peut également être utilisé dans des établissements de santé.
Le présent document s'applique également aux économiseurs intégrés à d'autres appareils.
EXEMPLE Économiseur associé à un détendeur[2], un concentrateur d'oxygène[7] ou un appareil à oxygène liquide[4].
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un économiseur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'économiseur.
Le présent document vise à préciser les différences de fonctionnement entre différents modèles d'économiseurs, ainsi que les différences de fonctionnement entre économiseurs et appareils à oxygène à débit continu, en exigeant des essais de performance et un étiquetage normalisés.
Le présent document ne s'applique qu'aux dispositifs actifs (par exemple, dotés d'une alimentation pneumatique ou électrique) et ne s'applique pas aux dispositifs non actifs (par exemple, canules de réservoir).
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 l'IEC 60601‑1:2005+AMD1:2012, 7.2.13 et 8.4.1.
NOTE 2 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.
Medicinska električna oprema - 2-67. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za shranjevanje kisika (ISO/DIS 80601-2-67:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Medicinska električna oprema - 2-67. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za shranjevanje kisika (ISO/DIS 80601-2-67:2024)
Medical electrical equipment - Part 2-67: Particular requirements for basic safety and
essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2024)
Medizinische elektrische Geräte - Teil 2-67: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Sauerstoff-Dosiergeräten
(ISO/DIS 80601 2 67:2024)
Appareils électromédicaux - Partie 2-67: Exigences particulières pour la sécurité de base
et les performances essentielles des économiseurs d'oxygène (ISO/DIS 80601-2-
67:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-67
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 80601-2-67
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-67:
Voting begins on:
Particular requirements for basic 2024-09-16
safety and essential performance of
Voting terminates on:
2024-12-09
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
ICS: 11.040.10; 11.040.10; 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
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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 80601-2-67:2024(en)
DRAFT
ISO/DIS 80601-2-67:2024(en)
International
Standard
ISO/DIS 80601-2-67
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-67:
Voting begins on:
Particular requirements for basic
safety and essential performance of
Voting terminates on:
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
ICS: 11.040.10; 11.040.10; 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
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-67:2024(en)
ii
ISO/DIS 80601-2-67:2024(en)
1 Contents Page
3 Foreword . iv
4 Introduction . vi
5 201.1 Scope, object and related standards . 1
6 201.2 Normative references . 3
7 201.3 Terms and definitions . 4
8 201.4 General requirements . 13
9 201.5 General requirements for testing of ME equipment . 16
10 201.6 Classification of ME equipment and ME systems . 17
11 201.7 ME equipment identification, marking and documents . 17
12 201.8 Protection against electrical hazards from ME equipment . 24
13 201.9 Protection against mechanical hazards of ME equipment and ME systems . 24
14 201.10 Protection against unwanted and excessive radiation hazards . 24
15 201.11 Protection against excessive temperatures and other hazards . 24
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 26
17 201.13 Hazardous situations and fault conditions . 29
18 201.14 Programmable electrical medical systems (PEMS) . 29
19 201.15 Construction of ME equipment . 30
20 201.16 ME systems . 30
21 201.17 Electromagnetic compatibility of ME equipment and ME systems . 31
22 201.101 Gas connections. 31
23 201.102 Requirements for parts and accessories . 32
24 201.103 Oxygen pressure regulators . 33
25 202 Electromagnetic disturbances – Requirements and tests . 34
26 202.4.3.1 Configurations . 34
27 206 Usability . 34
28 Annex C (informative) Guide to marking and labelling requirements for ME equipment and
29 ME systems . 36
30 Annex D (informative) Symbols on marking . 41
31 Annex AA (informative) Particular guidance and rationale . 42
32 Annex BB (informative) Reference to the IMDRF essential principles and labelling
33 guidances . 51
34 Annex CC (informative) Terminology — Alphabetized index of defined terms . 55
35 Bibliography . 58
36 Table ZA.2 — Applicable Standards to confer presumption of conformity as described in
37 this Annex ZA . 62
iii
ISO/DIS 80601-2-67:2024(en)
39 Foreword
40 ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
41 Commission) form the specialized system for worldwide standardization. National bodies that are
42 members of ISO or IEC participate in the development of International Standards through technical
43 committees established by the respective organization to deal with particular fields of technical activity.
44 ISO and IEC technical committees collaborate in fields of mutual interest. Other international
45 organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
46 work.
47 The procedures used to develop this document and those intended for its further maintenance are
48 described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
49 different types of document should be noted. This document was drafted in accordance with the editorial
50 rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or
51 www.iec.ch/members_experts/refdocs).
52 ISO and IEC draw attention to the possibility that the implementation of this document may involve the
53 use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any
54 claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had
55 not received notice of (a) patent(s) which may be required to implement this document. However,
56 implementers are cautioned that this may not represent the latest information, which may be obtained
57 from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall
58 not be held responsible for identifying any or all such patent rights.
59 Any trade name used in this document is information given for the convenience of users and does not
60 constitute an endorsement.
61 For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
62 expressions related to conformity assessment, as well as information about ISO's adherence to the World
63 Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
64 www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.
65 This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
66 equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and
67 Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC D, Particular
68 medical equipment, software, and systems, in collaboration with the European Committee for
69 Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
70 accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
71 This third edition cancels and replaces the second edition (ISO 80601-2-67:2020), which has been
72 technically revised.
73 The main changes are as follows:
74 — updated references, where appropriate;
75 — harmonization with ISO 20417, where appropriate;
76 — updated uncertainty of measurement requirements;
77 — added marking requirements for gas intake port, external gas sources and MR compatibility;
78 — requirements for processing of the enclosure;
iv
ISO/DIS 80601-2-67:2024(en)
79 — added cybersecurity recommendations; and
80 — updated connector requirements.
81 A list of all parts in the ISO 80601 and IEC 80601 series can be found on the ISO and IEC websites.
82 Any feedback or questions on this document should be directed to the user’s national standards body. A
83 complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-
84 committees.
v
ISO/DIS 80601-2-67:2024(en)
85 Introduction
86 Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong
87 survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of
88 therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and
89 oxygen from an oxygen concentrator.
90 Most clinicians prescribe low flow oxygen therapy as continuous flow oxygen (CFO) delivery in l/min.
91 CFO systems deliver the flow of oxygen without regard for the patient’s breathing rate or pattern. Outside
92 of the institutional care setting, the provision of CFO therapy is often a significant expense and can limit
93 the mobility of a patient to the immediate vi
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