EN ISO 80601-2-72:2023

SLOVENSKI STANDARD
01-oktober-2023
Nadomešča:
SIST EN ISO 80601-2-72:2015
Medicinska električna oprema - 2-72. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti respiratorjev za oskrbo od aparata odvisnih pacientov na domu
(ISO 80601-2-72:2023)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Medizinische elektrische Geräte - Teil 2-72: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Heimbeatmungsgeräten für vom
Gerät abhängige Patienten (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans l'environnement des soins
à domicile pour les patients ventilo-dépendants (ISO 80601-2-72:2023)
Ta slovenski standard je istoveten z: EN ISO 80601-2-72:2023
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 80601-2-72
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-72:2015
English Version
Medical electrical equipment - Part 2-72: Particular
requirements for basic safety and essential performance of
home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2023)
Appareils électromédicaux - Partie 2-72: Exigences Medizinische elektrische Geräte - Teil 2-72: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von
dans l'environnement des soins à domicile pour les Heimbeatmungsgeräten für vom Gerät abhängige
patients ventilo-dépendants (ISO 80601-2-72:2023) Patienten (ISO 80601-2-72:2023)
This European Standard was approved by CEN on 24 April 2023.

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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-72:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 80601-2-72:2023) 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 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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 80601-2-72:2015.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-72:2023 has been approved by CEN as EN ISO 80601-2-72:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 80601-2-72
Second edition
2023-06
Medical electrical equipment —
Part 2-72:
Particular requirements for basic
safety and essential performance
of home healthcare environment
ventilators for ventilator-dependent
patients
Appareils électromédicaux —
Partie 2-72: Exigences particulières pour la sécurité de base
et les performances essentielles des ventilateurs utilisés dans
l'environnement des soins à domicile pour les patients ventilo-
dépendants
Reference number
ISO 80601-2-72:2023(E)
ISO 80601-2-72:2023(E)
© ISO 2023
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 80601-2-72:2023(E)
Contents
Foreword . v
Introduction . vii
201.1 Scope, object, and related standards. 1
201.2 Normative references . 3
201.3 Terms and definitions . 5
201.4 General requirements . 21
201.5 General requirements for testing of ME equipment . 25
201.6 Classification of ME equipment and ME systems . 26
201.7 ME equipment identification, marking, and documents . 26
201.8 Protection against electrical hazards from ME equipment. 35
201.9 Protection against mechanical hazards of ME equipment and ME systems . 35
201.10 Protection against unwanted and excessive radiation hazards . 37
201.11 Protection against excessive temperatures and other hazards . 38
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 40
201.13 Hazardous situations and fault conditions . 59
201.14 Programmable electrical medical systems (PEMS) . 61
201.15 Construction of ME equipment . 61
201.16 ME systems . 62
201.17 Electromagnetic compatibility of ME equipment and ME systems . 63
201.101 Gas connections . 63
201.102 Requirements for the VBS and accessories . 66
201.103 Spontaneous breathing during loss of power supply . 67
201.104 Indication of duration of operation . 68
201.105 Functional connection . 68
201.106 Display loops . 69
201.107 Ventilator security . 69
201.108 Oxygen inlet port . 70
202 Electromagnetic disturbances — Requirements and tests . 70
206 Usability . 71
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems . 73
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment . 75
ISO 80601-2-72:2023(E)
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 78
Annex D (informative) Symbols on marking . 85
Annex AA (informative) Particular guidance and rationale . 87
Annex BB (informative) Data interface requirements . 113
Annex CC (informative) Reference to the IMDRF essential principles and labelling
guidances . 121
Annex DD (informative) Reference to the essential principles . 126
Annex EE (informative) Reference to the general safety and performance requirements . 130
Bibliography . 134

iv © ISO 2023 – All rights reserved

ISO 80601-2-72:2023(E)
Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that are
members of ISO or IEC participate in the development of International Standards through technical
committees established by the respective organization to deal with particular fields of technical activity.
ISO and IEC technical committees collaborate in fields of mutual interest. Other international
organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the
work.
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 document 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 or
www.iec.ch/members_experts/refdocs).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO and IEC 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 b
...