IEC 60601-1-12:2014
(Main)Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.
Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence
L'IEC 60601-1-12:2014 constitue une norme collatérale de l'IEC 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles désignée ci-après par norme générale. La pratique médicale utilise de plus en plus des appareils électromédicaux et des systèmes électromédicaux pour la surveillance, le traitement ou le diagnostic des patients dans l'environnement des services médicaux d'urgence. La sécurité des appareils électromédicaux dans cet environnement particulièrement difficile et non contrôlé, est source de préoccupation. La présente norme collatérale a été élaborée grâce aux contributions de médecins cliniciens, d'ingénieurs et d'autorités de tutelle. La terminologie, les exigences, les recommandations générales et les lignes directrices contenues dans la présente norme collatérale ont pour objectif d'être utiles aux fabricants d'appareils électromédicaux et de systèmes électromédicaux et aux comités techniques responsables de l'élaboration des normes particulières. La présente Norme internationale s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, désignés ci-après par appareils EM et systèmes EM, destinés, comme indiqué dans les instructions d'utilisation, par leur fabricant à être utilisés dans l'environnement SMU (environnement des Services Médicaux d'Urgence). L'objet de la présente norme collatérale est de fournir des exigences générales pour les appareils EM et les systèmes EM acheminés et utilisés sur les lieux d'une intervention en urgence, ainsi que pour leur transport, dans des situations où les conditions ambiantes sont différentes des conditions intérieures. La présente norme collatérale est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale et à servir de base pour les normes particulières.
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IEC 60601-1-12
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
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IEC 60601-1-12
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040 ISBN 978-2-8322-1654-5
– 2 – IEC 60601-1-12:2014 © IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 * Object . 8
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 11
4.2 * Environmental conditions for ME EQUIPMENT . 11
4.2.1 * Environmental conditions of transport and storage between uses . 12
4.2.2 * Environmental operating conditions . 13
5 * Classification of ME EQUIPMENT and ME SYSTEMS . 15
6 ME EQUIPMENT identification, marking and documents . 16
6.1 * Additional requirements for legibility of markings . 16
6.2 * Additional requirements for marking of IP classification . 16
6.3 * Instructions for use . 16
6.3.1 Additional general requirements . 16
6.3.2 * Additional requirements for an electrical power source . 17
6.3.3 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 17
6.3.4 * Additional requirements for operating instructions . 18
6.3.5 Additional requirements for ME EQUIPMENT messages . 18
6.4 Technical description – FIXED or PERMANENTLY INSTALLED CLASS I
ME EQUIPMENT . 18
7 * Protection against electrical HAZARDS from ME EQUIPMENT . 18
8 Protection against excessive temperatures and other HAZARDS . 19
8.1 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 19
8.1.1 * Ingress of water or particulate matter into ME EQUIPMENT . 19
8.1.2 * Ingress of water or particulate matter into ME SYSTEMS . 19
8.2 Additional requirements for interruption of the power supply to ME EQUIPMENT
and ME SYSTEM . 19
8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for
ME EQUIPMENT . 20
9 * Accuracy of controls and instruments and protection against hazardous outputs . 21
10 Construction of ME EQUIPMENT . 21
10.1 * Additional requirements for mechanical strength of ME EQUIPMENT intended
for the EMS ENVIRONMENT . 21
10.1.1 General requirements for mechanical strength . 21
10.1.2 * Requirements for mechanical strength for FIXED or PERMANENTLY
INSTALLED ME EQUIPMENT intended for use in a road ambulance . 22
10.1.3 * Requirements for mechanical strength for TRANSPORTABLE
ME EQUIPMENT . 23
10.1.4 * Requirements for mechanical strength for ME EQUIPMENT intended for
airborne use . 24
10.2 Requirements for mounting of ME EQUIPMENT . 25
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS . 25
Annex A (informative) General guidance and rationale . 26
A.1 General guidance . 26
A.2 Rationale for particular clauses and subclauses . 28
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 42
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 42
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 42
B.3 ACCOMPANYING DOCUMENTS, technical description . 43
Annex C (informative) Symbols on marking . 44
Bibliography . 46
Index of defined terms used in this collateral standard . 48
Figure A.1 – Saturation water vapour pressure as function of temperature . 31
Table 1 – Mechanical strength test applicability . 22
Table A.1 – Saturation water vapour pressure as function of temperature . 32
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 42
Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use . 42
Table B.3 – ACCOMPANYING DOCUMENTS, technical description . 43
Table C.1 – General symbols .
...
IEC 60601-1-12
Edition 1.1 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
IEC IEC 60601-1-12:2014-06+AMD1:2020-07 CSV(en-fr)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.
need further assistance, please contact the Customer Service
Centre: sales@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
plus récente, un corrigendum ou amendement peut avoir été publié.
Recherche de publications IEC - Electropedia - www.electropedia.org
webstore.iec.ch/advsearchform Le premier dictionnaire d'électrotechnologie en ligne au
La recherche avancée permet de trouver des publications IEC monde, avec plus de 22 000 articles terminologiques en
en utilisant différents critères (numéro de référence, texte, anglais et en français, ainsi que les termes équivalents dans
comité d’études,…). Elle donne aussi des informations sur les 16 langues additionnelles. Egalement appelé Vocabulaire
projets et les publications remplacées ou retirées. Electrotechnique International (IEV) en ligne.
IEC Just Published - webstore.iec.ch/justpublished Glossaire IEC - std.iec.ch/glossary
Restez informé sur les nouvelles publications IEC. Just 67 000 entrées terminologiques électrotechniques, en anglais
Published détaille les nouvelles publications parues. et en français, extraites des articles Termes et définitions des
Disponible en ligne et une fois par mois par email. publications IEC parues entre 2002 et 2015. Plus certaines
entrées antérieures extraites des publications des CE 37, 77,
Service Clients - webstore.iec.ch/csc 86 et CISPR de l'IEC.
Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
sales@iec.ch.
IEC 60601-1-12
Edition 1.1 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8708-8
IEC 60601-1-12
Edition 1.1 2020-07
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence
IEC IEC 60601-1-12:2014-06+AMD1:2020-07 CSV(en-fr)
– 2 – IEC 60601-1-12:2014+AMD1:2020 CSV
© IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
INTRODUCTION to Amendment 1 . 7
1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 * Object . 8
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 11
4.2 * Environmental conditions for ME EQUIPMENT . 12
4.2.1 * Environmental conditions of transport and storage between uses . 12
4.2.2 * Environmental operating conditions . 13
5 * Classification of ME EQUIPMENT and ME SYSTEMS . 15
6 ME EQUIPMENT identification, marking and documents . 16
6.1 * Additional requirements for legibility of markings . 16
6.2 * Additional requirements for marking of IP classification . 16
6.3 * Instructions for use . 16
6.3.1 Additional general requirements . 16
6.3.2 * Additional requirements for an electrical power source . 17
6.3.3 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 17
6.3.4 * Additional requirements for operating instructions . 18
6.3.5 Additional requirements for ME EQUIPMENT messages . 18
6.4 Technical description – FIXED or PERMANENTLY INSTALLED CLASS I
ME EQUIPMENT . 18
7 * Protection against electrical HAZARDS from ME EQUIPMENT . 18
8 Protection against excessive temperatures and other HAZARDS . 19
8.1 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 19
8.1.1 * Ingress of water or particulate matter into ME EQUIPMENT . 19
8.1.2 * Ingress of water or particulate matter into ME SYSTEMS . 19
8.2 Additional requirements for interruption of the power supply to ME EQUIPMENT
and ME SYSTEM . 19
8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for
ME EQUIPMENT . 20
9 * Accuracy of controls and instruments and protection against hazardous outputs . 21
10 Construction of ME EQUIPMENT . 21
10.1 * Additional requirements for mechanical strength of ME EQUIPMENT intended
for the EMS ENVIRONMENT . 21
10.1.1 General requirements for mechanical strength . 21
10.1.2 * Requirements for mechanical strength for FIXED or PERMANENTLY
INSTALLED ME EQUIPMENT intended for use in a road ambulance . 22
© IEC 2020
10.1.3 * Requirements for mechanical strength for TRANSPORTABLE
ME EQUIPMENT . 23
10.1.4 * Requirements for mechanical strength for ME EQUIPMENT intended for
airborne use . 24
10.2 Requirements for mounting of ME EQUIPMENT . 25
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS . 25
Annex A (informative) General guidance and rationale . 26
A.1 General guidance . 26
A.2 Rationale for particular clauses and subclauses . 28
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 42
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 42
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 42
B.3 ACCOMPANYING DOCUMENTS, technical description . 43
Annex C (informative) Symbols on marking . 44
Bibliography . 46
Index of defined terms used in this collateral standard . 48
Figure A.1 – Saturation water vapour pressure as function of temperature . 31
Table 1 – Mechanical strength test applicability . 22
Table A.1 – Saturation water vapour pressure as function of temperature .
...
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