IEC 60601-1-11:2015
(Main)Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-11:2015 is available as IEC 60601-1-11:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and
- harmonizing with the changes to the amendments to the general standard and other collateral standards.
Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme Collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soins à domicile
IEC 60601-1-11:2015 est disponible sous forme de IEC 60601-1-11:2015 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
IEC 60601-1-11:2015 s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, destinés à être utilisés dans l'environnement des soins à domicile. Elle s'applique sans distinguer si l'appareil électromédical ou le système électromédicalest prévu pour être utilisé par un opérateur non spécialiste ou par du personnel de santé qualifié. L'environnement des soins à domicile comprend:
- l'habitation dans laquelle un patient vit;
- d'autres environnements où des patients sont présents à l'intérieur comme à l'extérieur, à l'exclusion des environnements des établissements de soins où des opérateurs ayant une formation médicale sont disponibles de façon continue lorsque des patients sont présents.
Cette deuxième édition annule et remplace la première édition de l'IEC 60601-1-11, parue en 2010. Cette édition constitue une révision technique. Les modifications majeures par rapport à l'édition précédente sont les suivantes:
- correction de la méthode d'essai pour le contrôle de l'humidité relative à des températures supérieures à 35 °C;
- reformulation des paragraphes qui modifient plus qu'ils ne complètent la norme générale ou d'autres normes collatérales; et
- harmonisation avec les modifications apportées aux amendements de la norme générale et aux autres normes collatérales.
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IEC 60601-1-11
Edition 2.0 2015-01
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
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.
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
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IEC 60601-1-11
Edition 2.0 2015-01
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040 ISBN 978-2-8322-2214-0
– 2 – IEC 60601-1-11:2015 RLV © IEC 2015
CONTENTS
FOREWORD . 5
INTRODUCTION . 2
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 12
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and
ME SYSTEMS . 13
4.2 * Environmental conditions for ME EQUIPMENT . 13
4.2.1 General . 13
4.2.2 * Environmental conditions of transport and storage between uses . 13
4.2.3 * Environmental operating conditions . 15
5 * General requirements for testing ME EQUIPMENT . 17
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 18
7 ME EQUIPMENT identification, marking and documents . 18
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 18
7.2 * Additional requirements for marking of IP classification . 19
7.3 ACCOMPANYING DOCUMENTS . 19
7.3.1 Contact information . 19
7.3.2 LAY OPERATOR briefing information . 20
7.4 Instructions for use . 20
7.4.1 Additional requirements for warning and safety notices . 20
7.4.2 * Additional requirements for an electrical power source . 21
7.4.3 Additional requirements for ME EQUIPMENT description . 21
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 21
7.4.5 Additional requirements for operating instructions . 21
7.4.6 Additional requirements for ME EQUIPMENT messages . 22
7.4.7 * Additional requirements for cleaning, disinfection and sterilization . 22
7.4.8 Additional requirements for maintenance . 22
7.4.9 Additional requirements for environmental protection . 23
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS . 23
7.5 Technical description . 23
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 23
7.5.2 Additional requirements for professional hygienic maintenance . 23
8 Protection against excessive temperatures and other HAZARDS . 24
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS . 24
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS. 24
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 24
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT . 24
8.3.2 * Ingress of water or particulate matter into ME SYSTEMS . 24
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM . 25
8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 25
8.5.1 * Indication of state . 25
8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 26
9 Accuracy of controls and instruments and protection against hazardous outputs . 26
10 Construction of ME EQUIPMENT . 27
10.1 * Additional requirements for mechanical strength . 27
10.1.1 General requirements for mechanical strength . 27
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT . 28
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT . 29
10.2 * Additional requirements for an internal electrical power source .
10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 31
11 * Protection against strangulation or asphyxiation . 31
12 Additional requirements for electromagnetic compatibility ELECTROMAGNETIC
EMISSIONS of ME EQUIPMENT and ME SYSTEMS . 31
12.1 Emissions classification .
12.2 Protection of the PUBLIC MAINS NETWORK .
12.3 * Additional technical description requirements applicable to ME EQUIPMENT
and ME SYSTEMS .
12.4 * Additional requirements applicable to ME EQUIPMENT and ME SYSTEMS
specified for use only in a shielded location .
12.5 * Additional requirements for ELECTROSTATIC DISCHARGE (ESD) tests .
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 32
13.1 * Additional requirement for generation of ALARM SIGNALS . 32
13.2 * Additional requirement for ALARM SIGNAL volume . 33
Annex A (informative) General guidance and rationale . 34
A.1 General guidance . 34
A.2 Rationale for particular clauses and subclauses . 35
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 56
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 56
B.2 ACCOMPANYING DOCUMENTS, general . 56
B.3 ACCOMPANYING DOCUMENTS, instructions for use . 57
B.4 ACCOMPANYING DOCUMENTS, technical description . 58
Annex C (informative) Symbols on marking . 59
Bibliography . 61
Index of defined terms used in this collateral standard . 63
Figure 1 – Small finger probe Ø 5,6 . 18
Figure A.1 – Saturation water vapour pressure as function of temperature . 39
Table 1 – Mechanical strength test applicability, non-TRANSIT-OPERABLE . 27
Table 2 – Mechanical strength test applicability, TRANSIT-OPERABLE . 28
Table A.1 – Saturation water vapour pressure as function of temperature . 40
– 4 – IEC 60601-1-11:2015 RLV © IEC 2015
Table A.2 – Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
ENCLOSURE ingress of water and particulate matter requirements . 49
Table A.3 – Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT
subjected to shock and vibration . 50
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 56
Table B.2 – ACCOMPANYING DOCUMENTS, general . 56
Table B.3 – ACCOMPANYING DOCUMENTS, instructions for use . 57
Table B.4 – ACCOMPANYING DOCUMENTS, technical description . 58
Table C.1 – General symbols .
...
IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
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
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Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
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La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
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IEC 60601-1-11
Edition 2.0 2015-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040 ISBN 978-2-8322-2180-8
– 2 – IEC 60601-1-11:2015 © IEC 2015
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
1 Scope, object and related standards . 9
1.1 * Scope . 9
1.2 Object . 9
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 10
2 Normative references . 10
3 Terms and definitions . 11
4 General requirements . 12
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and
ME SYSTEMS . 12
4.2 * Environmental conditions for ME EQUIPMENT . 12
4.2.1 General . 12
4.2.2 * Environmental conditions of transport and storage between uses . 13
4.2.3 * Environmental operating conditions . 14
5 * General requirements for testing ME EQUIPMENT . 16
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 17
7 ME EQUIPMENT identification, marking and documents . 17
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 17
7.2 * Additional requirements for marking of IP classification . 18
7.3 ACCOMPANYING DOCUMENTS . 18
7.3.1 Contact information . 18
7.3.2 LAY OPERATOR briefing information . 18
7.4 Instructions for use . 19
7.4.1 Additional requirements for warning and safety notices . 19
7.4.2 * Additional requirements for an electrical power source . 19
7.4.3 Additional requirements for ME EQUIPMENT description . 20
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 20
7.4.5 Additional requirements for operating instructions . 20
7.4.6 Additional requirements for ME EQUIPMENT messages . 21
7.4.7 * Additional requirements for cleaning, disinfection and sterilization . 21
7.4.8 Additional requirements for maintenance . 21
7.4.9 Additional requirements for environmental protection . 21
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS . 22
7.5 Technical description . 22
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 22
7.5.2 Additional requirements for professional hygienic maintenance . 22
8 Protection against excessive temperatures and other HAZARDS . 22
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS . 22
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS. 23
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 23
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT . 23
8.3.2 * Ingress of water or particulate matter into ME SYSTEMS . 23
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM . 23
8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 24
8.5.1 * Indication of state . 24
8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 25
9 Accuracy of controls and instruments and protection against hazardous outputs . 25
10 Construction of ME EQUIPMENT . 25
10.1 * Additional requirements for mechanical strength . 25
10.1.1 General requirements for mechanical strength . 25
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT . 27
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT . 28
10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 29
11 * Protection against strangulation or asphyxiation . 30
12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and
ME SYSTEMS . 30
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 30
13.1 * Additional requirement for generation of ALARM SIGNALS . 30
13.2 * Additional requirement for ALARM SIGNAL volume . 30
Annex A (informative) General guidance and rationale . 31
A.1 General guidance . 31
A.2 Rationale for particular clauses and subclauses . 32
A
...
IEC 60601-1-11
Edition 2.1 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
IEC IEC 60601-1-11:2015-01+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 60601-1-11
Edition 2.1 2020-07
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.020.10; 11.040.01 ISBN 978-2-8322-8709-5
IEC 60601-1-11
Edition 2.1 2020-07
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 1-11: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances
essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux utilisés dans l’environnement des soins à
domicile
IEC IEC 60601-1-11:2015-01+AMD1:2020-07 CSV(en-fr)
– 2 – IEC 60601-1-11:2015+AMD1:2020 CSV
© IEC 2020
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
INTRODUCTION to Amendment 1 . 8
1 Scope, object and related standards . 10
1.1 * Scope . 10
1.2 Object . 10
1.3 Related standards . 10
1.3.1 IEC 60601-1 . 10
1.3.2 Particular standards . 11
2 Normative references . 11
3 Terms and definitions . 12
4 General requirements . 13
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and
ME SYSTEMS . 13
4.2 * Environmental conditions for ME EQUIPMENT . 14
4.2.1 General . 14
4.2.2 * Environmental conditions of transport and storage between uses . 14
4.2.3 * Environmental operating conditions . 15
5 * General requirements for testing ME EQUIPMENT . 18
6 * Classification of ME EQUIPMENT and ME SYSTEMS . 18
7 ME EQUIPMENT identification, marking and documents . 19
7.1 * USABILITY of the ACCOMPANYING DOCUMENTS . 19
7.2 * Additional requirements for marking of IP classification . 19
7.3 ACCOMPANYING DOCUMENTS . 20
7.3.1 Contact information . 20
7.3.2 LAY OPERATOR briefing information . 20
7.4 Instructions for use . 20
7.4.1 Additional requirements for warning and safety notices . 20
7.4.2 * Additional requirements for an electrical power source . 21
7.4.3 Additional requirements for ME EQUIPMENT description . 21
7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 21
7.4.5 Additional requirements for operating instructions . 22
7.4.6 Additional requirements for ME EQUIPMENT messages . 22
7.4.7 * Additional requirements for cleaning, disinfection and sterilization . 22
7.4.8 Additional requirements for maintenance . 23
7.4.9 Additional requirements for environmental protection . 23
7.4.10 Additional requirements for ME EQUIPMENT and ME SYSTEMS . 23
7.5 Technical description . 23
7.5.1 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 23
7.5.2 Additional requirements for professional hygienic maintenance . 24
8 Protection against excessive temperatures and other HAZARDS . 24
8.1 * Additional requirements for cleaning, disinfection of ME EQUIPMENT and
ME SYSTEMS . 24
8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS. 24
8.3 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 24
© IEC 2020
8.3.1 * Ingress of water or particulate matter into ME EQUIPMENT . 24
8.3.2 * Ingress of water or particulate matter into ME SYSTEMS . 25
8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT and ME SYSTEM . 25
8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE . 26
8.5.1 * Indication of state . 26
8.5.2 Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 26
8.5.3 * Additional requirements for separation of parts . 26
9 Accuracy of controls and instruments and protection against hazardous outputs . 27
10 Construction of ME EQUIPMENT . 27
10.1 * Additional requirements for mechanical strength . 27
10.1.1 General requirements for mechanical strength . 27
10.1.2 * Requirements for mechanical strength for non-TRANSIT-OPERABLE
ME EQUIPMENT . 29
10.1.3 * Requirements for mechanical strength for TRANSIT-OPERABLE
ME EQUIPMENT . 30
10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT . 31
11 * Protection against strangulation or asphyxiation . 32
12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and
ME SYSTEMS . 32
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 32
13.1 * Additional requirement for generation of ALARM SIGNALS .
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