IEC 60601-2-31:2008
(Main)Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
IEC 60601-2-31:2008 applies to the basic safety and essential performance of external pacemakers powered by an internal electrical power source. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of external cardiac pacemakers with an internal power source. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This second edition cancels and replaces the first edition published in 1994 and its Amendment 1 (1998). This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains minimal technical revisions from the first edition.
Appareils électromédicaux - Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne
La CEI 60601-2-31:2008 s'applique à la sécurité de base et aux performances essentielles des stimulateurs externes alimentés par une source d'énergie électrique interne. Les exigences minimales de sécurité spécifiées dans la présente norme particulière sont considérées comme assurant un degré pratique de sécurité dans le fonctionnement des stimulateurs cardiaques externes à source d'énergie interne. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette deuxième édition annule et remplace la première édition publiée en 1994 et son Amendement 1 (1998). Cette deuxième édition de la CEI 60601-2-31 est structurée selon la CEI 60601-1:2005 et apporte des modifications techniques mineures par rapport à la première édition.
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IEC 60601-2-31
Edition 2.0 2008-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential performance
of external cardiac pacemakers with internal power source
Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs cardiaques externes à source d'énergie interne
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
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et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur.
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publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
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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
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latest edition, a corrigenda or an amendment might have been published.
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normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
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définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
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IEC 60601-2-31
Edition 2.0 2008-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les
performances essentielles des stimulateurs cardiaques externes à source
d'énergie interne
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.01 ISBN 2-8318-9665-7
– 2 – 60601-2-31 © IEC:2008
CONTENTS
FOREWORD.3
INTRODUCTION.6
201.1 Scope, object and related standards .7
201.2 Normative references.8
201.3 Terms and definitions.9
201.4 General requirements.10
201.5 General requirements for testing ME EQUIPMENT.11
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .11
201.7 ME EQUIPMENT identification, marking and documents.11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.16
201.10 Protection against unwanted and excessive radiation HAZARDS.16
201.11 Protection against excessive temperatures and other HAZARDS.16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.17
201.13 HAZARDOUS SITUATIONS and fault conditions.21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .21
201.15 Construction of ME EQUIPMENT .21
201.16 ME SYSTEMS .21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21
202 Electromagnetic compatibility – Requirements and tests .21
Annexes .23
Annex AA (informative) Particular guidance and rationale.24
Bibliography.34
Index of defined terms used in this particular standard.35
Figure 201.101 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE.16
Figure 201.102 – Measuring circuit for the MAXIMUM TRACKING RATE .19
Figure 201.103 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE .19
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements .11
Table 201.102 – DUAL CHAMBER connector terminal marking .12
Table 201.103 – Measurement method accuracy .18
Table 202.101 – Static discharge requirements.22
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory .25
60601-2-31 © IEC:2008 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with
internal power source
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-31 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition published in 1994 and its
Amendment 1 (1998). This edition constitutes a technical revision.
This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains
minimal technical revisions from the first edition.
– 4 – 60601-2-31 © IEC:2008
The text of this particular standard is based on the following documents:
Enquiry draft Report on voting
62D/603/CDV 62D/667/RVC
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this collateral standard
...
IEC 60601-2-31 ®
Edition 2.1 2011-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential performance
of external cardiac pacemakers with internal power source
Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs cardiaques externes à source d'énergie interne
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 la CEI ou du Comité national de la CEI du pays du demandeur.
Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette
publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence.
IEC Central Office
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Email: inmail@iec.ch
Web: 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.
Catalogue of IEC publications: www.iec.ch/searchpub
The IEC on-line Catalogue enables you to search by a variety of criteria (reference number, text, technical committee,…).
It also gives information on projects, withdrawn and replaced publications.
IEC Just Published: www.iec.ch/online_news/justpub
Stay up to date on all new IEC publications. Just Published details twice a month all new publications released. Available
on-line and also by email.
Electropedia: www.electropedia.org
The world's leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions
in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical
Vocabulary online.
Customer Service Centre: www.iec.ch/webstore/custserv
If you wish to give us your feedback on this publication or need further assistance, please visit the Customer Service
Centre FAQ or contact us:
Email: csc@iec.ch
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
A propos de la CEI
La Commission Electrotechnique Internationale (CEI) 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 CEI
Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez
l’édition la plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue des publications de la CEI: www.iec.ch/searchpub/cur_fut-f.htm
Le Catalogue en-ligne de la CEI vous permet d’effectuer des recherches en utilisant différents critères (numéro de référence,
texte, comité d’études,…). Il donne aussi des informations sur les projets et les publications retirées ou remplacées.
Just Published CEI: www.iec.ch/online_news/justpub
Restez informé sur les nouvelles publications de la CEI. Just Published détaille deux fois par mois les nouvelles
publications parues. Disponible en-ligne et aussi par email.
Electropedia: www.electropedia.org
Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de 20 000 termes et
définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé
Vocabulaire Electrotechnique International en ligne.
Service Clients: www.iec.ch/webstore/custserv/custserv_entry-f.htm
Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions, visitez le FAQ du
Service clients ou contactez-nous:
Email: csc@iec.ch
Tél.: +41 22 919 02 11
Fax: +41 22 919 03 00
IEC 60601-2-31 ®
Edition 2.1 2011-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-31: Particular requirements for the basic safety and essential performance
of external cardiac pacemakers with internal power source
Appareils électromédicaux –
Partie 2-31: Exigences particulières pour la sécurité de base et les performances
essentielles des stimulateurs cardiaques externes à source d'énergie interne
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CP
CODE PRIX
ICS 11.040.01 ISBN 978-2-88912-612-5
– 2 – 60601-2-31 IEC:2008+A1:2011
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
Annexes . 25
Annex AA (informative) Particular guidance and rationale . 26
Bibliography . 36
Index of defined terms used in this particular standard . 37
Figure 201.101 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE . 18
Figure 201.102 – Measuring circuit for the MAXIMUM TRACKING RATE . 21
Figure 201.103 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE . 21
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – DUAL CHAMBER connector terminal marking . 13
Table 201.103 – Measurement method accuracy . 20
Table 202.101 – Static discharge requirements . 24
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 27
60601-2-31 IEC:2008+A1:2011 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with
internal power source
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of IEC 60601-2-31 consists of the second edition (2008)
[documents 62D/603/CDV and 62D/667/RVC] and its amendment 1 (2011) [documents
62D/918/FDIS and 62D/931/RVD]. It bears the edition number 2.1.
The technical content is therefore identical to the base edition and its amendment and
has been prepared for user convenience. A vertical line in the margin shows where the
base publication has been modified by amendment 1. Additions and deletions are
displayed in red, with deletions being struck through.
– 4 – 60601-2-31 IEC:2008+A1:2011
International standard IEC 60601-2-31 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains
minimal technical revisions from the first edition.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clau
...
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