IEC 60601-2-31:2020

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT. IEC 60601-2-31:2020 cancels and replaces the second edition published in 2008 and Amendment 1:2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) The requirement for testing for energy reduction has been removed;
b) The test for exposure to external defibrillation has been completely revised;
c) The exclusion for testing ESD immunity only with respect to air discharges has been removed;
d) Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;
e) Additional rationale for all changes.

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

L'IEC 60601-2-31:2020 s’applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des STIMULATEURS EXTERNES alimentés par une SOURCE D’ENERGIE ELECTRIQUE INTERNE désignés ci-après sous le terme APPAREILS EM. Le présent document s'applique aux CABLES PATIENT tels qu’ils sont définis en 201.3.209, mais ne s’applique pas aux DERIVATIONS telles qu’elles sont définies en 201.3.206. Les DANGERS inhérents à la fonction physiologique prévue de l'APPAREIL 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 7.2.13 et de 8.4.1 de la norme générale. Le présent document ne s'applique pas aux parties implantables des DISPOSITIFS MEDICAUX IMPLANTABLES ACTIFS traités par l’ISO 14708-1. Le présent document ne s'applique pas aux stimulateurs externes qui peuvent être connectés directement ou indirectement au RESEAU D’ALIMENTATION. Le présent document ne s’applique pas aux APPAREILS EM de stimulation transthoracique et œsophagienne ni aux APPAREILS EM pour la tachycardie. L'IEC 60601-2-31:2020 annule et remplace la deuxième édition parue en 2008 et l'Amendement 1:2011. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) L’exigence concernant l’essai de réduction d’énergie a été supprimée;
b) L’essai d’exposition à la défibrillation externe a été entièrement révisé;
c) L’exclusion des essais d'immunité aux DES uniquement relatives aux décharges dans l’air a été supprimée;
d) Alignement sur la version la plus récente de l’ISO 14708-2 pour les stimulateurs cardiaques, ainsi que sur la norme ISO 14117 associée relative à la CEM;
e) Justifications supplémentaires pour toutes les modifications.

General Information

• Status: Published
• Publication Date: 16-Jan-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 3 - TC 62/SC 62D/JWG 3
• Current Stage: PPUB - Publication issued
• Start Date: 03-Jan-2020
• Completion Date: 17-Jan-2020

Relations

• Revises: IEC 60601-2-31:2008/AMD1:2011 - Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-31:2008 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-31
Edition 3.0 2020-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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

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.: [phone]
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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 corrigendum or an amendment might have been published.

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IEC 60601-2-31
Edition 3.0 2020-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-7781-2

– 2 – IEC 60601-2-31:2020 RLV © IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 * Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 30
201.15 Construction of ME EQUIPMENT . 30
201.16 ME SYSTEMS . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 * ELECTROMAGNETIC compatibility DISTURBANCES – Requirements and tests . 30
Annexes . 33
Annex I Identification of IMMUNITY pass/fail criteria . 33
Annex AA (informative) Particular guidance and rationale . 34
Bibliography . 55
Index of defined terms used in this particular standard . 56

Figure 201.101 – Test waveform V implemented by example RCL circuit
test
, L = 25 µH, RL + R = 1 Ω . 18
using C = 120 µF
Figure 201.102 – Example circuit of defibrillation test voltage generator for generating
a decaying exponential waveform . 19
Figure 201.103 – Test setup for a SINGLE CHAMBER external CARDIAC PACEMAKER . 20
Figure 201.104 – Test setup for a DUAL CHAMBER external CARDIAC PACEMAKER . 20
Figure 201.105 – Test setup for a triple chamber external CARDIAC PACEMAKER, e.g. bi-
ventricular external CARDIAC PACEMAKER . 21
Figure 201.106 – Timing sequence . 21
Figure 201.101107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE . 23
Figure 201.102108 – Measuring circuit for the MAXIMUM TRACKING RATE . 27
Figure 201.103109 – Initial oscilloscope display when measuring MAXIMUM TRACKING
RATE . 28
Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during
defibrillation . 41

Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL
PACEMAKER . 44
Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according

to conditions during open heart surgery . 45
Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from
Figure AA.3 . 46
Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in
Figure AA.3 . 50

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – DUAL CHAMBER connector terminal marking. 14
Table 201.103 – Measurement method accuracy ME EQUIPMENT parameters . 25
Table 202.101 – Static discharge requirements . 31
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 35
Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % . 47
Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % . 48
Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % . 49

– 4 – IEC 60601-2-31:2020 RLV © IEC 2020
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.
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change has
been made. Additions are in green text, deletions are in strikethrough red text.

International standard IEC 60601-2-31 has been prepared by a Joint Working Group of IEC
subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical
equipment in medical practice, and ISO subcommittee SC6: Active implants, of ISO technical
committee 150: Implants for surgery.
This publication is published as a double logo standard.
This third edition cancels and replaces the second edition published in 2008 and
Amendment 1:2011. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
The requirement for testing for energy reduction has been removed;
The test for exposure to external defibrillation has been completely revised;
The exclusion for testing ESD immunity only with respect to air discharges has been
removed;
Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated
EMC standard ISO 14117;
Additional rat
...

IEC 60601-2-31
Edition 3.0 2020-01
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
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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
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.
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Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
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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.

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IEC 60601-2-31
Edition 3.0 2020-01
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
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-7671-6

– 2 – IEC 60601-2-31:2020 © IEC 2020
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 * Terms and definitions . 10
201.4 General requirements . 12
201.5 General requirements for testing ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents . 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 23
201.10 Protection against unwanted and excessive radiation HAZARDS . 23
201.11 Protection against excessive temperatures and other HAZARDS . 23
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 24
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS . 29
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 29
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 29
Annexes . 31
Annex I Identification of IMMUNITY pass/fail criteria . 31
Annex AA (informative) Particular guidance and rationale . 32
Bibliography . 52
Index of defined terms used in this particular standard . 53

Figure 201.101 – Test waveform V implemented by example RCL circuit using
test
, L = 25 µH, RL + R = 1 Ω . 18
C = 120 µF
Figure 201.102 – Example circuit of defibrillation test voltage generator for generating
a decaying exponential waveform . 19
Figure 201.103 – Test setup for a SINGLE CHAMBER external CARDIAC PACEMAKER . 20
Figure 201.104 – Test setup for a DUAL CHAMBER external CARDIAC PACEMAKER . 20
Figure 201.105 – Test setup for a triple chamber external CARDIAC PACEMAKER, e.g. bi-
ventricular external CARDIAC PACEMAKER . 21
Figure 201.106 – Timing sequence . 21
Figure 201.107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE . 23
Figure 201.108 – Measuring circuit for the MAXIMUM TRACKING RATE . 26
Figure 201.109 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE . 27
Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during
defibrillation . 39

Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL
PACEMAKER . 41
Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according

to conditions during open heart surgery . 42
Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from
Figure AA.3 . 43
Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in
Figure AA.3 . 47

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – DUAL CHAMBER connector terminal marking. 14
Table 201.103 – ME EQUIPMENT parameters . 25
Table 202.101 – Static discharge requirements . 30
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 33
Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % . 44
Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % . 45
Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % . 46

– 4 – IEC 60601-2-31:2020 © IEC 2020
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 t
...