EN 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 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. 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.

Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Herzschrittmachern mit geräteeigener Stromversorgung

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

IEC 60601-2-31:2020 est disponible sous forme de IEC 60601-2-31:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente. 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.

Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom (IEC 60601-2-31:2020)

General Information

• Status: Published
• Publication Date: 02-Apr-2020
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-Apr-2020
• Completion Date: 03-Apr-2020
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 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)

Relations

• Replaces: EN 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: 07-Apr-2020
• Replaces: EN 60601-2-31:2008/A1:2011 - 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: 07-Apr-2020
• Revised: prEN IEC 80601-2-31:2024 - 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: 20-Dec-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2020
Nadomešča:
SIST EN 60601-2-31:2008
SIST EN 60601-2-31:2008/A1:2011
Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom
(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)
Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit
interner Stromversorgung (IEC 60601-2-31:2020)
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 (IEC 60601-2-31:2020)
Ta slovenski standard je istoveten z: EN IEC 60601-2-31:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-31

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2020
ICS 11.040.01 Supersedes EN 60601-2-31:2008 and all of its
amendments and corrigenda (if any)
English Version
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)
Appareils électromédicaux - Partie 2-31: Exigences Medizinische elektrische Geräte - Teil 2-31: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des stimulateurs cardiaques externes à source wesentlichen Leistungsmerkmale von externen
d'énergie interne Schrittmachern mit interner Stromversorgung
(IEC 60601-2-31:2020) (IEC 60601-2-31:2020)
This European Standard was approved by CENELEC on 2020-01-01. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-31:2020 E

European foreword
The text of document 62D/1719/FDIS, future edition 3 of IEC 60601-2-31, prepared by SC 62D
"Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-31:2020.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2020-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-04-03
document have to be withdrawn
This document supersedes EN 60601-2-31:2008 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60601-2-31:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60086-2:2015 NOTE Harmonized as EN 60086-2:2016 (not modified)
IEC 61000-4-2:2008 NOTE Harmonized as EN 61000-4-2:2009 (not modified)
IEC 60086-1:2015 NOTE Harmonized as EN 60086-1:2015 (not modified)
IEC 60601-2-4:2010 NOTE Harmonized as EN 60601-2-4:2011 (not modified)

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
The annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replace
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
Addition
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
+A12 2014
+EN 60601-2010
1:2006/corrigendum
Mar. 2010
+AC 2014
+A11 2011
ISO 14117 2019 Active implantable medical devices – - -
Electromagnetic compatibility – EMC test
protocols for implantable cardiac
pacemakers, implantable cardioverter
defibrillators and cardiac resynchronization
devices
ISO 14708-2 2019 Implants for surgery – Active implantable - -
medical devices – Part 2: Cardiac
pacemakers
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

IEC 60601-2-31:2020 © IEC 2020 – 3 –
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
...