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

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.

Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit interner 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

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.

Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom (IEC 60601-2-31:2008)

General Information

• Status: Withdrawn
• Publication Date: 24-Jul-2008
• Withdrawal Date: 31-May-2011
• 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
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Apr-2023
• Completion Date: 03-Apr-2023
• 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 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

Relations

• Replaces: EN 60601-2-31:1995 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-31:1995/A1:1998 - Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
• Effective Date: 29-Jan-2023
• Replaced By: 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
• Effective Date: 07-Apr-2020
• Amended By: 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: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2008
1DGRPHãþD
SIST EN 60601-2-31:1995
SIST EN 60601-2-31:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]XQDQMLKVUþQLKVSRGEXMHYDOQLNRY]YJUDMHQLPQDSDMDOQLPYLURP
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Medical electrical equipment - Part 2-31: Particular requirements for basic safety and
essential performance of external cardiac pacemakers with internal power source (IEC
60601-2-31:2008)
Medizinische elektrische Geräte - Teil 2-31: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von externen Schrittmachern mit
interner Stromversorgung (IEC 60601-2-31:2008)
Appareils électromédicaux - Partie 2-31: Regles particulieres de sécurité de base et de
performances essentielles des stimulateurs cardiaques externes a source d'énergie
interne (CEI 60601-2-31:2008)
Ta slovenski standard je istoveten z: EN 60601-2-31:2008
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 60601-2-31
NORME EUROPÉENNE
July 2008
EUROPÄISCHE NORM
ICS 11.040.01 Supersedes EN 60601-2-31:1995 + A1:1998

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 60601-2-31:2008)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-31: Exigences particulières Teil 2-31: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des stimulateurs cardiaques externes von externen Schrittmachern
à source d'énergie interne mit interner Stromversorgung
(CEI 60601-2-31:2008) (IEC 60601-2-31:2008)

This European Standard was approved by CENELEC on 2008-06-01. 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 Central Secretariat 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-31:2008 E
Foreword
The text of document 62D/603/CDV, future edition 2 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 was approved by CENELEC as EN 60601-2-31 on 2008-06-01.
This European Standard supersedes EN 60601-2-31:1995 + A1:1998.
EN 60601-2-31:1995.
The following dates were fixed:

– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2009-03-01
national standard or by endorsement

– latest date by which the national standards conflicting
(dow) 2011-06-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
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 are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
– “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that
there is guidance or rationale related to that item in Annex AA.
Annexes ZA and ZZ have been added by CENELEC.
__________
- 3 - EN 60601-2-31:2008
Endorsement notice
The text of the International Standard IEC 60601-2-31:2008 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 60086-1 NOTE  Harmonized as EN 60086-1:2007 (not modified).
IEC 60086-2 NOTE  Harmonized as EN 60086-2:2007 (not modified).
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

Replacement in Annex ZA of EN 60601-1:2006:
Publication Year Title EN/HD Year

IEC 60601-1-2 2007 Medical electrical equipment - EN 60601-1-2 2007
(mod) Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
Addition to Annex ZA of EN 60601-1:2006:
Publication Year Title EN/HD Year

ISO 14708-2 2005 Implants for surgery - Active implantable - -
medical devices -
Part 2: Cardiac pacemakers
ANSI/AAMI PC69 2007 Active implantable medical devices - - -
Electromagnetic compatibility - EMC test
protocols for implantable cardiac pacemakers
and implantable cardioverter defibrillators

__________
- 5 - EN 60601-2-31:2008
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
__________
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
...