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

This International Standard 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 standard applies to PATIENT CABLES as defined in 201.3. 109. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

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• Status: Withdrawn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: 22-Sep-2008
• Withdrawal Date: 10-Apr-2023
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 11-Apr-2023
• Due Date: 04-May-2023
• Completion Date: 11-Apr-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: 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

• Replaced By: 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)
• Effective Date: 07-Apr-2020
• Replaces: SIST 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: 01-Nov-2008
• Replaces: SIST 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: 01-Nov-2008
• Amended By: SIST 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
• Amended By: SIST 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-Jun-2022
• Revised: SIST 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: 03-Sep-2010
• Revised: SIST 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: 07-Jun-2011
• Revised: SIST 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: 07-Jun-2011
• Replaces: SIST 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
• Replaces: SIST 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
• Revised: 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)
• Effective Date: 16-Aug-2016
• Replaces: SIST 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: 07-Jun-2022
• Replaces: SIST 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: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-31:2008
01-november-2008
1DGRPHãþD
SIST EN 60601-2-31:1995
SIST EN 60601-2-31:1995/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL]XQDQMLKVUþQLKVSRGEXMHYDOQLNRY]YJUDMHQLPQDSDMDOQLPYLURP
,(&
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
SIST EN 60601-2-31:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-31:2008

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SIST EN 60601-2-31:2008

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

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SIST EN 60601-2-31:2008
EN 60601-2-31:2008 - 2 -
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 60601-2-31:2008 is aligned with EN 60601-1:2006, and contains minimal technical revisions from
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.
__________

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SIST EN 60601-2-31:2008
- 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).
__________

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SIST EN 60601-2-31:2008
EN 60601-2-31:2008 - 4 -

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

__________

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SIST EN 60601-2-31:2008
- 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.
__________

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SIST EN 60601-2-31:2008

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SIST EN 60601-2-31:2008
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

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SIST EN 60601-2-31:2008
– 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

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SIST EN 60601-2-31:2008
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.

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SIST EN 60601-2-31:2008
– 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 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.
A list of all parts of the IEC 60601 series, published under the general title Medical electrical
equipment, can be found on the IEC website.

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SIST EN 60601-2-31:2008
60601-2-31 © IEC:2008 – 5 –
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 60601-2-31:2008
– 6 – 60601-2-31 © IEC:2008
INTRODUCTION
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.
Basically, CARDIAC PACEMAKERS treat cardiac arrhythmias. Such arrhythmias reduce cardiac
output and can lead to confusion, dizziness, loss of consciousness and death. The objective
of pacing is to restore cardiac rhythm and output appropriate to the PATIENT's physiological
needs.
There are two distinct families of CARDIAC PACEMAKERS, IMPLANTABLE PACEMAKERS and
EXTERNAL PACEMAKERS. EXTERNAL PACEMAKERS are used to pace PATIENTS temporarily prior to
implanting an IMPLANTABLE PACEMAKER as well as for temporary pacing related to other
medical procedures, e.g. open heart surgery.
CARDIAC PACEMAKERS differ in the various ways in which they maintain and monitor cardiac
activity in different circumstances. The simplest model stimulates the atrium or ventricle
independently of the cardiac activity; others detect atrial or ventricular activity and stimulate
the atrium or ventricle as and when this is necessary; others, more complex, detect the
spontaneous heart activity and stimulate appropriately the atrium and/or the ventricle. Certain
PACEMAKERS work on preset frequency values, amplitudes and impulse duration. Others can
have several values for parameters.
Standards for EXTERNAL PACEMAKERS require attention to information which will aid in selecting
and applying these devices. It is through these aspects of standardization that the central role
of clinical experience should be, or has been, acknowledged. The ability to predict how a
pacemaker will perform in a specific patient based on testing of a device to a set of technical
criteria is limited.
This particular standard does not take into consideration the specific safety aspects of
EXTERNAL PACEMAKERS that are connected to a SUPPLY MAINS while simultaneously connected
to the PATIENT.
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, hereinafter referred to as the general standard (see 1.4).
The requirements are followed by specifications for the relevant tests.
Following the decision taken by subcommittee 62D at the meeting in Washington in 1979, a
"General guidance and rationale" section giving some explanatory notes, where appropriate,
about the more important requirements is included in Annex AA.
Clauses or subclauses for which there are explanatory notes in Annex AA are marked with an
asterisk (*).
An inventory of the PATIENT's safety posed by EXTERNAL PACEMAKERS and a rationale for the
safety requirements contained in this particular standard are given in Annex AA. It is
considered that knowledge of the reasons for these requirements will not only facilitate the
proper application of the standard but will, in due course, expedite any revision necessitated
by changes in clinical practice or as a result of developments in technology. However, this
annex does not form part of the requirements of this standard.

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SIST EN 60601-2-31:2008
60601-2-31 © IEC:2008 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –

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



201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
BASIC SAFETY and ESSENTIAL PERFORMANCE of
This International Standard applies to the
EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred
to as ME EQUIPMENT.
This standard applies to PATIENT CABLES as defined in 201.3. 109.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of
this standard are not covered by specific requirements in this standard except in 7.2.13 and
8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard does not apply to the implantable parts of active implantable medical devices
covered by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be
connected directly or indirectly to a SUPPLY MAINS.
This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and
antitachycardia ME EQUIPMENT.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for EXTERNAL PACEMAKERS AS DEFINED IN 201.3. 103.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in
Clause 2 of the general standard and Clause 2 of this particular standard.
—————————
1)
The general standard is IEC 60601-1:2005.

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SIST EN 60601-2-31:2008
– 8 – 60601-2-31 © IEC:2008
IEC 60601-1-3 does not apply.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in e general as appropriate for the particular ME EQUIPMENT under consideration,
and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this particular standard corresponds to that of
the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content
of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x”
where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this
particular standard addresses the content of Clause 4 of the 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 60601-1-3 collateral
standard, etc.). The changes to the text of the general standard are specified by the use of
the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of the general standard are numbered
starting from 201.101, additional annexes are lettered AA, BB, etc., and additional items aa),
bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered
starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-
1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Replacement:

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SIST EN 60601-2-31:2008
60601-2-31 © IEC:2008 – 9 –
IEC 60601-1-2:2007, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic compatibility -
Requirements and tests
Addition:
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
NOTE Informative references are listed in the bibliography on page 34.
201.3 * Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
ISO 14708-2:2005 apply, except as follows:
NOTE An index of defined terms is found beginning on page 35.
Addition:
201.3.101
ACTIVE IMPLANTABLE MEDICAL DEVICE
active medical device which is intended to be totally or partially introduced, surgically or
medically, into the human body or by medical intervention into a natural orifice, and which is
intended to remain in place after the procedure
[ISO 14708-1:2000, definition 3.3
...