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.

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.

General Information

Status
Published
Publication Date
16-Jan-2020
Current Stage
PPUB - Publication issued
Completion Date
17-Jan-2020
Ref Project

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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
IEC 60601-2-31:2020-01(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

---------------------- Page: 5 ----------------------
– 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.

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any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

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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.

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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 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;
---------------------- Page: 6 ----------------------
IEC 60601-2-31:2020 © IEC 2020 – 5 –

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 rationale for all changes.

The text of this International Standard is based on the following documents of IEC:

FDIS Report on voting
62D/1719/FDIS 62D/1732A/RVD

Full information on the voting for the approval of this International Standard can be found in the

report on voting indicated in the above table. In ISO, the standard has been approved by 10

P members out of 10 having cast a vote.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, 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 document, 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 document are preceded by the term "Clause" followed by the

clause number. References to subclauses within this particular standard are by number only.

In this document, 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 document conform to usage described in Clause 7 of the ISO/IEC

Directives, Part 2. For the purposes of this document, the auxiliary verb:

– "shall" means that compliance with a requirement or a test is mandatory for compliance with

this document;

– "should" means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this document;

– "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.
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-2-31:2020 © IEC 2020

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC publication in

which to make products in accordance with the new requirements and to equip themselves for conducting new or

revised tests. It is the recommendation of the committee that the content of this publication be adopted for

implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

---------------------- Page: 8 ----------------------
IEC 60601-2-31:2020 © IEC 2020 – 7 –
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 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 developing

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 60601-1:2005 and

IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements

for basic safety and essential performance, hereinafter referred to as the general standard.

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 this particular standard but will, in due course, expedite any revision necessitated

by changes in clinical practice or as a result of developments in technology. However, Annex AA

does not form part of the requirements of this document.
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-2-31:2020 © IEC 2020
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
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:

This part of IEC 60601 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.
NOTE See also 4.2 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.
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 201.3.205.
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 201.2 of this particular standard.
___________

The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance.
---------------------- Page: 10 ----------------------
IEC 60601-2-31:2020 © IEC 2020 – 9 –

IEC 60601-1-2:2014 applies as modified in Clause 202. IEC 60601-1-3 does not apply. All other

published collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in the general standard and collateral standards as appropriate for the particular

ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
requirements.
PERFORMANCE
A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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 IEC 60601-1-2 collateral standard, 203.4 in

this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral

standard, etc.). The changes to the text of the general standard and applicable collateral

standards 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, figures or tables which are additional to those of the general standard are

numbered starting from 201.101. However, due to the fact that definitions in the general

standard are numbered 3.1 through 3.147, additional definitions in this document are numbered

beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items

aa), bb), etc.

Subclauses, figures or tables 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 document" 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.
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-2-31:2020 © IEC 2020
201.2 Normative references
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
IEC 60601-1-2:201
...

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