IEC 60601-2-31:2008
(Main)Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
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.
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.
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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
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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,
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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
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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.
– 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.
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.
– 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.
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.
– 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:
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]
201.3.102
BATTERY DEPLETION INDICATOR
means of indicating when the battery should be replaced
201.3.103
CARDIAC PACEMAKER
ME EQUIPMENT intended to treat bradyarrhythmias
201.3.104
DUAL CHAMBER
relating to both atrium and ventricle
201.3.105
EXTERNAL PACEMAKER
CARDIAC PACEMAKER with a NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE(S) (if used)
201.3.106
LEAD
flexible tube enclosing one or more insulated electrical conductors, intended to transfer
electrical energy along its length between the EXTERNAL PACEMAKER and the patient's heart
[ISO 14708-1:2000, definition 3.5 modified]
– 10 – 60601-2-31 © IEC:2008
201.3.107
MAXIMUM TRACKING RATE
maximum PULSE RATE at which the IMPLANTABLE PULSE GENERATOR will respond on a 1:1 basis
to a triggering signal
[ISO 14708-2:2005, definition 3.3.18]
201.3.108
NON-IMPLANTABLE PULSE GENERATOR
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE which is intended for use outside
the body and which produces a periodic electrical pulse intended to stimulate the heart
through a LEAD (or combination of a LEAD and PATIENT CABLE)
201.3.109
PATIENT CABLE
cable used to extend the distance between the NON-IMPLANTABLE PULSE GENERATOR and the
pacing LEAD
201.3.110
POST-VENTRICULAR ATRIAL REFRACTORY PERIOD
PVARP
atrial refractory period minus the AV delay
201.3.111
PRIMARY BATTERY
one or more cells, which are not designed to be electrically recharged, that are fitted with
devices necessary for use, for example case, terminals, marking and protective devices
[IEC 60050-482:2004, definition 482-01-04 modified]
201.3.112
SINGLE CHAMBER
relating to either atrium or ventricle
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMACNE requirements are found in the subclauses listed in
Table 201.101.
60601-2-31 © IEC:2008 – 11 –
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
BATTERY DEPLETION INDICATOR 201.11.8
ME EQUIPMENT parameter stability 201.12.1.101
PULSE AMPLITUDE stability 201.12.1.102
Disarming runaway rate protection 201.12.4.1
Deliberate action required to change settings 201.12.4.101
Parameter stability at onset of the BATTER DEPLETION INDICATOR 201.12.4.102
Runaway protection 201.12.4.103
Interference reversion in the presence of sensed electrical interference 201.12.4.104
Limit at which the ventricle is paced in response to sensed atrial activity 201.12.4.105
201.4.10.1 Source of power for ME EQUIPMENT
Replacement:
ME EQUIPMENT shall be powered by a PRIMARY BATTERY.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
ME EQUIPMENT and ME SYSTEMS
201.4.10.2 Supply mains for
This subclause of the general standard does not apply.
201.4.11 * Power input
This subclause of the general standard does not apply.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Replacement:
ME EQUIPMENT shall be classified as INTERNALLY POWERED ME EQUIPMENT.
ME EQUIPMENT shall be recognized as INTERNALLY POWERED only if no external connections to
an electrical power source are provided.
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS. APPLIED PARTS shall be classified
as DEFIBRILLATION-PROOF APPLIED PARTS.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
– 12 – 60601-2-31 © IEC:2008
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclauses:
201.7.2.101 ME EQUIPMENT intended for SINGLE CHAMBER application
If the ME EQUIPMENT is intended for SINGLE CHAMBER applications, the connector terminals (if
used) shall be conspicuously marked positive (+) and negative (–).
201.7.2.102 * ME EQUIPMENT intended for DUAL CHAMBER application
If the ME EQUIPMENT is intended for DUAL CHAMBER application, the connector terminals (if
used) shall be marked according to Table 201.102. If colour is used to differentiate between
channels in a DUAL CHAMBER application, then the ventricular channel should be marked with
the colour white and the atrial channel should be marked with a contrasting colour.
Table 201.102 – DUAL CHAMBER connector terminal marking
Symbol
Channel Terminal label
Positive terminal Negative terminal
Atrial channel A+ A– ATRIUM
Ventricular channel V+ V– VENTRICLE
201.7.2.103 Bipolar connectors
When bipolar connectors are used, they shall have keyways that prevent inadvertent polarity
reversal.
201.7.2.104 * Battery compartment
The means of access to the battery compartment shall be easily identifiable. The battery
compartment shall be clearly and permanently marked with the IEC battery nomenclature, the
voltage and type. The battery compartment shall be clearly and permanently marked to show
the correct orientation of the battery or batteries.
201.7.4 Marking of controls and instruments
Additional subclauses:
201.7.4.101 * Control or indicator for pacing output
If constant current output is used, the control for selecting pacing output or the relevant
indicating means shall be marked in terms of current in milliamperes (mA) through a resistive
load of 500 Ω ± 1 %. If a constant voltage output is used, the pacing output or the relevant
indicating means shall be marked in terms of volts (V) across a resistive load of 500 Ω ± 1 %.
PULSE RATE
201.7.4.102 * Control or indicator for
The control for selecting PULSE RATE or the relevant indicating means shall be marked in terms
of reciprocal minutes.
201.7.4.103 * Control for selecting pacing mode
If a means of selecting the pacing mode is provided, the ME EQUIPMENT shall indicate, as well
as the mode selected, the possible pacing modes using the codes described in Annex DD of
ISO 14708-2:2005.
60601-2-31 © IEC:2008 – 13 –
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2.2 * Warning and safety notices
Replacement:
The instructions for use shall include all warning and safety notices.
NOTE General warnings and safety notices should be placed in a specifically identified section of the instructions
for use. A warning or safety notice that applies only to a specific instruction or action should precede the
instruction to which it applies.
The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with
warnings regarding any significant RISKS of reciprocal interference posed by the presence of
the ME EQUIPMENT during specific investigations or treatments.
The instructions for use shall include the following:
aa) * Warnings regarding potential changes in the behaviour of the pulse generator caused
by electromagnetic or other interference sources (e.g. communication transmitters in
hospitals, emergency transport vehicles, cellular telephones, etc.) and the effects of
therapeutic and diagnostic energy sources (e.g. external cardioversion, diathermy,
transcutaneous electrical nerve stimulators [TENS] devices, high-frequency surgical
equipment, magnetic resonance imaging or similar sources) on the pulse generator. This
shall include advice on recognizing when the behaviour of the pulse generator is being
influenced by external interference sources and steps to be taken to avoid such
interference.
bb) * A warning about the danger of inadvertently introducing leakage current into the heart
if supply mains-operated equipment is connected to the lead system.
cc) * A warning that the patient cable shall be connected to the non-implantable pulse
generator before the pacing leads are connected to the patient cable.
dd) * A warning that when handling indwelling leads, the terminal pins or exposed metal are
not to be touched nor be allowed to contact electrically conductive or wet surfaces.
ee) * A warning regarding the HAZARDS of using PRIMARY BATTERIES other than those
recommended by the manufacturer (for example, short battery life after the indication of
low battery condition, degraded ME EQUIPMENT performance, overall reduced battery life,
and erratic or no pacing).
ff) * A warning that, before handling the external pulse generator, the patient cable or
indwelling leads, steps shall be taken to equalize the electrostatic potential between the
user and the patient, for example by touching the patient at a site remote from the
pacing lead.
gg) * A caution that, when clinically indicated, supplemental monitoring of the patient should
be considered.
201.7.9.2.4 * Electrical power source
Replacement:
The instructions for use shall contain advice on removal of the PRIMARY BATTERY if the
ME EQUIPMENT is to be stored or when a long period of disuse is anticipated.
The instructions for use shall state the recommended primary battery specification.
The instructions for use shall contain the estimated service time from a fully charged battery
at 20 °C ambient temperature when operating under specified conditions;
The instructions for use shall contain the estimated service time following activation of the
BATTERY DEPLETION INDICATOR when operating under specified conditions.
– 14 – 60601-2-31 © IEC:2008
The instructions for use shall contain the information (including a reference to the appropriate
PRIMARY BATTERY specified in IEC 60086-2 [3]) giving the identity of the PRIMARY BATTERIES to
be used so that they may be obtained from local sources.
201.7.9.2.5 ME EQUIPMENT description
Addition:
The instructions for use shall include the following:
aa) * A general description, explanation of function available, and a description of each
heart/PULSE GENERATOR interaction for each available pacing mode. See Annex DD.3 of
ISO 14708-2:2005 for a description of pacing modes.
bb) * The connector configuration, the geometry and/or dimensions of the receiving
connectors and instructions for connecting the LEAD(S) OR PATIENT CABLE(S) to the NON-
IMPLANTABLE PULSE GENERATOR.
cc) * The electrical characteristics (including tolerances where applicable) at 20 °C ± 2 °C
with 500 Ω ± 1 % load, unless otherwise stated, as follows:
– ranges of BASIC, ESCAPE, MAXIMUM TRACKING and INTERFERENCE PULSE RATES (as
applicable);
– PULSE AMPLITUDE(S);
– PULSE DURATION(S);
– the SENSITIVITY range for both positive and negative polarities (if a sensing function
is provided);
– sensing amplifier blanking period(s) (if a sensing function is provided);
– the REFRACTORY PERIOD(S) (pacing and sensing) and A-V INTERVAL(S) (as
applicable);
– mode of operation in the presence of sensed interference;
– the rate limit (runaway protection), in reciprocal minutes.
dd) * The electrical characteristics upon activation of the BATTERY DEPLETION INDICATOR
(including tolerances where applicable, and measured at 20 °C ± 2 °C with 500 Ω ± 1 %
load), including as applicable, unless these are unchanged from the values provided in
7.9.2.5 cc):
– BASIC RATE or equivalent PULSE INTERVAL;
– PULSE AMPLITUDES(s);
– PULSE DURATION(s);
– SENSITIVITY (if a sensing function is provided);
– mode change (if applicable).
201.7.9.2.8 * Start-up PROCEDURE
Addition:
The instructions for use shall contain any environmental limitations regarding storing the
EQUIPMENT immediately prior to use.
201.7.9.2.13 * Maintenance
Addition:
The instructions for use shall contain details for replacing the PRIMARY BATTERY and the means
of ascertaining when replacement is required.
60601-2-31 © IEC:2008 – 15 –
The instructions for use shall contain information calling the RESPONSIBLE ORGANIZATION’S
attention to the need for periodic maintenance, as well as to the need for maintenance after
any malfunction or accident of the ME EQUIPMENT irrespective of usage, especially:
– cleaning and disinfection of reusable PATIENT CABLES;
– cleaning and disinfection of the NON-IMPLANTABLE PULSE GENERATOR;
– inspection of cables and connections for possible defects, for example, loosening of
connections and other wear and tear from such causes as PATIENT movement;
– inspection of the NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE for signs of
physical damage or contamination, in particular damage or contamination that can have a
detrimental effect on the electrical isolation properties of the ME EQUIPMENT;
– functional checks, calibration, activation of keys, switches, etc., especially if the EQUIPMENT
has suffered severe shock, for example, by being dropped.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.5.5 Defibrillation-proof applied parts
201.8.5.5.1 Defibrillation protection
Replacement:
The ME EQUIPMENT shall comply with 6.2.1 of ANSI/AAMI PC69:2007.
201.8.7.3 * Allowable values
Amendment:
In Table 3 [of IEC 60601-1:2005], replace the values for PATIENT AUXILIARY CURRENT for TYPE
CF APPLIED PARTS for both d.c. and a.c. with 1 µA in NORMAL CONDITION (NC) and 5 µA in
SINGLE FAULT CONDITION (SFC).
201.8.7.4 Measurements
201.8.7.4.1 General
Addition:
aa) * The NON-IMPLANTABLE PULSE GENERATOR output should be disabled during LEAKAGE
CURRENT testing if possible. If the output is to be active, its contribution should not be
considered part of the LEAKAGE CURRENT.
201.8.7.4.8 * Measurement of the PATIENT AUXILIARY CURRENT
Replacement:
For measurement of PATIENT AUXILIARY CURRENT, the ME EQUIPMENT is connected as shown in
Figure 201.101 to a d.c. measuring device with an input resistance of 100 kΩ. The
ME EQUIPMENT shall be connected to the measuring device for a minimum of 5 min before
PATIENT AUXILIARY CURRENT measurement. When measured just before the pacing
making the
pulse, the measured voltage shall not exceed 100 mV for NORMAL CONDITIONS and shall not
exceed 500 mV for SINGLE FAULT CONDITION.
– 16 – 60601-2-31 © IEC:2008
+
MD
–
IEC 404/08
Legend
1 ME EQUIPMENT ENCLOSURE
4 PATIENT CONNECTIONS
INTERNAL ELECTRICAL POWER SOURCE
MD Measuring device (see Figure 12 of IEC 60601-1:2005)
See also Table 5 of IEC 60601-1:2005.
Figure 201.101 – Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT
with an INTERNAL ELECTRICAL POWER SOURCE
Additional subclause:
201.8.101 High-frequency surgical ME EQUIPMENT protection
The ME EQUIPMENT shall comply with 6.1.1 of ANSI/AAMI PC69:2007.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies, except as follows:
201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS
Replacement:
The EQUIPMENT shall be so constructed that, in the event of spillage of liquids (accidental
wetting), no HAZARDOUS SITUATION shall result.
60601-2-31 © IEC:2008 – 17 –
Compliance is checked by the following test:
The ME EQUIPMENT is placed in the least favourable position of NORMAL USE with the PATIENT
CABLE attached. The ME EQUIPMENT is subjected to a spill of 400 ml of 9 g/l saline solution
from a height of 30 cm. The entire 400 ml is poured over the ME EQUIPMENT in less than 5 s.
Following the spill, the ME EQUIPMENT is not to be resting in a depth of more than 5 mm of
saline solution.
Immediately after 30 s of exposure, the ME EQUIPMENT is removed from the saline solution and
visible moisture on the outside of the ENCLOSURE is removed.
The ME EQUIPMENT is to operate within specification during and after the spill.
After at least 24 h have passed, the ME EQUIPMENT is to operate within specification.
The ME EQUIPMENT is then disassembled and inspected. Any evidence that liquid has entered
the electronic compartment constitutes a failure.
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Replacement:
The ME EQUIPMENT shall be equipped with a BATTERY DEPLETION INDICATOR which clearly
indicates when the power source is to be replaced.
Compliance is checked by inspection and by functional test.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard applies, except as follows:
201.12.1 Accuracy of controls and instruments
Replacement:
201.12.1.101 * ME EQUIPMENT PARAMETERS
The measured values of the ME EQUIPMENT parameters shown in Table 201.103 shall be within
the MANUFACTURER'S published tolerance when measured at PULSE RATE settings of 60 and
120 pulses per minute with a fully charged battery and the NON-IMPLANTABLE PULSE GENERATOR
at 20 °C ± 2 °C. If 60 or 120 pulses per minute are not within the range for PULSE RATE
settings for the ME EQUIPMENT, then the test shall be conducted at the minimum or maximum
allowable settings.
Compliance is checked by either the appropriate methods described below and in 6.1 of
ISO 14708-2:2005, or by any other method provided it can demonstrate an accuracy equal to
or better than the accuracy listed in Table 201.103. In case of dispute, the test described
below and in 6.1 of ISO 14708-2:2005 shall apply.
– 18 – 60601-2-31 © IEC:2008
Table 201.103 – Measurement method accuracy
Accuracy
Measurement
%
PULSE AMPLITUDE ±5
PULSE DURATION ±5
PULSE RATE ±0,5
SENSITIVITY (if applicable) ±10
ESCAPE interval ±10
REFRACTORY PERIOD(S) (if applicable) ±10
A.V. INTERVAL (if applicable) ±5
MAXIMUM TRACKING RATE (if applicable) ±0,5
Measurement of MAXIMUM TRACKING RATE is made using the following test.
With a fully charged battery and the NON-IMPLANTABLE PULSE GENERATOR in an A-V sequential
mode with sensing and pacing in both chambers (DDD) at 20 °C ± 2 °C, the ME EQUIPMENT
is connected according to Figure 201.102. The test apparatus is described in 6.1 of
I
...
IEC 60601-2-31 ®
Edition 2.1 2011-09
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
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IEC 60601-2-31 ®
Edition 2.1 2011-09
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
PRICE CODE
INTERNATIONALE
CP
CODE PRIX
ICS 11.040.01 ISBN 978-2-88912-612-5
– 2 – 60601-2-31 IEC:2008+A1:2011
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 8
201.2 Normative references . 9
201.3 Terms and definitions . 10
201.4 General requirements . 11
201.5 General requirements for testing ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 18
201.11 Protection against excessive temperatures and other HAZARDS . 18
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 19
201.13 HAZARDOUS SITUATIONS and fault conditions . 23
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 23
201.15 Construction of ME EQUIPMENT . 23
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 Electromagnetic compatibility – Requirements and tests . 23
Annexes . 25
Annex AA (informative) Particular guidance and rationale . 26
Bibliography . 36
Index of defined terms used in this particular standard . 37
Figure 201.101 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE . 18
Figure 201.102 – Measuring circuit for the MAXIMUM TRACKING RATE . 21
Figure 201.103 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE . 21
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – DUAL CHAMBER connector terminal marking . 13
Table 201.103 – Measurement method accuracy . 20
Table 202.101 – Static discharge requirements . 24
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 27
60601-2-31 IEC:2008+A1:2011 – 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
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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
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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6) All users should ensure that they have the latest edition of this publication.
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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.
This consolidated version of IEC 60601-2-31 consists of the second edition (2008)
[documents 62D/603/CDV and 62D/667/RVC] and its amendment 1 (2011) [documents
62D/918/FDIS and 62D/931/RVD]. It bears the edition number 2.1.
The technical content is therefore identical to the base edition and its amendment and
has been prepared for user convenience. A vertical line in the margin shows where the
base publication has been modified by amendment 1. Additions and deletions are
displayed in red, with deletions being struck through.
– 4 – 60601-2-31 IEC:2008+A1:2011
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 of IEC 60601-2-31 is aligned with IEC 60601-1:2005, and contains
minimal technical revisions from the first edition.
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.
60601-2-31 IEC:2008+A1:2011 – 5 –
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until the stability 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.
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 publication using a colour printer.
– 6 – 60601-2-31 IEC:2008+A1:2011
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 implantable PACEMAKERS
and EXTERNAL PACEMAKERS. EXTERNAL PACEMAKERS are used to pace PATIENTS temporarily
prior to implanting an IMPLANTABLE 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 PACEMAKER will perform in a specific patient 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.
60601-2-31 IEC:2008+A1:2011 – 7 –
INTRODUCTION
(to amendment 1)
The purpose of this amendment is to address comments received during the process of
harmonizing the standard in Europe, update several references to defined terms that were not
printed in SMALL CAPS, and improve terminology usage.
– 8 – 60601-2-31 IEC: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
201.1 Scope, object and related standards
1)
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred
ME EQUIPMENT.
to as
This standard applies to PATIENT CABLES as defined in 201.3. 109.
This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS
as defined in 201.3.106.
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
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 as defined in 201.3. 103.
201.1.3 Collateral standards
Addition:
—————————
1)
The general standard is IEC 60601-1:2005.
60601-2-31 IEC:2008+A1:2011 – 9 –
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.
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 the general standard 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:
– 10 – 60601-2-31 IEC:2008+A1:2011
Replacement:
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 36.
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]
201.3.102
BATTERY DEPLETION INDICATOR
means of indicating when the battery should be replaced
201.3.103
CARDIAC PACEMAKER
ME EQUIPMENT intended to treat bradyarrhythmias
201.3.104
DUAL CHAMBER
relating to both atrium and ventricle
201.3.105
EXTERNAL PACEMAKER
CARDIAC PACEMAKER with consisting of a NON-IMPLANTABLE PULSE GENERATOR and PATIENT
CABLE(S) (if used)
201.3.106
LEAD
flexible tube enclosing one or more insulated electrical conductors, intended to transfer
electrical energy along its length between the EXTERNAL PACEMAKER and the patient's
PATIENT'S heart
[ISO 14708-1:2000, definition 3.5 modified]
60601-2-31 IEC:2008+A1:2011 – 11 –
201.3.107
MAXIMUM TRACKING RATE
maximum PULSE RATE at which the NON-IMPLANTABLE PULSE GENERATOR will respond on a 1:1
basis to a triggering signal
[ISO 14708-2:2005, definition 3.3.18 modified]
201.3.108
NON-IMPLANTABLE PULSE GENERATOR
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE which is intended for use outside
the body and which produces a periodic electrical pulse PULSE intended to stimulate the heart
through a LEAD (or combination of a LEAD and PATIENT CABLE)
201.3.109
PATIENT CABLE
cable used to extend the distance between the NON-IMPLANTABLE PULSE GENERATOR and the
pacing LEAD
201.3.110
POST-VENTRICULAR ATRIAL REFRACTORY PERIOD
PVARP
atrial refractory period minus the AV delay
201.3.111
PRIMARY BATTERY
one or more cells, which are not designed to be electrically recharged, that are fitted with
devices necessary for use, for example case, terminals, marking and protective devices
[IEC 60050-482:2004, definition 482-01-04 modified]
201.3.112
SINGLE CHAMBER
relating to either atrium or ventricle
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Additional subclause:
201.4.3.101 Additional ESENTIAL PERFORMANCE requirements
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in
Table 201.101.
– 12 – 60601-2-31 IEC:2008+A1:2011
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
BATTERY DEPLETION INDICATOR 201.11.8
ME EQUIPMENT parameter stability 201.12.1.101
PULSE AMPLITUDE stability 201.12.1.102
Disarming runaway rate protection 201.12.4.1
Deliberate action required to change settings 201.12.4.101
Parameter stability at onset of the BATTER DEPLETION INDICATOR 201.12.4.102
Runaway protection 201.12.4.103
Interference reversion in the presence of sensed electrical interference 201.12.4.104
Limit at which the ventricle is paced in response to sensed atrial activity 201.12.4.105
201.4.10.1 Source of power for ME EQUIPMENT
Replacement:
ME EQUIPMENT shall be powered by a PRIMARY BATTERY.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
201.4.10.2 Supply mains SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
This subclause of the general standard does not apply.
201.4.11 * Power input
This subclause of the general standard does not apply.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 * Protection against electric shock
Replacement:
ME EQUIPMENT shall be classified as INTERNALLY POWERED ME EQUIPMENT.
ME EQUIPMENT shall be recognized as INTERNALLY POWERED only if no external connections to
an electrical power source are provided.
APPLIED PARTS shall be classified as TYPE CF APPLIED PARTS. APPLIED PARTS shall be classified
as DEFIBRILLATION-PROOF APPLIED PARTS.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
60601-2-31 IEC:2008+A1:2011 – 13 –
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
Additional subclauses:
201.7.2.101 ME EQUIPMENT intended for SINGLE CHAMBER application
If the ME EQUIPMENT is intended for SINGLE CHAMBER applications, the connector terminals (if
used) shall be conspicuously marked positive (+) and negative (–).
201.7.2.102 * ME EQUIPMENT intended for DUAL CHAMBER application
If the ME EQUIPMENT is intended for DUAL CHAMBER application, the connector terminals (if
used) shall be marked according to Table 201.102. If colour is used to differentiate between
channels in a DUAL CHAMBER application, then the ventricular channel should be marked with
the colour white and the atrial channel should be marked with a contrasting colour.
Table 201.102 – DUAL CHAMBER connector terminal marking
Symbol
Channel Terminal label
Positive terminal Negative terminal
Atrial channel A+ A– ATRIUM
Ventricular channel V+ V– VENTRICLE
201.7.2.103 Bipolar connectors
When bipolar connectors are used, they shall have keyways that prevent inadvertent polarity
reversal.
201.7.2.104 * Battery compartment
The means of access to the battery compartment shall be easily identifiable. The battery
compartment shall be clearly and permanently marked with the IEC battery nomenclature, the
voltage and type. The battery compartment shall be clearly and permanently marked to show
the correct orientation of the battery or batteries.
201.7.4 Marking of controls and instruments
Additional subclauses:
201.7.4.101 * Control or indicator for pacing output
If constant current output is used, the control for selecting pacing output or the relevant
indicating means shall be marked in terms of current in milliamperes (mA) through a resistive
load of 500 Ω ± 1 %. If a constant voltage output is used, the pacing output or the relevant
indicating means shall be marked in terms of volts (V) across a resistive load of 500 Ω ± 1 %.
201.7.4.102 * Control or indicator for PULSE RATE
The control for selecting PULSE RATE or the relevant indicating means shall be marked in terms
of reciprocal minutes.
201.7.4.103 * Control for selecting pacing mode
If a means of selecting the pacing mode is provided, the ME EQUIPMENT shall indicate, as well
as the mode selected, the possible pacing modes using the codes described in Annex DD of
ISO 14708-2:2005.
– 14 – 60601-2-31 IEC:2008+A1:2011
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2.2 * Warning and safety notices
Replacement:
The instructions for use shall include all warning and safety notices.
NOTE General warnings and safety notices should be placed in a specifically identified section of the instructions
for use. A warning or safety notice that applies only to a specific instruction or action should precede the
instruction to which it applies.
The instructions for use shall provide the OPERATOR or RESPONSIBLE ORGANIZATION with
warnings regarding any significant RISKS of reciprocal interference posed by the presence of
the ME EQUIPMENT during specific investigations or treatments.
The instructions for use shall include the following:
aa) * Warnings regarding potential changes in the behaviour of the pulse generator NON-
IMPLANTABLE PULSE GENERATOR caused by electromagnetic or other interference sources
(e.g. communication transmitters in hospitals, emergency transport vehicles, cellular
telephones, etc.) and the effects of therapeutic and diagnostic energy sources (e.g.
external cardioversion, diathermy, transcutaneous electrical nerve stimulators [TENS]
devices, high-frequency surgical equipment, magnetic resonance imaging or similar
sources) on the pulse generator NON-IMPLANTABLE PULSE GENERATOR. This shall include
advice on recognizing when the behaviour of the pulse generator NON-IMPLANTABLE
PULSE GENERATOR is being influenced by external interference sources and steps to be
taken to avoid such interference.
bb) * A warning about the danger of inadvertently introducing leakage current LEAKAGE
CURRENT into the heart if supply mains SUPPLY MAINS -operated equipment is connected
to the lead LEAD system.
cc) * A warning that the patient cable PATIENT CABLE shall be connected to the non-
implantable pulse generator NON-IMPLANTABLE PULSE GENERATOR before the pacing leads
LEADS are connected to the patient cable PATIENT CABLE.
dd) * A warning that when handling indwelling leads LEADS, the terminal pins or exposed
metal are not to be touched nor be allowed to contact electrically conductive or wet
surfaces.
ee) * A warning regarding the HAZARDS of using PRIMARY BATTERIES other than those
recommended by the manufacturer MANUFACTURER (for example, short battery life after
the indication of low battery condition, degraded ME EQUIPMENT performance, overall
reduced battery life, and erratic or no pacing).
ff) * A warning that, before handling the external pulse generator NON-IMPLANTABLE PULSE
GENERATOR, the patient cable PATIENT CABLE or indwelling leads LEADS, steps shall be
taken to equalize the electrostatic potential between the user and the patient PATIENT,
for example by touching the patient PATIENT at a site remote from the pacing lead LEADS.
gg) * A caution that, when clinically indicated, supplemental monitoring of the patient
PATIENT should be considered.
201.7.9.2.4 * Electrical power source
Replacement:
The instructions for use shall contain advice on removal of the PRIMARY BATTERY if the
ME EQUIPMENT is to be stored or when a long period of disuse is anticipated.
The instructions for use shall state the recommended primary battery PRIMARY BATTERY
specification.
60601-2-31 IEC:2008+A1:2011 – 15 –
The instructions for use shall contain the estimated service time from a fully charged battery
at 20 °C ambient temperature when operating under specified conditions;
The instructions for use shall contain the estimated service time following activation of the
BATTERY DEPLETION INDICATOR when operating under specified conditions.
The instructions for use shall contain the information (including a reference to the appropriate
PRIMARY BATTERY specified in IEC 60086-2 [3]) giving the identity of the PRIMARY BATTERIES to
be used so that they may be obtained from local sources.
201.7.9.2.5 ME EQUIPMENT description
Addition:
The instructions for use shall include the following:
aa) * A general description, explanation of function available, and a description of each
heart/PULSE GENERATOR interaction for each available pacing mode. See Annex DD.3 of
ISO 14708-2:2005 for a description of pacing modes.
bb) * The connector configuration, the geometry and/or dimensions of the receiving
connectors and instructions for connecting the LEAD(S) OR PATIENT CABLE(S) to the NON-
IMPLANTABLE PULSE GENERATOR.
cc) * The electrical characteristics (including tolerances where applicable) at 20 °C ± 2 °C
with 500 Ω ± 1 % load, unless otherwise stated, as follows:
– ranges of BASIC, ESCAPE, MAXIMUM TRACKING and INTERFERENCE PULSE RATES (as
applicable);
– PULSE AMPLITUDE(S);
– PULSE DURATION(S);
– the SENSITIVITY range for both positive and negative polarities (if a sensing function
is provided);
– sensing amplifier blanking period(s) (if a sensing function is provided);
– the REFRACTORY PERIOD(S) (pacing and sensing) and A-V INTERVAL(S) (as
applicable);
– mode of operation in the presence of sensed interference;
– the rate limit (runaway protection), in reciprocal minutes.
dd) * The electrical characteristics upon activation of the BATTERY DEPLETION INDICATOR
(including tolerances where applicable, and measured at 20 °C ± 2 °C with 500 Ω ± 1 %
load), including as applicable, unless these are unchanged from the values provided in
7.9.2.5 cc):
– BASIC RATE or equivalent PULSE INTERVAL;
– PULSE AMPLITUDES(s);
– PULSE DURATION(s);
– SENSITIVITY (if a sensing function is provided);
– mode change (if applicable).
201.7.9.2.8 * Start-up PROCEDURE
Addition:
The instructions for use shall contain any environmental limitations regarding storing the
EQUIPMENT immediately prior to use.
– 16 – 60601-2-31 IEC:2008+A1:2011
201.7.9.2.13 * Maintenance
Addition:
The instructions for use shall contain details for replacing the PRIMARY BATTERY and the means
of ascertaining when replacement is required.
The instructions for use shall contain information calling the RESPONSIBLE ORGANIZATION’S
attention to the need for periodic maintenance, as well as to the need for maintenance after
any malfunction or accident of the ME EQUIPMENT irrespective of usage, especially:
– cleaning and disinfection of reusable PATIENT CABLES;
– cleaning and disinfection of the NON-IMPLANTABLE PULSE GENERATOR;
– inspection of cables and connections for possible defects, for example, loosening of
connections and other wear and tear from such causes as PATIENT movement;
– inspection of the NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE for signs of
physical damage or contamination, in particular damage or contamination that can have a
detrimental effect on the electrical isolation properties of the ME EQUIPMENT;
– functional checks, calibration, activation of keys, switches, etc., especially if the EM
EQUIPMENT has suffered severe shock, for example, by being dropped.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.5.5 Defibrillation-proof applied parts DEFIBRILLATION-PROOF APPLIED PARTS
201.8.5.5.1 Defibrillation protection
Replacement:
The ME EQUIPMENT shall comply with 6.2.1 of ANSI/AAMI PC69:2007.
NOTE ANSI/AAMI PC69:2007 is being adopted as ISO 14117.
201.8.7.3 * Allowable values
Amendment:
In Table 3 [of IEC 60601-1:2005], replace the values for PATIENT AUXILIARY CURRENT for TYPE
CF APPLIED PARTS for both d.c. and a.c. with 1 µA in NORMAL CONDITION (NC) and 5 µA in
SINGLE FAULT CONDITION (SFC).
NOTE Where the a.c. component of the current is intended to produce a physiological effect, it is therefore
outside the definition of PATIENT AUXILIARY CURRENT.
201.8.7.4 Measurements
201.8.7.4.1 General
Addition:
aa) * The NON-IMPLANTABLE PULSE GENERATOR output should be disabled during LEAKAGE
CURRENT testing if possible. If the output is to be active, its contribution should not be
considered part of the LEAKAGE CURRENT.
60601-2-31 IEC:2008+A1:2011 – 17 –
201.8.7.4.8 * Measurement of the PATIENT AUXILIARY CURRENT
Replacement:
For measurement of PATIENT AUXILIARY CURRENT, the ME EQUIPMENT is connected as shown in
Figure 201.101 to a d.c. measuring device with an input resistance of 100 kΩ. The
ME EQUIPMENT shall be connected to the measuring device for a minimum of 5 min before
making the PATIENT AUXILIARY CURRENT measurement. When measured just before the pacing
pulse, the measured voltage shall not exceed 100 mV for NORMAL CONDITIONS and shall not
exceed 500 mV for SINGLE FAULT CONDITION.
For measurement of the PATIENT AUXILIARY CURRENT, the ME EQUIPMENT is connected as shown
in Figure 201.101. Each PATIENT CONNECTION is connected to a common bus through a
500 Ω ± 1% load resistor (R ). Using a measuring device (MD) consisting of a DC voltmeter,
L
resolution better than 2 µV, fed through a low pass filter with a time constant of at least 10 s,
measure the average direct voltage across each low resistor. Steady state condition shall be
reached before the measurement is made.
The NON-IMPLANTABLE PULSE GENERATOR shall be set to the nominal settings recommended by
the manufacturer (i.e., the factory recommended settings) but with the PULSE AMPLITUDE and
PULSE DURATION programmed to the highest available settings.
NOTE The low pass filter can be implemented by a four-element RC filter with elements built from 1 MΩ resistors
and 10 µF metalized polypropylene capacitors. The input resistance of the dc voltmeter should be ≥ 400 MΩ.
+
MD
–
IEC 404/08
Legend
1 ME EQUIPMENT ENCLOSURE
4 PATIENT CONNECTIONS
INTERNAL ELECTRICAL POWER SOURCE
MD Measuring device (see Figure 12 of IEC 60601-1:2005)
See also Table 5 of IEC 60601-1:2005.
– 18 – 60601-2-31 IEC:2008+A1:2011
R
L
+
–
4 R
L
MD
IEC 1373/11
Legend
ME EQUIPMENT ENCLOSURE
4 PATIENT CONNECTIONS
INTERNAL ELECTRICAL POWER SOURCE
Load resistor
R
L
MD Measuring device (see 201.8.7.4.8)
Figure 201.101 – Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT
with an INTERNAL ELECTRICAL POWER SOURCE
Additional subclause:
201.8.101 High-frequency surgical ME EQUIPMENT protection
The ME EQUIPMENT shall comply with 6.1.1 of ANSI/AAMI PC69:2007.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard
...
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