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IEC 60601-2-31
Edition 3.0 2020-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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
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IEC 60601-2-31
Edition 3.0 2020-01
REDLINE VERSION
INTERNATIONAL
STANDARD
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-7781-2
– 2 – IEC 60601-2-31:2020 RLV © 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 . 14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 17
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
201.10 Protection against unwanted and excessive radiation HAZARDS . 24
201.11 Protection against excessive temperatures and other HAZARDS . 24
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 25
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 30
201.15 Construction of ME EQUIPMENT . 30
201.16 ME SYSTEMS . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 * ELECTROMAGNETIC compatibility DISTURBANCES – Requirements and tests . 30
Annexes . 33
Annex I Identification of IMMUNITY pass/fail criteria . 33
Annex AA (informative) Particular guidance and rationale . 34
Bibliography . 55
Index of defined terms used in this particular standard . 56
Figure 201.101 – Test waveform V implemented by example RCL circuit
test
, L = 25 µH, RL + R = 1 Ω . 18
using 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 201.101107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for
ME EQUIPMENT with an INTERNAL ELECTRICAL POWER SOURCE . 23
Figure 201.102108 – Measuring circuit for the MAXIMUM TRACKING RATE . 27
Figure 201.103109 – Initial oscilloscope display when measuring MAXIMUM TRACKING
RATE . 28
Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during
defibrillation . 41
Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL
PACEMAKER . 44
Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according
to conditions during open heart surgery . 45
Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from
Figure AA.3 . 46
Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in
Figure AA.3 . 50
Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
Table 201.102 – DUAL CHAMBER connector terminal marking. 14
Table 201.103 – Measurement method accuracy ME EQUIPMENT parameters . 25
Table 202.101 – Static discharge requirements . 31
Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 35
Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % . 47
Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % . 48
Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % . 49
– 4 – IEC 60601-2-31:2020 RLV © 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
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This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change has
been made. Additions are in green text, deletions are in strikethrough red text.
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;
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 rat
...