prEN IEC 80601-2-31:2024
(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
Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen Herzschrittmachern mit geräteeigener Stromversorgung
Appareils électromédicaux - Partie 2-31: Exigences particulières pour la sécurité de base et les performances essentielles des stimulateurs cardiaques externes à source d'énergie interne
Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2024
Medicinska električna oprema - 2-31. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti zunanjih srčnih spodbujevalnikov z vgrajenim napajalnim virom
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and
essential performance of external cardiac pacemakers with internal power source
Medizinische elektrische Geräte - Teil 2-31: Besondere Anforderungen an die
Basissicherheit einschließlich der wesentlichen Leistungsmerkmale von externen
Herzschrittmachern mit geräteeigener Stromversorgung
Appareils électromédicaux - Partie 2-31: Exigences particulières pour la sécurité de base
et les performances essentielles des stimulateurs cardiaques externes à source
d'énergie interne
Ta slovenski standard je istoveten z: prEN IEC 80601-2-31:2024
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2136/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-31 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-06-28 2024-09-20
SUPERSEDES DOCUMENTS:
62D/2040/CD, 62D/2061A/CC
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries”
clauses to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for
submitting ISC clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential
performance of external cardiac pacemakers with internal power source
PROPOSED STABILITY DATE: 2029
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.
You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without
permission in writing from IEC.
62D/2136/CDV – 2 – IEC CDV 80601-2-31 © IEC 2024
2 CONTENTS
3 FOREWORD . 4
4 INTRODUCTION . 7
5 201.1 Scope, object and related standards . 8
6 201.2 Normative references . 9
7 201.3 * Terms and definitions. 10
8 201.4 General requirements . 12
9 201.5 General requirements for testing ME EQUIPMENT . 12
10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
11 201.7 ME EQUIPMENT identification, marking and documents . 12
12 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
13 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
14 201.10 Protection against unwanted and excessive radiation HAZARDS . 22
15 201.11 Protection against excessive temperatures and other HAZARDS . 22
16 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 22
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 26
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 27
19 201.15 Construction of ME EQUIPMENT . 27
20 201.16 ME SYSTEMS . 27
21 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 27
22 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 27
23 Annexes . 29
24 Annex I (xxx) Identification of IMMUNITY pass/fail criteria . 30
25 Annex AA (informative) Particular guidance and rationale . 31
26 Bibliography . 52
27 Index of defined terms used in this particular standard . 53
29 Figure 201.101 – Test waveform V implemented by example RCL circuit using C = 120 µF
test
30 L = 25 µH, RL + R = 1 Ω. 17
31 Figure 201.102 – Example circuit of defibrillation test voltage generator for generating a
32 decaying exponential waveform . 18
33 Figure 201.103 – Test setup for a SINGLE CHAMBER external CARDIAC PACEMAKER . 19
34 Figure 201.104 – Test setup for a DUAL CHAMBER external CARDIAC PACEMAKER . 19
35 Figure 201.105 – Test setup for a triple chamber external CARDIAC PACEMAKER, e.g. bi-
36 ventricular external CARDIAC PACEMAKER . 20
37 Figure 201.106 – Timing sequence . 20
38 Figure 201.107 – Measuring circuit for the PATIENT AUXILIARY CURRENT for ME EQUIPMENT with
39 an INTERNAL ELECTRICAL POWER SOURCE . 21
IEC CDV 80601-2-31 © IEC 2024 – 3 – 62D/2136/CDV
40 Figure 201.108 – Measuring circuit for the MAXIMUM TRACKING RATE . 24
41 Figure 201.109 – Initial oscilloscope display when measuring MAXIMUM TRACKING RATE . 25
42 Figure AA.1 – Simple model of a SINGLE CHAMBER EXTERNAL PACEMAKER during defibrillation 40
43 Figure AA.2 – First proposal for a defib-protection test of SINGLE CHAMBER EXTERNAL PACEMAKER
44 42
45 Figure AA.3 – Circuit for a defibrillation test generator for defibrillation test according to
46 conditions during open heart surgery. 43
47 Figure AA.4 – Defibrillation PULSE generated by the defibrillation test generator from
48 Figure AA.3 . 44
49 Figure AA.5 – Rise times of a defibrillation PULSE according to the circuit proposed in
50 Figure AA.3 . 48
52 Table 201.101 – Colours and meanings of indicators lights for EXTERNAL PACEMAKERS. 14
53 Table 201.102 – ME EQUIPMENT parameters . 23
54 Table 202.101 – Static discharge requirements . 28
55 Table AA.1 – EXTERNAL PACEMAKER HAZARD inventory . 32
56 Table 201.101 from IEC 60601-2-31:2020 – Distributed ESSENTIAL PERFORMANCE requirements
57 34
58 Table AA.2 – PULSE energies calculated for C = 120 µF ± 5 % . 45
59 Table AA.3 – PULSE energies calculated for C = 122 µF ± 5 % . 46
60 Table AA.4 – PULSE energies calculated for C = 126,32 µF ± 5 % . 47
62D/2136/CDV – 4 – IEC CDV 80601-2-31 © IEC 2024
63 INTERNATIONAL ELECTROTECHNICAL COMMISSION
64 ____________
66 MEDICAL ELECTRICAL EQUIPMENT –
68 Part 2-31: Particular requirements for the basic safety and essential performance
69 of external cardiac pacemakers with internal power source
71 FOREWORD
72 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all
73 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co -
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79 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions
80 determined by agreement between the two organizations.
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98 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
99 indispensable for the correct application of this publication.
100 9) IEC draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). IEC
101 takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of
102 the date of publication of this document, IEC [had/had not] received notice of (a) patent(s), which may be required to
103 implement this document. However, implementers are cautioned that this may not represent the latest information, which
104 may be obtained from the patent database available at https://patents.iec.ch. IEC shall not be held responsible for
105 identifying any or all such patent rights.
106 IEC 80601-2-31 has been prepared by a Joint Working Group of IEC subcommittee 62D:
107 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice,
108 and ISO subcommittee SC6: Active implants, of ISO technical committee 150: Implants for surgery. It
109 is an International Standard.
110 This publication is published as a double logo standard.
111 This first edition of IEC 80601-2-31 cancels and replaces the third edition of IEC 60601-2-31
112 published in 2020. This edition constitutes a technical revision.
113 This edition includes the following significant technical changes with respect to the previous edition:
114 • The requirements regarding essential performance have been simplified;
115 • The allowed colours for indicators have been modified from those specified in the general standard;
oSIST prEN IEC 80601
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