EN 60601-2-4:2011/prA2:2024

SLOVENSKI STANDARD
01-februar-2025
Medicinska električna oprema - 2-4. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti srčnih defibrilatorjev - Dopolnilo A2
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and
essential performance of cardiac defibrillators
Medizinische elektrische Geräte - Teil 2-4: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Defibrillatoren
Appareils électromédicaux - Partie 2-4: Exigences particulières pour la sécurité de base
et les performances essentielles des défibrillateurs cardiaques
Ta slovenski standard je istoveten z: EN 60601-2-4:2011/prA2:2024
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

62D/2185/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-4/AMD2 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-12-13 2025-03-07
SUPERSEDES DOCUMENTS:
62D/2129/CD, 62D/2147A/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: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
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
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Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
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:
Amendment 2 - Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and
essential performance of cardiac defibrillators

PROPOSED STABILITY DATE: 2030
NOTE FROM TC/SC OFFICERS:
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62D/2185/CDV 2 IEC 60601-2-4/AMD2 ED3 © IEC 2024

2 INTERNATIONAL ELECTROTECHNICAL COMMISSION
3 ____________
5 MEDICAL ELECTRICAL EQUIPMENT –
7 Part 2-4: Particular requirements for the basic safety
8 and essential performance of cardiac defibrillators
12 FOREWORD
13 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
14 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
15 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
16 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
17 Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
18 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
19 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
20 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
21 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
22 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
23 consensus of opinion on the relevant subjects since each technical committee has representation from all
24 interested IEC National Committees.
25 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
26 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
27 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
28 misinterpretation by any end user.
29 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
30 transparently to the maximum extent possible in their national and regional publications. Any divergence between
31 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
32 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
33 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
34 services carried out by independent certification bodies.
35 6) All users should ensure that they have the latest edition of this publication.
36 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
37 members of its technical committees and IEC National Committees for any personal injury, property damage or
38 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
39 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
40 Publications.
41 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
42 indispensable for the correct application of this publication.
43 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
44 rights. IEC shall not be held responsible for identifying any or all such patent rights .
45 Amendment 2 to IEC 60601-2-4:2010 has been prepared by subcommittee 62D: Particular
46 medical equipment, software, and systems, of IEC technical committee 62: Medical equipment,
47 software, and systems.
48 The text of this Amendment is based on the following documents:
Draft Report on voting
XX/XX/FDIS XX/XX/RVD
50 Full information on the voting for its approval can be found in the report on voting indicated in
51 the above table.
IEC 60601-2-4/AMD2 ED3 © IEC 2024 3 62D/285/CDV
52 The language used for the development of this Amendment is English [change language if
53 necessary].
54 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
55 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, [and the
56 ISO/IEC Directives, JTC 1 Supplement] available at www.iec.ch/members_experts/refdocs. The
57 main document types developed by IEC are described in greater detail at
58 www.iec.ch/publications.
59 The committee has decided that the contents of this document will remain unchanged until the
60 stability date indicated on the IEC website under webstore.iec.ch in the data related to the
61 specific document. At this date, the document will be
62 • reconfirmed,
63 • withdrawn,
64 • replaced by a revised edition, or
65 • amended.
62D/2185/CDV 4 IEC 60601-2-4/AMD2 ED3 © IEC 2024

68 INTRODUCTION to Amendment 2
69 Amendment 2 to the International standard IEC 60601-2-4 has been prepared by IEC
70 subcommittee 62D: Particular medical equipment, software, and systems, of IEC technical
71 committee 62: Medical equipment, software, and systems in medical practice. Amendment 2
72 changes is to align to IEC 60601-1:2005+A1:2012+A2:2020 and IEC 60601-1-2:2014+A1:2020.
IEC 60601-2-4/AMD2 ED3 © IEC 2024 5 62D/285/CDV
74 MEDICAL ELECTRICAL EQUIPMENT –
76 Part 2-4: Particular requirements for the basic safety
77 and essential performance of cardiac defibrillators
81 201.1   Scope, object, and related standards
82 Updated footer 1 with the following text:
83 The general standard is IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment –
84 Part 1: General requirements for basic safety and essential performance.
85 201.2   Normative references
86 Replace the existing fourth paragraph with the following:
87 IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
88 safety and essential performance – Collateral standard: Electromagnetic disturbances –
89 Requirements and tests
90 IEC 60601-1-2:2014+A1:2020
91 Add the following paragraph under Addition:
92 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic safety
93 and essential performance – Collateral Standard: Requirements for medical electrical equipment and
94 medical electrical systems used in the home healthcare environment
95 IEC 60601-1-11:2015+A1:2020
96 Replace the existing seventh paragraph with the following:
97 IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
98 and essential performance
99 IEC 60601-1:2005+A1:2012+A2:2020
101 Replace the existing eighth paragraph with the following:
102 ISO 15223-1:2021 Medical devices – Symbols to be used with medical device labels, labelling
103 and information to be supplied – Part 1: General requirements.
104 201.3 Terms and definitions
105 Replace the existing text in the first paragraph with the following updated text:
106 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
107 IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2014, and IEC 60601-1-
108 2:2014+A1:2020 apply, except as follows:
109 201.7.2.103 Disposable defibrillator electrodes
110 Replace the existing text with the following updated text for reference to ISO 15223-1:

62D/2185/CDV 6 IEC 60601-2-4/AMD2 ED3 © IEC 2024

111 a) symbols (in accordance with ISO 15223-1:2021) or a statement indicating the date the
112 electrodes will expire (e.g., "use before ____") and the lot number or the date of
113 manufacture;
115 201.8.5.3 * MAXIMUM MAINS VOLTAGE
116 Replace the existing text with the following updated text:
117 Where the MAXIMUM MAINS VOLTAGE has been assigned the value of 240 V, and the derivation
118 of test voltage from the value of the MAXIMUM MAINS VOLTAGE includes a 110 % multiplier, that
119 multiplier shall not apply.
121 201.8.5.5.1 * Defibrillation protection
122 Replace the existing text with the following updated text:
123 • Differential-mode test
124 Replacement of the fourth paragraph (“After the operation of S, the peak….”) by the following:
126 201.12.3 ALARM SYSTEMS
127 New clause for ALARM SYSTEMS with the following text:
128 Replacement:
129 RISK MANAGEMENT is used to determine RISK CONTROL measures required for reducing the RISK(S)
130 due to unsatisfactory PATIENT physiological states or unsatisfactory functional states of the
131 MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM, to an acceptable level.
132 Requirements of IEC 60601-1-8:2006, IEC 60601-1-8:2006+A1:2012 and IEC 60601-1-
133 8:2006+A2:2020 apply when RISK MANAGEMENT has determined a requirement to indicate to the
134 OPERATOR of unsatisfactory physiological PATIENT states or unsatisfactory functional states of
135 the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEM, or to warn the OPERATOR of
136 HAZARDS to the PATIENT or OPERATOR due to the MEDICAL ELECTRICAL EQUIPMENT or MEDICAL
137 ELECTRICAL SYSTEM.
138 RISK CONTROL measures shall be appropriate for the environment of use and level of OPERATOR
139 training.
140 Deviations from the alarm standard shall be validated (e.g. usability).
142 201.101 * Charging time
143 201.101.1 Requirements for FREQUENT USE, MANUAL DEFIBRILLATORS
144 Replaced the text in a) with the following text:

IEC 60601-2-4/AMD2 ED3 © IEC 2024 7 62D/285/CDV
145 a) The time from the MANUAL DEFIBRILLATOR discharging or disarming its ENERGY STORAGE
146 DEVICE to the MANUAL DEFIBRILLATOR being ready for discharge at maximum energy shall not
147 exceed 15 s under the following conditions:
148 − when the MANUAL DEFIBRILLATOR is operated on 90 % of the RATED MAINS VOLTAGE.
149 − when the MANUAL DEFIBRILLATOR is operated with batteries depleted by whichever of the
150 following conditions comes last:
151 − the delivery of charge/discharge cycles until the MANUAL DEFIBRILLATOR indicates
152 when non-rechargeable batteries require replacement or rechargeable batteries
153 require recharging.
154 − the delivery of the maximum number of charge/discharge cycles after which the
155 battery is specified as still useable by the MANUFACTURER.
157 Replaced the text in b) with the following text:
158 b) The time from initially switching power on, or from within any OPERATOR programming mode,
159 to the MANUAL DEFIBRILLATOR being ready for discharge at maximum energy shall not exceed
160 25 s under the following conditions:
161 − when the MANUAL DEFIBRILLATOR is operated on 90 % of the RATED MAINS VOLTAGE.
162 − when the MANUAL DEFIBRILLATOR is operated with batteries depleted by whichever of the
163 following conditions comes last:
164 − the delivery of charge/discharge cycles until the MANUAL DEFIBRILLATOR indicates
165 when non-rechargeable batteries require replacement or rechargeable batteries
166 require recharging.
167 − the delivery of the maximum number of charge/discharge cycles after which the
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