FprEN IEC 60601-2-40:2024
(Main)Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und Geräten für evozierte Potentiale
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in bistvene lastnosti za elektromiografe in opremo za izzvane odzive
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-40:2023
01-maj-2023
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za elektromiografe in opremo za izzvane odzive
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and evoked response equipment
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und
Geräten für evozierte Potentiale
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base
et les performances essentielles des électromyographes et des appareils à potentiel
évoqué
Ta slovenski standard je istoveten z: prEN IEC 60601-2-40:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 60601-2-40:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN IEC 60601-2-40:2023
oSIST prEN IEC 60601-2-40:2023
62D/2019/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-40 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2023-03-17 2023-06-09
SUPERSEDES DOCUMENTS:
62D/1901/CD, 62D/1928A/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 ,
• any relevant “in some countries” clauses to be included should this proposal proceed. Recipients are remin ded
that the enquiry stage is the final stage for submitting "in some countries" clauses. See AC/22/2007.
TITLE:
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response equipment
PROPOSED STABILITY DATE: 2029
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.
oSIST prEN IEC 60601-2-40:2023
62D/2019/CDV – 2 – IEC CDV 60601-2-40:2016 © IEC 2023
NOTE FROM TC/SC OFFICERS:
IEC 60601-2-40 is revised to align to the Amendment projects of the IEC 60601-1 series and to incorporate
several significant technical changes. Please refer to 62D/1792/DC and 62D/1808/INF for maintenance
decision. National Committees are invited to vote on the Committee Draft for Vote at this stage.
oSIST prEN IEC 60601-2-40:2023
IEC CDV 60601-2-40:2016 © IEC 2023 – 3 – 62D/2019/CDV
1 CONTENTS
2 FOREWORD . 4
3 INTRODUCTION . 7
4 201.1 Scope, object and related standards . 8
5 201.2 Normative references . 10
6 201.3 Terms and definitions . 10
7 201.4 General requirements . 12
8 201.5 General requirements for testing of ME EQUIPMENT . 12
9 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
10 201.7 ME EQUIPMENT identification, marking and documents . 12
11 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
12 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
13 201.10 Protection against unwanted and excessive radiation HAZARDS . 15
14 201.11 Protection against excessive temperatures and other HAZARDS . 15
15 201.12 Accuracy of controls and instruments and protection against hazardous
16 outputs . 16
17 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
18 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
19 201.15 Construction of ME EQUIPMENT . 19
20 201.16 ME SYSTEMS . 19
21 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 19
22 202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 19
23 Annexes . 24
24 Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
25 and ME SYSTEMS . 24
26 Annex AA (informative) Particular guidance and rationale . 25
27 Bibliography . 31
28 Index of defined terms used in this particular standard . 32
30 Figure AA.1 – Suggested test layout for EMISSION and IMMUNITY testing . 28
31 Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
32 ME EQUIPMENT . 29
33 Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
34 ME EQUIPMENT . 30
36 Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014/AMD1:2020 . 21
37 Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014/AMD1:2020 . 22
38 Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014/AMD1:2020 . 23
39 Table 202.104 – Pass/fail criteria for Table 5, 6, 9 of IEC 60601-1-2:2014/AMD1:2020 . 23
41 Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
42 RESPONSE EQUIPMENT or its parts . 24
oSIST prEN IEC 60601-2-40:2023
62D/2019/CDV – 4 – IEC CDV 60601-2-40:2016 © IEC 2023
45 INTERNATIONAL ELECTROTECHNICAL COMMISSION
46 _____________
48 MEDICAL ELECTRICAL EQUIPMENT –
50 Part 2-40: Particular requirements for the basic safety and essential
51 performance of electromyographs and evoked response equipment
53 FOREWORD
54 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
55 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
56 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
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63 agreement between the two organizations.
64 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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66 interested IEC National Committees.
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71 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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74 the latter.
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78 6) All users should ensure that they have the latest edition of this publication.
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82 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
83 Publications.
84 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
85 indispensable for the correct application of this publication.
86 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
87 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
88 International Standard IEC 60601-2-40 has been prepared by subcommittee 62D:
89 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
90 practice.
91 This third edition cancels and replaces the second edition of IEC 60601-2-40 published in
92 2016. This edition constitutes a technical revision.
93 This edition includes the following significant technical changes with respect to the previous
94 edition:
95 a) added requirements for constant voltage stimulators ;
96 b) clarified requirements for VISUAL STIMULATORS.
97 The text of this standard is based on the following documents:
oSIST prEN IEC 60601-2-40:2023
IEC CDV 60601-2-40:2016 © IEC 2023 – 5 – 62D/2019/CDV
FDIS Report on voting
62D/XXXX/FDIS 62D/XXXX/RVD
99 Full information on the voting for the approval of this standard can be found in the report on
100 voting indicated in the above table.
101 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
102 In this standard, the following print types are used:
103 – Requirements and definitions: roman type.
104 – Test specifications: italic type.
105 – Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
106 Normative text of tables is also in a smaller type.
107 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
108 NOTED: SMALL CAPITALS.
109 In referring to the structure of this document, the term
110 – “clause” means one of the seventeen numbered divisions within the table of contents,
111 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
112 – “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
113 subclauses of Clause 7).
114 References to clauses within this document are preceded by the term “Clause” followed by
115 the clause number. References to subclauses within this particular standard are by number
116 only.
117 In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
118 combination of the conditions is true.
119 The verbal forms used in this document conform to usage described in Clause 7 of the
120 ISO/IEC Directives, Part 2. For the purposes of this document, the auxiliary verb:
121 – “shall” means that compliance with a requirement or a test is mandatory for compliance
122 with this document;
123 – “should” means that compliance with a requirement or a test is recommended but is not
124 mandatory for compliance with this document;
125 – “may” is used to describe a permissible way to achieve compliance with a requirement or
126 test.
127 An asterisk (*) as the first character of a title, or at the beginning of a paragraph or table title,
128 indicates that there is guidance or rationale related to that item in Annex AA.
129 A list of all parts of the IEC 60601 series, published under the genera
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