SIST EN IEC 60601-2-40:2025

SLOVENSKI STANDARD
01-april-2025
Medicinska električna oprema - 2-40. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti za elektromiografe in opremo za izzvane odzive (IEC 60601-2-
40:2024)
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and evoked response equipment (IEC 60601
-2-40:2024)
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektromyographen und
Geräten für evozierte Potentiale (IEC 60601-2-40:2024)
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base
et les performances essentielles des électromyographes et des appareils à potentiel
évoqué (IEC 60601-2-40:2024)
Ta slovenski standard je istoveten z: EN IEC 60601-2-40:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60601-2-40

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2025
ICS 11.040.20; 11.040.55; 11.040.99 Supersedes EN 60601-2-40:2019
English Version
Medical electrical equipment - Part 2-40: Particular requirements
for the basic safety and essential performance of
electromyographs and evoked response equipment
(IEC 60601-2-40:2024)
Appareils électromédicaux - Partie 2-40: Exigences Medizinische elektrische Geräte - Teil 2-40: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des électromyographes et des appareils à wesentlichen Leistungsmerkmale von Elektromyographen
potentiel évoqué und Geräten für evozierte Potentiale
(IEC 60601-2-40:2024) (IEC 60601-2-40:2024)
This European Standard was approved by CENELEC on 2025-01-24. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-40:2025 E

European foreword
The text of document 62D/2168/FDIS, future edition 3 of IEC 60601-2-40, prepared by SC 62D
"Particular medical equipment, software, and systems" of IEC/TC 62 "Medical equipment, software,
and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-02-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-02-29
document have to be withdrawn
This document supersedes EN 60601-2-40:2019 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-2-40:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-1-3 NOTE Approved as EN 60601-1-3
IEC 60601-1-8 NOTE Approved as EN 60601-1-8
IEC 60601-1-10 NOTE Approved as EN 60601-1-10
IEC 60601-2-2 NOTE Approved as EN IEC 60601-2-2
IEC 60601-2-10 NOTE Approved as EN 60601-2-10
IEC 60645-3 NOTE Approved as EN IEC 60645-3
IEC 62368-1 NOTE Approved as EN IEC 62368-1
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1  Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2  Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Annex ZA of EN 60601-1:2006 , applies, except as follows:
Add:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + AC 2010
+ A1 2012 + A1 2013
- - + AC 2014
- - + A12 2014
+ A2 2020 + A2 2021
- - + AC 2022
- - + A13 2024
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
IEC 60318 series Electroacoustics - Simulators of human EN 60318 series
head and ear
ISO 15004-2 - Ophthalmic instruments - Fundamental EN ISO 15004-2 -
requirements and test methods - Part 2:
Light hazard protection
As impacted by EN 60601-1:2006/AC:2010, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A1:2013/AC:2014,
EN 60601-1:2006/A12:2014, EN 60601-1:2006/A2:2021, EN 60601-1:2006/AC:2022-12 and
EN 60601-1:2006/A13:2024.
IEC 60601-2-40 ®
Edition 3.0 2024-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-40: Particular requirements for the basic safety and essential performance

of electromyographs and evoked response equipment

Appareils électromédicaux –
Partie 2-40: Exigences particulières pour la sécurité de base et les performances

essentielles des électromyographes et des appareils à potentiel évoqué

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.20; 11.040.55; 11.040.99 ISBN 978-2-8327-0033-4

– 2 – IEC 60601-2-40:2024 © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
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 . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 14
201.11 Protection against excessive temperatures and other HAZARDS . 14
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 ELECTROMAGNETIC compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 18
Annexes . 22
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 22
Annex AA (informative) Particular guidance and rationale . 23
Bibliography . 29
Index of defined terms used in this particular standard . 30

Figure AA.1 – Suggested cable layout for EMISSION and radiated IMMUNITY testing . 26
Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 27
Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 28

Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 19
Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 20
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 21
Table 202.104 – Pass/fail criteria for Table 5, Table 6, Table 9 of IEC 60601-1-2:2014
and IEC 60601-1-2:2014/AMD1:2020 . 21
Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
RESPONSE EQUIPMENT or its parts . 22

IEC 60601-2-40:2024 © IEC 2024 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-40: Particular requirements for the basic safety and
essential performance of electromyographs and
evoked response equipment
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 Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely 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
...