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
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.
Appareils électromédicaux - Partie 2-40: Exigences particulières pour la sécurité de base et les performances essentielles des électromyographes et des appareils à potentiel évoqué
L'IEC 60601-2-40:2024 s'applique à la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ELECTROMYOGRAPHES et des APPAREILS A POTENTIEL EVOQUE, désignés ci-après sous le terme APPAREILS EM.
Les APPAREILS EM suivants sont exclus de la liste:
- APPAREILS EM destinés à une application thérapeutique;
- APPAREILS EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs musculaires électriques (APPAREILS EM couverts par l'IEC 60601-2-10).
L'IEC 60601-2-40:2024 annule et remplace la deuxième édition parue en 2016. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) des exigences relatives aux stimulateurs à tension constante ont été ajoutées;
b) des exigences relatives aux STIMULATEURS VISUELS ont été clarifiées.
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IEC 60601-2-40 ®
Edition 3.0 2024-12
REDLINE VERSION
INTERNATIONAL
STANDARD
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INTERNATIONALE
colour
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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
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IEC 60601-2-40 ®
Edition 3.0 2024-12
REDLINE VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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 978-2-8327-0122-5
– 2 – IEC 60601-2-40:2024 RLV © IEC 2024
CONTENTS
FOREWORD . 3
INTRODUCTION . 2
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 11
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 . 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 15
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 15
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 ELECTROMAGNETIC compatibility of ME EQUIPMENT and ME SYSTEMS . 19
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 19
Annexes . 24
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 24
Annex AA (informative) Particular guidance and rationale . 25
Bibliography . 31
Index of defined terms used in this particular standard . 32
Figure AA.1 – Suggested test cable layout for EMISSION and radiated IMMUNITY testing. 28
Figure AA.2 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 29
Figure AA.3 – Example of test setup for protection against the effects of HF SURGICAL
ME EQUIPMENT . 30
Table 202.101 – Pass/fail criteria for Table 4 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 21
Table 202.102 – Pass/fail criteria for Table 7 of IEC 60601-1-2:2014 . 22
Table 202.103 – Pass/fail criteria for Table 8 of IEC 60601-1-2:2014 and IEC 60601-1-
2:2014/AMD1:2020 . 23
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 . 23
Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
RESPONSE EQUIPMENT or its parts . 24
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
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