IEC 60601-2-40:2016

IEC 60601-2-40 ®
Edition 2.0 2016-08
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

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IEC 60601-2-40 ®
Edition 2.0 2016-08
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 978-2-8322-3592-8

– 2 – IEC 60601-2-40:2016  IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
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 . 14
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 16
201.15 Construction of ME EQUIPMENT . 17
201.16 ME SYSTEMS . 17
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 17
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 17
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 test layout for EMISSION and 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 . 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 . 20
Table 201.C.101 – Marking on the outside of ELECTROMYOGRAPHS and EVOKED
RESPONSE EQUIPMENT or its parts . 22

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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International Standard IEC 60601-2-40 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and r
...