IEC 60601-2-40:2016

Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

IEC 60601-2-40:2016 applies to the basic safety and essential performance of electromyographs and evoked response equipment, hereafter referred to as ME equipment. ME equipment intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are excluded (covered by IEC 60601-2-10). This second edition cancels and replaces the first edition of IEC 60601-2-40 published in 1998. This edition constitutes a technical revision.

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 60601-2-40:2016 s'applique à la sécurité de base et aux performances essentielles des électromyographes et des appareils à potentiel évoqué, désignés ci-après par appareils EM. Les appareils EM destinés à être utilisés avec les neurostimulateurs électriques transcutanés et les stimulateurs de muscles électriques sont exclus (couverts par l'IEC 60601-2-10). Cette deuxième édition annule et remplace la première édition de l'IEC 60601-2-40 parue en 1998. Cette édition constitue une révision technique.

General Information

• Status: Published
• Publication Date: 17-Aug-2016
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 26 - TC 62/SC 62D/MT 26
• Current Stage: PPUB - Publication issued
• Start Date: 15-Oct-2016
• Completion Date: 18-Aug-2016

Relations

• Revises: IEC 60601-2-40:1998 - Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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
...