prEN IEC 60601-2-40:2023

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

General Information

• Status: Not Published
• Publication Date: 07-Oct-2024
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 4060 - Enquiry results established and sent to TC, SR, BTTF - Enquiry
• Start Date: 09-Jun-2023
• Completion Date: 09-Jun-2023
• Ref Project: oSIST prEN IEC 60601-2-40:2023 - Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

Relations

• Revises: EN 60601-2-40:2019 - Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
• Effective Date: 07-Sep-2021

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.

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oSIST prEN IEC 60601-2-40:2023

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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

Copyright © 2023 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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.

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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.

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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 .
...