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EN 60601-2-40:1998

(Main)

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

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

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit von Elektromyographen und Geräten für evozierte Potentiale

Appareils électromédicaux - Partie 2-40: Règles particulières de sécurité pour les électromyographes et les appareils à potentiel évoqué

Etablit des règles particulières de sécurité pour les électromyographes et les appareils à potentiel évoqué définis à l'article 2 de cette norme.

Medicinska električna oprema - 2-40. del: Posebne varnostne zahteve za elektromiografe in opremo za izzvane odzive (IEC 60601-2-40:1998)

General Information

Status
Withdrawn
Publication Date
13-Apr-1998
Withdrawal Date
31-Dec-2000
ICS
11.040.50 - Radiographic equipment
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62D - IEC_SC_62D
Parallel Committee
IEC/SC 62D - IEC_SC_62D
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
11-Jan-2022
Completion Date
11-Jan-2022
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
Ref Project
SIST EN 60601-2-40:1998 - Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998)

Relations

Replaced By
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-Jun-2022

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SLOVENSKI STANDARD
SIST EN 60601-2-40:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
HOHNWURPLRJUDIHLQRSUHPR]DL]]YDQHRG]LYH ,(&
Medical electrical equipment - Part 2-40: Particular requirements for the safety of
electromyographs and evoked response equipment (IEC 60601-2-40:1998)
Medizinische elektrische Geräte - Teil 2-40: Besondere Festlegungen für die Sicherheit
von Elektromyographen und Geräten für evozierte Potentiale (IEC 60601-2-40:1998)
Appareils électromédicaux - Partie 2-40: Règles particulières de sécurité pour les
électromyographes et les appareils à potentiel évoqué (CEI 60601-2-40:1998)
Ta slovenski standard je istoveten z: EN 60601-2-40:1998
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-40:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998

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SIST EN 60601-2-40:1998
NORME CEI
INTERNATIONALE IEC
60601-2-40
INTERNATIONAL
Première édition
STANDARD
First edition
1998-02
Appareils électromédicaux –
Partie 2-40:
Règles particulières de sécurité pour
les électromyographes et les appareils
à potentiel évoqué
Medical electrical equipment –
Part 2-40:
Particular requirements for the safety
of electromyographs and evoked
response equipment
 IEC 1998 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
PRICE CODE Q
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

---------------------- Page: 7 ----------------------

SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 3 –
CONTENTS
Page
FOREWORD . 7
INTRODUCTION . 9
SECTION ONE: GENERAL
Clause
1 Scope and object . 11
2 Terminology and definitions. 13
5 Classification . 15
6 Identification, marking and documents. 15
7 Power input. 19
SECTION TWO: ENVIRONMENTAL CONDITIONS
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification . 21
20 Dielectric strength . 21
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility . 21
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures . 25
46 Human errors . 25

---------------------- Page: 8 ----------------------

SIST EN 60601-2-40:1998
60601-2-40 © IEC:1998 – 5 –
Pages
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data .
...

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