EN 60601-2-10:2000

Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

Specifies particular requirements for the safety of electrical stimulators of muscles and nerves in the specialized practice of physical medicine. It excludes stimulators used with implanted electrodes, brain stimulation, neurological research, cardiac pacemakers, defibrillators and other surgical procedures.

Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit von Geräten zur Stimulation von Nerven und Muskeln

Appareils électromédicaux - Partie 2-10: Règles particulières de sécurité pour stimulateurs de nerfs et de muscles

Spécifie les règles particulières de sécurité des stimulateurs des nerfs et des muscles utilisés dans la pratique spécialisée de la médecine physique. (En sont exclus les stimulateurs utilisés avec des électrodes implantées, les stimulateurs du cerveau ou du coeur, la recherche neurologique, les implants, les défibrillateurs et autres procédés chirurgicaux.)

Medicinska električna oprema - 2-10. del: Posebne varnostne zahteve za živčne in mišične stimulatorje (IEC 60601-2-10:1987)

General Information

• Status: Withdrawn
• Publication Date: 12-Nov-2000
• Withdrawal Date: 13-May-2001
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 11.040.60 - Therapy 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: 22-May-2018
• Completion Date: 22-May-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: 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 60601-2-10:2002 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators

Relations

• Replaces: HD 395.2.10 S1:1989 - Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 29-Jan-2023
• Replaced By: EN 60601-2-10:2015 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-10:2000/A1:2001 - Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-10:2002
01-februar-2002
1DGRPHãþD
SIST HD 395.2.10 S1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DåLYþQHLQ
PLãLþQHVWLPXODWRUMH,(&
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve
and muscle stimulators
Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit
von Geräten zur Stimulation von Nerven und Muskeln
Appareils électromédicaux - Partie 2-10: Règles particulières de sécurité pour
stimulateurs de nerfs et de muscles
Ta slovenski standard je istoveten z: EN 60601-2-10:2000
ICS:
11.040.60 Terapevtska oprema Therapy equipment
SIST EN 60601-2-10:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-10:2002

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SIST EN 60601-2-10:2002
EUROPEAN STANDARD EN 60601-2-10
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2000

ICS 11.040.55; 11.040.60 Supersedes HD 395.2.10 S1:1989


English version


Medical electrical equipment
Part 2-10: Particular requirements for the safety of
nerve and muscle stimulators
(IEC 60601-2-10:1987)


Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-10: Règles particulières Teil 2-10: Besondere Festlegungen
de sécurité pour stimulateurs de nerfs für die Sicherheit von Geräten zur
et de muscles Stimulation von Nerven und Muskeln
(CEI 60601-2-10:1987) (IEC 60601-2-10:1987)






This European Standard was approved by CENELEC on 2000-04-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,
Portugal, Spain, Sweden, Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2000 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

  Ref. No. EN 60601-2-10:2000 E

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SIST EN 60601-2-10:2002
Page 2
EN 60601-2-10:2000
Foreword
The text of the International Standard IEC 60601-2-10:1987, prepared by SC 62C, Equipment for
radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical
practice, was approved by CENELEC as HD 395.2.10 S1 on 1988-09-13.
This Harmonization Document was submitted to the formal vote for conversion into a European Standard
and was approved by CENELEC as EN 60601-2-10 on 2000-04-01.
The following date was fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2001-04-01
__________
Endorsement notice
The text of the International Standard IEC 60601-2-10:1987 was approved by CENELEC as a European
Standard without any modification.
__________

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SIST EN 60601-2-10:2002
CEI
NORME
IEC
INTERNATIONALE
601-2-10
INTERNATIONAL
Première édition
STANDARD
First edition
1987
Appareils électromédicaux
Deuxième partie:
Règles particulières de sécurité
pour stimulateurs de nerfs et de muscles
Medical electrical equipment
Part 2:
Particular requirements for the safety
of nerve and muscle stimulators
Copyright — all rights reserved
© CEI 1987 Droits de reproduction réservés —
of this publication may be reproduced or utilized in
Aucune partie de cette publication ne peut être reproduite ni No part
any form or by any means, electronic or mechanical,
utilisée sous quelque forme que ce soit et par aucun pro-
including photocopying and microfilm, without permission
cédé, électronique ou mécanique, y compris la photocopie et
in writing from the publisher.
les microfilms, sans l'accord écrit de l'éditeur.
Genève, Suisse
Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé
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Intern
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