EN 60601-2-10:2000/A1:2001
(Amendment)Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
EN following parallel vote
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
Medicinska električna oprema - 2-10. del: Posebne varnostne zahteve za živčne in mišične stimulatorje - Dopolnilo A1 (IEC 60601-2-10:1987/A1:2001)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2002
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQHYDUQRVWQH]DKWHYH]DåLYþQHLQ
PLãLþQHVWLPXODWRUMH'RSROQLOR$ ,(& $
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve
and muscle stimulators (IEC 60601-2-10:1987/A1:2001)
Medizinische elektrische Geräte - Teil 2-10: Besondere Festlegungen für die Sicherheit
von Geräten zur Stimulation von Nerven und Muskeln (IEC 60601-2-10:1987/A1:2001)
Appareils électromédicaux - Partie 2-10: Règles particulières de sécurité pour
stimulateurs de nerfs et de muscles (CEI 60601-2-10:1987/A1:2001)
Ta slovenski standard je istoveten z: EN 60601-2-10:2000/A1:2001
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60601-2-10/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2001
ICS 11.040.60
English version
Medical electrical equipment
Part 2-10: Particular requirements for the safety
of nerve and muscle stimulators
(IEC 60601-2-10:1987/A1:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-10: Règles particulières Teil 2-10: Besondere Festlegungen
de sécurité pour stimulateurs für die Sicherheit von Geräten
de nerfs et de muscles zur Stimulation von Nerven und Muskeln
(CEI 60601-2-10:1987/A1:2001) (IEC 60601-2-10:1987/A1:2001)
This amendment A1 modifies the European Standard EN 60601-2-10:2000; it was approved by
CENELEC on 2001-11-01. CENELEC members are bound to comply with the CEN/CENELEC Internal
Regulations which stipulate the conditions for giving this amendment 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 amendment 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, Malta, 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
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-10:2000/A1:2001 E
Foreword
The text of document 62D/413/FDIS, future amendment 1 to IEC 60601-2-10:1987, prepared by
1)
SC 62D , Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was
submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as amendment A1 to
EN 60601-2-10:2000 on 2001-11-01.
The following dates were fixed:
– latest date by which the amendment has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-08-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2004-11-01
__________
Endorsement notice
The text of amendment 1:2001 to the International Standard IEC 60601-2-10:1987 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
)
The foreword of EN 60601-2-10:2000 mistakenly indicated SC 62C as the technical body that drafted the text of
the International Standard.
INTERNATIONAL IEC
STANDARD
60601-2-10
AMENDMENT 1
2001-09
Amendment 1
Medical electrical equipment –
Part 2-10:
Particular requirements for the safety
of nerve and muscle stimulators
Amendement 1
Appareils électromédicaux –
Partie 2-10:
Règles particulières de sécurité
pour stimulateurs de nerfs et de muscles
IEC 2001 Copyright - all rights reserved
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
Commission Electrotechnique Internationale
PRICE CODE
J
International Electrotechnical Commission
For price, see current catalogue
– 2 – 60601-2-10 Amend. 1 IEC:2001(E)
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/413/FDIS 62D/420/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
The committee has decided that the contents of the base publication and its amendments will
remain unchanged until 2004. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
The contents of the corrigendum of January 2002 have been included in this copy.
_____________
Page 5
PREFACE
Replace the final two paragraphs of the Preface with the following new text:
A rationale for the more important requirements, where appropriate, is given in annex AA. It is
considered that a knowledge of the reasons for these requirements will not only facilitate the
proper application of the Particular Standard but will, in due course, expedite any revision
necessitated by changes in clinical practice or as a result of developments in technology.
However this annex does not form part of the requirements of this standard.
The clauses and subclauses which have corresponding rationale statements are marked with
an asterisk (*) before their number.
The numbers of the following clauses should be preceded by an asterisk in the main body of
the text:
1.1, 5.2, 5.6, 6.1, 6.8.2 aa), 14.6, 19, 20.2, 46.101, 50.1, 50.2, 51.101, 51.102, 50.103, 51.104,
57.3
60601-2-10 Amend. 1 IEC:2001(E) – 3 –
SECTION ONE – GENERAL
Page 7
1 Scope and object
1.1 Scope
th
At the end of the 4 dashed item add: (partly covered by IEC 60601-2-31)
th
At the end of the 7 dashed item add: (covered by IEC 60601-2-40)
th
At the end of the 8 dashed item add: (covered by IEC 60601-2-40)
Add the following subclauses:
1.3 Particular Standards
Add the following new text:
This Particular Standard for NERVE AND MUSCLE STIMULATORS is to be read in conjunction with
the following standard:
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
The requirements of this Particular Standard take priority over the above-mentioned standard
and its amendments, hereinafter referred to as the General Standard.
1.5 Collateral Standards
Add the following new text:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment – Part 1-1: General requireme
...
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