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EN 60601-1-6:2007

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability EN 60601-1-6:2007

Publication date:   Mar 28, 2008

General information

99.60 Withdrawal effective   Apr 1, 2013

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical equipment

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Scope

Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-1-6:2004

NOW

WITHDRAWN
EN 60601-1-6:2007
99.60 Withdrawal effective
Apr 1, 2013

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 60601-1-6:2007/corrigendum Mar. 2010

REVISED BY

PUBLISHED
EN 60601-1-6:2010