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SRPS EN 60601-1-6:2009

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

Apr 27, 2009
95.99 Withdrawal of Standard   Mar 31, 2011

General information

95.99     Mar 31, 2011

ISS

N062

European Norm

11.040  

English  

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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 directives

Directives related to this standard.

93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

WITHDRAWN
SRPS EN 60601-1-6:2009
95.99 Withdrawal of Standard
Mar 31, 2011

REVISED BY

PUBLISHED
SRPS EN 60601-1-6:2011

Related project

Adopted from EN 60601-1-6:2007

Regulation

"Сл. гласник РС" бр. 92/2020 Правилник о боверавању мерних уређаја који су саставни део неонаталних и педијатријских инкубатора и реанимационих топлих столова