SR EN 60601-1-6:2007

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

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.

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General information

Status : Withdrawn
Approval date : 12/14/2007
Publish date : 12/16/2007
Withdrawal date : 4/1/2013
Number of pages : 153
ICS : 11.040 Medical equipment
Technical Committee : 22 - Electrical equipment in medical practice

Relations with other standards:

Replaces SR EN 60601-1-6:2005
Replaced by SR EN 60601-1-6:2010