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EVS-EN 50103:2001

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry

General information
Withdrawn from 06.11.2009
Base Documents
EN 50103:1995
Directives or regulations
None

Standard history

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Date
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The guidelines contained in this European Standard are applicable to a quality system as specified by EN 29001 and EN 46001 or 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a supplier's quality system. The guidelines provide concepts and objectives which should be considered by a supplier of active medical devices while developing and maintaining his quality system.
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