DS DS/EN 50103 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
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DS DS/EN 50103 Document Information:
Title
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
Guide til anvendelse af EN 29001 og EN 46001 og af EN 29002 og EN 46002 i virksomheder, der producerer aktivt medicinsk udstyr (herunder aktivt implantabelt)
Dansk Standard
Publication Date:
Aug 21, 1996
Scope:
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.
Keywords:
- MEDICAL ELECTRICAL EQUIPMENT
- ACTIVE MEDICAL DEVICE
- QUALITY SYSTEM
- QUALITY ASSURANCE
- MANUFACTURING
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