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
inactive, Most Current
| Organization: | DS |
| Publication Date: | 21 August 1996 |
| Status: | inactive |
| Page Count: | 32 |
| ICS Code (Quality management and quality assurance): | 03.120.10 |
| ICS Code (Medical equipment in general): | 11.040.01 |
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.
Document History
DS/EN 50103
August 21, 1996
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
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...
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