DS/EN 928
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
inactive, Most Current
| Organization: | DS |
| Publication Date: | 28 November 1995 |
| Status: | inactive |
| Page Count: | 14 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
This Standard provides guidance on the implementation of EN 29001 and EN 46001 and of EN 29002 and EN 46002 as applied to the manufacturer of IVDs. It is aimed at affording a better understanding of the standards themselves as well as assistance in their use, either in implementing or evaluating such a quality system.
Document History
DS/EN 928
November 28, 1995
In vitro diagnostic systems - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
This Standard provides guidance on the implementation of EN 29001 and EN 46001 and of EN 29002 and EN 46002 as applied to the manufacturer of IVDs. It is aimed at affording a better understanding of...
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