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BS EN 928:1996- Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

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This European 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. The guidance given is not intended to be exhaustive, but to highlight important aspects to which attention should be drawn.
Contributor(s):
NAAR - Data Entry Person
Primary Item Type:
British Standard
Identifiers:
ICS 11.100.10 In vitro diagnostic test systems
ISBN 0580257460
Language:
English
Subject Keywords:
Process control; Management; Product design; Quality assurance; Conformity; Quality assurance systems; Inspection; Medical equipment; Quality; Documents; Records (documents); Clinical investigation instruments; Verification
First presented to the public:
1/3/2023
Original Publication Date:
6/15/1996
Previously Published By:
British Standards Institution
Place Of Publication:
London, United Kingdom
Citation:
Extents:
Number of Pages - 12
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2023-01-03 14:33:44.506
Submitter:
Nurul Aini Abdul Rahman

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Thumbnail Name Version Created Date
BS EN 928:1996- Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices1 2023-01-03 14:33:44.506
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