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.