EN 928:1995

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 EN 928:1995

Publication date:   Jan 22, 2004

Scope

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 its use, either 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. The adoption of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the particular requirements in EN 46001 and EN 46002.

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