99.60 Withdrawal effective Jun 8, 2005
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100 Laboratory medicine
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.
Legislation related to this standard
WITHDRAWN
EN 928:1995
99.60
Withdrawal effective
Jun 8, 2005