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90.60 Close of review Jun 4, 2019
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.140 Hospital equipment
Published
for labelling and the disclosure of information relevant to the test methods used. This European Standard applies to existing, new and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period of time. This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Legislation related to this standard
PUBLISHED
EN 455-4:2009
90.60
Close of review
Jun 4, 2019