99.60 Withdrawal effective Dec 15, 2009
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100 Laboratory medicine
This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
NOTE 2 This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.
Legislation related to this standard
WITHDRAWN
EN 592:1994
WITHDRAWN
EN 592:2002
99.60
Withdrawal effective
Dec 15, 2009
WITHDRAWN
EN ISO 18113-5:2009