99.60 Withdrawal effective Jun 3, 2009
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100 Laboratory medicine
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or trough diffusion a) with extracts of a device , and/or b) in contact with a device. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
Legislation related to this standard
WITHDRAWN
EN 30993-5:1994
WITHDRAWN
EN ISO 10993-5:1999
99.60
Withdrawal effective
Jun 3, 2009
PUBLISHED
EN ISO 10993-5:2009