60.60 Standard published Dec 15, 2007
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
Legislation related to this standard
WITHDRAWN
EN 12442-3:2000
PUBLISHED
EN ISO 22442-3:2007
60.60
Standard published
Dec 15, 2007
IN_DEVELOPMENT
prEN ISO 22442-3 rev