90.93 Standard confirmed Sep 14, 2022
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
11.100.20 Biological evaluation of medical devices
Published
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.
PUBLISHED
ISO 22442-3:2007
90.93
Standard confirmed
Sep 14, 2022