90.92 Standard to be revised Oct 29, 2024
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
International Standard
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.
PUBLISHED
ISO 22442-3:2007
90.92
Standard to be revised
Oct 29, 2024
IN_DEVELOPMENT
ISO/AWI 22442-3