DIN Standards Committee Optics and Precision Mechanics
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Abstract
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.
Begin
2024-11-11
WI
00206110
Planned document number
DIN EN ISO 22442-3 rev
Project number
02703459
Responsible national committee
NA 027-05-10 AA - Medical devices utilizing tissues
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194 - Biological and clinical evaluation of medical devices
