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 (ISO 22442-3:2007, IDT)
This Malaysian Standard 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 MS ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
This standard does not consider the effect of any method of elimination and/or inactivation on the suitability of the medical device for its intended use.
Published
• (none) / (none) / (none)
PDF
22/01/2021
34
NSC 18 - Medical Devices and Facilities for Healthcare
