ISO 22442-3

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 (December 15, 2007).

BioScience Laboratories provides a scale-down testing per ISO 22442-3 to meet ICH Guideline “Q5A Viral Safety Evaluation of Biotechnology Product Derived From Cell Lines of Human or Animal Origin”. ISO 22442-3 specifies testing 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 is non-viable or has been rendered non-viable.

Virology Testing Laboratory

Nelson Labs can assist with new product development, R&D projects, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabilities with ov...