1 Scope
This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs).
The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues.
This Technical Report does not intend to imply a need for validation of methods involving specific materials identified as having a “negligible risk” of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007.
This Technical Report is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160.
This Technical Report builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.