Medical devices utilising animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
This Malaysian Standard 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 standard 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 standard is intended to clarify standards included in the MS ISO 22442 series, as well as in MS ISO 14160. This standard builds upon the specific discussion in MS ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination.
Published
• (none) / (none) / (none)
PDF
17/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
