scope:

Applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, non-viable or rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate, using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis). This part is intended to provide requirements and guidance on risk analysis related to the typical hazards of medical devices manufactured utilizing aninmal tissues or derivatives such as a) contamination by bacteria, moulds or yeasts; b) contamination by viruses or transmissible agents such as pathogenic entities, or agents causing spongiform encephalopathies prions and similar entities (e.g. BSE, scrapie); c) undesired pyrogenic, immunological or toxicological reactions.