EN 12442-1:2000

Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 1: Analysis and management of risk EN 12442-1:2000

Publication date:   Jan 22, 2004

Scope

This part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are 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).

Related legislation

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