DR 03114 CP
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Animal tissues and their derivatives utilized in the manufacture of medical devices Part 1: Analysis and management of risk
26-10-2017
28-02-2003
Proposes a procedure to investigate, using available information, the safety of medical devices by identifying hazards and estimating the risks associated with the device (risk analysis). EN 12442.1 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 have been rendererd non-viable.
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