AS EN 12442.1-2003
- Animal tissues and their derivatives utilized in the manufacture of medical devices - Analysis and management of risk
- standard by Standards Australia, 01/01/2003
- Category: AS
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Specifies 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). This Standrad 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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