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AS EN 12442.1-2003

M00004384

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AS EN 12442.1-2003 [ Withdrawn ] Animal tissues and their derivatives utilized in the manufacture of medical devices, Part 1: Analysis and management of risk

standard by Standards Australia, 01/01/2003

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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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Edition: 1st Published: 01/01/2003 ISBN(s): 0733753671 Number of Pages: 17 File Size: 1 file , 280 KB Product Code(s): 10089813, 10089829, 10089867