AS EN 12442.1

AS EN 12442.1

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Animal tissues and their derivatives utilized in the manufacture of medical devices, Part 1: Analysis and management of risk

Published by Publication Date Number of Pages
AS 01/01/2003

 17
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Description

AS EN 12442.1 – Animal tissues and their derivatives utilized in the manufacture of medical devices, Part 1: Analysis and management of risk

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.

Product Details

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
Note:
This product is unavailable in Ukraine, Russia, Belarus

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