AS EN 12442.1

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