Description

Specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. Does not stipulate levels of acceptability nor is it intended to give guidance on all aspects of management of risks. This Standard is identical with and has been reproduced from ISO 14971-1:1998.

Product Details

Edition:

1st

Published:

01/01/2000

ISBN(s):

0733733190

Number of Pages:

17

File Size:

1 file , 760 KB

Product Code(s):

10142779, 10142771, 10142783