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AS/NZS 4810.1:2000 [ Withdrawn ]

Medical devices - Risk management, Part 1: Application of risk analysis

standard by Standards Australia / Standards New Zealand , 05/18/2000

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Full 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:
05/18/2000
ISBN(s):
0733733190
Number of Pages:
17
File Size:
1 file , 760 KB
Product Code(s):
10142779, 10142771, 10142783
Note:
This product is unavailable in Ukraine, Russia, Belarus