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AS/NZS 4810.1:2000

$33.80

Medical devices – Risk management – Application of risk analysis

Published By Publication Date Number of Pages
AS 2000-05-18 25
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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.

AS/NZS 4810.1:2000
$33.80