AS/NZS 4810.1:2000
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical devices - Risk management Application of risk analysis
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
04-27-2018
English
05-18-2000
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.
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