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AS/NZS 4810.1 PDF
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Medical devices – Risk management, Part 1: Application of risk analysis
| Published by | Publication Date | Number of Pages |
| AS/NZS | 05/18/2000 | 17 |
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AS/NZS 4810.1 – Medical devices – Risk management, Part 1: Application of risk analysis
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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