AS/NZS 4810.1:2000废止
Medical devices - Risk management Application of risk analysis
出版：Standards Australia
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基本信息
标准编号： AS/NZS 4810.1:2000
发布时间：2000/5/18 0:00:00
标准类别：Standard
出版单位：Standards Australia
标准页数：17
标准简介
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.
本标准替代的旧标准
等同采用的国际标准
ISO 14971-1:1998 - Identical
