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AS/NZS 4810.1:2000廢止

Medical devices - Risk management Application of risk analysis

出版：Standards Australia

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基本信息
標(biāo)準(zhǔn)編號(hào)： AS/NZS 4810.1:2000
發(fā)布時(shí)間：2000/5/18 0:00:00
標(biāo)準(zhǔn)類(lèi)別：Standard
出版單位：Standards Australia
標(biāo)準(zhǔn)頁(yè)數(shù)：17
標(biāo)準(zhǔn)簡(jiǎn)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.

本標(biāo)準(zhǔn)替代的舊標(biāo)準(zhǔn)

DR 99069 CP

等同采用的國(guó)際標(biāo)準(zhǔn)

ISO 14971-1:1998 - Identical