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AAMI 14971 1:1999被替代

Medical Devices - Risk Management - Part 1: Application Of Risk Analysis

出版：Association for Advancement of Medical Instrumentation

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基本信息
標(biāo)準(zhǔn)編號(hào)： AAMI 14971 1:1999
發(fā)布時(shí)間：1999/1/1 0:00:00
標(biāo)準(zhǔn)類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標(biāo)準(zhǔn)頁(yè)數(shù)：16
標(biāo)準(zhǔn)簡(jiǎn)介

Defines a method for the investigation, using available information, of the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. Possibly of particular assistance in areas where relevant standards are not available or are not used.

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

AAMI ISO 14971 : 2007

AAMI ISO 14971:2007 (R2016)

等同采用的國(guó)際標(biāo)準(zhǔn)

ISO 14971-1:1998 - Identical

ISO 14971-1 : 1998 - Identical

ISO 14971-1 : 1998 - Identical