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AAMI ISO 14971 : 2007 : R2010現(xiàn)行

MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

出版：Association for the Advancement of Medical Instrumentation

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基本信息
標(biāo)準(zhǔn)編號(hào)： AAMI ISO 14971 : 2007 : R2010
標(biāo)準(zhǔn)類(lèi)別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標(biāo)準(zhǔn)頁(yè)數(shù)：0
標(biāo)準(zhǔn)簡(jiǎn)介

Describes a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

等同采用的國(guó)際標(biāo)準(zhǔn)

ISO 14971 : 2007(R2010) - Identical