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99/563585 DC : DRAFT JULY 1999被替代

EN ISO 14971 - MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

出版：British Standards Institution

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基本信息
標(biāo)準(zhǔn)編號(hào)： 99/563585 DC : DRAFT JULY 1999
標(biāo)準(zhǔn)類別：Draft
出版單位：British Standards Institution
標(biāo)準(zhǔn)頁(yè)數(shù)：0
標(biāo)準(zhǔn)簡(jiǎn)介

Defines a procedure for manufacturers to identify the hazards concerned with medical devices and accessories, including in vitro diagnostic devices, to evaluate and estimate and control the risks, and monitor the control effectiveness. Applies to all stages of a medical device';s lifestyle, but not to clinical judgements regarding its use or to acceptable risk levels.

替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)

BS EN ISO 14971 : 2012