99/563585 DC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
標準編號： 99/563585 DC
發布時間：1999/7/5 0:00:00
標準類別：Draft
出版單位：British Standards Institution
標準頁數：32
標準簡介
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.
標準備注
? British Standards Institution 2013
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