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
专家解读视频
基本信息
标准编号： 99/563585 DC : DRAFT JULY 1999
标准类别：Draft
出版单位：British Standards Institution
标准页数：0
标准简介
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.
替代本标准的新标准
