
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
出版:South African Bureau of Standards

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基本信息
标准编号: SANS 14971 : 2ED 2008(R2014)
标准类别:Standard
出版单位:South African Bureau of Standards
标准页数:0
标准简介
Defines 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.