
Medical Devices Utilizing Animal Tissues And Their Derivatives - Part 1: Application Of Risk Management
出版:Danish Standards

专家解读视频
Pertains to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It also defines, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
EN ISO 22442-1:2015 - Identical