ISO13485:2016质量体系术语变化 发布时间: 2020-10-02 12:14
Iso13485:2016 quality system terminology changes
1. The new standard retains the five terms of advisory notice, implantable medical device, label, medical device and sterile medical device in the old version of the standard, and refines the terms of marking and medical device, and modifies customer complaint into complaint;
2. Two terms of active implantable medical device and active medical device are deleted in the new standard;
3. In the new standard, 13 terms such as medical device family, risk, risk management, performance evaluation and post marketing supervision are added.
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