ISO13485:2016质量体系术语变化

Iso13485:2016 quality system terminology changes

1、新标准中保留了老版标准中的忠告性通知、植入性医疗器械、标记、医疗器械及无菌医疗器械5个术语，同时细化了标记与医疗器械术语，修改顾客抱怨为抱怨；

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、新标准中删除了有源植入性医疗器械及有源医疗器械2个术语；

2. Two terms of active implantable medical device and active medical device are deleted in the new standard;

3、新标准中新增了医疗器械族、风险、风险管理、性能评价、上市后监督等13个术语。

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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