原文 Introduction of a Formal Risk Management Process Risk management is inextricably woven into the fabric of the third edition. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 but there are also more than 100 times where the standard directs manufacturers to determine risk acceptability in applying a particular requirement. 试译 正式风险管理过程的介绍 风险管理跟第三版的内容是密不可分的。 它不仅是制造厂建立ISO14971的风险管理过程时 ，需符合的总体要求，同时也是针对某些特定要求时，这标准指引制造商去设定风险接受 度的100倍以上。 问题 : 想问一下, 这里的 100 times 是指 100 倍吗, 还是指 困难度多了 100 倍? 谢谢 --

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