Standard Number: YY/T 0316-2016(YY/T0316-2016)
Chinese:医疗器械 风险管理对医疗器械的应用
English:Medical devices Application of risk management to medical devices
Effective Date:2017-01-01
ICS:11.040.01
Standard Applicability:This standard specifies the process requirements for analyzing, evaluating, controlling and monitoring the risks of medical devices. This standard applies to the risk management of medical devices at all stages of the life cycle. This standard replaces YY/T 0316-2008 “Application of medical device risk management to medical devices”.
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