风险管理与医疗器械标准

Risk Management and Medical Device Standard

随着IEC60601-1:2005版标准的发布,国际标准组织已经开始把风险管理的概念引入到医疗器械的标准化工作中。越来越多新发布的国际标准引入了风险管理的内容。这似乎是国际医疗器械标准发展的新趋势。如何看待并理解这个趋势成为今后医疗器械制造和监管需要考虑的内容。

With the publication of IEC60601-1：2005,the international standard organization began to introduce the concept of Risk Management into standardization of medical devices. More and more new international standards had introduce the risk management requirements. This will be the new development trend of the international medical device standards. So how to regard and understand this trend becomes the consideration to the medical device manufactures and supervisors.