医疗器械风险分析方法的介绍与应用展望

Introduction and Application Prospect of Risk Analysis Methods for Medical Devices

本文根据ISO14971:2000介绍的风险分析方法,归纳了当前国际医疗器械行业用于分析与医疗器械及其使用有关的风险的主要方法,分析了国际上对这些方法使用及其研究的主要进展,讨论了不同类型分析方法的过程机理、影响因素及其可能的应用。在此基础上,本文还对在我国开展和加强医疗器械风险分析技术的研究前景进行了展望。

Based on risk analysis methods introduced by ISO 14971, this article summarizes the main methods currently used to analyze the risks associated with medical devices and their uses in international medical device industry. As well it presents the important global evolutions for the use and study of the risk analysis methods. The article discusses the different types, process mechanism, contributing factors and potential area of use（s） of those methods, and is designed to help the user select the appropriate method or combination of methods. On this basis, it makes the prospects about how to develop and enhance the research on methods or risk analysis for medical device for Chinese manufacturers and regulation authorities.