一、前言多年来的实践表明 :为了保证医疗器械的安全、有效 ,并促进国际合作与发展 ,减少贸易壁垒 ,需要有一个世界多国公认的对医疗器械的基本要求或基本原则 ,并且 ,为了判断医疗机构对基本原则的符合性 ,还要提供一个相关标准的适用指南 ,经过各有关国家和地区的共同努力 , I. Preface The practice over the years has shown that: In order to ensure the safety and effectiveness of medical devices, and to promote international cooperation and development and reduce trade barriers, it is necessary to have a basic requirement or basic principle for medical devices recognized by many countries around the world. The conformity of medical institutions to the basic principles, but also to provide guidance on the application of relevant standards, through joint efforts of all relevant countries and regions,