众所周知 ,医疗器械种类繁多 ,原理结构千差万别 ,涉及电子工程、微电子技术、计算机技术 ,材料科学、机械工程、声光、光学、原子核科学等生命科学。面对这些种类繁多的医疗器械产品 ,鉴于其使用的高风险性 ,“安全、有效”是各国长期以来在制定标准中坚持的原则。为此 ,我国? As we all know, a wide range of medical devices, the principle of the structure vary widely, involving electronic engineering, microelectronics, computer technology, materials science, mechanical engineering, sound and light, optics, nuclear science and other life sciences. In the face of these various types of medical device products, due to the high risk of its use, “safe and effective” is the principle that all countries have long adhered to in establishing standards. For this reason, my country?