医疗器械安全有效基本要求清单译文.docVIP

——PAGE 28— —PAGE 12—— List of basic requirements on safe and effective medical device Regulation number Requirements Applicable Adopted method for proving conformance File providing objective evidence to conformance A General principles A1 The design and manufacturing of medical device shall ensure to be used according to the expected using manner by the expected users (if applicable) with corresponding technology knowledge, experience, education, training, medical treatment and hardware condition under the expected conditions and purposes; it will not damage the medical environment, suffe