1/29INTERNATIONALISOSTANDARD13485第三版2016-3-1医疗器械------质量管理体系----用于法规的要求Dispositifsmedicaux-SystemesdemanagementdeInqualite-ExIGENCESadesfinsreglementaires目录目录............................................................................................................................................................................................11.范围.......................................................................................................................................................................................52.规范性引用文件................................................................................................................................................................53.术语和定义.........................................................................................................................................................................63.1忠告性通知................................................................................................................................................................63.2授权代表.....................................................................................................................................................................63.3临床评价.....................................................................................................................................................................63.4抱怨..............................................................................................................................................................................62/293.5经销商.........................................................................................................................................................................63.6植入性医疗器械.......................................................................................................................................................63.7进口商.........................................................................................................................................................................73.8标记..............................................................................................................................................................................73.9寿命期.........................................................................................................................................................................73.10制造商.......................................................................................................................................................................73.11医疗器械...................................................................................................................................................................83.12医疗器械族...............................................................................................................................................................83.13性能评价...................................................................................................................................................................83.14上市后监督.............................................................................................
