ICS11.080.30CCSC30团体标准T/CAMDI082—2022包装试验方法确认指南StandardGuideforPackagingTestMethodValidation2022-12-22发布2023-07-01实施中国医疗器械行业协会发布全国团体标准信息平台T/CAMDI082—2022I目次前言..................................................................................II引言.................................................................................III1范围...............................................................................12规范性引用文件.....................................................................13术语和定义.........................................................................14意义和用途.........................................................................34.1实验室间研究.................................................................34.2属性试验方法确认(ATMV)......................................................54.3变量试验方法确认(VTMV).....................................................11附录A（资料性）可接受准则示例.....................................................18附录B（资料性）ATMV工作表示例...................................................19参考文献.............................................................................20图1观察变异........................................................................12图2观察变异........................................................................12表1ATMV示例.......................................................................5表2选择VTMV方法和可接受准则操作注释.............................................13表3GageR&R研究建议的最小试验次数................................................14表A.1可接受准则示例...............................................................18表B.1ATMV工作表示例.............................................................19全国团体标准信息平台T/CAMDI082—2022II前言本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规定起草。请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。...
