BS EN 13975-2003 体外诊断用医疗装置的验收试验用取样规程.统计特性

标准号：BS EN 13975-2003
中文标准名称：体外诊断用医疗装置的验收试验用取样规程.统计特性
英文标准名称：Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
标准类型：C30
发布日期：2003/3/28 12:00:00
实施日期：2003/3/28 12:00:00
中国标准分类号：C30
国际标准分类号：11.100.10
适用范围：This European Standard specifies sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body. Two different provisions are addressed: a) verification by testing attributes and/or variables on a statistical basis; b) verification by testing a homogeneous batch which has been defined by appropriate means of process validation and in-process control. This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. This standard is also applicable for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.