计数抽样检验程序及其在医疗器械领域的应用  

Sampling Procedures for Inspection by Attributes and Application on Field of Medical Devices

作　　者：张博 万敏 张翔 熊巍 李文丽 陈聪 ZHANG Bo;WAN Min;ZHANG Xiang;XIONG Wei;LI Wenli;CHEN Cong(Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection,Jinan,250101;NMPA Key Laboratory for Quality Evaluation of Medical Materials and Biological Protective Devices,Jinan,250101)

机构地区：[1]山东省医疗器械和药品包装检验研究院,济南市250101 [2]国家药品监督管理局医用卫生材料及生物防护器械质量评价重点实验室,济南市250101

出　　处：《中国医疗器械杂志》2022年第5期538-544,共7页Chinese Journal of Medical Instrumentation

摘　　要：计数抽样检验是医疗器械质量控制的常用手段之一,在生产和监管过程中得到了广泛应用。GB/T 2828系列标准给出了不同类型的计数抽样检验程序。介绍了GB/T 2828系列标准,以及在不同情景下计数抽样检验方案的设计与检索。同时,还对如何平衡准确性和经济性给出了建议,对于医疗器械生产企业和监管部门的使用具有指导作用。Sampling inspection by attributes is one of the most popular means for quality control of medical devices,and has widespread application in the process of production and supervision.GB/T 2828 series standards list different types of sampling procedures for inspection by attributes.This study introduced GB/T 2828 series standards and how to design and index the sampling schemes under different scenarios.At the same time,it also provided suggestions on how to balance accuracy and economy,which can provide guidance the application of medical devices manufactures and regulatory departments.

关 键 词：抽样检验 监督抽验 接收质量限 极限质量 声称质量水平 

分 类 号：TH77[机械工程—仪器科学与技术] R197.39[机械工程—精密仪器及机械]