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

      • 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。

         

        Abstract: 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.

         

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