计数抽样检验程序在医疗器械新法规下的应用探讨

Discussion on the Application of Sampling Procedures for Inspection by Attributes in the Field of Medical Devices

针对新法规下仍有大量医疗器械生产企业按传统执行计数抽样检验程序的问题,文章提出基于修改判定数组的计数抽样检验程序,并将计数抽样检验与风险管理进行结合,使企业的检验工作能够反馈定性数据和定量数据,从而能够深度参与企业的技术活动,为医疗器械生产企业在新法规下的检验工作提出思路。

In view of the that a large number of medical device manufacturers still implement sampling procedures for inspection by attributes according to the traditional regulations under the new regulations,this article proposes a sampling procedures for inspection by attributes based on modified judgment array,and combines sampling procedures for inspection with risk management,so that the company’s inspection work can feed back qualitative and quantitative data so as to be deeply involved in the company’s technical activities.This article provides ideas for the inspection work of medical device manufacturers under the new regulations.