摘要
国内快诊产品的研发、生产在近几年得到快速的发展,国内市场不断增长的同时,很多企业也逐渐成为国外大公司的OEM生产基地。双方需建立OEM协议,在出厂检验这块越来越多的要求建立在共同的认知水平上,GB/T 2828.1-2003(国际标准为ISO2859-1:1999)成为各公司签署质量协议的共同语言。同时在一些法规中也有相应的要求,如美国联邦法规法典第21册第820部分质量体系法规(即21CFR Part 820 QSReg)中250条款明确规定抽样检验必须要有统计学依据。而GB/T 2828.1-2003正是建立在统计学依据上的用于指导抽样检验的技术性标准。本文分析了如何利用GB/T 2828.1-2003为快诊产品设定AQL,选取检验水平(Inspection level),制定转移规则等。
Design and manufacturing of rapid tests in domestic market has been growing quickly in the recent years.Meanwhile,many domestic factories became to OEMs（Original Equipment Manufacturer） of international companies by degrees.Usually OEM agreement needs to be established between two parties and there is no doubt that finished products criteria is one of the most important part of the agreement.Both parties should be on the same page.Talking of products criteria,sampling is a key step.In additional to the requirements of OEM business,US FDA regulation coded as 21 CFR Part 820 also requires sampling plan shall be written and based on a valid statistical rational in section 250.GB/T 2828.1-2003 establishes sampling plans and procedures for inspection by attributes using statistical rationale.Accordingly GB/T 2828.1-2003（ISO2859-1：1999,IDT） became the common base of OEM agreement.This article demonstrates how to apply of GB/T 2828.1-2003 for in-vitro diagnostic products including setting up AQL（Acceptance Quality Limit）,selection of IL（Inspection Level） and establishing switching rules,etc.
出处
《中国医疗器械信息》
2011年第3期8-11,52,共5页
China Medical Device Information
