测量不确定-2.docVIP

PA/PH/OMCL (07) 106 DEF - OMCL Guideline on Uncertainty of Measurement (for compliance testing) OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 欧盟质量保证文件委员会官方药品控制实验室网络 PA/PH/OMCL (07) 106 DEF UNCERTAINTY OF MEASUREMENT - PART 2 测量不确定度-2 Full document title and reference 完整的文件标题和参考文献 Uncertainty of Measurement - Part 2 OMCL Policy on the Estimation and Application of Uncertainty in Analytical Measurement. To be used by OMCLs for activities other than compliance testing. PA/PH/OMCL (07) 106 DEF 测量不确定度-2 官方药品检验实验室政策中关于分析测量不确定度的评估和应用。对于除符合性测试以外的活动，由官方药品检验实验室使用。 PA/PH/OMCL (07) 106 DEF Document type 文件种类 Guideline 指导 Legislative basis 法律依据 -- Date of first adoption 首次执行日期 May 2002 2002年5月 Date of original entry into force 原始生效日期 January 2003 2003年1月 Date of entry into force of revised document 修订文件生效日期 December 2007 2007年12月 Previous titles/other references 旧标题/其他参考文献 This document replaces document PA/PH/OMCL (2001) 7 DEF 该文件替换PA/PH/OMCL(2001)7DEF文件 Custodian Organisation 管理机构 The present document was elaborated by OMCL Network/EDQM of the Council of Europe 该文件由官方药品控制实验室网络/欧委会药品质量管理局详细说明 Concerned Network 相关网络 GEON 一般欧盟官方药品控制实验室网络 OMCL POLICY ON THE ESTIMATION AND APPLICATION OF UNCERTAINTY IN ANALYTICAL MEASUREMENT 官方药品检验实验室政策中关于分析测量不确定度的评估和应用 To be used by OMCLs for activities other than compliance testing 由官方药品检验实验室使用除符合性测试以外的活动 1. INTRODUCTION 介绍 This document is intended to give guidance for the interpretation and application of ISO 17025 “General requirements for the testing and calibration laboratories” [1] and its pertinence to activities other than compliance testing performed in Official Medicines Control Laboratories (OMCL). 该文件是为了给ISO 17025“测验和校准实验室的一般要求” [1] 的解释和应用提供指导，它针对在官方药品检验实验室中执行的除符合性测试以外的活动。 Measurement uncertainty is mentioned in ISO 17025 in several aspects and as described in a separate OMCL guidance [2]. 不确定性测试在ISO 17025标准的几个章节中都有提到，且在单独的官方药品检验实验室指导中进行了描述。 The laboratory is to demonstrate that it has ade