质量保证文件 仪器确认 附件6：活塞移液器的确认.pdf

OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 质量保证文件 PA/PH/OMCL (09) 64 2R QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 6: QUALIFICATION OF PISTON PIPETTES 附件6：活塞移液器的确认 Full document title and reference Qualification of Equipment 文件全名和索引号 Annex 6: Qualification of piston pipettes PA/PH/OMCL(09) 64 2R Document type 文件类型 Guideline Legislative basis 立法基础 - th Date of first adoption 19 May 2010 首次发行日期 Date of original entry into force 1st July 2010 首次执行日期 Date of entry into force of revised - document 修订后执行日期 Previous titles/other references - 原文件名/其它索引号 Custodian Organisation The present document was elaborated by the OMCL 保管机构 Network/EDQM of the Council of Europe Concerned Network GEON 相关网络 ANNEX 6 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” QUALIFICATION OF PISTON PIPETTES 活塞移液器的确认 INTRODUCTION 介绍 The present document is the 6th Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the qualification process of piston pipettes. 本文是核心文件“仪器确认”的第6个附件，在计划、实施和记录活塞移液器的确认过程中，应与 核心文件结合使用。 The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments. 核心文件包括介绍，和对所有类型仪器都适用的第一级和第二级确认通用表格。 The present annex contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry