仪器确认 附件6 塞移液管确认 中英文.docVIP

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 文件全名和索引号 QAnnex 6: Qualification of piston pipettes PA/PH/OMCL(09) 64 2R Document type 文件类型 G Legislative basis 立法基础 Date of first adoption 首次发行日期 Date of original entry into force 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 保管机构 Tpresent document was elaborated by the OMCL Network/EDQM of the Council of Europe Concerned Network 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 out these checks. 本附件包含与仪器相关参数及其相应的典型可接受限度的推荐，这些参数应在第三级和第四级确认时进行检查，以及在实施这些检查时可以使用的一些实用方法举例。 AIM AND SCOPE OF THE GUIDELINE 指南目的和范围 This guideline describes the requirements for piston pipettes used in chemical and biological tests irrespective of the mode of operation (manual or electronical). 本指南描述了在化学和微生物检测中所用的活塞式移液器的要求，包括所有操作模式（手动和电子） Requirements and test procedures are based on the EN ISO 8655. 本指南要求和测试程序依据于EN ISO 8655. The following types of pipettes have been considered in this guideline: 本指南考虑了以下类型的移液器