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1、OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT 质量保证文件质量保证文件 PA/PH/OMCL (09) 64 2R QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 6: QUALIFICATION OF PISTON PIPETTES 附件附件 6：活塞移液器的确认：活塞移液器的确认Full document title and reference 文件全名和索引号文件全名和索引号Qualification of Equipment Annex 6: Qualification of
2、 piston pipettes PA/PH/OMCL(09) 64 2RDocument type 文件类型文件类型Guideline Legislative basis 立法基础立法基础-Date of first adoption 首次发行日期首次发行日期19th May 2010Date of original entry into force 首次执行日期首次执行日期1st July 2010Date of entry into force of revised document 修订后执行日期修订后执行日期-Previous titles/other references 原文件名
3、原文件名/其它索引号其它索引号-Custodian Organisation 保管机构保管机构The present document was elaborated by the OMCL Network/EDQM of the Council of EuropeConcerned Network 相关网络相关网络GEONANNEX 6 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION“QUALIFICATION OFOF EQUIPMENT”EQUIPMENT” QUALIFICATION OF PISTON PIPETTES 活塞移液器的确认活塞移液
4、器的确认INTRODUCTION 介绍介绍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 c
5、ore 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
6、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 指南目的和范围指南目的和范围This guideline describes the requirement
7、s 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 con
8、sidered in this guideline:本指南考虑了以下类型的移液器1.Fixed volume monochannel pipettes (air-displacement (type A) and positive displacement or direct displacement pipettes (type D) 固定体积单通道移液器（空气置换型（类型A）和正向置换型或直接置换型（类型D）2.Variable volume monochannel pipettes (air-displacement (type A) and positive displacement
9、or direct displacement pipettes (type D) 可调体积单通道移液器（空气置换型（类型A）和正向置换型或直接置换型（类型D）3.Fixed volume multichannel pipettes (air-displacement (type A) 固定体积多通道移液器（空气置换型（类型A）4.Variable volume multichannel pipettes (air-displacement (type A) 可调体积多通道移液器（空气置换型（类型A）NOTE: Repetitive piston pipettes are also covere
10、d in the guideline as “variable volume monochannel pipettes (positive displacement or direct displacement pipettes)”.注：连续分配活塞式移液器也包括在本指南中作为“可调体积单通道移液器（正向置换或直接置 换移液器）”CONSIDERATIONS FOR LEVEL I AND II OF EQUIPMENT QUALIFICATION第一级和第二级设备确认需考虑的内容第一级和第二级设备确认需考虑的内容It is recommended, at Level I of the qua
11、lification of pipettes (Selection of instruments and suppliers) to select a manufacturer of pipettes that can certify its compliance with the requirements of EN ISO 8655.推荐在第一级移液器确认中（仪器和供应商选择）选择一个移液器的供应商，其应证明符合EN ISO 8655的要求。It is recommended, at Level II of the qualification of pipettes (Installati
12、on and release for use), to check if all requirements set during the selection of the instrument and supplier are met by the pipette supplier and all necessary aspects are covered in the provided certificate.推荐在第二级移液器确认（安装和使用放行）中，确认是否所有在选择仪器和供应商时设定的要 求都已满足，确认在提供的证书内包括了所有要求的方面。FREQUENCY OF CALIBRATIO
13、N 校正频次校正频次The recommended minimum calibration frequency is as follows: 推荐的最低校正频次如下At reception (unless already calibrated by the supplier).接收时校正（供应商已校正者除外）Once a year during the use of the pipette.使用期间每年校正一次After any repair or adjustment.在修复或调整后校正GLOSSARY 术语术语The following terms and definitions are
14、extracted from the EN ISO 8655-Part 1, chapter 3: Terms and definitions.下列术语和定义摘自EN ISO 8655-第1部分，第3章：术语和定义Systematic error (accuracy) 系统误差（准确度）系统误差（准确度）(piston-operated volumetric apparatus) Difference between the dispensed volume and the nominal volume or selected volume of the piston-operated vol
15、umetric apparatus.（活塞操作定量仪器）活塞操作定量仪器的移液体积和标示体积或所选择的体积之间的误差。Random error (repeatability) 偶然误差（重复性）偶然误差（重复性）(piston-operated volumetric apparatus) Scatter of the dispensed volumes around the mean of the dispensed volumes.（活塞操作定量仪器）移取体积对移取体积的平均值的分散性Nominal volume 标示体积标示体积(piston-operated volumetric app
16、aratus) Volume specified by the manufacturer and used for identification and for indication of the measuring range.（活塞操作定量仪器）由供应商指定的体积或用于识别的体积，以指示测量的范围NOTE: for a variable-volume piston-operated volumetric apparatus, the nominal volume corresponds to the maximum volume that can be set by the user and that is specified by the manufacturer.注：对于可调体积活塞操作定量仪器，标示体积对应的是用户可以设定的最大体积，由供应商指 定。Selected volume 选择体积选择体积(variable-volume volumetric apparatus) Volume se
