仪器确认附件质谱仪确认中英文.doc

仪器确认-附件-质谱仪确认-中英文 PAGE PAGE 1 ———————————————————————————————— 作者： ———————————————————————————————— 日期： OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT 质量管理文件 PA/PH/OMCL (10) 86 2R QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 7: QUALIFICATION OF MASS SPECTROMETERS 附件7：质谱仪的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment Annex 7: Qualification of mass spectrometers PA/PH/OMCL(10)86 2R Document type 文件类型 Guideline Legislative basis 立法基础 - Date of first adoption 首次发行日期 25th May 2011 Date of original entry into force 首次执行日期 1st July 2011 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 The present document was elaborated by the OMCL Network/EDQM of the Council of Europe Concerned Network 相关网络 GEON ANNEX 7 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件7 7.1: QUALIFICATION OF GAS CHROMATOGRAPHY-MASS SPECTROMETERS WITH ELECTRON IMPACT IONIZATION (GC-EI-MS) 装备电子碰撞电离的气相色谱-质谱仪的确认 Introduction 介绍 The present document is the first part of the 7th 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 GC-EI-MS. 本文件是核心文件“仪器确认”的第7个附件，在计实施和记录GC-EI-MS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. 核心文件包括了介绍和适用于所有类型仪器的第一级和第二级确认用通用表格。 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. 本附件包括与仪器相关的在第三级和第四级要检查的参数及其相关的典型可接受限度的推荐，以及在实施这些检查时可以采用的方法学实例。 TABLE III 表3 Level III. Periodic and motivated instrument