仪器确认附件紫外确认中英文doc.docVIP

OMCL Network of the Council of Europe QUALITY ASSURANCE DOCUMENT PA/PH/OMCL (07) 11 DEF CORR QUALIFICATION OF EQUIPMENT 仪器确认 ANNEX 3: QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETERS 附件3：紫外-可见光分光光度仪的确认 Full document title and reference 文件全名和索引号 Qualification of Equipment Annex 3: Qualification of UV-Visible spectrophotometers PA/PH/OMCL (07) 11 DEF CORR Document type 文件类型 Guideline 指南 Legislative basis 立法基础 The present document was also accepted by EA as recommendation document to be used in the context of Quality Management System audits of OMCLs Date of first adoption 首次发行日期 May 2007 Date of original entry into force 首次执行日期 July 2007 Date of entry into force of revised document 修订后执行日期 December 2007 Previous titles/other references 原文件名/其它索引号 This document replaces document PA/PH/OMCL (07) 11DEF 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 3 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” OMCL网络指南“仪器确认”附件3 QUALIFICATION OF UV-VISIBLE SPECTROPHOTOMETERS 紫外-可见光分光光度仪的确认 Introduction The present document is the third Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the UV-Visible spectrophotometer qualification process. 本文件是核心文件“仪器的确认”的第三个附件，在计划、实施和记录紫外-可见光分光光度计的确认时应与该核心文件结合使用。 The core document contains the Introduction and general forms for Level I and II of qualification, which are common to all type of instruments. 核心文件包括了对第一级和第二级确认的介绍和一般表格，它们适用于所有类型的仪器。 For UV-Visible spectrometers, an example has been added to give instrument-specific proposals that may be used in combination with the general requirements presented in the core document “Qualification of Equipment”, when drawing up a Level I checklist. 对于紫外-可见光分光光度计，增加了一个例表给出仪器相关的方案，可以在规划第一级检查清单时，与核心文件里的通用要求“仪器的确认”结合使用。 The present annex contains instrument-related recommendations on pa