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1、 Revised as of 23 November 2020OMCL仪器确认核心文件中英文Network of the Council of EuropeQUALITY MANAGEMENT DOCUMENT质量管理文件PA/PH/OMCL (08) 73 2RQUALIFICATION OF EQUIPMENT仪器确认CORE DOCUMENT核心文件?Full document title and reference文件全名和索引号Qualification of Equipment Core document仪器确认核心文件PA/PH/OMCL (08)73 2RDocument ty
2、pe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 OMCLsDate of first adoption首次采用日期1st October 1999Date of original entry into force首次生效日期1st February 2000Date of entry into f
3、orce of revised document修订版本生效日期1st July 2011Previous titles/other references曾用文件名/索引号This document replaces document PA/PH/OMCL(08)73 RCustodian Organisation管理组织The present document was elaborated by the OMCL Network/EDQM of the Council of EuropeConcerned Network相关网络GEON?Introduction 介绍The standard
4、 ISO/IEC 17025 requires an appropriate choice and qualification of equipment to be used for testing purposes. Particularly, checks and calibrations before and during use and, if needed, intermediate tests (see ISO/IEC 17025 chapter are necessary.ISO/IEC 17025标准要求用于检测的仪器应进行适当的选择和确认，特别是在使用前和使用中应进行检查和校
5、正，必要时应进行中间测试（见ISO/ICE 17025 第章节）。In order to guarantee a harmonized interpretation and application within the OMCL Network, the guideline Qualification of Equipment has been elaborated.为了保证在OMCL网络内的统一解释和应用，特制订此指南仪器确认。From experience, the terms DQ, IQ, OQ and PQ (not explicitly mentioned by ISO/IEC 1
6、7025) have been used in a non-harmonized way amongst the different OMCLs. Therefore their mention has been avoided in this document. This does not exclude their use in OMCLs quality systems where already approved and in application, or a reference to literature using this?nomenclature.根据经验，术语DQ, IQ,
7、 OQ和PQ（在ISO/IEC 17025中未明确提出）已由非协调方式在不同OMCL中采用，因此在本文中避免对这些术语的使用。但这并不排除OMCL的质量体系在已批准和实际中采用这些术语，或者引用一些使用了这些术语的文献。In order to simplify the management of the guideline, the present document contains only the general introduction and the first two levels of qualification, which are common to all type of e
8、quipment. The third and fourth levels of qualification can be found in separate instrument-related annexes. When considered appropriate, additional requirements and/or examples related to Level I and/or Level II have also been included in the annexes, which are to be used in combination with the gen
9、eral recommendations given in the core document.为了简化指南管理，本文件仅包括通用介绍，以及前两个级别的确认，可以适用于所有类型的仪器。第三级和第四级的确认可以在单独的仪器相关的附件中找到。考虑到适用性，附加要求和/或第一级和/第二级的相关举例也列在了附件中，这些内容应与核心文件中的通用推荐结合使用。The list of annexes, included in this document, will be updated as soon as new annexes are issued.如有新附件增加，包括在本文件中的附件清单将同步更新。T
10、his document should be considered as a guide to OMCLs for planning, performing and documenting the equipment qualification process. It should not be taken as an exhaustive list of compulsory tests. It is left to the professional judgment and background experience of each OMCL to decide on the most r
11、elevant tests and the most appropriate tolerance limits for each of the parameters, in order to give evidence that the instrument is working properly and is appropriate for its intended use.本文件应被作为OMCL的指南，用于计划、实施和记录仪器确认过程。它不应该作为一个必检内容的完全列举清单。各OMCL应根据自己的专业判断和背景经验来决定最相关的测试，每个参数的最合适允许限度，以证明仪器能正常工作，并适合适
12、其使用目的。If the qualification of equipment is done by the manufacturer itself or an external service, it is under the responsibility of the OMCL to make sure that the checks performed are in line with the minimum requirements set in this guideline.如果仪器的确认由供应商提供，或委托外部服务机构进行，那么OMCL有责任保证所进行的检查符合本指南的最低要求。T
13、o facilitate the implementation of a documented qualification process for the various analytical instruments, specific recommendations on minimum requirements are given in the corresponding annexes.为方便不同的分析仪器实施和记录确认过程，在相关的附件中给出了针对不同仪器的推荐和最低要求。For the more technique-related aspects of equipment quali
14、fication checks, practical examples of possible approaches are also presented in the annexes.对于与技术相关方面的仪器确认检查，在附件中也给出了可能方法的实际例子。The following four levels of Equipment Qualification should be considered by the OMCLs:OMCL应考虑以下四级仪器确认?Level I. Selection of instruments and suppliers第一级 仪器和供应商的选择The selec
15、tion and purchase of new instruments shall follow a conscious decision process, based on the needs related to the intended use of the instrument.新仪器的选择和采购应根据仪器的用途，采用明确的决策流程，An example for setting and documenting such specifications and decisions taken is given in Table I.表一给出了设置和文件的接受标准和决策的例子。?Level II. Installation and release for use第二级 安装和放行使用When receiving an instrument, the OMCL should check that it is received in good conditions, as ordered, and should monitor and document the installation process of the instrument in the selected environment. This includes the start up checks done
