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Standard Guide for Establishing Calibration for a Measurement Method Used to Analyze Nuclear Fuel Cycle Materials 用于分析核燃料循环材料的测量方法校准的标准指南
发布日期: 2018-09-01
1.1 本指南为分析核材料的分析化学实验室中通常使用的测量方法的校准提供了基础。指南包括准备校准程序、选择校准标准、控制校准设备和记录校准等活动。该指南是通用的,必须从其他来源获得特定于给定方法的任何所需技术信息。 1.2 以下章节提供了指导信息: 部分 一般注意事项 5. 校准程序 6. 校准标准 7. 校准设备的控制 8. 文档 9 关键词 10 1.3 本标准并非旨在解决与其使用相关的所有安全问题(如有)。 本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 校准是进行测量的一个基本部分,它对测量数据的质量影响很大。因此,在确定测量方法时,必须充分注意校准,以便产生的数据可以接受。 使用不适当的校准标准、校准说明不充分以及校准过程的文件记录不良都是可能对校准有效性产生不利影响的情况的例子。因此,校准过程必须符合为确保校准结果和任何相关测量数据的有效性而制定的标准。指南中给出了此类标准 C1009 ,其中校准被确定为实验室质量保证的一个组成部分(参见 图1 ). 本指南扩展了这些标准,为建立校准提供了更全面的指导。 图1 分析实验室数据的质量保证 4.2 校准测量方法的校准方式和其他技术要求通常在方法首次引入实验室时确定,可以通过指南中定义的验证和鉴定 C1068 (参见 图1 ). 然而,校准涉及的不仅仅是校准过程的技术方面。该过程的另一个方面是必要的操作要求,以确保校准结果有效,并在其完整性受到质疑时记录和验证。本指南的规定提供了这些操作要求,在规划和建立校准时应予以考虑。
1.1 This guide provides the basis for establishing calibration for a measurement method typically used in an analytical chemistry laboratory analyzing nuclear materials. Guidance is included for such activities as preparing a calibration procedure, selecting a calibration standard, controlling calibrated equipment, and documenting calibration. The guide is generic and any required technical information specific for a given method must be obtained from other sources. 1.2 The guidance information is provided in the following sections: Section General Considerations 5 Calibration Procedure 6 Calibration Standard 7 Control of Calibrated Equipment 8 Documentation 9 Keywords 10 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Calibration is a fundamental part of making measurements and its effect on the quality of measurement data is significant. Thus, sufficient attention must be given to calibration when it is established for a measurement method so that the data produced will be acceptable. The use of an inappropriate calibration standard, inadequate instructions for calibration, and poor documentation of the calibration process are examples of circumstances that can adversely affect the validity of a calibration. Thus, the calibration process must conform to criteria established to ensure the validity of calibration results and any associated measurement data. Such criteria are given in Guide C1009 , in which calibration is identified as a component of laboratory quality assurance (see Fig. 1 ). This guide expands upon those criteria to provide more comprehensive guidance for establishing calibration. FIG. 1 Quality Assurance of Analytical Laboratory Data 4.2 The manner of calibration and other technical requirements for calibrating a measurement method are usually established when a method is first introduced into a laboratory, which may be through validation and qualification as defined by Guide C1068 (see Fig. 1 ). However, calibration involves more than the technical aspects of the calibration process. The other dimension of the process is the operational requirements that are necessary to ensure that calibration results are valid and that they are documented and verifiable should their integrity be questioned. The provisions of this guide provide those operational requirements and should be considered whenever calibration is planned and established.
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归口单位: C26.08
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