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Standard Guide for Qualification of Measurement Methods by a Laboratory Within the Nuclear Industry 核工业实验室测量方法鉴定的标准指南
发布日期: 2021-10-01
1.1 本指南提供了在特定项目需要鉴定时选择、验证和鉴定测量方法的指南。本指南中提出的推荐做法是实验室数据质量保证计划的主要部分(见 图1 ). 鉴定有助于确保生成的数据符合既定要求。 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 出于对安全和防止核材料被盗的考虑,对核材料的化学过程以及化学和物理特性制定了严格的规范。对核材料的使用者提出了严格的管制和问责要求。因此,当实验室进行分析以支持核燃料材料制造等项目时,可能会对实验室提出各种性能要求。其中一个要求通常是使用合格的方法。它们的使用更能确保生成的数据符合这些数据的预期用途。合格方法将有助于确保生成的数据与其他实验室中相同合格方法生成的数据具有可比性。 4.2 本指南为鉴定测量方法和保持鉴定提供了指导。尽管大多数资格认证项目都采用了所有做法,但在某些情况下,可能只需要选定的部分。然而,应注意,当有选择地应用这些实践时,资格的有效性不会降低。本指南中的推荐做法是通用的;根据这些实践,应制定具体行动,以建立资格认证计划。
1.1 This guide provides guidance for selecting, validating, and qualifying measurement methods when qualification is required for a specific program. The recommended practices presented in this guide provide a major part of a quality assurance program for the laboratory data (see Fig. 1 ). Qualification helps to assure that the data produced will meet established requirements. 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 Because of concerns for safety and the protection of nuclear materials from theft, stringent specifications are placed on chemical processes and the chemical and physical properties of nuclear materials. Strict requirements for the control and accountability of nuclear materials are imposed on the users of those materials. Therefore, when analyses are made by a laboratory to support a project such as the fabrication of nuclear fuel materials, various performance requirements may be imposed on the laboratory. One such requirement is often the use of qualified methods. Their use gives greater assurance that the data produced will be satisfactory for the intended use of those data. A qualified method will help assure that the data produced will be comparable to data produced by the same qualified method in other laboratories. 4.2 This guide provides guidance for qualifying measurement methods and for maintaining qualification. Even though all practices would be used for most qualification programs, there may be situations in which only a selected portion would be required. Care should be taken, however, that the effectiveness of qualification is not reduced when applying these practices selectively. The recommended practices in this guide are generic; based on these practices, specific actions should be developed to establish a qualification program.
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