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Standard Guide for Qualification of Laboratory Analysts for the Analysis of Nuclear Fuel Cycle Materials 核燃料循环材料分析用实验室分析员资格的标准指南
发布日期: 2018-07-01
1.1 本指南涵盖了分析员对核燃料循环材料进行化学分析或物理测量的资格。本指南具有普遍性,适用于所有分析方法,但必须逐个应用。此外,该指南是通用的,因为它可以应用于初始鉴定或再鉴定。 1.2 以下章节提供了指南: 部分 资格审查注意事项 5. 演示过程 6. 统计测试 7. 1.3 本标准不适用于在常规使用方法期间保持资格。维护资格包括在指南中 C1210 . 1.4 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。 1.5 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 这是一系列指南之一,旨在为实施符合健全实验室质量保证计划要求的活动提供指导。第一个,指南 C1009 是一个总括指南,提供了确保分析实验室数据质量的一般标准。其他指南在影响质量的各个领域提供了扩展的标准,产生了一套全面的数据质量控制标准。这些指南中描述的确保分析测量质量的方法如所示 图1 . 图1 分析实验室数据的质量保证 4.2 分析员的培训和资格是本指南中提出的实验室质量保证要素之一 C1009 ,它提供了一些关于资格的一般标准。本指南扩展了这些标准,为合格的分析师提供了更全面的指导。如指南所示 C1009 鉴定过程的方法可能有所不同;本指南提供了一种这样的方法。 4.3 本指南描述了一种分析师资格认证方法,该方法旨在与严格的分析测量系统资格认证和控制程序结合使用。这需要一个现有的数据库来定义日常使用中系统的特征(精度和偏差)。指南中描述了该数据库的初步开发 C1068 . 此处描述的过程仅用于在存在此类数据库且方法处于控制状态时鉴定分析师。 4.4 本指南中描述的鉴定活动假设分析员已经精通一般实验室操作。本指南不包括培养这种能力的培训或其他活动。 4.5 本指南描述了实验室分析员资格鉴定的基本方法和原则。提醒用户确保实施的鉴定程序满足其实验室的需要和要求。
1.1 This guide covers the qualification of analysts to perform chemical analysis or physical measurements of nuclear fuel cycle materials. The guidance is general in that it is applicable to all analytical methods, but must be applied method by method. Also, the guidance is general in that it may be applied to initial qualification or requalification. 1.2 The guidance is provided in the following sections: Section Qualification Considerations 5 Demonstration Process 6 Statistical Tests 7 1.3 This standard does not apply to maintaining qualification during routine use of a method. Maintaining qualification is included in Guide C1210 . 1.4 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. 1.5 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 This is one of a series of guides designed to provide guidance for implementing activities that meet the requirements of a sound laboratory quality assurance program. The first of these, Guide C1009 , is an umbrella guide that provides general criteria for ensuring the quality of analytical laboratory data. Other guides provide expanded criteria in various areas affecting quality, producing a comprehensive set of criteria for controlling data quality. The approach to ensuring the quality of analytical measurements described in these guides is depicted in Fig. 1 . FIG. 1 Quality Assurance of Analytical Laboratory Data 4.2 The training and qualification of analysts is one of the elements of laboratory quality assurance presented in Guide C1009 , which provides some general criteria regarding qualification. This guide expands on those criteria to provide more comprehensive guidance for qualifying analysts. As indicated in Guide C1009 , the qualification process can vary in approach; this guide provides one such approach. 4.3 This guide describes an approach to analyst qualification that is designed to be used in conjunction with a rigorous program for the qualification and control of the analytical measurement system. This requires an existing data base which defines the characteristics (precision and bias) of the system in routine use. The initial development of this data base is described in Guide C1068 . The process described here is intended only to qualify analysts when such a data base exists and the method is in control. 4.4 The qualification activities described in this guide assume that the analyst is already proficient in general laboratory operations. The training or other activities that developed this proficiency are not covered in this guide. 4.5 This guide describes a basic approach and principles for the qualification of laboratory analysts. Users are cautioned to ensure that the qualification program implemented meets the needs and requirements of their laboratory.
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归口单位: C26.08
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