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Standard Guide for Evaluating Test Method Capability and Fitness for Use 评估试验方法能力和适用性的标准指南
发布日期: 2022-11-01
1.1 本指南涵盖了用于测量石油产品、液体燃料和润滑剂性能的标准测试方法的统计能力和适用性评估技术。具体而言,本指南提供了评估测试方法的能力的策略,以提供预期参数与该参数的给定水平或值之间的足够精确的估计,并以足够的置信度评估测试方法用于确定产品可接受性与规范、规管或制造限制之间的适用性。 1.2 本指南中的能力评估适用于总是产生非负数值结果且具有硬的、固定的零下限或固定的上限(例如,100 %). 在确定本指南对某些测试方法的适用性时,可能需要对测试方法的详细知识和专业判断。 1.3 根据本指南,测试方法适用性与规范、法规或制造限制的评估通常适用于提供数值结果并具有适用再现性精度值的测试方法。 1.4 本指南旨在供测试方法开发人员、规范制定者和选择测试方法的实验室使用,以针对特定目的或特定限制评估产品。 1.5 本指南不适用于测量温度以确定特性(例如但不限于凝固点、倾点、闪点和蒸馏)的试验方法。 本指南不适用于实验室评估实验室测试方法执行能力,也不适用于评估制造过程能力。 1.6 使用本指南得出的能力和适用性表达式不应是选择和使用给定测试方法的唯一标准。其他因素,如实验室使用测试方法的经验、完成分析的时间长度、相对于监管或制造规范限制的典型产品结果、结果接近于零以及成本因素,可能会对特定应用使用给定测试方法的决定产生更大的影响。 1.7 本指南借鉴了支持石油产品、液体燃料和润滑剂的其他标准中包含的统计方法,包括实践 第244页 , D6259型 , 第6299页 , 6300美元 , 第6792页 以及ISO 4259。 1.8 本标准并不旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践,并确定监管限制的适用性。 1.9 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《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 本指南为测试方法的开发人员提供了系统的方法,以评估精度的内在充分性(能力)和- 根据实践通过实验室间测试确定的实验室标准化 6300美元 新的或修改的测试方法。 4.1.1 本指南中介绍的工具可用于评估给定试验方法相对于其预期应用确定的重复性和再现性的充分性。对于精度低于最佳精度的试验方法,负责的小组委员会将有机会进行调查,提出程序改进建议,并在必要时设计实验室间研究。需要注意的是,非最佳精度不一定意味着测试方法无效,但测试方法可能不适合预期应用。 4.2 本指南适用于测试方法用户,以评估不同测试方法的相对性能,这些测试方法旨在测量与测试方法特定应用相同的性能。 4.3 本指南可用于评估与规范中预期用途相关的试验方法再现性的适用性。 4.3.1 当测试方法结果与规范限值进行比较时,本指南提供了评估测试方法的再现性是否符合规定限值的工具。 4.4 当结合充分的化学知识、仪器技术、计量原理、样品特性以及对统计意义和与所评估试验方法的重复性和再现性相关的含义的基本理解使用本指南时,本指南最为有效。 4.5 本指南不包括在判断测试方法的能力或适用性与特定应用时可能考虑的定性和商业因素。
1.1 This guide covers techniques for evaluating the statistical capability and fitness for use of standard test methods used for measuring properties of petroleum products, liquid fuels, and lubricants. Specifically, this guide provides strategies for evaluating the capability of a test method to provide a sufficiently precise estimate of the intended parameter versus a given level or value of that parameter and for assessing, with sufficient confidence, the fitness for use of a test method for determining the acceptability of products versus specification, regulatory, or manufacturing limits. 1.2 The assessment of capability in this guide is applicable to test methods that always yield non-negative numerical results and have a hard, fixed zero lower limit or fixed upper limit (for example, 100 %). Detailed knowledge of a test method and professional judgement may be required in determining the applicability of this guide to certain test methods. 1.3 In accordance with this guide, the assessment of fitness for use of a test method versus specification, regulatory, or manufacturing limits is generally applicable to test methods that provide numerical results and have applicable reproducibility precision values. 1.4 This guide is intended for use by test method developers, specification setters, and laboratories selecting test methods to evaluate products for specific purposes or versus specific limits. 1.5 This guide is not applicable to test methods that measure temperature to determine properties such as, but not limited to, freeze point, pour point, flash point, and distillations. This guide is not intended for use by laboratories for evaluating laboratory test method execution capability, nor is it intended to evaluate manufacturing process capability. 1.6 The expressions of capability and fitness for use derived from use of this guide should not be the only criteria for selection and use of a given test method. Other factors such as the laboratory’s experience with the test method, length of time to complete an analysis, typical product results relative to the regulatory or manufacturing specification limit, closeness of the results to zero, and cost factors may contribute more significantly to the decision to use a given test method for a specific application. 1.7 This guide draws on statistical approaches covered in other standards supporting petroleum products, liquid fuels, and lubricants, including Practices D3244 , D6259 , D6299 , D6300 , D6792 and ISO 4259. 1.8 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. 1.9 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 guide provides the developers of test methods with systematic approaches to evaluate the inherent adequacy (capability) of the precision and the adequacy of between-laboratory standardization as determined by interlaboratory testing in accordance with Practice D6300 for a new or modified test method. 4.1.1 The tools presented in this guide can be used to assess the adequacy of the repeatability and reproducibility determined for a given test method relative to their intended applications. For those test methods with less than optimal precision, the responsible subcommittees would have an opportunity to investigate, suggest improvements in the procedure, and design an interlaboratory study as necessary. It is important to note that non-optimal precision does not necessarily imply that the test method is invalid, but that the test method may be less capable for an intended application. 4.2 This guide is applicable to test method users to evaluate the relative performance of different test methods that purport to measure the same property as applied to a specific application of the test methods. 4.3 This guide can be used to evaluate the fitness for use of a test method reproducibility relative to its intended use in specifications. 4.3.1 When test method results are intended to be compared against specification limits, this guide provides the tools to assess whether the test method’s reproducibility is expected to be fit for use relative to the stated limits. 4.4 This guide is most effective when used in conjunction with sufficient knowledge of the chemistry, instrumental technology, metrology principles, sample characteristics, and a fundamental understanding of statistical meaning and implications associated with repeatability and reproducibility of the test method being evaluated. 4.5 This guide does not cover the qualitative and business factors that might also be considered in judging a test method’s capability or fitness for use versus a specific application.
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