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Standard Practice for Conducting an Interlaboratory Study to Evaluate the Performance of an Analytical Method 进行实验室研究评估分析方法性能的标准实践
发布日期: 2019-11-01
1.1 本规程涵盖了分析方法性能的实验室间研究(ILS)的程序和统计数据。该研究提供了统计值,用于确定一种方法是否符合其开发目的。这些统计值可纳入方法的精度和偏差部分。本实践讨论了统计数据的含义以及分析方法的用户可以从中学习到什么。 1.2 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。 1.3 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====== 5.1 理想情况下,方法的实验室间测试由一组随机选择的实验室进行,这些实验室代表可能使用该方法的实验室类型。实际上,只有可用且愿意承担测试工作的实验室才能近似实现这一理想。项目协调员必须确保每个参与实验室都有适当的设施和人员,并严格按照书面规定执行方法。 如果实现了这一目标,ILS期间开发的统计数据将足以确定该方法是否能够在实际使用中产生令人满意的精度。如果程序包括经认证的参考材料,测试数据还提供有关方法偏差的信息。统计数据为该方法的预期性能提供了一般指导。
1.1 This practice covers procedures and statistics for an interlaboratory study (ILS) of the performance of an analytical method. The study provides statistical values which are useful in determining if a method is satisfactory for the purposes for which it was developed. These statistical values may be incorporated in the method's precision and bias section. This practice discusses the meaning of the statistics and what users of analytical methods may learn from them. 1.2 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. 1.3 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 ====== 5.1 Ideally, interlaboratory testing of a method is conducted by a randomly chosen group of laboratories that typifies the kind of laboratory that is likely to use the method. In actuality, this ideal is only approximated by the laboratories that are available and willing to undertake the test work. The coordinator of the program must ensure that every participating laboratory has appropriate facilities and personnel and performs the method exactly as written. If this goal is achieved, the statistics developed during the ILS will be adequate for determining if the method is capable of producing satisfactory precision in actual use. If the program includes certified reference materials, the test data also provide information concerning the bias of the method. The statistics provide a general guide to the expected performance of the method.
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归口单位: E01.22
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