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Standard Terminology Relating to Performance Validation in Thermal Analysis and Rheology 热分析和流变学中与性能验证有关的标准术语
发布日期: 2023-08-01
1.1 质量倡议要求或要求对方法和设备进行验证,或者结果可能用于法律目的。 1.2 本标准提供了与验证热分析和流变学方法及仪器性能有关的术语。不包括在其他现成来源中普遍理解或充分定义的术语。 1.3 本标准中描述的术语是验证过程的术语,可能与ASTM标准中传统的术语不同。 1.4 定义是包含在 讨论 。 1.5 本术语仅包括ASTM标准中包含的术语或正在考虑采取措施的术语。它并不是一个包罗万象的性能验证相关条款清单。 1.6 在研究精度和偏差、热分析、流变学和热物理性质时常用的术语可在实践中找到 E177 和术语 E473 和 E1142 有关方法验证的其他信息,请参阅《美国药典》和《国家处方集》。 2. 1.7 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。
1.1 Validation of methods and apparatus is requested or required for quality initiatives or where results may be used for legal purposes. 1.2 This standard provides terminology relating to validating performance of thermal analysis and rheology methods and instrumentation. Terms that are generally understood or defined adequately in other readily available sources are not included. 1.3 The terminology described in this standard is that of the validation process and may differ from that traditionally encountered in ASTM standards. 1.4 A definition is a single sentence with additional information included in a Discussion . 1.5 This terminology only includes those terms that are included in an ASTM standard or for which some action is under consideration. It is not intended as an all-inclusive listing of terms relating to performance validation. 1.6 Terminology commonly used in the study of precision and bias, in thermal analysis, rheology, and thermophysical properties may be found in Practice E177 and Terminologies E473 and E1142 . Additional information on method validation may be found in the U.S. Pharmacopeia and National Formulary. 2 1.7 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.
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归口单位: E37.03
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