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现行 ASTM F2717-14(2019)
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Standard Guide for Development of an Independent Third-Party Verification of Reference Materials 标准物质独立第三方验证的标准指南
发布日期: 2019-07-01
1.1 本指南涵盖了标准物质独立第三方验证的意义和使用、规划、实施和完成。 1.2 在本指南中,独立第三方验证(ITPV)被定义为对由一个或多个独立第三方(ITPV)审查的设计或结果的概念和技术稳健性的评估,该独立第三方(ITPV)由其在同一学科或密切相关的科学领域的教育、培训和经验认证,判断设计的价值或评估设计实现预期目标和预期结果的可能性。 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====== 3.1 本指南介绍了独立验证的规划、实施和完成以及其他相关细节。 3.2 ITPV旨在帮助制造商、用户和监管机构以高置信度确保标准物质的准确性。
1.1 This guide covers the significance and use, planning, conduct and completion of an independent third-party verification of reference materials. 1.2 In this guide, independent third-party verification (ITPV) is defined as the evaluation of the conceptual and technical soundness a design or outcome being reviewed by one or more independent third party (ITPV) qualified by their education, training, and experience in the same discipline, or closely related field of science, to judge the worthiness of the design or assess the design’s likelihood of achieving the intended objectives and anticipated outcomes. 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 ====== 3.1 In this guide, the planning, conduct, and completion of the independent verification, and other related details are addressed. 3.2 The ITPV is intended to assist manufacturers, users, and regulating authorities in ensuring the accuracy of a reference material with a high level of confidence.
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归口单位: F10.20
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