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现行 ASTM E2972-15(2019)
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Standard Guide for Production, Testing, and Value Assignment of In-House Reference Materials for Metals, Ores, and Other Related Materials 金属 矿石和其他相关材料的内部参考材料的生产 测试和价值指定标准指南
发布日期: 2019-10-01
1.1 本文件为金属和采矿行业中遇到的金属、矿石、炉渣和其他材料的分析测试提供了内部参考材料制备程序的实施指南。 1.2 本指南仅适用于标准物质的生产(通常供内部使用),不适用于认证标准物质(CRM)的生产。材料可能包括金属、合金、矿物、地质材料、制造中间体和副产品。样品可能有多种物理形式,包括块、盘、棒、线、碎片、颗粒、粉末和液体。 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====== 4.1 本文件提供了用于以下文件中列举的与化学和物理测量过程的开发、验证和控制相关的多种目的的内部标准物质(以下简称iRM)的制备、测试和记录程序的实施指南。 4.2 本指南主要涉及金属、矿石和相关材料化学成分的表征。对于所有这些材料,对标准物质(RMs)的需求持续强劲,计量机构和私人认证标准物质(CRM)开发商难以满足,因为CRM开发需要大量的时间和资金投入。 金属和采矿业消耗RMs,并以高速率创造新产品和副产品成分。它们使用的分析方法能够提供快速准确的测定结果,并且只要有合适的IRM可用,就可以使用有效的程序来维持质量保证和质量控制。 4.3 本指南的用户必须认识到,为任何目的开发iRM都有责任正确设计和执行开发过程,并彻底记录该过程。此外,iRM用户有责任在其设计限制内正确使用iRM材料。 4.4 本指南包含关于RMs材料选择和取样的讨论,并注意到最终形式的转换。 4.5 iRMs适用于控制图程序,以证明化学测量过程处于统计控制之下。该函数需要证明材料的充分均匀性,但不需要指定具有相关、详尽评估的不确定性的化学和物理特性值。 4.6 iRMs的使用适合于以多种方式校准测试方法和评估校准,包括检查偏差、系统测试基质效应校正,以及测试样品制备程序。 参见第节 6. . 本指南解释了iRM可作为验证过程一部分的一般情况(请参阅指南) E2857 ). 4.7 由于本文件是一份标准指南,因此旨在教育那些在质量体系范围内参与实验室操作、质量体系开发和维护以及实验室操作认证的人员。然而,本指南并不构成评估和认可的要求。
1.1 This document provides guidance for the implementation of procedures for preparation of in-house reference materials for analytical testing of metals, ores, slags, and other materials encountered within the metals and mining industries. 1.2 This guide is applicable to the production of reference materials only (usually for internal use) and does not apply to the production of certified reference materials (CRMs). Materials may include metals, alloys, minerals, geological materials, manufacturing intermediates, and byproducts. Samples may be in a number of physical forms including blocks, disks, rods, wires, chips, granules, powders, and liquids. 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 ====== 4.1 This document provides guidance for the implementation of procedures for the preparation, testing, and documentation of an in-house reference material (hereafter called an iRM) to be used for a number of purposes, enumerated in the following document, associated with development, validation, and control of chemical and physical measurement processes. 4.2 This guide is primarily concerned with characterization of the chemical compositions of metals, ores, and related materials. For all these materials, there is a continuing, strong demand for reference materials (RMs) that is difficult for metrology institutes and private certified reference material (CRM) developers to meet because CRM development requires substantial investments of time and money. The metals and mining industries consume RMs and create new product and by-product compositions at high rates. They use analytical methods that provide rapid and accurate determinations, and both quality assurance and quality control can be maintained using efficient procedures provided appropriate iRMs are available. 4.3 The user of this guide must recognize that development of an iRM for any purpose carries with it the responsibility to design and execute the development process correctly, and to document the process thoroughly. In addition, the user of an iRM bears the responsibility for correct use of the iRM material within its design limitations. 4.4 This guide contains discussions on material selection and sampling for RMs with some attention given to conversion to the final forms. 4.5 The use of iRMs is appropriate for control chart procedures to demonstrate that chemical measurement processes are under statistical control. This function requires demonstration of sufficient homogeneity of a material, but it does not require assignment of chemical and physical property values with associated, exhaustively evaluated uncertainties. 4.6 The use of iRMs is appropriate for calibration of test methods and evaluation of calibrations in several ways, including checking for bias, systematic testing of corrections for matrix effects, and testing of sample preparation procedures. See Section 6 . This guide provides explanations of general cases in which an iRM can be used as part of a validation process (see Guide E2857 ). 4.7 Because this document is a standard guide, it is intended to educate those who are involved in laboratory operation, quality system development and maintenance, and accreditation of laboratory operations within the scope of a quality system. However, this guide does not constitute requirements for assessment and accreditation.
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