1.1 本规程涵盖了可用于开发基于光谱的在线、在线、实验室和现场分析仪的仪器性能测试的基本程序。本规程旨在适用于在近红外和中红外区域工作的拉曼光谱仪和红外分光光度计。 1.2 本规程不旨在替代特定规程，如规程 E275 , E925 , E932 , E958 , E1421 或 E1683 用于测量特定类型的实验室光谱仪器的性能。相反，本规程旨在提供指南，说明当特定仪器类型不存在特定规程，或由于取样或安全问题而不适用特定规程时，应如何制定类似规程。 本规程可用于开发在线过程光谱分析仪的仪器性能测试。 1.2.1 本实践中描述的性能测试通常仅评估分析仪系统的红外分光光度计或拉曼分光光度仪部分的性能，本文称为仪器。 1.2.2 仪器性能测试通常不会评估分析仪取样系统的性能。 1.3 本规程描述了可用于测量仪器性能的单变量零级和一级测试，以及多变量A级和B级测试。这些测试设计用于快速、常规检查仪器性能。它们旨在揭示仪器操作中的故障或其他变化，但不专门诊断或定量评估故障或变化。 试验不用于比较不同制造商的仪器或分析仪。 1.4 本规程中描述的仪器性能测试用于通过实践开发多元校准 D8321 以确定校准开发时的性能水平。在通过实践验证分析仪的过程中使用相同的测试 D6122 通过证明可比性能来鉴定工作分析仪。 1.4.1 仪器性能测试用于在分析仪维护后重新鉴定仪器。 1.4.2 仪器性能测试用于鉴定二次分析仪中的仪器，在一次分析仪上开发后，校准将转移至二次分析仪。 1.5 本标准并不旨在解决与其使用相关的所有安全问题（如有）。 本标准的用户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。 1.6 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 如果ASTM E13委员会没有为特定类型的仪器规定适当的测试程序，或者如果E13委员会程序规定的样品与预期的仪器操作不兼容，则本规程可用于开发实际性能测试。 4.1.1 对于配备永久或半永久取样附件的仪器，E13委员会规程中规定的试样可能与仪器配置不兼容。例如，对于配备有透射率或IRS流动池的FT-MIR仪器，基于将聚苯乙烯薄膜置于样品位置的测试是不可行的。在这种情况下，本规程提出了通过改变试验材料或推荐试验材料的位置来修改推荐试验程序的方法。 4.1.2 对于过程测量中使用的仪器，由于过程污染和安全考虑，测试材料的选择可能受到限制。实践表明，可以根据与分析仪预期用途兼容的材料进行性能测试。 4.2 使用本规程开发的测试旨在允许用户将仪器在任何给定日期的性能与之前的性能进行比较，特别是将分析仪校准期间的性能与分析仪验证期间和分析仪常规使用期间的性能进行对比。这些测试旨在揭示仪器操作中的故障或其他变化，但其目的不是诊断或定量评估故障或变化。本试验不用于比较不同制造商的分析仪。 4.3 使用本规程开发的测试也旨在允许用户将用于开发多元模型的主要分析仪的性能与用于将该模型应用于过程或产品样本分析的次要分析仪的性能进行比较。

1.1 This practice covers basic procedures that can be used to develop instrument performance tests for spectroscopic based online, at-line, laboratory and field analyzers. The practice is intended to be applicable to Raman spectrometers and to infrared spectrophotometers operating in the near-infrared and mid-infrared regions. 1.2 This practice is not intended as a replacement for specific practices, such as Practices E275 , E925 , E932 , E958 , E1421 , or E1683 that exist for measuring performance of specific types of laboratory spectroscopic instruments. Instead, this practice is intended to provide guidelines as to how similar practices should be developed when specific practices do not exist for a particular instrument type, or when specific practices are not applicable due to sampling or safety concerns. This practice can be used to develop instrument performance tests for on-line process spectroscopic-based analyzers. 1.2.1 The performance tests described in this practice typically only evaluate the performance of the infrared spectrophotometer or Raman spectrometer part of the analyzer system, referred to herein as the instrument. 1.2.2 Instrument performance tests do not typically evaluate performance of analyzer sampling systems. 1.3 This practice describes univariate level zero and level one tests, and multivariate level A and level B tests which can be implemented to measure instrument performance. These tests are designed to be used as rapid, routine checks of instrument performance. They are designed to uncover malfunctions or other changes in instrument operation, but do not specifically diagnose or quantitatively assess the malfunction or change. The tests are not intended for the comparison of instruments or analyzers of different manufacture. 1.4 The instrument performance tests described in this practice are used during the development of multivariate calibrations via Practice D8321 to establish the performance level at the time the calibration is developed. The same tests are used during validation of analyzers via Practice D6122 to qualify the working analyzer by demonstrating comparable performance. 1.4.1 Instrument performance tests are used to requalify instruments after analyzer maintenance. 1.4.2 Instrument performance tests are used to qualify instruments in secondary analyzers to which calibrations are being transferred after development on a primary analyzer. 1.5 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. 1.6 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 If ASTM Committee E13 has not specified an appropriate test procedure for a specific type of instrument, or if the sample specified by a Committee E13 procedure is incompatible with the intended instrument operation, then this practice can be used to develop practical performance tests. 4.1.1 For instruments which are equipped with permanent or semi-permanent sampling accessories, the test sample specified in a Committee E13 practice may not be compatible with the instrument configuration. For example, for FT-MIR instruments equipped with transmittance or IRS flow cells, tests based on putting polystyrene films into the sample position are impractical. In such cases, this practice suggests means by which the recommended test procedures can be modified by changing the test material or the location of the recommended test material. 4.1.2 For instruments used in process measurements, the choice of test materials may be limited due to process contamination and safety considerations. The practice suggests means of developing performance tests based on materials which are compatible with the intended use of the analyzer. 4.2 Tests developed using the practice are intended to allow the user to compare the performance of an instrument on any given day with prior performance, and specifically to compare performance during calibration of the analyzer to performance during validation of the analyzer and during routine use of the analyzer. The tests are intended to uncover malfunctions or other changes in instrument operation, but they are not designed to diagnose or quantitatively assess the malfunction or change. The tests are not intended for the comparison of analyzers of different manufacture. 4.3 Tests developed using this practice are also intended to allow the user to compare the performance of a primary analyzer used in development of a multivariate model to the performance of secondary analyzers used to apply that model for the analysis of process or product samples.