1.1 本指南涵盖了使用相关ASTM标准实践和指南中概述的原则和方法，开发和评估总分析仪系统产生的结果与分析仪系统拟模拟的相应主要测试方法（PTM）产生的结果之间的线性关系的一般方法。 1.2 本指南介绍了实践的统计方法 D6708 可用于评估PTM和分析仪结果之间的一致性，如有必要，发展线性相关性，以进一步改善分析仪整个工作范围内的一致性。 例如，财产水平变化不足以应用实践 D6708 多层次方法论，用户参考实践 D3764 进行特定水平的偏差评估。在应用本指南中获得的相关关系信息仅适用于代表用于执行评估的材料的材料类型和性能范围。提醒用户不要将关系外推到所研究的材料类型和性能范围之外。 1.3 如果工艺流分析仪系统和主要测试方法基于相同的测量原理，或者如果工艺流分析仪系统使用与主要测试方法的测量原理类似的直接且易于理解的测量原理，则本指南适用。如果过程流分析仪系统使用与主要测试方法不同的测量技术，前提是分析仪直接输出的校准协议不需要使用PTM，则本规程也适用。 1.4 如果过程流分析仪系统使用间接或数学建模的测量原理，如化学计量学或多元分析技术，而化学计量学或多元模型开发需要PTM的结果，则本指南不适用。用户应参考实践 D8321 和 D6122 了解这些类型分析仪系统的详细相关性和模型验证程序。 注1: 例如，本指南适用于从mid进行苯测量的比较- 基于测试方法的红外过程分析仪系统 D6277 使用PTM测试方法获得的结果 D3606 ，一种基于气相色谱的测试方法。对于每个样品，使用方法（测试方法）将中红外光谱转换为单个分析仪结果 D6277 )独立于主要试验方法（试验方法 D3606 ). 然而，当同一分析仪使用多元模型将测量的中红外光谱与测试方法关联时 D3606 使用实践方法的参考值 D8321 ，本指南不适用。在这种情况下，分析仪的直接输出是频谱，将该多变量输出转换为分析仪结果需要来自主要测试方法的结果。 1.5 本指南假设分析仪采样系统适合使用，并且分析仪和实验室系统在执行所需任务期间处于统计控制状态。分析仪取样系统正确功能的测试程序不在本指南的范围内。有关确定系统是否处于统计控制中的信息，请参阅实践 D6299 或其他同等技术文件。 1.6 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。 1.7 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 本指南旨在与实践结合使用 D3764 （案例1）和实践 D6122 （案例2）。本指南中的方法可用于确定线性相关性是否可以提高整个分析仪系统的性能，即预测PTM应用于相同材料时的结果的能力。该方法基于与实践相同的统计数据处理 D6708 ，用于推导线性关系的参数并评估改善程度。 4.2 本指南为工艺流分析仪系统的开发人员或制造商提供了有用的程序，用于开发新设计的工业应用系统的能力，这些应用需要通过流动部件或产品的主要测试方法可靠预测特定特性的测量。 4.3 本指南为工艺流分析仪系统的购买者提供了一些可靠的选项，用于指定工艺流分析仪系统的性能要求，这些系统用于需要通过流动部件或产品的主要测试方法可靠预测特定特性测量的应用中。 4.4 本指南为过程流分析仪系统的用户提供了有关建立PTM预测关系和预测性能的工作过程的有用信息。 4.5 应用本指南获得的预测（相关性）关系仅适用于用于执行研究的材料类型和性能范围。样品的性能水平和成分特征的选择必须适合分析仪系统的应用。 提醒用户不要将预测关系外推到用于获得关系的材料类型和性能范围之外。 4.6 本指南中提倡的一致程度评估基于实践中阐述的统计原则 D6708 ，这纯粹是统计性质。未尝试评估过程分析仪和PTM之间分析技术的相似程度；因此，PTM和分析仪装置之间的结果可以高度相关，但它们的测量原理可能完全不同，并且可能会 不 是相关性的主要原因。因此，用户应注意，结果之间的高度相关性并不一定意味着测量原则中的高度相似性；这也不意味着在未来的测量中可以预期类似程度的一致性。一般来说，如果检测到样本特定偏差，则表明测量原理可能不同，并且可能会影响未来使用比例/偏差校正方程的一致程度。有无样品- 特定效应可用于衡量相关方程对样本组成或基质差异的稳健性。 4.7 本指南的实施要求工艺流分析仪系统符合以下条件: 4.7.1 符合API RP-555过程分析仪中规定的原则， 4.7.2 符合供应商的建议， 4.7.3 符合制造商规定的操作条件， 4.7.4 如有必要，已经建立了预测的PTM算法，并且 4.7.5 符合适用的质量保证、数据收集和数据遥测协议。 4.8 安装或主要维护后，进行制造商建议的诊断测试，以证明分析仪符合制造商的规范、历史性能水平或两者。如有必要，调整分析仪系统部件，以获得指定参考物质的推荐分析仪输出水平。 4.9 检查整个分析仪系统，确保其安装正确，处于工作状态，并在完成初始调试程序后进行适当调整。

1.1 This guide covers a general methodology to develop and assess the linear relationship between results produced by a total analyzer system versus the results produced by the corresponding primary test method (PTM) that the analyzer system is intended to emulate, using the principles and approaches outlined in relevant ASTM standard practices and guides. 1.2 This guide describes how the statistical methodology of Practice D6708 can be employed to assess agreement between the PTM and analyzer results, and, if necessary, develop linear correlation to further improve the agreement over the complete operating range of the analyzer. For instances where there is insufficient variation in property level to apply the Practice D6708 multi-level methodology, users are referred to Practice D3764 to perform a level specific bias evaluation. The correlation relationship information obtained in the application of this guide is applicable only to the material type and property range of the materials representative of those used to perform the assessment. Users are cautioned against extrapolation of the relationship beyond the material type and property range being studied. 1.3 This guide applies if the process stream analyzer system and the primary test method are based on the same measurement principle(s), or, if the process stream analyzer system uses a direct and well-understood measurement principle that is similar to the measurement principle of the primary test method. If the process stream analyzer system uses a different measurement technology from the primary test method, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTM, this practice also applies. 1.4 This guide does not apply if the process stream analyzer system utilizes an indirect or mathematically modeled measurement principle such as chemometric or multivariate analysis techniques where results from PTM are required for the chemometric or multivariate model development. Users should refer to Practices D8321 and D6122 for detailed correlation and model validation procedures for these types of analyzer systems. Note 1: For example, this guide would apply for the comparison of benzene measurements from a mid-infrared process analyzer system based on Test Method D6277 to those obtained using PTM Test Method D3606 , a gas chromatography based test method. For each sample, the mid-infrared spectrum is converted into a single analyzer result using methodology (Test Method D6277 ) that is independent of the primary test method (Test Method D3606 ). However, when the same analyzer uses a multivariate model to correlate the measured mid-infrared spectrum to Test Method D3606 reference values using the methodology of Practice D8321 , this guide does not apply. In this case, the direct output of the analyzer is the spectrum, and the conversion of this multivariate output to an analyzer result require results from the primary test method. 1.5 This guide assumes that the analyzer sampling system is fit for use, and both analyzer and lab systems are in statistical control during the execution of the required tasks. Procedures for testing for proper function of the analyzer sampling system are beyond the scope of this guide. For ascertaining whether the systems are in statistical control, refer to Practice D6299 or other technical equivalent documents. 1.6 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. 1.7 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. ====== Significance And Use ====== 4.1 This guide is intended to be used in conjunction with Practice D3764 (Case 1) and Practice D6122 (Case 2). Methodology in this guide can be used to determine if a linear correlation can improve the performance of the total analyzer system in terms of its ability to predict the results that the PTM would have been if applied to the same material. This methodology, which is based on the same statistical data treatment as Practice D6708 , is used to derive the parameters of the linear relationship and to assess the degree of improvement. 4.2 This guide provides developers or manufacturers of process stream analyzer systems with useful procedures for developing the capability of newly designed systems for industrial applications that require reliable prediction of measurements of a specific property by a primary test method of a flowing component or product. 4.3 This guide provides purchasers of process stream analyzer systems with some reliable options for specifying performance requirements for process stream analyzer systems that are used in applications requiring reliable prediction of measurements of a specific property by a primary test method of a flowing component or product. 4.4 This guide provides the user of a process stream analyzer system with useful information on the work process for establishing the PTM prediction relationship and prediction performance. 4.5 Prediction (correlation) relationship obtained in the application of this guide is applicable only to the material type and property range of the materials used to perform the study. Selection of the property levels and the compositional characteristics of the samples must be suitable for the application of the analyzer system. Users are cautioned against extrapolation of the prediction relationship beyond the material type and property range used to obtain the relationship. 4.6 The degree-of-agreement assessment promoted in this guide is based on the statistical principles articulated in Practice D6708 , which is purely statistical in nature. No attempt is made in assessing the degree of similarity in the analytical technique between the process analyzer and the PTM; hence, results between the PTM and analyzer unit can be highly correlated, but their measurement principles may be completely different, and may not be the principal cause for correlation. Users are therefore cautioned that a high degree of correlation between results does not necessarily imply a high degree of similarity in the measurement principles; nor does it imply a similar degree of agreement can be expected in future measurements. In general, if sample-specific biases are detected, it suggests that the measurement principles may be different, and may affect the degree-of-agreement in future use of the scaling/bias-correction equation. Presence or absence of sample-specific effect can be used as a measure of the robustness of the correlation equation to sample composition or matrix differences. 4.7 Implementation of this guide requires that the process stream analyzer system complies with the following conditions: 4.7.1 Meets the principles set forth in Process Analyzers of API RP-555, 4.7.2 Meets the supplier’s recommendation, 4.7.3 Complies with operating conditions specified by the manufacturer, 4.7.4 A predicted PTM algorithm has already been established if necessary, and 4.7.5 Meets applicable quality assurance, data collection and data telemetry protocols. 4.8 After installation or major maintenance, conduct such diagnostic tests as recommended by the manufacturer to demonstrate that the analyzer meets manufacturer's specifications, historical performance levels or both. If necessary, adjust the analyzer system components so as to obtain recommended analyzer output levels for specified reference materials. 4.9 Inspect the entire analyzer system to ensure it is installed properly, is in operating condition, and is properly adjusted after completion of the initial commissioning procedures.