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Standard Practice for Determining the Site Precision of a Process Stream Analyzer on Process Stream Material 在工艺流材料上测定工艺流分析仪现场精度的标准实施规程
发布日期: 2022-04-01
1.1 本规程描述了通过在延长的时间段内重复测量单个过程样品来量化过程分析仪现场精度的程序。该程序可应用于多个过程样本,以获得不同性能水平下的现场精度估计 1.1.1 使用统计方法需要现场精度 D6708 使用实践建立分析仪结果和主要测试方法结果之间的相关性 D7235 . 1.1.2 当采用以下统计方法时,还需要现场精度: D6708 通过实践验证过程分析器 D3764 或 D6122 . 1.2 本规程不适用于不能重复引入相同质量控制样品的在线分析仪。 1.3 本规程适用于测量物理性质或成分的分析仪。 1.4 该实践可适用于任何过程分析仪系统,在该系统中,进料流可以被捕获并储存足够的量,而不存在分层或稳定性问题。 1.4.1 捕获的流样品引入必须能够满足过程分析仪样品调节要求、进料温度和入口压力。 1.4.2 本规程设计用于在取样和样品储存条件下蒸汽压小于或等于110的单液相石油产品样品 千帕(16.0 psi)绝对值和 D86 最终沸点小于或等于400 °C(752 °F)。 注1: 本规程中描述的一般程序可能适用于该范围以外的材料,包括多相材料,但此类应用可能涉及本规程范围以外的特殊取样和安全考虑。 1.5 工作条件值以国际单位制表示,并视为标准。括号中给出的值是历史英寸-磅单位,仅供参考。 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 分析仪现场精度是对分析仪产生的UAR或PPTMR中预期的可变性的估计,当在延长的时间段内应用于相同材料的分析时。 4.2 对于要求过程分析仪系统结果与独立PTM产生的结果一致的应用,导出了将UAR与PPTMR关联的数学函数。 将该数学函数应用于分析仪结果会产生预测的PPTMR。对于数学函数(即相关性)由以下公式开发的分析仪: D7235 ,UARs的分析仪现场精度是计算所需的输入。 4.3 在建立分析仪结果和主要试验方法结果之间的相关性后,进行试用验证(见 D3764 和 D6122 )使用不属于相关活动的独立但有限的一组材料执行。该试用验证旨在证明PPTMR与PTMRs在分析仪系统应用的用户指定要求范围内一致。分析仪现场精度是试用验证程序的必需输入。 4.3.1 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PTM测量原理类似的直接且易于理解的测量原理,则通过以下方式进行验证: D3764 . 实践 D3764 如果过程流分析仪系统使用与PTM不同的测量技术,也适用,前提是分析仪直接输出的校准协议不需要使用PTM。 4.3.2 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,其中需要PTMR来开发化学计量学或多元模型,则使用实践对分析仪进行验证 D6122 . 4.3.3 两者都是 D3764 和 D6122 验证实践使用实践的统计方法 D6708 进行试用验证。该方法要求PTM的现场精度和分析仪现场精度可用。 4.4 本文所述程序也可作为过程分析仪质量控制系统的基础。QC材料的代表性样品以可重复的方式引入分析仪系统。这种样本引入允许捕捉分析仪系统操作变量对过程分析仪UAR和PPTMR输出信号的影响。通过将观察到的分析仪响应与QC样品的预期响应进行比较,可以确定分析仪系统的适用性。
1.1 This practice describes a procedure to quantify the site precision of a process analyzer via repetitive measurement of a single process sample over an extended time period. The procedure may be applied to multiple process samples to obtain site precision estimates at different property levels 1.1.1 The site precision is required for use of the statistical methodology of D6708 in establishing the correlation between analyzer results and primary test method results using Practice D7235 . 1.1.2 The site precision is also required when employing the statistical methodology of D6708 to validate a process analyzer via Practices D3764 or D6122 . 1.2 This practice is not applicable to in-line analyzers where the same quality control sample cannot be repetitively introduced. 1.3 This practice is meant to be applied to analyzers that measure physical properties or compositions. 1.4 This practice can be applied to any process analyzer system where the feed stream can be captured and stored in sufficient quantity with no stratification or stability concerns. 1.4.1 The captured stream sample introduction must be able to meet the process analyzer sample conditioning requirements, feed temperature and inlet pressure. 1.4.2 This practice is designed for use with samples that are single liquid phase, petroleum products whose vapor pressure, at sampling and sample storage conditions, is less than or equal to 110 kPa (16.0 psi) absolute and whose D86 final boiling point is less than or equal to 400 °C (752 °F). Note 1: The general procedures described in this practice may be applicable to materials outside this range, including multiphase materials, but such application may involve special sampling and safety considerations which are outside the scope of this practice. 1.5 The values for operating conditions are stated in SI units and are to be regarded as the standard. The values given in parentheses are the historical inch-pound units for information only. 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 The analyzer site precision is an estimate of the variability that can be expected in a UAR or a PPTMR produced by an analyzer when applied to the analysis of the same material over an extended time period. 4.2 For applications where the process analyzer system results are required to agree with results produced from an independent PTM, a mathematical function is derived that relates the UARs to the PPTMRs. The application of this mathematical function to an analyzer result produces a predicted PPTMR. For analyzers where the mathematical function, that is, a correlation, is developed by D7235 , the analyzer site precision of the UARs is a required input to the computation. 4.3 After the correlation relationship between the analyzer results and primary test method results has been established, a probationary validation (see D3764 and D6122 ) is performed using an independent but limited set of materials that were not part of the correlation activity. This probationary validation is intended to demonstrate that the PPTMRs agree with the PTMRs to within user-specified requirements for the analyzer system application. The analyzer site precision is a required input to the probationary validation procedures. 4.3.1 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 PTM then validation is done via D3764 . Practice D3764 also applies if the process stream analyzer system uses a different measurement technology from the PTM, provided that the calibration protocol for the direct output of the analyzer does not require use of the PTM. 4.3.2 If the process stream analyzer system utilizes an indirect or mathematically modeled measurement principle such as chemometric or multivariate analysis techniques where PTMRs are required for the development of the chemometric or multivariate model, then validation of the analyzer is done using Practice D6122 . 4.3.3 Both the D3764 and D6122 validation practices utilize the statistical methodology of Practice D6708 to conduct the probationary validation. This methodology requires that the site precision for the PTM and the analyzer site precision be available. 4.4 The procedures described herein also serve as the basis for a process analyzer quality control system. A representative sample of the QC material is introduced into the analyzer system in a repeatable fashion. Such sample introduction permits capturing the effect of the analyzer system operating variables on the UAR and PPTMR output signal from the process analyzer. By comparing the observed analyzer responses to the expected response for the QC sample, the fitness for use of the analyzer system can be determined.
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