ASTM D3764-06e1
Standard Practice for Validation of the Performance of Process Stream Analyzer Systems

Standard No.
ASTM D3764-06e1
Release Date
2006
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM D3764-09
Latest
ASTM D3764-23
Scope

1.1 This practice describes procedures and methodologies based on the statistical principles of Practice D 6708 to validate whether the degree of agreement between the results produced by a total analyzer system (or its subsystem), versus the results produced by an independent test method that purports to measure the same property, meets user-specified requirements. This is a performance-based validation, to be conducted using a set of materials that are not used a priori in the development of any correlation between the two measurement systems under investigation. A result from the independent test method is herein referred to as a Primary Test Method Result (PTMR).

1.2 This practice assumes any correlation necessary to mitigate systemic biases between the analyzer system and PTM have been applied to the analyzer results.

1.3 This practice requires that both the primary method against which the analyzer is compared to, and the analyzer system under investigation, are in statistical control. Practices described in Practice D 6299 should be used to ensure this condition is met.

1.4 This practice 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. This practice also applies 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 PTMRs (see Case 1 in Note 1).

1.5 This practice 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 PTMRs are required for the chemometric or multivariate model development. Users should refer to Practice D 6122 for detailed validation procedures for these types of analyzer systems (see Case 2 in ).

Note 0

For example, for the measurement of benzene in spark ignition fuels, comparison of a Mid-Infrared process analyzer system based on Test Method D 6277 to a Test Method D 3606 gas chromatography primary test method would be considered Case 1, and this practice would apply. For each sample, the Mid-Infrared spectrum is converted into a single analyzer result using methodology (Test Method D 6277) that is independent of the primary test method (Test Method D 3606). However, when the same analyzer uses a multivariate model to correlate the measured Mid-Infrared spectrum to Test Method D 3606 reference values using the methodology of Practice E 1655, it is considered Case 2 and Practice D 6122 applies. In this case 2 example, the direct output of the analyzer is the spectrum, and the conversion of this multivariate output to an analyzer result require use of Practice D 6122, hence it is not independent of the primary test method.

1.6 Performance Validation is conducted by calculating the precision and bias of the differences between results from the analyzer system (or subsystem) after the application of any necessary correlation, (such results are herein referred to as Predicted Primary Test Method Results (PPTMRs)), versus the PTMRs for the same sample set. Results used in the calculation are for samples that are not used in the development of the correlation. The calculated precision and bias are statistically compared to user-specified requirements for the analyzer system application.

1.6.1 For analyzers used in product release or product quality certification applications, the precision and bias requirement for the degree of agreement are typically based on the site or published precision of the Primary Test Method.

Note 2

In most applications of this type, the PTM is the specification-cited test method.

1.6.2 This pr......

ASTM D3764-06e1 Referenced Document

  • ASTM D1265 Standard Practice for Sampling Liquefied Petroleum (LP) Gases (Manual Method)
  • ASTM D3606 Standard Test Method for Determination of Benzene and Toluene in Finished Motor and Aviation Gasoline by Gas Chromatography
  • ASTM D4057 Standard Practice for Manual Sampling of Petroleum and Petroleum Products
  • ASTM D4177 Standard Practice for Automatic Sampling of Petroleum and Petroleum Products
  • ASTM D5842 Standard Practice for Sampling and Handling of Fuels for Volatility Measurement
  • ASTM D6122 Standard Practice for Validation of Multivariate Process Infrared Spectrophotometers
  • ASTM D6277 Standard Test Method for Determination of Benzene in Spark-Ignition Engine Fuels Using Mid Infrared Spectroscopy
  • ASTM D6299 Standard Practice for Applying Statistical Quality Assurance and Control Charting Techniques to Evaluate Analytical Measurement System Performance
  • ASTM D6708 Standard Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport to Measure the Same Property of a Material
  • ASTM E1655 Standard Practices for Infrared Multivariate Quantitative Analysis*2024-04-19 Update
  • ASTM E456 Standard Terminology for Relating to Quality and Statistics
  • ASTM F307 Standard Practice for Sampling Pressurized Gas for Gas Analysis

ASTM D3764-06e1 history

  • 2023 ASTM D3764-23 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2022 ASTM D3764-22 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2019 ASTM D3764-19 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2015 ASTM D3764-15e1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2015 ASTM D3764-15 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2013 ASTM D3764-13 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2009 ASTM D3764-09 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2006 ASTM D3764-06e1 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2006 ASTM D3764-06 Standard Practice for Validation of the Performance of Process Stream Analyzer Systems
  • 2001 ASTM D3764-01 Standard Practice for Validation of Process Stream Analyzer Systems
  • 1992 ASTM D3764-92(1998) Standard Practice for Validation of Process Stream Analyzer Systems
Standard Practice for Validation of the Performance of Process Stream Analyzer Systems



Copyright ©2024 All Rights Reserved