Standard Practice for Performance-Based Qualification of Spectroscopic Analyzer Systems

Importancia y uso:

5.1 This practice is intended for use by parties interested in releasing product by use of vibrational spectroscopic analyzer systems. It is expected to meet the industry need for a written practical reference describing a scientifically systematic approach to show the degree of confidence and degree of uncertainty in analyzer predicted values in relation to the PTM.

5.2 This is a performance-based practice that relies on the demonstrated quality of the test result and on strict adherence to the referenced standards and the additional requirements in this practice.

5.3 As part of demonstrating performance, this practice incorporates by reference other ASTM standardized practices as key steps in the process.

5.4 There are prescriptive requirements included for this practice.

5.4.1 The practice requires sample temperature to be carefully controlled in analyzer system hardware or that effects of temperature change be compensated in modeling or software.

5.4.2 Outlier detection capability is required for demonstrating the multivariate calibration model is applicable for the analysis of the sample spectrum, that is, that the analysis interpolates the model, that the sample does not contain a statistically significant amount of unmodeled components above a certain limit based on spectral residual statistic and that the sample spectrum does not fall within gap in the multivariate calibration space.

5.5 In order to follow this practice, all criteria must be met.

5.5.1 The user shall investigate the cause of not meeting the practice requirements.

5.5.2 For any nonconformities noticed, the user shall make corrections to the analyzer system or procedures to conform to the requirements of this practice.

Subcomité:

D02.25

Referida por:

D7453-22, D4814-24A, D8470-22, D4814-24A, D8321-22, D3764-23, D3764-23, D4814-24A, D6122-23

Volúmen:

05.05

Número ICS:

17.180.30 (Optical measuring instruments)

Palabras clave:

infrared; performance-based; Raman;