【国外标准】 Standard Practice for Development and Implementation of Instrument Performance Tests for Use on Multivariate Online, At-Line and Laboratory Spectroscopic Based Analyzer Systems

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.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.