【国外标准】 Standard Guide for Fluorescence—Instrument Calibration and Qualification

4.1 By following the general guidelines (Section 5) and instrument calibration methods (Sections 6 – 16) in this guide, users should be able to more easily conform to good laboratory and manufacturing practices (GXP) and comply with regulatory and QA/QC requirements, related to fluorescence measurements.4.2 Each instrument parameter needing calibration (for example, wavelength, spectral responsivity) is treated in a separate section. A list of different calibration methods is given for each instrument parameter with a brief usage procedure. Precautions, achievable precision and accuracy, and other useful information are also given for each method to allow users to make a more informed decision as to which method is the best choice for their calibration needs. Additional details for each method can be found in the references given.1.1 This guide (1)2 lists the available materials and methods for each type of calibration or correction for fluorescence instruments (spectral emission correction, wavelength accuracy, and so forth) with a general description, the level of quality, precision and accuracy attainable, limitations, and useful references given for each entry.1.2 The listed materials and methods are intended for the qualification of fluorometers as part of complying with regulatory and other quality assurance/quality control (QA/QC) requirements.1.3 Precision and accuracy or uncertainty are given at a 1 σ confidence level and are approximated in cases where these values have not been well established.31.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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.