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现行 ASTM E2719-09(2022)
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Standard Guide for Fluorescence—Instrument Calibration and Qualification 荧光仪器校准和鉴定标准指南
发布日期: 2022-11-01
1.1 本指南 ( 1. ) 2. 列出了每种类型的荧光仪器校准或校正(光谱发射校正、波长精度等)的可用材料和方法,并提供了一般说明、质量水平、可达到的精度和准确度、限制以及每个条目的有用参考。 1.2 所列材料和方法用于鉴定荧光计,作为遵守监管和其他质量保证/质量控制(QA/QC)要求的一部分。 1.3 精度和准确度或不确定度以1σ置信水平给出,并在这些值未得到充分确定的情况下进行近似。 3. 1.4 以国际单位表示的值应视为标准值。本标准不包括其他计量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全问题(如有)。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践,并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《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 遵循一般指南(第 5. )和仪器校准方法(章节 6 – 16 )在本指南中,用户应能够更容易地遵守良好的实验室和制造规范(GXP),并遵守与荧光测量相关的监管和QA/QC要求。 4.2 需要校准的每个仪器参数(例如波长、光谱响应度)在单独的章节中处理。给出了每个仪器参数的不同校准方法列表以及简要的使用程序。还为每种方法提供了预防措施、可实现的精度和准确度以及其他有用信息,以允许用户做出更明智的决定,确定哪种方法是满足其校准需求的最佳选择。 有关每种方法的更多详细信息,请参阅所提供的参考资料。
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. 3 1.4 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. ====== Significance And Use ====== 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.
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归口单位: E13.01
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