【国外标准】 Standard Guide for Validating Analytical Methods

4.1 Method validation is a process of demonstrating that the method meets the required performance capabilities. International standards such as ISO/IEC 17025, certifying bodies, and regulatory agencies require evidence that analytical methods are capable of producing valid results. This applies to laboratories using published standard test methods, modified standard test methods, and in-house test methods.4.2 Although a collaborative study is part of this guide, this guide may be used by a single laboratory for method validation when a formal collaboration study is not practical. This guide may also be applied before a full collaboration study to predict the reliability of the method.4.3 The use of multiple validation techniques described in this guide increases confidence in the validity or application of the method.4.4 It is beyond the scope of this guide to describe fully the fundamental considerations in Section 5. For a more descriptive definition of these concepts, refer to the International Union of Pure and Applied Chemistry (IUPAC) technical report, “Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis” (1), the IUPAC Compendium of Analytical Nomenclature (Orange Book) (2), and the Eurachem publication, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics (3).1.1 This guide describes procedures for the validation of chemical and spectrochemical analytical test methods that are used by a metals, ores, and related materials analysis laboratory.1.2 This guide may be applied to the validation of laboratory developed (in-house) methods, addition of analytes to an existing standard test method, variation or scope expansion of an existing standard method, or the use of new or different laboratory equipment.1.3 The suggested approaches in this guide may also be used to validate the implementation of standard test methods used routinely by laboratories of the mining, ore processing, and metals industry.1.4 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.1.5 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.