ISO/TS 22176:2020 化妆品 分析方法 定量分析方法验证的全球方法的发展

标准编号：ISO/TS 22176:2020

中文名称：化妆品 分析方法 定量分析方法验证的全球方法的发展

英文名称：Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods

发布日期：2020-01

标准范围

本文件定义了基于准确度曲线的构造和解释的定量分析方法验证的整体方法，并规定了其表征程序。本程序特别适用于化妆品检测实验室的内部验证，但其范围可扩展至解释根据ISO 5725-1建议设计的实验室间研究所收集的数据。它不适用于微生物试验。目前的方法特别适合处理化妆品中广泛多样的基质。本文件仅适用于已经充分开发和最终确定的方法，这些方法的选择性/特异性已经过研究，且待验证方法的范围已经根据基质类型和被测物（例如分析物）浓度进行了定义。

This document defines a global approach for the validation of a quantitative analytical method, based on the construction and interpretation of an accuracy profile, and specifies its characterization procedure.This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but its scope can be extended to the interpretation of data collected for an interlaboratory study designed according to the recommendations of the ISO 5725-1. It does not apply to microbiological trials. The present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This document only applies to already fully-developed and finalized methods for which selectivity/specificity have already been studied and the scope of the method to be validated has already been defined, in terms of matrix types and measurand (for example analyte) concentrations.

标准预览图