ISO 16140-5:2020 食物链微生物学 方法验证 第5部分： 非专利方法的析因实验室间验证规程
标准编号：ISO 16140-5:2020
中文名称：食物链微生物学 方法验证 第5部分： 非专利方法的析因实验室间验证规程
英文名称：Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
发布日期：2020-07
标准范围
本文件规定了食品链微生物学非专利方法验证的一般原则和技术协议（基于正交、析因研究）。本文件适用于以下微生物分析（检测或量化）方法的验证:-供人类消费的产品；-用于动物饲养的产品；-食品和饲料生产、处理领域的环境样品；-初级生产阶段的样品。本文件尤其适用于细菌和真菌。有些条款可适用于其他（微生物）有机体或其代谢产物，具体取决于具体情况。本文件规定了针对定量和定性方法的参考方法进行验证的方案。本文件还提供了无参考方法的定量方法验证方案。如果没有符合本文件要求的参考方法，则无法验证定性方法。注:ISO 16140-2规定了对照参考方法验证替代方法（主要是专有方法）的一般原则和技术协议。本文件仅适用于对所有相关参数（包括温度公差和培养基规格）进行充分规定且已优化的方法进行验证。根据本文件验证的方法可由指定实验室群体的实验室使用。
This document specifies the general principles and the technical protocols (based on orthogonal, factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.This document is applicable to the validation of methods used for the analysis (detection or quantification) of microorganisms in:— products intended for human consumption;— products intended for animal feeding;— environmental samples in the area of food and feed production, handling;— samples from the primary production stage.This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms or their metabolites, to be determined on a case-by-case basis.This document specifies protocols for the validation against a reference method for both quantitative and qualitative methods. This document also provides a protocol for the validation of quantitative methods without a reference method. Qualitative methods cannot be validated without a reference method in accordance with this document.NOTE ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods against a reference method.This document is only applicable to the validation of methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.Methods that have been validated in accordance with this document can be used by the laboratories of the specified population of laboratories.
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