ISO 16140-4:2020 食物链微生物学 方法验证 第4部分：单实验室方法验证方案

标准编号：ISO 16140-4:2020

中文名称：食物链微生物学 方法验证 第4部分：单实验室方法验证方案

英文名称：Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory

发布日期：2020-07

标准范围

本文件规定了食物链微生物学方法单实验室验证的一般原则和技术方案。本文件中的方案仅验证进行研究的实验室的方法。本文件适用于:-用于分析（检测或定量）以下微生物的方法:-供人食用的产品；-用于动物喂养的产品；-食品和饲料生产、处理领域的环境样本；-来自初级生产阶段的样品；-微生物的确认或分型方法。该验证将仅取代指定方法的确认或分型程序（见附录G）。该文献尤其适用于细菌和真菌。有些条款可能适用于其他（微生物）生物或其代谢物，具体情况要确定。如果不适合按照ISO 16140-2进行实验室间验证，则需要进行单个实验室验证。可能的应用有:-内部方法的验证；-根据ISO 17468，在参考方法的验证过程中进行方法评价研究；-扩展ISO 16140-2验证方法的范围，例如类别扩展或测试部分大小；-对现有方法的修改。单实验室验证是参考方法标准化的第二步（参见ISO 17468）。它仅适用于所有相关参数（包括温度公差和培养基规格）完全规定且已经优化的方法。

This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study.This document is applicable to single-laboratory validation of:— methods used in 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;

— methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G).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.Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possible applications are:— validation of an in-house method;— method evaluation study in the validation process of a reference method in accordance with ISO 17468;— extension of the scope of an ISO 16140-2 validated method, e.g. category extension or test portion size;— modifications of existing methods.Single-laboratory validation is the second step in the standardization of a reference method (see ISO 17468). It is only applicable to 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.

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