ISO 16140-6:2019 食物链的微生物学 方法验证 第6部分：微生物鉴定和分型程序的替代（专有）方法的验证方案

标准编号：ISO 16140-6:2019

中文名称：食物链的微生物学 方法验证 第6部分：微生物鉴定和分型程序的替代（专有）方法的验证方案

英文名称：Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

发布日期：2019-11

标准范围

本文件规定了食品链中微生物替代确认方法验证的一般原则和技术方案。本文件将替代确认方法的结果与参考方法或参考确认方法（如需要）的确认程序（如全基因组测序）进行比较。本文件适用于以下情况下用于分析（检测或量化）分离微生物的替代确认方法的验证:-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。经验证的替代确认方法可用于替换（部分或全部）下述确认程序:-参考方法；-仅当使用替代确认方法验证研究中规定的一种分离琼脂时，根据ISO 16140-2验证的替代方法。本文件也适用于替代分型方法的验证，其中参考方法可以是血清学方法（例如，沙门氏菌的血清分型）或分子方法（例如，产志贺毒素的大肠杆菌的分型）。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）生物体，具体视具体情况而定。根据本文件进行的验证研究主要由参与方法验证的组织或专家实验室进行，但也可由单个实验室使用，尤其是在-特定条件下的房屋验证（见ISO 16140-4）。

This document specifies the general principle and the technical protocol for the validation of alternative confirmation methods for microbiology in the food chain. This document compares the result of the alternative confirmation method against the confirmation procedure of a reference method or, if needed, a reference confirmation method (e.g. whole genome sequencing).This document is applicable to the validation of alternative confirmation methods used for the analysis (detection or quantification) of isolated 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.Validated alternative confirmation methods can be used to replace (partly or completely) the confirmation procedure described in:— the reference method;— an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars specified in the validation study of the alternative confirmation method is used.This document is also applicable to the validation of alternative typing methods, where the reference method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method (e.g. typing of Shiga toxin-producing E. coli).This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, to be determined on a case-by-case basis.Validation studies in accordance with this document are primarily intended to be performed by organizations or expert laboratories involved in method validation, but can also be used by a single laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4).

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