食品链的微生物学 - 方法验证 - 第6部分:验证微生物确认和打字的替代（专有）方法的协议

[中文适用范围]： 本文件规定了食品链中微生物学替代确认方法验证的一般原则和技术协议。 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（例如全基因组测序）的确认程序（如果需要）进行比较。 本文件适用于用于分析（检测或定量）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代（部分或完全）以下所述的确认程序： ——参考方法； ——仅当使用替代确认方法的验证研究中指定的分离琼脂之一时，才根据 ISO 16140-2 进行验证的替代方法。 本文件还适用于替代分型方法的验证，其中参考方法可以是例如血清学方法（例如沙门氏菌的血清分型）或分子方法（例如产生志贺毒素的大肠杆菌的分型）。 本文件特别适用于细菌和真菌。 某些条款可能适用于其他（微生物）生物，具体取决于具体情况。 根据本文件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，特别是在某些条件下进行内部验证时（参见 ISO 16140-4） 。 [外文原描述]： 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).