标准摘要
[中文适用范围]： 本文件规定了微生物学在食品链中验证微生物鉴定方法的一般原则和技术协议。由于没有参考方法，无法进行方法比较研究。因此，本文件提供了一种评估性能特性和验证方法工作流程的协议，使用定义明确的菌株。当需要时，可以额外使用一种鉴定方法。本文件适用于验证用于分析从以下样品分离的菌落所使用的鉴定方法：——预期供人类消费的产品；——饲喂动物的产品；——食品和饲料生产及处理区域中的环境样本；——初级生产阶段的样品。仅根据本文件进行验证的鉴定方法不能替代以下描述的确证：——参考方法；——根据ISO 16140-2进行验证的其他方法；——根据ISO 16140-6进行验证的其他方法。在这种情况下，鉴定方法应根据用作确证方法的ISO 16140-6方法进行验证。本文件适用于细菌和真菌。某些条款也可适用于其他（微）生物，具体可根据实际情况确定。 [外文原描述]： This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used. This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from: — products intended for human consumption; — products for feeding animals; — environmental samples in the area of food and feed production and handling; — samples from the primary production stage. Identification methods only validated in accordance with this document cannot be used instead of confirmation described in: — the reference method; — an alternative method validated in accordance with ISO 16140-2; — an alternative method validated in accordance with ISO 16140-6. In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method. This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.
英文名称Microbiology of the food chain — Method validation — Part 7: Protocol for the validation of identification methods of microorganisms