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现行 EN ISO 16140-7:2024
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Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024) 食物链微生物学方法验证第7部分:微生物鉴定方法验证方案
发布日期: 2024-11-13
实施日期: 2024-11-13
本文件规定了食品链微生物鉴定方法验证的一般原则和技术方案。由于没有参考方法,本文件提供了一个协议来评估性能特征,并使用定义明确的菌株验证方法工作流程。必要时,可以使用额外的识别方法。 本文件适用于用于分析以下微生物的微生物鉴定方法的验证: -供人类消费的产品; -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; -初级生产阶段的样品。 不能使用经验证的识别方法代替中所述的确认: -参考方法; -根据ISO 16140验证的替代方法- 2. -根据ISO 16140-6验证的替代方法。 在这些情况下,应根据ISO 16140-6对识别方法进行验证,以用作确认方法。 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,具体情况另行确定。
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.
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归口单位: CEN/TC 463
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现行
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