标准摘要
[中文适用范围]: 本文件规定了在用户实验室中实施参考方法和经过验证的替代方法的验证协议。 本文件适用于用于微生物分析(检测和/或定量)、确认和分型的方法的验证: ——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。 本文件特别适用于细菌和真菌。 某些条款可适用于其他(微生物)生物或其代谢物,具体取决于具体情况。 用于验证经验证的定性方法和经验证的定量方法的技术协议在第 5 条和第 6 条中描述。 用于验证经验证的替代确认和分型方法的技术协议在第 7 条中描述。 用于验证未经验证的方法的技术协议在第 7 条中描述。 参考方法在附录 F 中描述。 [外文原描述]: This document specifies the protocol for the verification of reference methods and validated alternative methods for implementation in the user laboratory. This document is applicable to the verification of methods used for the analysis (detection and/or quantification), confirmation and typing 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. 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. The technical protocols for the verification of validated qualitative methods and validated quantitative methods are described in Clauses 5 and 6. The technical protocol for the verification of validated alternative confirmation and typing methods is described in Clause 7. The protocols for the verification of non-validated reference methods are described in Annex F.
英文名称Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory