标准摘要
[中文适用范围]： 本文件规定了食品链微生物学方法单一实验室验证的一般原则和技术方案。 本文件中的方案仅验证进行研究的实验室的方法。 本文件适用于以下方面的单一实验室验证： ——用于分析（检测或定量）微生物的方法： ——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； ——微生物的确认或分型方法。 该验证将仅取代指定方法的确认或打字程序（参见附录 G）。 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。 如果不适合根据 ISO 16140-2 进行实验室间验证，则需要进行单实验室验证。 可能的应用是： ——内部方法的验证； ——参考方法验证过程中的方法评估研究，符合 — ISO 16140-2 验证方法范围的扩展，例如类别扩展或测试部分大小； ——现有方法的修改。 单一实验室验证是参考方法标准化的第二步（参见 ISO 17468）。 它仅适用于对所有相关参数（包括温度公差和培养基规格）进行全面指定并且已经优化的方法。 [外文原描述]： This document specifies the general principles and the technical protocols for single-laboratory validation of methods for microbiology in the food chain. The protocols in this document only validate the method for the laboratory conducting the study. This document is applicable to single-laboratory validation of: — methods used in the analysis (detection or quantification) 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; — methods for the confirmation or typing of microorganisms. This validation will replace only the confirmation or typing procedure of a specified method (see Annex G). 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. Single-laboratory validation is required if an interlaboratory validation in accordance with ISO 16140-2 is not appropriate. Possible applications are: — validation of an in-house method; — method evaluation study in the validation process of a reference method in accordance with ISO 17468; — extension of the scope of an ISO 16140-2 validated method, e.g. category extension or test portion size; — modifications of existing methods. Single-laboratory validation is the second step in the standardization of a reference method (see ISO 17468). It is only applicable to methods that are fully specified with regard to all relevant parameters (including tolerances on temperatures and specifications on culture media) and that have already been optimized.
英文名称Microbiology of the food chain — Method validation — Part 4: Protocol for method validation in a single laboratory