EN ISO 16140-4:2020
食品链微生物学.方法验证.第4部分:单一实验室方法验证规程

Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)

作废

非常抱歉，我们暂时无法提供预览，您可以试试： 免费下载 EN ISO 16140-4:2020 前三页，或者稍后再访问。

您也可以尝试购买此标准，
点击右侧 “购买” 按钮开始采购（由第三方提供）。

注意： 点击下载后，生成下载文件时间比较长，请耐心等待......

标准号

EN ISO 16140-4:2020

发布

2020年

发布单位

欧洲标准化委员会

当前最新

EN ISO 16140-4:2020

 

 

适用范围

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.

EN ISO 16140-4:2020相似标准

推荐