标准编号：ISO 16140-6:2019
中文名称：食物链的微生物学 方法验证 第6部分：微生物鉴定和分型程序的替代（专有）方法的验证方案
英文名称：Microbiology of the food chain — Method validation — Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing procedures
发布日期：2019-11
标准范围
This document specifies the general principle and the technical protocol for the validation of alternative
confirmation methods for microbiology in the food chain. This document compares the result of the
alternative confirmation method against the confirmation procedure of a reference method or, if
needed, a reference confirmation method (e.g. whole genome sequencing).
This document is applicable to the validation of alternative confirmation methods used for the analysis
(detection or quantification) of isolated 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.
Validated alternative confirmation methods can be used to replace (partly or completely) the
confirmation procedure described in:
— the reference method;
— an alternative method validated in accordance with ISO 16140-2 only if one of the isolation agars
specified in the validation study of the alternative confirmation method is used.
This document is also applicable to the validation of alternative typing methods, where the reference
method can be, for example, a serological method (e.g. serotyping of Salmonella) or a molecular method
(e.g. typing of Shiga toxin-producing E. coli).
This document is, in particular, applicable to bacteria and fungi. Some clauses can be applicable to other
(micro)organisms, to be determined on a case-by-case basis.
Validation studies in accordance with this document are primarily intended to be performed by
organizations or expert laboratories involved in method validation, but can also be used by a single
laboratory, especially when performing in-house validation under certain conditions (see ISO 16140-4).
立即下载标准文件