标准编号：ISO 16140-5:2020
中文名称：食物链微生物学 方法验证 第5部分： 非专利方法的析因实验室间验证规程
英文名称：Microbiology of the food chain — Method validation — Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods
发布日期：2020-07
标准范围
This document specifies the general principles and the technical protocols (based on orthogonal,
factorial studies) for the validation of non-proprietary methods for microbiology of the food chain.
This document is applicable to the validation of methods used for 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.
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.
This document specifies protocols for the validation against a reference method for both quantitative
and qualitative methods. This document also provides a protocol for the validation of quantitative
methods without a reference method. Qualitative methods cannot be validated without a reference
method in accordance with this document.
NOTE ISO 16140-2 specifies the general principle and the technical protocol for the validation of alternative,
mostly proprietary, methods against a reference method.
This document is only applicable to the validation of 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.
Methods that have been validated in accordance with this document can be used by the laboratories of
the specified population of laboratories.
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