标准摘要
[中文适用范围]： 本部分 specifications the general principles and the technical protocol of alternative, mostly proprietary, methods for microbiology in the food chain. The validation studies according to this part are intended to be performed by organizations involved in method validation. This part of ISO 16140 is applicable to the validation of methods 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, and — samples from the primary production stage. This part of ISO 16140 is particularly applicable to bacteria and fungi. Some clauses of this part may be applicable to other (micro)organisms or their metabolites on a case-by-case basis. [外文原描述]： ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation. It is applicable to the validation of methods 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, and - samples from the primary production stage. It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).
英文名称Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method