ISO 16140-2:2016
食物鏈的微生物學(xué).方法驗證.第2部分:參考法替代(專有)方法驗證協(xié)議

Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method

被代替

標(biāo)準(zhǔn)號: ISO 16140-2:2016
發(fā)布: 2016年
總頁數(shù): 74頁
發(fā)布單位: 國際標(biāo)準(zhǔn)化組織
替代標(biāo)準(zhǔn): ISO 16140-2:2016/Amd 1:2024
當(dāng)前最新: ISO 16140-2:2016/Amd 1:2024

引用標(biāo)準(zhǔn): 79/373/EWG-1979 ISO 11133:2014 ISO 16140-1:2016 ISO 16297:2013 ISO 5725-2:1994 ISO/TS 22117:2010

本體: 方法驗證食品鏈

適用范圍: 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.

術(shù)語	描述
Acceptability Limits (AL) Acceptability Limits (AL)	基于專家意見和現(xiàn)有驗證研究數(shù)據(jù)，用于評估方法性能的可接受標(biāo)準(zhǔn)。
相對檢測水平（RLOD） Relative Level of Detection (RLOD)	在人工污染樣品中確定替代方法與參考方法之間的檢測水平差異。