Microbiology-PTM-OMA_Modules_1-5

Harmonization Studies:  Guidelines & Standards

• ISO 16140‐2 (2016):  Microbiology of the food chain — Method validation  — Part 2: Protocol for the validation of alternative (proprietary) methods  against a reference method https://www.iso.org/standard/54870.html • ISO/DIS 16140‐6 (2018):  Microbiology of the food chain — Method  validation — Part 6: Protocol for the validation of alternative (proprietary)  methods for Microbial Confirmation and Typing Procedures https://www.iso.org/standard/66327.html • The ISO 16140 series (1‐6), developed by ISO TC34/SC9/WG3 forms the  basis for the European certification of alternative methods, thus fulfilling  European legislation.