Two parts of the ISO 16140 series have now been published. (ISO photo)

ISO Updates Standard on Validating Microorganism Testing in Food

The ISO 16140-1:2016 standard for the validation of alternative (proprietary) microbiological methods provides a specific protocol and guidelines.

ISO announced that the ISO 16140:2003 standard for the validation of alternative (proprietary) microbiological methods has been revised. Two parts of the ISO 16140 series have now been published: ISO 16140-1:2016, Microbiology of the food chain – Method validation – Part 1: Vocabulary, describes the terminology used in microbial testing, while 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 is dedicated to the validation of proprietary microbiological methods.

The two parts are designed to help food and feed testing laboratories, test kit manufacturers, competent authorities, and food and feed business operators implement microbiological methods. ISO 16140-2 includes two phases, the method comparison study and the interlaboratory study, with separate protocols for the validation of qualitative and quantitative microbiological methods.

The new multipart standard provides a specific protocol and guidelines for the validation of methods both proprietary (commercial) or not. Proprietary methods are generally cheaper to use, produce results faster than traditional culturing methods, and are simpler to perform as they require fewer technical skills. Also, more than 100 alternative methods have been validated based on the previous version of ISO 16140 and the standard has been updated to provide new insights on the validation of microbiological methods and experience gained from conducting validation studies across the world.

"The validation according to ISO 16140-2 will lead to a higher reliability of the alternative method test result and the users will benefit from having microbiological test results available sooner. Most likely, this will contribute to greater food safety," said Paul in ‘t Veld, the convenor of Working Group 3 on method validation, which is responsible for the development of the ISO 16140 series.

Four other new parts of ISO 16140 are still under development with these topics:

  • Protocol for the verification of reference and validated alternative methods implemented in a single laboratory (Part 3 of ISO 16140)
  • Protocol for single-laboratory (in-house) method validation (Part 4)Protocol for factorial interlaboratory validation for non-proprietary methods (Part 5)
  • Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing (Part 6)

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