EN 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 (ISO 16140-2:2016)

Standard No.
EN ISO 16140-2:2016
Release Date
2016
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 16140-2:2016
Replace
FprEN ISO 16140-2:2016
Scope
This part of ISO 16140 specifies the general principle and technical procedure for the validation of alternative, mostly proprietary, methods in the microbiology of the food chain. Validation studies according to this part of ISO 16140 should be carried out by organizations involved in process validation. This part of ISO 16140 is applicable to the validation of methods for the examination (detection or quantification) of microorganisms in: products intended for human consumption; products intended as animal feed; Environmental samples in the area of food and feed production and handling; Samples from the area of primary production. This part of ISO 16140 applies specifically to bacteria and fungi. Some clauses of this part of ISO 16140 are 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 either this or another part of ISO 16140.

EN ISO 16140-2:2016 Referenced Document

  • ISO 11133:2014 Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media
  • ISO 16140-1:2016 Microbiology of the food chain - Method validation - Part 1: Vocabulary
  • ISO 16297:2013 Milk - Bacterial count - Protocol for the evaluation of alternative methods
  • ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
  • ISO/TS 22117:2010 Microbiology of food and animal feeding stuffs - Specific requirements and guidance for proficiency testing by interlaboratory comparison

EN ISO 16140-2:2016 history

  • 2016 EN 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 (ISO 16140-2:2016)

EN 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 (ISO 16140-2:2016) has been changed from EN ISO 16140:2003 Microbiology of Food and Animal Feeding Stuffs - Protocol for the Validation of Alternative Methods ISO 16140:2003.




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