The ISO 16140-2 standard
The validation protocol for alternative analysis methods changed in June 2016, with the publication of the ISO 16140-2 standard.
This revision aims to better take into account market expectations and the harmonisation of requirements between Europe and North America. Enriched by worldwide experience in the realisation of validation studies, it incorporates new approaches and now acceptability criteria. These enable the establishment of a common decision-making frame of reference for all validation network experts.
Transition procedures in the context of the NF VALIDATION certification
Positioned in the method validation market for over 25 years, AFNOR Certification has prepared the transition through a document specifying the application procedures for this protocol and describing the impact of its changes on your certificate.
Find out more about the new technical requirements
- AFNOR Certification by your side during the transition of your approach
AFNOR Certification has been preparing the transition for more than a year and a half, alongside work groups made up of experts in microbiology and statistics. This work has resulted in a document specifying the rules for the application of the new protocol in the context of the NF VALIDATION mark, based on the final draft of the ISO/FDIS 16140-2 standard.
Download the list of certified methods and discover which of the alternative methods are already certified NF VALIDATION in accordance with the ISO 16140-2 standard
- When will the new ISO 16140-2 validation protocol be applicable?
After publication of the French version of the ISO 16140-2 standard, which is planned for September 2016, only the new standard may be used for validation testing. Until then, manufacturers may choose between requesting validation in accordance with the earlier version of the NF EN ISO 16140 (2003) standard or in accordance with the new ISO 16140-2 (2016) protocol.
- When should I update the validation file for my NF VALIDATION-certified alternative method?
AFNOR Certification has established flexible transitional rules. You have until the next validation renewal date to update your file. If you wish, you may already anticipate the update of your file.
- What impact will this have on my validation file?
The main change in the standard concerns the scope validated. The new protocol involves the testing of at least 5 food product categories, excluding environmental samples, in order to apply for validation in the “all human food products” scope. Additional testing will be required to maintain this posting in your certificates.
Furthermore, the new standard includes new result calculation and interpretation methods: your files will have to be reprocessed, in order to check that they meet the new criteria.
With regard to Salmonella detection methods, since the number of strains to be tested in inclusivity study has been increased to 100, additional tests will be required.
With regard to counting methods, a new criterion, “the accuracy profile”, has been introduced, which will involve further study.
Rest assured that some of the earlier data obtained in accordance with the ISO 16140 (2003) validation protocol will remain reusable.
All these technical procedures are detailed in a document written by AFNOR Certification, with the support of its network of food microbiology experts.