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Standards Development
This document is applicable to the validation of alternative (proprietary and non-proprietary) qualitative or quantitative methods against
a reference method for viruses and parasites in:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling.
Validation studies according to this document are intended to be performed by organizations involved in method validation.
This document is applicable to common and emerging foodborne viruses (e.g. human norovirus, hepatitis A virus) and parasites (e.g.
Cryptosporidium, Cyclospora) which have a reference method.
ISO/NP 16140-8 addresses the validation of methods for viruses and parasites against a reference method. This document covers relevant areas such as virology or parasitology, statistical design, and analysis as indicated in the respective sections. The proposed document encompasses design of experiments, statistical analysis of (qualitative and quantitative) data, and overview of statistical
concepts on random sampling, sample heterogeneity, sample stability, design of experiments, and variance components. There are several meaningful differences compared to the applicability of 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’, namely:
— The proposed document will allow for the validation of both proprietary and non-proprietary methods and will provide
requirements/guidance for the validation of reference methods for viruses and parasites in accordance with ISO 17468:2023
‘Microbiology of the food chain — Technical requirements and guidance on establishment or revision of a standardized reference method’.
— Clauses 5 and 6 of this document will describe the validation studies for qualitative and quantitative analysis which are adapted from ISO 16140-2:2016 but include different study designs and requirements due to inherent challenges in evaluating viruses or parasites that are difficult to propagate (e.g., unavailability of homogenous naturally occurring test material). If needed, differentiation between viruses and parasites can be made in different (sub)clauses of the proposed document.
— The selection of categories/types/items as presented in ISO 16140-2:2016, Annex A, is not applicable to the detection and enumeration of viruses and parasites. The development or expansion of current categories sufficient for viruses and parasites will be included in the proposed document.
— Terminology used in ISO 16140-2:2016 is applicable to bacterial and fungal organisms (colony-forming units) but is not applicable to viruses and parasites. Applicable terminology for viruses and parasites is incorporated into ISO/NP 16140-8 and/or the future revision of ISO 16140-1:2016 ‘Microbiology of the food chain — Method validation — Part 1: Vocabulary’.
— Confirmation of test portions may or may not require further molecular analysis. If required, additional information to describe the
related requirements for the process will be added in the proposed document.
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