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This document specifies the general principles and the technical protocols applicable to the validation of alternative, proprietary and non-proprietary, methods for the detection, quantification and typing of known preformed bacterial toxins or known biogenic amines in food intended for human consumption.
The validation process described in this document can also be applied to validate methods in bacterial culture supernatant.
ISO/TC 34/SC 9 ‘Microbiology’ agreed in resolution N 2024/11 to start with the preparations of the development of ISO 16140-9 and registered Part 9 as a “Preliminary Work Item”. The rationale for the development of a dedicated part in the ISO 16140 series for bacterial toxins and biogenic amines can be found in doc. SC 9/N 3376, and can be summarized as follows.
— ISO/NP 16140-9 describes the validation studies for qualitative and quantitative analysis which are adapted from ISO 16140-2 but include sufficiently different study designs and requirements due to inherent challenges in detecting preformed bacterial toxins and biogenic amines that are difficult to generate, for example, because of: 1. unavailability of homogenous naturally occurring test material, 2. rarity with which naturally contaminated samples occur , 3. unavailability of toxin standards (pure toxin solutions for all toxin types), 4. shipping restrictions due to national regulations of dangerous goods.
— The selection of categories/types/items as presented in Annex A of ISO 16140-2 may not be applicable to the detection or quantification of preformed bacterial toxins and bioge nic amines. An informative annex ‘Classification of food categories and suggested target combinations for validation studies’ is included in ISO/NP 16140-9.
— An alternative way to calculate performance characteristics based on AOAC protocols is provided in ISO/NP 16140-9. ISO/TC 34/SC 9/WG 2 ‘Statistics’ is also invited to give their opinion on this matter.
— Laboratories that perform detection or quantification of bacterial toxins and biogenic amines are specialized laboratories that may not perform cul tural detection or quantification methods. The other instructions and information provided in ISO 16140-2 are not expected to be needed frequently in the laboratories performing the testing for bacterial toxins or biogenic amines.
Note that in WG 3 ‘Method validation’ the Project Group ‘Bacterial toxins and biogenic amines’ is active which supported the project leader in preparing ISO/NP 16140-9. In this Project Group experts from the following countries are a member: Belgium, France, Germany, India, Italy, Netherlands, United Kingdom, United States.
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