This European Standard specifies how to use the standards for immunoassays, nucleic based and chromatographic methods and their relationship in the analysis of food allergens; and contains general definitions, requirements and guidelines for laboratory set-up, method validation requirements, description of methods, and test reports.This document also specifies general guidelines for the requirements and use of reference materials for the determination of allergenic commodities in food products. The term "reference materials" inThis document includes certified reference materials as well as quality control materials. Currently only a limited number of reference materials for food allergen determination are available. As new materials become accepted and validated, they may be appended as an annex toThis document.This document does not deal with sampling issues. It simply details processes involved from receipt of the laboratory sample to the end result.
EN 15842:2010 Referenced Document
EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ISO 17511:2003
EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)
ISO Guide 31:2000 Reference materials - Contents of certificates and labels
ISO Guide 35:2006 Reference materials - General and statistical principles for certification
EN 15842:2010 history
2010EN 15842:2010 Foodstuffs - Detection of food allergens - General considerations and validation of methods