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DIN EN ISO 11781:2025-07

Molecular biomarker analysis - Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods (ISO 11781:2025); German version EN ISO 11781:2025

Fecha edición: 2025-07-01
En Vigor
Idiomas disponibles: Inglés, Alemán
Resumen: This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods. The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e. g. for species detection and identification. The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

Keywords: Analysis|Biomarkers|Chain reactions|Criterion|Definitions|Detection|Diet|DNA|Food control|Food inspection|Food products|Food testing|Foodstuff|Identification|Instructions|Laboratories|Laboratory testing|Laboratory tests|Methods|PCR|Performance|Polymerase|Polymerase chain reaction|Qualitative|Real-time|Validation
ICS: 67.050 - Métodos generales de análisis y de ensayo de productos alimenticios
CTN:

Equivalencia Internacional

Idéntica EN ISO 11781:2025

Idéntica ISO 11781:2025

Reemplazo Normas

Reemplaza a DIN CEN/TS 17329-1:2021-09

Reemplaza a DIN EN ISO 11781:2024-01

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