ČSN EN ISO 11781 (569918)

Molecular biomarker analysis - Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods

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STANDARD published on 1.9.2025


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The information about the standard:

Designation standards: ČSN EN ISO 11781
Classification mark: 569918
Catalog number: 521781
Publication date standards: 1.9.2025
SKU: NS-1229903
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

Annotation of standard text ČSN EN ISO 11781 (569918):

This document specifies minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods.

The document is applicable to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products (e.g. for the detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins).

The document does not apply to single laboratory validation of qualitative microbiological real-time PCR methods.

The document does not apply to the evaluation of applicability and practicability with respect to the specific scope of the PCR method

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