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Standard

NS-EN 12682:1998

Published

Corrigenda and amendments are bought separately.

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Abstract

This European Standard provides guidance on the design and execution of experiments for the analysis of the functional expression of the genomic modification. It gives criteria for the setup of an experimental design and the determination of the validity of its execution. The main factors influencing the specificity, reliability and limits of detection for an analysis are given for the following categories of experiments : - analysis of the expression of a genomic modification within GMOs (or clones of) or any specified part of them, including its response to internal (developmental stage, growth, organ or tissue location) and external factors (temperature, humidity, pH, other) ; - establishment of identity of a desired product resulting from the expression of a genomic modification in comparison with a reference ; - characterization of the novel trait(s) of a GMO. This European Standard does not cover procedures for the analysis of pleïotropic effects of a genomic modification or the act of generating the GMO (e.g. somaclonal variation) on the phenotype of modified organisms, which cannot be predicted from the knowledge of the type of the genomic modification. However, the principles stated in this European Standard are applicable for the execution of any analysis of gene functions.

Document information

  • Standard from SN
  • Published:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 07.080
  • National Committee CEN/TC 233

Legal references

EU law: 90/219/EEC, 90/220/EEC, 90/679/EEC

Product Relations

  • Adopted from: EN 12682:1998 , 0