International Standard
ISO 20166-3:2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
Reference number
ISO 20166-3:2018
Edición 1
2018-12
International Standard
Vista previa
ISO 20166-3:2018
69803
No disponible en español
Publicado (Edición 1, 2018)

ISO 20166-3:2018

ISO 20166-3:2018
69803
Idioma
Formato
CHF 96
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Resumen

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Informaciones generales

  •  : Publicado
     : 2018-12
    : Cierre de la revisión [90.60]
  •  : 1
     : 17
  • ISO/TC 212
    11.100.10 
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