International Standard
ISO 4307:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
Reference number
ISO 4307:2021
Edición 1
2021-10
International Standard
Vista previa
ISO 4307:2021
79865
No disponible en español
Publicado (Edición 1, 2021)

ISO 4307:2021

ISO 4307:2021
79865
Idioma
Formato
CHF 63
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Resumen

This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human DNA examination during the pre-examination phase before a molecular examination is performed.

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

Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.

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

Informaciones generales

  •  : Publicado
     : 2021-10
    : Norma Internacional publicada [60.60]
  •  : 1
     : 12
  • ISO/TC 212
    11.100.10 
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