Reference number
ISO 4307:2021
International Standard
ISO 4307:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
Edition 1
2021-10
Read sample
ISO 4307:2021
79865
Published (Edition 1, 2021)

ISO 4307:2021

ISO 4307:2021
79865
Language
Format
CHF 63
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Abstract

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.

General information

  •  : Published
     : 2021-10
    : International Standard published [60.60]
  •  : 1
     : 12
  • ISO/TC 212
    11.100.10 
  • RSS updates

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