ISO 4307:2021

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

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.

Edition	2021
Published Date	2021
Published By	International Standardization Organisation
Page Count	12