ISO 4307:2021 PDF

Scope: 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.

ISO 4307:2021 Referenced Document

ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
ISO 15190 Medical laboratories — Requirements for safety

2021 ISO 4307:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA