BS EN ISO 4307:2021 - TC

This standard BS EN ISO 4307:2021 - TC Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document gives requirements 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 is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing materiasl 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.