What is PD CEN/TS 17305- Specifications for pre-examination processes for saliva about?
PD CEN/TS 17305 is a standard on Molecular in vitro diagnostic examinations that outline specifications for pre-examination processes for saliva for Isolated human DNA.
PD CEN/TS 17305 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.
PD CEN/TS 17305 applies to molecular in vitro diagnostic examination including laboratory
developed tests performed by medical laboratories.
Note 1: Dedicated measures that need to be taken for saliva collected on absorbing material or by mouthwashes are not described in PD CEN/TS 17305 . Neither are measures for preserving and handling native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.
Note 2: International, national, or regional regulations or requirements can also apply to specific topics covered in PD CEN/TS 17305.
Who is PD CEN/TS 17305 - Specifications for pre-examination processes for saliva for?
PD CEN/TS 17305 on the specifications for pre-examination processes for saliva is relevant to:
Diagnostics developers
Medical laboratory
manufacturers of biomedical
Biobanks
Institutions and commercial organizations performing biomedical research
Medical regulatory authorities
Why should you use PD CEN/TS 17305 - Specifications for pre-examination processes for saliva ?
Открыть превью (PDF)Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
