PD CEN/TS 17811:2022

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for urine and other body fluids. Isolated cell free DNA. | Status: Current

1 Scope This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNAexamination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, 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 cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving ccfDNA from other body fluids such as blood, lymph and others. These are not described in this document. ccfDNA from blood is covered in EN ISO 20186‑3.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.