Information service
11.100 Laboratory medicine
New standards
EVS-EN ISO 18704:2026
Molecular in vitro diagnostic examinations - Requirements and recommendations for pre-examination processes for urine and other body fluids - Isolated cell-free DNA (ISO 18704:2026)
Scope: This document specifies requirements and provides recommendations for the pre-examination process of cell-free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
This document does not cover dedicated measures for cytohistological analysis of nucleated cells derived from body fluid, nor measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described.
Dedicated measures for preserving circulating cell-free DNA (ccfDNA) from blood are covered in ISO 20186-3.
This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Base documents: ISO 18704:2026; EN ISO 18704:2026
Replaces: CEN/TS 17811:2022
EVS-EN ISO 24443:2021/A1:2026
Cosmetics - Determination of sunscreen UVA photoprotection in vitro - Amendment 1 (ISO 24443:2021/Amd 1:2026)
Scope: Amendment to EN ISO 24443:2021.
Base documents: ISO 24443:2021/Amd 1:2026; EN ISO 24443:2021/A1:2026
Replaced standards
CEN/TS 17811:2022
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA
Scope: This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination 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.
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.
Base documents: CEN/TS 17811:2022
Replaced: EVS-EN ISO 18704:2026