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  • BSI
    BS 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
    Edition: 2026
    $495.05
    / user per year

Description of BS EN ISO 18704:2026 2026

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.

Standard NumberBS EN ISO 18704:2026
TitleMolecular in vitro diagnostic examinations. Requirements and recommendations for pre-examination processes for urine and other body fluids. Isolated cell-free DNA
StatusDefinitive
Publication Date2026-02-26
ReplacesPD CEN/TS 17811:2022
Identical National Standard OfEN ISO 18704, ISO 18704
DescriptorsBody fluids, DNA, Diagnostic instruments (medical), Laboratory equipment, Medical equipment, Diagnostic equipment (medical), Medical laboratory equipment
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 24422 9
PublisherBSI
Pages34



The following editions for this book are also available...

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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