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  • BSI
    20/30379067 DC BS EN ISO 20166-4. Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4. In situ detection techniques
    Edition: 2020
    $44.66
    / user per year

Description of 20/30379067 DC 2020

This document gives requirements and recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.

This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities.

This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO 20166-1, -2 and -3, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively.

Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI 00140128, CEN WI 00140126, and CEN WI 00140129, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively.

NOTE

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



Standard Number20/30379067 DC
TitleBS EN ISO 20166-4. Molecular in vitro diagnostic examinations. Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4. In situ detection techniques
StatusDefinitive
Publication Date2020-07-13
Identical National Standard OfISO/DIS 20166-4
DescriptorsMedical sciences, Quality management, Laboratory accreditation, Quality assurance, Quality, Quality assurance systems, Laboratories, Medical technology, Laboratory testing, Medical laboratory equipment, Management
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
PublisherBSI
Pages33

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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