BS EN ISO 20166-3:2019 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated DNA

BS EN ISO 20166-3:2019

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated DNA

Status : Current   Published : January 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document gives guidelines on the handling, documentation, storage and processing of formalinfixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the preexamination phase before a molecular assay is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.




Standard NumberBS EN ISO 20166-3:2019
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated DNA
StatusCurrent
Publication Date28 January 2019
Normative References(Required to achieve compliance to this standard)ISO 15190, ISO 15189:2012
Informative References(Provided for Information)ISO/IEC 17025, ISO/IEC 17020:2012, ISO 9000:2015, ISO 17511:2003, ISO Guide 30:2015, ISO/IEC 17043:2010, ISO 22174:2005
ReplacesPD CEN/TS 16827-3:2015
International RelationshipsEN ISO 20166-3:2019,ISO 20166-3:2018
Draft Superseded By16/30331325 DC
DescriptorsBlood plasma, Management, Quality assurance systems, Medical technology, Deoxyribonucleic acid, Laboratory accreditation, Laboratory testing, Laboratories, Quality management, Cells (biology), Medical laboratory equipment, Quality assurance, Quality, Medical sciences
ICS11.100.10
Title in FrenchAnalyses de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus fixés au formol et inclus en paraffine (FFPE) ADN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)- Gewebeproben Isolierte DNS
CommitteeCH/212
ISBN978 0 580 91925 1
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size879 KB
Price£182.00


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