BS EN ISO 20166-1:2018 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated RNA

BS EN ISO 20166-1:2018

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

Status : Current   Published : December 2018

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 RNA 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 20166-1:2018
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue. Isolated RNA
StatusCurrent
Publication Date19 December 2018
Normative References(Required to achieve compliance to this standard)ISO/IEC 17020:2012, ISO 15190, ISO 15189:2012
Informative References(Provided for Information)ISO 9000:2015, ISO 17511:2003, ISO/TS 17822-1:2014, ISO Guide 30:2015, ISO 9000:2015 Advanced Access, ISO/IEC 17043:2010, ISO 22174:2005
ReplacesPD CEN/TS 16827-1:2015
International RelationshipsEN ISO 20166-1:2018,ISO 20166-1:2018
Amended ByCorrigendum, February 2019
DescriptorsMedical sciences, Quality management, Laboratory accreditation, Quality assurance, Quality, Quality assurance systems, Laboratories, Medical technology, Laboratory testing, Medical laboratory equipment, Management
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) ARN extrait
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für formalinfixierte und paraffineingebettete (FFPE)-Gewebeproben Isolierte RNS
CommitteeCH/212
ISBN978 0 539 04040 1
PublisherBSI
FormatA4
DeliveryYes
Pages30
File Size1.918 MB
Price£182.00


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