PD CEN/TS 16826-2:2015 - Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins

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PD CEN/TS 16826-2:2015

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins

Status : Superseded, Withdrawn   Published : August 2015 Replaced By : BS EN ISO 20184-2:2018

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This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for the analysis of extracted proteins during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). Protein profiles and protein-protein interactions in tissues can change drastically before and after collection (due to e.g., gene induction, gene down regulation, protein degradation). Protein species amounts can change differently in different donors’ / patients’ tissues. The expression of genes can be influenced by the given treatment or intervention (surgery, biopsy), or drugs administered for anaesthesia or even treatment of concomitant disease as well as by the different environment conditions after the tissue removal from the body. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent protein analysis. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. In addition this document is not applicable for protein analysis by immunohistochemistry.




Standard NumberPD CEN/TS 16826-2:2015
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue. Isolated proteins
StatusSuperseded, Withdrawn
Publication Date31 August 2015
Withdrawn Date12 December 2018
Cross ReferencesEN ISO 15189:2012, ISO 15189:2012, ISO 15190, ISO Guide 30:1992
Replaced ByBS EN ISO 20184-2:2018
International RelationshipsCEN/TS 16826-2:2015
DescriptorsMedical laboratory equipment, Medical technology, Laboratory accreditation, Quality, Quality assurance, Medical sciences, Management, Laboratory testing, Quality management, Quality assurance systems, Laboratories
ICS11.100.10
Title in FrenchTests de diagnostic moléculaire in vitro. Spécifications relatives aux processus préanalytiques pour les tissus à congélation rapide. Protéines extraites
Title in GermanMolekularanalytische in-vitro-diagnostische Verfahren. Spezifikationen für präanalytische Prozesse für schockgefrorene Gewebeproben. Isolierte Proteine
CommitteeCH/212
ISBN978 0 580 85035 6
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size492 KB
Price£130.00


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