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Norm
ÖNORM EN ISO 20184-3
Issue date: 2021 11 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)
This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examin...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 23 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.
This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
ÖNORM EN ISO 20184-3
2021 11 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen...
Norm
↖
ONR CEN/TS 16826-3
2018 10 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap f...
Technische Regel
ONR CEN/TS 16826-3
2018 02 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap f...
Technische Regel Entwurf
Norm
ISO 15189:2012
Issue date :
2012 11 05
Medical laboratories — Requirements for quality and competence
Norm
ISO 20184-3:2021
Issue date :
2021 05 07
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA