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Norm
ÖNORM EN ISO 20166-3
Issue date: 2019 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA exa...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 25 Pages
Language:
German
| English
Optionally co-design standards:
ICS
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination 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.
ÖNORM EN ISO 20166-3
2019 06 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formal...
Norm
↖
ONR CEN/TS 16827-3
2015 11 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel
ONR CEN/TS 16827-3
2015 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel Entwurf
Norm
ISO 20166-3:2018
Issue date :
2018 12 14
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
Norm
ISO 15189:2012
Issue date :
2012 11 05
Medical laboratories — Requirements for quality and competence