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Norm
ÖNORM EN ISO 20166-2
Issue date: 2019 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the exa...
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Publisher:
Austrian Standards International
Format:
Digital | 28 Pages
Language:
German
| English
| Download GER/ENG
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 the examination of isolated proteins 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.
This document is not applicable for protein examination by immunohistochemistry.
ÖNORM EN ISO 20166-2
2019 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for forma...
Norm
↖
ONR CEN/TS 16827-2
2015 11 01
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel
ONR CEN/TS 16827-2
2015 04 15
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE t...
Technische Regel Entwurf
Norm
ISO 20166-2:2018
Issue date :
2018 11 30
Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
Norm
ISO 15189:2012
Issue date :
2012 11 05
Medical laboratories — Requirements for quality and competence
Norm
ISO/IEC 17020:2012
Issue date :
2012 02 27
Conformity assessment — Requirements for the operation of various types of bodies performing inspection