DIN EN ISO 20166-1:2019-04
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018); German version EN ISO 20166-1:2018
| Edition date: |
2019-04-01
In Force
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| Available languages: | English, German |
| Summary: | This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard 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, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities. The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the examination test results. RNA profiles in tissues can change drastically during collection and change differently in different tissue donors' / patients' tissues. Therefore, it is essential to take special measures to minimize the described RNA profile changes and modifications within the tissue for subsequent examination. |
| Keywords: | Biomedical|Definitions|Insulated|Investigations|In-vitro diagnostic|Laboratories|Laboratory medicine|Medical sciences|Medical technology|Methods of analysis|Molecular structure|Ribonucleic acid|Samples|Specification (approval)|Specimens|Storage|Test materials|Tissue |
| ICS: | 11.100.10-In vitro diagnostic test systems |
| CTN: | |
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International Equivalence |
Identic EN ISO 20166-1:2018 Identic ISO 20166-1:2018 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 20166-1:2016-08 Reemplaza a DIN CEN/TS 16827-1:2015-11;DIN SPEC 13227-1:2015-11 |










