DIN CEN/TS 17688-3:2022-07
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 3: Isolated genomic DNA; German version CEN/TS 17688-3:2021
| Fecha edición: |
2022-07-01
En Vigor
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| Idiomas disponibles: | Alemán |
| Resumen: | This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs)intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine DNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities.Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA B) and are not covered in this document, but in CEN/TS 16826-3, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA and ISO 20166-3, Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalinfixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA. DNA in pathogens present in FNA is not covered by this document. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document. |
| Keywords: | Definitions|Diagnosis|Diagnosis (medical)|DNA|Documentation|In vitro|Insulated|In-vitro diagnostic|Laboratory tests|Medical sciences|Molecular biological methods|Needles|Process|Samples|Specimens|Storage |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica CEN/TS 17688-3:2021 |
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