STN P CEN/TS 17981-1
| Name: | STN P CEN/TS 17981-1 |
| Validity: | Valid |
| Number of pages: | 64 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Pracovné postupy na diagnostiku in vitro metódou sekvenovania novej generácie. Časť 1: Vyšetrenie ľudskej DNA |
| English title | In vitro diagnostic Next Generation Sequencing (NGS) workflows - Part 1: Human DNA examination |
| Release Date: | 01. 03. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1050 |
| Level of incorporation: | idt CEN/TS 17981-1:2023 |
| Official Journal | 02/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do novembra 2025 Úradu pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky. |
| Subject of the standard: | This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. |
| Preview: | Náhľad normy (PDF) |