STN EN ISO 20166-3
| Name: | STN EN ISO 20166-3 |
| Validity: | Valid |
| Number of pages: | 28 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Molekulárno-diagnostické vyšetrenia in vitro. Špecifikácie postupov pred vyšetrením formalínom fixovaného a parafínom zaliateho (FFPE) tkaniva. Časť 3: Izolovaná DNA (ISO 20166-3: 2018) |
| English title | 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) |
| Release Date: | 01. 07. 2019 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 6574 |
| Level of incorporation: | idt ISO 20166-3:2018, idt EN ISO 20166-3:2019 |
| Official Journal | 06/19 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN P CEN/TS 16827-3:2016-01 (85 6574) |
| Note in Official Journal: | |
| Subject of the standard: | 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. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document. |
| Preview: | Náhľad normy (PDF) |