STN P CEN/TS 17811
| Name: | STN P CEN/TS 17811 |
| 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 moču a iných telesných tekutín. Izolovaná bezbunková DNA |
| English title | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA |
| Release Date: | 01. 09. 2022 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1024 |
| Level of incorporation: | idt CEN/TS 17811:2022 |
| Official Journal | 08/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do júna 2024 Úradu pre normalizáciu metrológiu a skúšobníctvo SR. |
| Subject of the standard: | This document specifies requirements and gives recommendations on the handling, storage, processing and documentation of body fluids specimens intended for human cfDNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this technical specification. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. |
| Preview: | Náhľad normy (PDF) |