STN P CEN/TS 17305
| Name: | STN P CEN/TS 17305 |
| Validity: | Valid |
| Number of pages: | 18 |
| 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 slín. Izolovaná ľudská DNA |
| English title | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA |
| Release Date: | 01. 08. 2019 |
| Date of withdrawal: | 30. 11. 2024 |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 6575 |
| Level of incorporation: | idt CEN/TS 17305:2019 |
| Official Journal | 07/19 |
| Amendments | |
| Replaced by: | STN EN ISO 4307:2022-02 (85 6575) |
| Repleces: | |
| Note in Official Journal: | Táto predbežná STN je určená na overenie. Pripomienky zasielajte ÚNMS SR najneskôr do apríla 2021. |
| Subject of the standard: | This document gives requirements on the handling, storage, processing and documentation of saliva specimens intended for human 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. 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. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this technical specification. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described. |
| Preview: | Náhľad normy (PDF) |