STN EN ISO 4307
| Name: | STN EN ISO 4307 |
| Validity: | Valid |
| Number of pages: | 24 |
| 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 (ISO 4307: 2021) |
| English title | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021) |
| Release Date: | 01. 02. 2022 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 6575 |
| Level of incorporation: | idt EN ISO 4307:2021, idt ISO 4307:2021 |
| Official Journal | 01/22 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN P CEN/TS 17305:2019-08 (85 6575) |
| Note in Official Journal: | |
| 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 materiasl or by mouth washes are not described in this document. 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) |