STN P CEN ISO/TS 5798
| Name: | STN P CEN ISO/TS 5798 |
| Validity: | Valid |
| Number of pages: | 56 |
| Language: |
EN
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Diagnostické skúšobné systémy in vitro. Požiadavky a odporúčania na detekciu závažného akútneho respiračného syndrómu koronavírusu 2 (SARS-CoV-2) metódami amplifikácie nukleovej kyseliny (ISO/TS 5798: 2022) |
| English title | In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022) |
| Release Date: | 01. 02. 2023 |
| Date of withdrawal: | |
| ICS: | 11.100.01 |
| Sorting character/National clasification code | 85 1035 |
| Level of incorporation: | idt ISO/TS 5798:2022, idt CEN ISO/TS 5798:2022 |
| Official Journal | 01/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | Táto predbežná slovenská technická norma je určená na overenie. Prípadné pripomienky pošlite do novembra 2024 Úradu pre normalizáciu, metrológiu a skúšobníctvo Slovenskej republiky. |
| Subject of the standard: | This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples. |
| Preview: | Náhľad normy (PDF) |