EN ISO 15197:2013
Systémy diagnostických zkoušek in vitro - Požadavky na systémy monitorování glykémie pro sebetestování pacientů s diabetes mellitus
| Status: | Canceled (still harmonized) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 15197:2013: | IVDD | In vitro diagnostic medical devices (placed on the market to 26. 5. 2022) |
| Sphere of EN ISO 15197:2013: | Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 |
| Notified bodies (NANDO): | Notified bodies for Directive EP and Council 98/79/EC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Directive EP and Council 98/79/EC
/ will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text with amendment (EU)2024/1860 / Commission Implementing regulation No (EU)2017/2185 / Commission Decision No 2008/932/ES, 2010/227/EC |
||
| nariadenie vlády SR č. 569/2001 Z.z. (consolidated text) | ||
| nařízení vlády č. 56/2015 Sb. |