EN ISO 15197:2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
| Status: | Harmonized EN ISO 15197:2015 replaces EN ISO 15197:2003 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 15197:2015: | IVDD | In vitro diagnostic medical devices |
| Sphere of EN ISO 15197:2015: | 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/ will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text withamendment (EU)2023/607 / Commission Implementing regulation No (EU)2017/2185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.
repealed by Law No 375/2022 Coll. |
| Applicability date: | 13.05.2016 (IVDD) |
| Co-existence period end date: | 31.07.2016 (IVDD) |
| Released: | June, 2016 |
Note
Pro zkušební proužky ke stanovení glykémie a kontrolní roztoky je datem ukončení presumpce shody nahrazované normy 30. 6. 2017.
ČSN
| ČSN EN ISO 15197 ed. 3:2016 | replaces | ČSN EN ISO 15197:2004 - Canceled |
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