EN ISO 18113-5:2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
| Status: | Harmonized EN ISO 18113-5:2011 replaces EN ISO 18113-5:2009 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 18113-5:2011: | IVDD | In vitro diagnostic medical devices (placed on the market to 26. 5. 2022) |
| Sphere of EN ISO 18113-5:2011: | 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/ will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text with amendment (EU)2024/1860 / Commission Implementing regulation No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. |
| Co-existence period end date: | 30.04.2012 (IVDD) |
| Released: | April, 2012 |
ČSN
| ČSN EN ISO 18113-5:2012 | Note to ČSN EN ISO 18113-5:2012: Nahrazena od 30.06.2027 ČSN EN ISO 18113-5 ed. 2 (857027) z listopadu 2024 | ||
| Změna Z1-11.24 |
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