EN 62366:2008 (IEC 62366:2007)
Medical devices - Application of usability engineering to medical devices
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN 62366:2008: | MDD | Medical devices (placed on the market to 26. 5. 2021) IVDD | In vitro diagnostic medical devices (placed on the market to 26. 5. 2022) |
| Sphere of EN 62366:2008: | Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (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 Council Directive 93/42/EEC Notified bodies for Directive EP and Council 98/79/EC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Council Directive 93/42/EEC
/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Recommendations (EU)2021/1433 wiil gradually expire Recommendations (EU)2020/403 / Recommendations (EU)2020/403 without Corrigendum / Commission Implementing regulation No (EU)2017/2185
/ Regulation Commission No 722/2012
/ Commission Desicion No 2010/227/EU / Agreement No 2017/2118
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nařízení vlády č. 54/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
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Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
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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/ will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text with amendment (EU)2024/1860 / Commission Implementing regulation No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 |
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| nariadenie vlády SR č. 569/2001 Z.z. (consolidated text) | ||
| nařízení vlády č. 56/2015 Sb. |
| Released: | November, 2008 |
Note
Tato evropská norma nemusí nutně zahrnovat požadavky zavedené směrnicí 2007/47/ES.
ČSN
| ČSN EN 62366:2008 | Note to ČSN EN 62366:2008: Nahrazena od 1.9.2018 ČSN EN 62366-1 (364861) z prosince 2015 | ||
| Změna A1-12.15 |
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