EN ISO 10993-11:2018
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
| Status: | Harmonized EN ISO 10993-11:2018 replaces EN ISO 10993-11:2009 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 10993-11:2018: | AIMD | Active implantable medical devices (placed on the market to 26. 5. 2021) MDD | Medical devices (placed on the market to 26. 5. 2021) |
| Sphere of EN ISO 10993-11:2018: | Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (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 |
| Notified bodies (NANDO): | Notified bodies for Council directive 90/385/EEC Notified bodies for Council Directive 93/42/EEC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
nařízení vlády č. 55/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
||
|
Government Regulation SR No 167/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
|
||
|
Council directive 90/385/EEC
/repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 |
||
|
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/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197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
|
||
|
nařízení vlády č. 54/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
||
|
Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
|
| Co-existence period end date: | 30.09.2021 (AIMD) 30.09.2021 (MDD) |
| Released: | April, 2020 |
ČSN
| ČSN EN ISO 10993-11:2018 | replaces | ČSN EN ISO 10993-11:2009 - Canceled |
Customers who have agreed on their computer from ÚNMZ service CSN on-line-for electronic access to the full texts of standards in pdf (version for companies or individuals) may open directly quoted CSN here.