EN ISO 10993-18:2020
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
| Status: | Harmonized EN ISO 10993-18:2020 replaces EN ISO 10993-18:2009 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 10993-18:2020: | AIMD | Active implantable medical devices (placed on the market to 26. 5. 2021) MDD | Medical devices (placed on the market to 26. 5. 2021) MDR | Medical devices (NLF) |
| Sphere of EN ISO 10993-18:2020: | Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 90/2016 - harmonized sphere (NLF) |
| 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 (EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (EU)2024/2631 (hEN 9. 10. 2024) (EU)2024/815 (hEN 8. 3. 2024) (EU)2023/1410 (hEN 5. 7. 2023) (EU)2022/757 (hEN 17. 5. 2022) (EU)2022/6 (hEN 5. 1. 2022) / consolidated text (EU)2021/1182 without amendment (EU)2024/2631 Summary list hEN for information purposes only (9. 10. 2024) |
| Notified bodies (NANDO): | Notified bodies for Council directive 90/385/EEC Notified bodies for Council Directive 93/42/EEC Notified bodies for Regulation (EU)2017/745 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
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nařízení vlády č. 55/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
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Government Regulation SR No 167/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
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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/repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 |
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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/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197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 |
||
|
Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
|
||
|
Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024) / amendment (EU)2023/2197 applicable from 9. 11. 2025 / amendment (EU)2024/568 applicable from 1. 1. 2025 / applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC, exceptions viz Article 122 / Commission Implementig Regulation No (EU)2022/2347 / Commission Implementig Regulation No (EU)2022/2346 consolidated text with amendment No (EU)2023/1194 Rules for the application of Regulation (EU) 2017/745: Commission Implementig Regulation No (EU)2021/2226 Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
/ amendment (EU)2024/1860 / amendment (EU)2023/2197 applicable from 9. 11. 2025 / amendment (EU)2024/568 applicable from 1. 1. 2025 / applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC, exceptions viz Article 122 Law No 375/2022 Coll. / amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024 / Commission Implementig Regulation No (EU)2022/2347 / Commission Implementig Regulation No (EU)2022/2346 consolidated text with amendment No (EU)2023/1194 Rules for the application of Regulation (EU) 2017/745: Commission Implementig Regulation No (EU)2021/2226 Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
/ amendment (EU)2024/1860 / amendment (EU)2023/2197 applicable from 9. 11. 2025 / amendment (EU)2024/568 applicable from 1. 1. 2025 / applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC, exceptions viz Article 122 / Commission Implementig Regulation No (EU)2022/2347 / Commission Implementig Regulation No (EU)2022/2346 consolidated text with amendment No (EU)2023/1194 Rules for the application of Regulation (EU) 2017/745: Commission Implementig Regulation No (EU)2021/2226 Commission Implementig Regulation No (EU)2021/2078 |
| Released: | March, 2024 |
Changes EN ISO 10993-18:2020
| A1:2023 |
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (EU)2024/2631 (hEN 9. 10. 2024) (EU)2024/815 (hEN 8. 3. 2024) (EU)2023/1410 (hEN 5. 7. 2023) (EU)2022/757 (hEN 17. 5. 2022) (EU)2022/6 (hEN 5. 1. 2022) / consolidated text (EU)2021/1182 without amendment (EU)2024/2631 Summary list hEN for information purposes only (9. 10. 2024) |
ČSN
| ČSN EN ISO 10993-18:2020 | replaces | ČSN EN ISO 10993-18:2009 - Canceled | |
| Změna A1-1.24 |
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