EN ISO 11135:2014
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 11135:2014: | MDR | Medical devices (NLF) IVDR | In vitro diagnostic medical devices (IVDR) |
| Sphere of EN ISO 11135:2014: | Regulation No. 90/2016 - harmonized sphere (NLF) Regulation No. 90/2016 - harmonized sphere (NLF) |
| Publications in the Official Journal: |
(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) (EU)2021/1195 (hEN 20. 7. 2021) |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU)2017/745 Notified bodies for Regulation (EU) 2017/746 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
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 |
|
Regulation (EU) 2017/746
consolidated text 9. 7. 2024 pdf format |
Regulation (EU) 2017/746
consolidated text 9. 7. 2024 pdf format
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024) / applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 Act No 375/2022 Sb. applicable from 22. 12. 2022 / amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024 Decree No 377/2022 Sb. applicable from 22. 12. 2022 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
Regulation (EU)2017/746
consolidated text 9. 7. 2024 pdf format
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024) / applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
| Released: | August, 2021 |
Changes EN ISO 11135:2014
| A1:2019 |
(EU)2021/1195 (hEN 20. 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 11135:2015 | |||
| Změna A1-5.20 |
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