EN ISO 25424:2019
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 25424:2019: | IVDR | In vitro diagnostic medical devices (IVDR) MDD | Medical devices AIMD | Active implantable medical devices MDR | Medical devices (NLF) |
| Sphere of EN ISO 25424:2019: | Regulation No. 90/2016 - harmonized sphere (NLF) 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)2021/1195 (hEN 20. 7. 2021) without amendments: with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (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)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU) 2017/746 Notified bodies for Council Directive 93/42/EEC Notified bodies for Council directive 90/385/EEC Notified bodies for Regulation (EU)2017/745 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Regulation (EU) 2017/746
consolidated text 2023 |
Regulation (EU) 2017/746
consolidated text
/ 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 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
/ 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 |
|
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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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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Regulation (EU)2017/745
consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 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 / Commission Implementig Regulation No (EU)2021/2226 / Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 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 / Commission Implementig Regulation No (EU)2021/2226 / Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 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 / Commission Implementig Regulation No (EU)2021/2226 / Commission Implementig Regulation No (EU)2021/2078 |
| Released: | March, 2020 |
Changes EN ISO 25424:2019
| A1:2022 |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
ČSN
| ČSN EN ISO 25424:2020 | Note to ČSN EN ISO 25424:2020: Připravuje se vydání změny A1:2022 - úkol č. 85/0034/22, ukončení 22-10 (Věstník č. 9/2022) | ||
| Změna A1-12.22 |
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