EN ISO 11137-2:2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Status: | Harmonized EN ISO 11137-2:2015 replaces EN ISO 11137-2:2013 (Canceled) |
Poznámka: |
Full text EAD: | |
Sector of EN ISO 11137-2:2015: | IVDR | In vitro diagnostic medical devices (IVDR) MDD | Medical devices AIMD | Active implantable medical devices IVDD | In vitro diagnostic medical devices MDR | Medical devices (NLF) |
Sphere of EN ISO 11137-2:2015: | Regulation No. 90/2016 - harmonized sphere (NLF) Regulation No. 22/1997 Sb. - harmonized sphere 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)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 (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 Directive EP and Council 98/79/EC 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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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 withamendment (EU)2023/607 / 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.
repealed by Law No 375/2022 Coll. |
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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 |
Applicability date: | 08.03.2024 (IVDR) 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 08.03.2024 (MDR) |
Co-existence period end date: | 30.06.2016 (MDD) 30.06.2016 (AIMD) 30.06.2016 (IVDD) |
Released: | June, 2016 |
Changes EN ISO 11137-2:2015
A1:2023 |
(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) , (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
ČSN
ČSN EN ISO 11137-2:2016 | replaces | ČSN EN ISO 11137-2:2014 - Canceled | |
Změna A1-11.23 |
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