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EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Status: Harmonized EN ISO 11737-2:2020 replaces   EN ISO 11737-2:2009 (Canceled)
Poznámka:
Full text EAD:
Sector of EN ISO 11737-2:2020: 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 11737-2:2020: 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:
(EU)2024/817 (hEN 8. 3. 2024)
(EU)2023/1411 (hEN 5. 7. 2023)
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ consolidated text (EU)2021/1195 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)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

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

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 decision No (EU)2019/1396
/ Commission Desicion No (EU)2018/1617
/ 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.
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
/ amendment (EU)2023/2197 applicable from 9. 11. 2025
/ 2020/C/171/1 - Guidelines on the adoption of derogations
/ Commission implementing decision No (EU)2019/1396
/ Commission decision No 2010/227/EU
/ Regulation Commission No 207/2012
will be repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024)
/ Regulation Commission No 722/2012

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
nariadenie vlády SR č. 569/2001 Z.z. (consolidated text)
nařízení vlády č. 56/2015 Sb. repealed by Law No 375/2022 Coll.

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: April, 2021

ČSN

ČSN EN ISO 11737-2:2020 replaces ČSN EN ISO 11737-2:2010 - Canceled

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