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EN ISO 11737-1:2018

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

Status: Harmonized
Poznámka:
Full text EAD:
Sector of EN ISO 11737-1:2018: MDR | Medical devices (NLF) IVDR | In vitro diagnostic medical devices (IVDR)
Sphere of EN ISO 11737-1:2018: 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) 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:
(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)

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 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
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
Released: January, 2022

Changes EN ISO 11737-1:2018

A1:2021

(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)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)
 

ČSN

ČSN EN ISO 11737-1:2018  
Změna A1-12.21  
Oprava 1-5.22  

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