EN ISO 14160:2021
Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 14160:2021: | MDR | Medical devices (NLF) |
| Sphere of EN ISO 14160:2021: | 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) |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU)2017/745 |
| 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 |
| Released: | January, 2022 |
ČSN
| ČSN EN ISO 14160:2022 |
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