Updates | Období : 01.03.2024 - 31.03.2024

Sector of : In vitro diagnostic medical devices (placed on the market to 26. 5. 2022)

Zobrazit aktualizace pro sektor:

Standard code	ČSN	Description	Applicability date	Date of cessation of presumption of conformity of superseded standard	Publications in the Official Journal	Regulations
EN ISO 11137-2:2015 replaces EN ISO 11137-2:2013Canceled	ČSN EN ISO 11137-2:2016 Změna A1-11.23 replaces ČSN EN ISO 11137-2:2014Canceled	Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose	08.03.2024 (IVDR) 08.03.2024 (MDR) 13.05.2016 (AIMD) 13.05.2016 (MDD) 13.05.2016 (IVDD)	30.06.2016 (AIMD) 30.06.2016 (MDD) 30.06.2016 (IVDD)	OJ-IVDR , OJ-MDR , OJ-AIMD , OJ-MDD , OJ-IVDD (EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (EU)2025/679 (hEN 10. 4. 2025) (EU)2024/2625 (hEN 9. 10. 2024) (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)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024) (EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (EU)2025/681 (hEN 9. 4. 2025) (EU)2024/2631 (hEN 9. 10. 2024) (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)2024/2631 Summary list hEN for information purposes only (9. 10. 2024) (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)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	(EU)2017/746 108/2024 Z.z. (EU)2017/745 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb.
A1:2023			08.03.2024 (MDR) 08.03.2024 (IVDR)
EN ISO 11607-1:2020 replaces EN ISO 11607-1:2009Canceled	ČSN EN ISO 11607-1:2020 Změna A1-5.24 Změna A11-12.22 replaces ČSN EN ISO 11607-1:2010 Změna A1-1.15Canceled	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems	15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (IVDR)		OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR (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)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/439 (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) Amendments (EU)2021/1182: (EU)2025/681 (hEN 9. 4. 2025) (EU)2024/2631 (hEN 9. 10. 2024) (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)2024/2631 Summary list hEN for information purposes only (9. 10. 2024) (EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (EU)2025/679 (hEN 10. 4. 2025) (EU)2024/2625 (hEN 9. 10. 2024) (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)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)	55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746 108/2024 Z.z.
A1:2023			08.03.2024 (MDR) 08.03.2024 (IVDR)
EN ISO 11607-2:2020 replaces EN ISO 11607-2:2006Canceled	ČSN EN ISO 11607-2:2020 Změna A1-5.24 Změna A11-12.22 replaces ČSN EN ISO 11607-2:2006 Změna A1-1.15Canceled	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes	15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (IVDR)		OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR (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)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/439 (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) Amendments (EU)2021/1182: (EU)2025/681 (hEN 9. 4. 2025) (EU)2024/2631 (hEN 9. 10. 2024) (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)2024/2631 Summary list hEN for information purposes only (9. 10. 2024) (EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (EU)2025/679 (hEN 10. 4. 2025) (EU)2024/2625 (hEN 9. 10. 2024) (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)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)	55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746 108/2024 Z.z.
A1:2023			08.03.2024 (MDR) 08.03.2024 (IVDR)