EN ISO 11135:2014
|
ČSN EN ISO 11135:2015Změna A1-5.20 |
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
|
19.07.2021
(MDR)
20.07.2021
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
A1:2019
|
|
|
20.07.2021
(IVDR)
19.07.2021
(MDR)
|
|
|
|
EN ISO 11137-1:2015
replaces
EN ISO 11137-1:2006Canceled
|
ČSN EN ISO 11137-1:2016
replaces
ČSN EN ISO 11137-1:2007Změna A1-3.14Canceled
|
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
|
20.07.2021
(IVDR)
13.05.2016
(AIMD)
13.05.2016
(MDD)
17.11.2017
(IVDD)
19.07.2021
(MDR)
|
30.06.2016
(AIMD)
30.09.2021
(MDD)
30.06.2016
(IVDD)
|
OJ-IVDR , OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR
(EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (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 without amendment (EU)2024/2625 / 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)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without amendment (EU)2024/2631 Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/746
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
|
A2:2019
|
|
|
20.07.2021
(IVDR)
25.03.2020
(MDD)
25.03.2020
(IVDD)
19.07.2021
(MDR)
|
30.09.2021
(IVDD)
|
|
|
EN ISO 11137-2:2015
replaces
EN ISO 11137-2:2013Canceled
|
ČSN EN ISO 11137-2:2016Změna A1-11.23
replaces
ČSN EN ISO 11137-2:2014Canceled
|
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
|
13.05.2016
(AIMD)
13.05.2016
(MDD)
13.05.2016
(IVDD)
08.03.2024
(MDR)
08.03.2024
(IVDR)
|
30.06.2016
(AIMD)
30.06.2016
(MDD)
30.06.2016
(IVDD)
|
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)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 without 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)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 without 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
|
A1:2023
|
|
|
08.03.2024
(MDR)
08.03.2024
(IVDR)
|
|
|
|
EN ISO 11607-1:2020
replaces
EN ISO 11607-1:2009Canceled
|
ČSN EN ISO 11607-1:2020Změna A1-5.24Změna A11-12.22
replaces
ČSN EN ISO 11607-1:2010Změna 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)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 without 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)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 without 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
|
A1:2023
|
|
|
08.03.2024
(MDR)
08.03.2024
(IVDR)
|
|
|
|
EN ISO 11607-2:2020
replaces
EN ISO 11607-2:2006Canceled
|
ČSN EN ISO 11607-2:2020Změna A1-5.24Změna A11-12.22
replaces
ČSN EN ISO 11607-2:2006Změna 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)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 without 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)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 without 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
|
A1:2023
|
|
|
08.03.2024
(MDR)
08.03.2024
(IVDR)
|
|
|
|
EN ISO 11737-1:2018
|
ČSN EN ISO 11737-1:2018Změna A1-12.21Oprava 1-5.22 |
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
|
05.01.2022
(MDR)
07.01.2022
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
A1:2021
|
|
|
07.01.2022
(IVDR)
05.01.2022
(MDR)
|
|
|
|
EN ISO 11737-2:2020
replaces
EN ISO 11737-2:2009Canceled
|
ČSN EN ISO 11737-2:2020
replaces
ČSN EN ISO 11737-2:2010Canceled
|
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
|
15.04.2021
(AIMD)
15.04.2021
(MDD)
15.04.2021
(IVDD)
19.07.2021
(MDR)
20.07.2021
(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)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 without 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)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 without 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
|
EN ISO 13408-1:2024
|
ČSN EN ISO 13408-1:2024 |
Aseptic processing of health care products - Part 1: General requirements
|
09.10.2024
(MDR)
09.10.2024
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
EN ISO 13408-6:2021
|
ČSN EN ISO 13408-6:2011 |
Aseptic processing of health care products - Part 6: Isolator systems
|
05.01.2022
(MDR)
07.01.2022
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
EN ISO 13485:2016
replaces
EN ISO 13485:2012Canceled
|
ČSN EN ISO 13485 ed. 2:2016Změna A11-4.22Oprava 1-7.17
replaces
ČSN EN ISO 13485:2012Oprava 1-1.13Oprava 2-1.13Změna Z1-12.16Canceled
|
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
|
17.11.2017
(AIMD)
17.11.2017
(MDD)
17.11.2017
(IVDD)
05.01.2022
(MDR)
07.01.2022
(IVDR)
|
31.03.2019
(AIMD)
31.03.2019
(MDD)
31.03.2019
(IVDD)
|
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)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 without 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)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 without 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
|
AC:2018
|
|
|
07.01.2022
(IVDR)
25.03.2020
(AIMD)
25.03.2020
(MDD)
25.03.2020
(IVDD)
17.05.2022
(MDR)
|
30.09.2021
(AIMD)
30.09.2021
(MDD)
30.09.2021
(IVDD)
|
|
|
EN ISO 14971:2019
|
ČSN EN ISO 14971:2020Změna A11-6.22 |
Medical devices - Application of risk management to medical devices
|
17.05.2022
(MDR)
12.05.2022
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
A11:2021
|
|
|
17.05.2022
(MDR)
12.05.2022
(IVDR)
|
|
|
|
EN ISO 15223-1:2021
|
ČSN EN ISO 15223-1:2022 |
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
|
05.01.2022
(MDR)
07.01.2022
(IVDR)
|
|
OJ-MDR , OJ-IVDR
(EU)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
|
(EU)2017/745
(EU)2017/746
|
EN ISO 17511:2021
|
ČSN EN ISO 17511 ed. 2:2021 |
In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
|
07.01.2022
(IVDR)
|
|
OJ-IVDR
(EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
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(EU)2017/746
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EN ISO 20916:2024
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ČSN EN ISO 20916:2024 |
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
|
09.10.2024
(IVDR)
|
|
OJ-IVDR
(EU)2021/1195 (hEN 20. 7. 2021) Amendments (EU)2021/1195: (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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
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(EU)2017/746
|
EN ISO 25424:2019
|
ČSN EN ISO 25424:2020Změna A1-12.22 |
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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25.03.2020
(AIMD)
25.03.2020
(MDD)
19.07.2021
(MDR)
20.07.2021
(IVDR)
|
|
OJ-AIMD , OJ-MDD , 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)2021/1182 (hEN 19. 7. 2021) Amendments (EU)2021/1182: (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 without 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)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 without amendment (EU)2024/2625 / Summary list hEN for information purposes only (9. 10. 2024)
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55/2015 Sb.
167/2020 Z.z.
90/385/EHS
93/42/EHS
54/2015 Sb.
166/2020 Z.z.
(EU)2017/745
(EU)2017/746
|
A1:2022
|
|
|
05.07.2023
(MDR)
05.07.2023
(IVDR)
|
|
|
|