Updates | Období : 01.03.2024 - 31.03.2024
Standard code | ČSN | Description | Applicability date | Date of cessation of presumption of conformity of superseded standard | Publications in the Official Journal | Regulations |
---|---|---|---|---|---|---|
EN 455-3:2023 | EN 455-3.....připravuje se | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation | 08.03.2024 (MDR) |
(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)2017/745 | |
EN ISO 10088:2023 Concurrent concurrent validity with EN ISO 10088:2017 | ČSN EN ISO 10088:2023 replaces ČSN EN ISO 10088:2018Canceled (still harmonized) | Small craft - Permanently installed fuel systems | 12.01.2024 (RCD) | 12.07.2025 (RCD) |
(EU)2022/1954 (hEN 17.10.2022) (EU)2019/919 (hEN 5. 6. 2019) as amended by: |
77/2016 Z.z. 96/2016 Sb. 2013/53/EU |
EN ISO 10993-15:2023 | ČSN EN ISO 10993-15:2023 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys | 08.03.2024 (MDR) |
(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)2017/745 | |
EN ISO 10993-17:2023 | ČSN EN ISO 10993-17....připravuje se | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | 08.03.2024 (MDR) |
(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)2017/745 | |
EN ISO 10993-18:2020 replaces EN ISO 10993-18:2009Canceled | ČSN EN ISO 10993-18:2020Změna A1-1.24 replaces ČSN EN ISO 10993-18:2009Canceled | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process | 15.04.2021 (AIMD) 15.04.2021 (MDD) 08.03.2024 (MDR) |
(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) 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) |
55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. (EU)2017/745 | |
A1:2023 | 08.03.2024 (MDR) | |||||
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 | 08.03.2024 (IVDR) 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 08.03.2024 (MDR) | 30.06.2016 (MDD) 30.06.2016 (AIMD) 30.06.2016 (IVDD) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: 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) |
(EU)2017/746 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 |
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 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 | 08.03.2024 (IVDR) 15.04.2021 (MDD) 15.04.2021 (AIMD) 15.04.2021 (IVDD) 08.03.2024 (MDR) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: 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) |
(EU)2017/746 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 | |
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 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 | 08.03.2024 (IVDR) 15.04.2021 (MDD) 15.04.2021 (AIMD) 15.04.2021 (IVDD) 08.03.2024 (MDR) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: 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) |
(EU)2017/746 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 | |
A1:2023 | 08.03.2024 (MDR) 08.03.2024 (IVDR) | |||||
EN 13232-3:2003+A1:2011 | ČSN EN 13232-3+A1:2012(Canceled (still harmonized)) | Railway applications - Track - Switches and crossings - Part 3: Requirements for wheel/rail interaction | 21.11.2023 (IRS) | EU) 2023/2584 (hEN 21.11.2023) | (EU)2016/797 513/2009 Z.z. zákon č. 266/1994 Sb | |
EN ISO 17664-2:2023 | ČSN EN ISO 17664-2....připravuje se | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices Part 2: Non-critical medical devices | 08.03.2024 (MDR) |
(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)2017/745 | |
EN 60335-2-14:2006 replaces EN 60335-2-14:2003Canceled | ČSN EN 60335-2-14 ed. 3:2007Změna A1-5.09Změna Z1-3.24Změna A11-9.12Oprava 1-1.14 | Household and similar electrical appliances - Safety -- Part 2-14: Particular requirements for kitchen machines |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. | ||
AC:2007 | ||||||
A1:2008 | ||||||
A11:2012 | ||||||
A12:2016 | ||||||
A11:2012/AC:2013 | ||||||
A11:2012/AC:2016 | ||||||
EN 60670-23:2008 | ČSN EN 60670-23:2009Změna A1-3.24Změna A11-3.24 | Boxes and enclosures for electrical accessories for household and similar fixed electrical installations -- Part 23: Particular requirements for floor boxes and enclosures | 08.07.2016 (LVD) |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. | |
A11:2023 | 23.04.2024 (LVD) | |||||
EN 60730-2-5:2015 replaces EN 60730-2-5:2002Canceled | ČSN EN 60730-2-5 ed. 3:2015Změna A2-11.21Oprava 1-3.24Změna A1-10.19 replaces ČSN EN 60730-2-5 ed. 2:2002Změna A1-7.05Změna A11-12.05Změna A2-2.11Změna Z1-8.15Canceled | Automatic electrical controls - Part 2-5: Particular requirements for automatic electrical burner control systems | 08.07.2016 (LVD) | 17.11.2017 (LVD) |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. |
EN 60811-201:2012 | ČSN EN 60811-201:2013Změna A1-3.18 | Electric and optical fibre cables - Test methods for non-metallic materials -- Part 201: General tests - Measurement of insulation thickness | 08.07.2016 (LVD) | 13.06.2025 (LVD) |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. |
EN 62020:1998 | ČSN EN 62020:2000Změna A1-12.05Změna Z1-10.21(Canceled (still harmonized)) | Electrical accessories - Residual current monitors for household and similar uses (RCMs) | 08.07.2016 (LVD) 13.05.2016 (EMC) |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) 2018/C/246/1(EU)2019/1326 (hEN 6. 8. 2019) amendments of Implementing Decision (EU)2019/1326: (EU)2022/910 (10. 6. 2022) (EU)2022/622 (hEN 13. 4. 2022), (EU)2021/455 (hEN 16. 3. 2021) (EU)2020/660 (hEN 18. 5. 2020), (EU)2020/1630 (hEN 4. 11. 2020) / (EU)2019/1326 (consolidated text with (EU)2022/910 (10. 6. 2022)) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. 117/2016 Sb. 2014/30/EU 127/2016 Z.z. | |
A1:2005 IEC 62020:1998/A1:2003 (Modified) |
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EN IEC 62040-1:2019 replaces EN 62040-1:2008Canceled | ČSN EN IEC 62040-1 ed. 2:2019Změna A1-3.24Oprava 1-3.20Změna A11-8.21 replaces ČSN EN 62040-1:2009Změna A1-9.13Změna Z1-12.19Canceled | Uninterruptible power systems (UPS) - Part 1: Safety requirements | 21.12.2021 (LVD) | 21.06.2023 (LVD) |
(EU)2023/2723 (hEN 13. 12. 2023) without amendment EU)2024/1198 (23. 4. 2024) // (EU)2023/2723 repealed (Annex II, Annex III): 2018/C/326/2 (EU)2019/1956 (hEN 27. 11. 2019) with amendments: (EU)2023/2723 (hEN 13. 12. 2023) (EU)2023/600 (hEN 17. 3. 2023) (EU)2023/98 (hEN 11. 1. 2023) (EU)2022/713 (hEN 10. 5. 2022) (EU)2022/405 (hEN 10. 3. 2022) (EU)2021/1015 (hEN 22. 6. 2021) (EU)2021/2273 (hEN 21. 12. 2021) (EU)2020/1779 (hEN 30. 11. 2020) (EU)2020/1146 (hEN 3. 8. 2020) text with Corrigendum (EU)2020/1146 (6. 8. 2020) / consolidated text (EU)2019/1956 pdf format with amendment (EU)2023/600 Summary list hEN for information purposes only (23. 4. 2024) |
148/2016 Z.z. 2014/35/EU 118/2016 Sb. |
A11:2021 | ||||||
EN 62053-23:2003 Canceled is replaced EN IEC 62053-23:2021 | ČSN EN 62053-23:2003Změna Z1-8.21Změna A1-8.17Oprava 1-11.18(Canceled) is replaced ČSN EN IEC 62053-23 ed. 2:2021Změna A11-12.21 | Electricity metering equipment (a.c.) - Particular requirements -- Part 23: Static meters for reactive energy (classes 2 and 3) | 13.05.2016 (EMC) |
2018/C/246/1 (EU)2019/1326 (hEN 6. 8. 2019) amendments of Implementing Decision (EU)2019/1326: (EU)2022/910 (10. 6. 2022) (EU)2022/622 (hEN 13. 4. 2022), (EU)2021/455 (hEN 16. 3. 2021) (EU)2020/660 (hEN 18. 5. 2020), (EU)2020/1630 (hEN 4. 11. 2020) / (EU)2019/1326 (consolidated text with (EU)2022/910 (10. 6. 2022)) |
117/2016 Sb. 2014/30/EU 127/2016 Z.z. |