Information system Product regulation

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Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations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)
with amendment (EU)2024/201 (hEN 12. 1. 2024), (EU)2024/1197 (hEN 25. 4. 2024)
/ repeals Implementing Decision (EU)2019/919 and Commission Communication 2018/C/209/5, for exceptions see Article 3

2018/C/209/5

(EU)2019/919 (hEN 5. 6. 2019) as amended by:
(EU)2022/1029 (hEN 29. 6. 2022)
(EU)2022/404 (hEN 10. 3. 2022)
(EU)2021/2173 (hEN 9. 12. 2021)
(EU)2021/1407 (hEN 27. 8. 2021)
(EU)2021/117 (hEN 2. 2. 2021)
(EU)2020/50 (hEN 22. 1. 2020)
/ (EU)2019/919 (consolidated text with amendment (EU)2022/1029 (hEN 29. 6. 2022))

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:
(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)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)2020/438 (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:
(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)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)2020/438 (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:
(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)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)2020/438 (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)
       
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.
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