Information system Product regulation

Updates | Období : 01.04.2021 - 30.04.2021

Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations
EN 61496-1:2013 Canceled is replaced EN 61496-1:2004Canceled ČSN EN 61496-1 ed. 3:2014Změna Z1-4.21 replaces ČSN EN 61496-1 ed. 2:2005Oprava 1-4.11Změna Z1-4.14Změna A1-3.09Canceled Safety of machinery - Electro-sensitive protective equipment -- Part 1: General requirements and tests 11.04.2014 (MD) 10.05.2015 (MD) (EU)2023/1586 (hEN 2. 8. 2023 - processing) repealed:
2018/C/092/1 (hEN 9. 3. 2018)
(EU)2019/436 (hEN 19. 3. 2019)
amendments and correction of Implementing Decision (EU)2019/436 (hEN 19. 3. 2019):
amendment (EU)2023/69 (hEN 10. 1. 2023),
amendment (EU)2022/621 (hEN 13. 4. 2022),
amendment (EU)2021/1813 (hEN 15. 10. 2021),
amendment (EU)2020/480 (hEN 2. 4. 2020),
amendment  (EU)2019/1863 (hEN 7. 11. 2019),
correcting the Czech language version (EU)2019/1680 (8. 10. 2019),
amendment  (EU)2019/1766 (as regard harmonised standard EN ISO 19085-3:2017).
/ consolidated text (EU)2019/436 (10. 1. 2023) with amendment (EU)2023/69
Summary list hEN for information purposes only (3. 8. 2023) 		2006/42/ES 176/2008 Sb. 436/2008 Z.z.
EN 1789:2007+A1:2010 Canceled is replaced EN 1789:2020 ČSN EN 1789+A1:2010(Canceled) is replaced ČSN EN 1789:2020 Medical vehicles and their equipment - Road ambulances 18.01.2011 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 1789:2020 replaces EN 1789:2007+A1:2010Canceled ČSN EN 1789:2020 replaces ČSN EN 1789+A1:2010Canceled Medical vehicles and their equipment - Road ambulances 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 4126-3:2020 replaces EN ISO 4126-3:2006Canceled ČSN EN ISO 4126-3:2021 replaces ČSN EN ISO 4126-3:2006Canceled Bezpečnostní pojistná zařízení proti nadměrnému tlaku - Část 3: Kombinace pojistných ventilů a bezpečnostních zařízení s průtržnou membránou 10.02.2021 (PED) 10.08.2022 (PED) 2018/C/326/3 (hEN)
2016/C/447/6 (EAD)
2018/C/400/8 (EAM)
(EU)2019/1616 (hEN 30. 9. 2019) with amendments:
(EU)2022/1844 (hEN 3. 10. 2022)
(EU)2021/1801 (hEN 12. 10. 2021)
(EU)2020/542 (hEN 20. 4. 2020)
(EU)2021/157 (hEN 10. 2. 2021)
(EU)2021/2272 (hEN 21. 12. 2021)
(EU)2019/1616 (consolidated text with amendment (EU)2022/1844)
Summary list hEN for information purposes only (3. 10. 2022) 		2014/68/EU 219/2016 Sb. 1/2016 Z.z.
EN ISO 5361:2016 ČSN EN ISO 5361 ed. 2:2017(Canceled (still harmonized)) Anaesthetic and respiratory equipment - Tracheal tubes and connectors 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 10993-16:2010 Canceled is replaced EN ISO 10993-16:2009Canceled EN ISO 10993-16:2017 ČSN EN ISO 10993-16:2010(Canceled) is replaced ČSN EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) 07.07.2010 (AIMD) 07.07.2010 (MDD) 31.08.2010 (AIMD) 31.08.2010 (MDD) (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 		55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 10993-16:2017 replaces EN ISO 10993-16:2010Canceled ČSN EN ISO 10993-16:2018 replaces ČSN EN ISO 10993-16:2010Canceled Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables 15.04.2021 (AIMD) 15.04.2021 (MDD) (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 		55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 10993-18:2009 Canceled is replaced EN ISO 10993-18:2020EN ISO 10993-18:2005Canceled ČSN EN ISO 10993-18:2009(Canceled) is replaced ČSN EN ISO 10993-18:2020Změna A1-1.24 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) 02.12.2009 (AIMD) 02.12.2009 (MDD) 21.03.2010 (AIMD) 21.03.2010 (MDD) (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 		55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z.
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 11607-1:2009 Canceled is replaced EN ISO 11607-1:2006Canceled EN ISO 11607-1:2020 ČSN EN ISO 11607-1:2010Změna A1-1.15(Canceled) is replaced ČSN EN ISO 11607-1:2020Změna A11-12.22 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) 02.12.2009 (AIMD) 02.12.2009 (MDD) 15.04.2021 (IVDD) 21.03.2010 (AIMD) 21.03.2010 (MDD) (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 		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.
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 15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (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) 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)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)

 		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 11607-2:2006 Canceled is replaced EN ISO 11607-2:2020 ČSN EN ISO 11607-2:2006Změna A1-1.15(Canceled) is replaced ČSN EN ISO 11607-2:2020Změna A11-12.22 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) 07.09.2006 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
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 15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (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) 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)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)

 		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 11737-2:2009 Canceled is replaced EN ISO 11737-2:2020 ČSN EN ISO 11737-2:2010(Canceled) is replaced ČSN EN ISO 11737-2:2020 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) 07.07.2010 (AIMD) 07.07.2010 (MDD) 07.07.2010 (IVDD) (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 		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.
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) (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) 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)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)

 		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 13718-1:2008 Canceled is replaced EN 13718-1:2014+A1:2020EN 13718-1:2002

Canceled 		ČSN EN 13718-1:2009(Canceled) is replaced ČSN EN 13718-1 + A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances 19.02.2009 (MDD) 28.02.2009 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 13718-1:2014+A1:2020 replaces EN 13718-1:2008Canceled ČSN EN 13718-1 + A1:2020 replaces ČSN EN 13718-1:2009Canceled ČSN EN 13718-1 + A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 13718-2:2015 Canceled is replaced EN 13718-2:2015+A1:2020 ČSN EN 13718-2:2015(Canceled) is replaced ČSN EN 13718-2 + A1:2020 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances 10.07.2015 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 13718-2:2015+A1:2020 replaces EN 13718-2:2015Canceled ČSN EN 13718-2 + A1:2020 replaces ČSN EN 13718-2:2015Canceled Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 14116:2015 replaces EN ISO 14116:2008Canceled ČSN EN ISO 14116:2021 replaces ČSN EN ISO 14116:2008Oprava 1-5.09Canceled Protective clothing - Protection against flame - Limited flame spread materials, material assemblies and clothing (ISO 14116:2015) 31.01.2016 (PPE) 2018/C/113/3
2018/C/282/1
(EU)2019/1217

 		89/686/EHS 21/2003 Sb. 35/2008 Z.z.
EN ISO 14155:2011 Canceled is replaced EN ISO 14155:2020EN ISO 14155:2011zrCanceled ČSN EN ISO 14155:2012(Canceled) is replaced ČSN EN ISO 14155:2011Canceled ČSN EN ISO 14155:2021 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) 17.11.2017 (AIMD) 17.11.2017 (MDD) 30.04.2012 (AIMD) 30.04.2012 (MDD) (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 		55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z.
AC:2011        
EN ISO 14155:2020 replaces EN ISO 14155:2011Canceled ČSN EN ISO 14155:2021 replaces ČSN EN ISO 14155:2012Canceled Clinical investigation of medical devices for human subjects - Good clinical practice 15.04.2021 (MDD) 15.04.2021 (IVDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb.
EN ISO 14607:2009 Canceled is replaced EN ISO 14607:2018EN ISO 14607:2007Canceled ČSN EN ISO 14607:2009(Canceled) is replaced ČSN EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) 02.12.2009 (MDD) 21.03.2010 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 14607:2018 replaces EN ISO 14607:2009Canceled ČSN EN ISO 14607:2018 replaces ČSN EN ISO 14607:2009Canceled Non-active surgical implants - Mammary implants - Particular requirements 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 16452:2015+A1:2019 ČSN EN 16452+A1:2021 Railway applications - Braking - Brake blocks 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 22442-1:2007 Canceled is replaced EN 12442-1:2000Canceled EN ISO 22442-1:2020 ČSN EN ISO 22442-1:2008(Canceled) is replaced ČSN EN ISO 22442-1:2021 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007) 27.02.2008 (MDD) 30.06.2008 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 22442-1:2020 replaces EN ISO 22442-1:2007Canceled ČSN EN ISO 22442-1:2021 replaces ČSN EN ISO 22442-1:2008Canceled Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 22442-2:2007 Canceled is replaced EN 12442-2:2000Canceled EN ISO 22442-2:2020 ČSN EN ISO 22442-2:2008(Canceled) is replaced ČSN EN ISO 22442-2 připravuje se Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) 27.02.2008 (MDD) 30.06.2008 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN ISO 22442-2:2020 replaces EN ISO 22442-2:2007Canceled ČSN EN ISO 22442-2 připravuje se replaces ČSN EN ISO 22442-2:2008Canceled Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 55024:2010 Canceled is replaced EN 55035:2017 ČSN EN 55024 ed. 2:2011Změna A1-1.16Změna Z1-7.22(Canceled) is replaced ČSN EN 55035:2018Oprava 1-4.20Oprava 2-7.22Změna A11-2.21 Information technology equipment - Immunity characteristics - Limits and methods of measurement CISPR 24:2010 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.
A1:2015        
EN 55035:2017 replaces EN 55103-2:2009Canceled EN 55024:2010Canceled ČSN EN 55035:2018Oprava 1-4.20Oprava 2-7.22Změna A11-2.21 replaces ČSN EN 55024 ed. 2:2011Změna A1-1.16Změna Z1-7.22Canceled ČSN EN 55103-2 ed. 2:2010Změna Z1-12.12Změna Z2-7.22Canceled Electromagnetic compatibility of multimedia equipment - Immunity requirements CISPR 35:2016 (Modified) 06.08.2019 (EMC) 17.11.2017 (RTTED) 28.07.2022 (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))

2018/C/49/3

 		117/2016 Sb. 2014/30/EU 127/2016 Z.z. 1999/5/ES 426/2000 Sb. 443/2001 Z.z.
A11:2020     16.03.2021 (EMC)    
EN 55103-2:2009 Canceled is replaced EN 55035:2017 ČSN EN 55103-2 ed. 2:2010Změna Z1-12.12Změna Z2-7.22(Canceled) is replaced ČSN EN 55035:2018Oprava 1-4.20Oprava 2-7.22Změna A11-2.21 Electromagnetic compatibility - Product family standard for audio, video, audio-visual and entertainment lighting control apparatus for professional use -- Part 2: Immunity 18.03.2021 (EMC) 28.07.2022 (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.
EN 60118-13:2005 Canceled is replaced EN 60118-13:1997Canceled EN IEC 60118-13:2020 ČSN EN 60118-13 ed. 2:2005Změna Z1-12.11(Canceled) is replaced ČSN EN IEC 60118-13 ed. 4:2020 Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC) 19.01.2006 (MDD) 01.02.2008 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN IEC 60118-13:2020 replaces EN 60118-13:2005Canceled ČSN EN IEC 60118-13 ed. 4:2020 replaces ČSN EN 60118-13 ed. 2:2005Změna Z1-12.11Canceled Electroacoustics - Hearing aids - Part 13: Requirements and methods of measurement for electromagnetic immunity to mobile digital wireless devices 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 60335-2-15:2016 replaces EN 60335-2-15:2002Canceled ČSN EN 60335-2-15 ed. 3:2016Změna A12-2.22Změna A11-1.19Změna A1-2.22Změna A2-2.22 replaces ČSN EN 60335-2-15 ed. 2:2003Oprava 4-1.14Změna Z1-6.16Oprava 1-3.05Změna A1-6.06Oprava 3-2.07Změna A2-5.09Změna A11-9.12Canceled Household and similar electrical appliances - Safety - Part 2-15: Particular requirements for appliances for heating liquids 27.11.2019 (LVD) 27.05.2021 (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.
A1:2021     10.05.2022 (LVD)    
A2:2021     10.05.2022 (LVD)    
A11:2018        
A12:2021     10.05.2022 (LVD)    
EN 60601-2-4:2003 Canceled is replaced EN 60601-2-4:2011 ČSN EN 60601-2-4:2003Změna Z1-1.12(Canceled) is replaced ČSN EN 60601-2-4 ed. 2:2012Změna A1 Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators 15.10.2003 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN 60601-2-4:2011 replaces EN 60601-2-4:2003Canceled ČSN EN 60601-2-4 ed. 2:2012Změna A1 replaces ČSN EN 60601-2-4:2003Změna Z1-1.12Canceled Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN IEC 60601-2-66:2020 ČSN EN IEC 60601-2-66 ed. 3:2020 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
EN IEC 60601-2-83:2020 ČSN EN IEC 60601-2-83:2020Změna A11-10.21 Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
A11:2021     05.01.2022 (MDR)    
EN 61535:2009 Canceled is replaced EN IEC 61535:2019 ČSN EN 61535:2010Změna Z2-4.21Změna A1-8.13Změna Z1-6.20(Canceled) is replaced ČSN EN IEC 61535 ed. 2:2021 Installation couplers intended for permanent connection in fixed installations 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.
A1:2013
IEC 61535:2009/A1:2012 		       
EN IEC 61535:2019 replaces EN 61535:2009Canceled ČSN EN IEC 61535 ed. 2:2021 replaces ČSN EN 61535:2010Změna Z2-4.21Změna A1-8.13Změna Z1-6.20Canceled Installation couplers intended for permanent connection in fixed installations 03.08.2020 (LVD) 03.02.2022 (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 62275:2015 Canceled is replaced EN 62275:2009Canceled EN IEC 62275:2019 ČSN EN 62275 ed. 2:2016Změna Z2-4.21(Canceled) is replaced ČSN EN 62275:2010Změna Z1-1.16Canceled ČSN EN IEC 62275 ed. 3:2021 Cable management systems - Cable ties for electrical installations 08.07.2016 (LVD) 19.01.2018 (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 IEC 62275:2019 replaces EN 62275:2015Canceled ČSN EN IEC 62275 ed. 3:2021 replaces ČSN EN 62275 ed. 2:2016Změna Z2-4.21Canceled Cable management systems - Cable ties for electrical installations 03.08.2020 (LVD) 03.02.2022 (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 ISO 80601-2-55:2018 ČSN EN ISO 80601-2-55 ed. 2: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors 15.04.2021 (MDD) (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 		93/42/EHS 54/2015 Sb. 166/2020 Z.z.
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