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Sector of: Active implantable medical devices

Sphere of: Regulation No. 22/1997 Sb. - harmonized sphere

Abbreviation: AIMD
Publications in the Official Journal: (EU)2020/438 (hEN 25. 3. 2020)
amendment: (EU)2021/611 (hEN 15. 4. 2021)
/ consolidated text (EU)2020/438
2017/C/389/2
Notified bodies (NANDO): Notified bodies for Council directive 90/385/EEC
ES/EU regulation ČR regulation SR regulation
nařízení vlády č. 55/2015 Sb. repealed by 89/2021 Coll. from 26th May 2021
Government Regulation SR No 167/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
Council directive 90/385/EEC

/repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 2025
/ 2020/C/171/1 - Guidelines on the adoption of derogations
/ Commission implementing decision No (EU)2019/1396
/ Commission decision No 2010/227/EU
/ Regulation Commission No 207/2012
will be repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024)
/ Regulation Commission No 722/2012
Sector (abbr.) hEN:
Sphere:
Status:   Regulation:
Name/code Advanced search
Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations
EN 556-1:2001 replaces EN 556:1994 + A1:1998Canceled ČSN EN 556-1:2002Oprava 1-1.07 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices 15.11.2006 (MDD) 15.11.2006 (AIMD) 15.11.2006 (IVDD) 30.04.2002 (MDD) 30.04.2002 (AIMD) 30.04.2002 (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)2020/438 (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 		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.
AC:2006        
EN 556-2:2015 replaces EN 556-2:2003Canceled ČSN EN 556-2:2016 replaces ČSN EN 556-2:2004Canceled Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 30.06.2016 (MDD) 30.06.2016 (AIMD) 30.06.2016 (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)2020/438 (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 		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.
EN 1041:2008 replaces EN 1041:1998

Canceled 		ČSN EN 1041:2009(Canceled (still harmonized)) Information supplied by the manufacturer of medical devices 19.02.2009 (AIMD) 19.02.2009 (MDD) 31.08.2011 (AIMD) 31.08.2011 (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 10993-1:2009 replaces EN ISO 10993-1:2009(zruš)Canceled ČSN EN ISO 10993-1:2010Oprava 1-9.10 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) 18.01.2011 (AIMD) 18.01.2011 (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.
AC:2010        
EN ISO 10993-3:2014 replaces EN ISO 10993-3:2009Canceled ČSN EN ISO 10993-3:2015 replaces ČSN EN ISO 10993-3:2009Canceled Biologické hodnocení zdravotnických prostředků - Část 3: Zkoušky na genotoxicitu, karcinogenitu a reprodukční toxicitu 10.07.2015 (AIMD) 10.07.2015 (MDD) 17.11.2017 (AIMD) 17.11.2017 (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 10993-4:2009 replaces EN ISO 10993-4:2002Canceled ČSN EN ISO 10993-4:2009(Canceled (still harmonized)) Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) 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 10993-5:2009 replaces EN ISO 10993-5:1999Canceled ČSN EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) 02.12.2009 (AIMD) 02.12.2009 (MDD) 31.12.2009 (AIMD) 31.12.2009 (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 10993-6:2009 replaces EN ISO 10993-6:2007Canceled ČSN EN ISO 10993-6:2009(Canceled (still harmonized)) Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) 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 10993-7:2008 ČSN EN ISO 10993-7:2009 Změna A1-7.22Oprava 1-8.10 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) 07.07.2010 (AIMD) 07.07.2010 (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.
AC:2009        
EN ISO 10993-9:2009 ČSN EN ISO 10993-9:2010(Canceled (still harmonized)) Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) 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 10993-11:2018 replaces EN ISO 10993-11:2009Canceled ČSN EN ISO 10993-11:2018 replaces ČSN EN ISO 10993-11:2009Canceled Biological evaluation of medical devices - Part 11: Tests for systemic toxicity 25.03.2020 (AIMD) 30.03.2020 (MDD) 30.09.2021 (AIMD) 30.09.2021 (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 10993-12:2012 replaces EN ISO 10993-12:2009Canceled ČSN EN ISO 10993-12:2012(Canceled (still harmonized)) Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) 24.01.2013 (AIMD) 24.01.2013 (MDD) 31.01.2013 (AIMD) 31.01.2013 (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 10993-13:2010 replaces EN ISO 10993-13:2009Canceled ČSN EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) 18.01.2011 (AIMD) 18.01.2011 (MDD) 31.12.2010 (AIMD) 31.12.2010 (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 10993-17:2009 replaces EN ISO 10993-17:2002Canceled ČSN EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) 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
EN ISO 11135-1:2007 replaces EN 550:1994Canceled ČSN EN ISO 11135-1:2008Změna Z1-2.15(Canceled (still harmonized)) Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) 09.08.2007 (AIMD) 09.08.2007 (MDD) 31.05.2010 (AIMD) 31.05.2010 (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 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 13.05.2016 (AIMD) 13.05.2016 (MDD) 17.11.2017 (IVDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) 30.06.2016 (AIMD) 30.09.2021 (MDD) 30.06.2016 (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 (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 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) (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 ISO 11138-2:2009 replaces EN ISO 11138-2:2006Canceled ČSN EN ISO 11138-2:2009(Canceled (still harmonized)) Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) 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.
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