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Sector of: Active implantable medical devices (placed on the market to 26. 5. 2021)

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 repealed by 89/2021 Coll.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		Government Regulation SR No 167/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.
Council directive 90/385/EEC /repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable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implementing decision No (EU)2019/1396 / Commission decision No 2010/227/EU / Regulation Commission No 207/2012 repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024) / Regulation Commission No 722/2012

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Standard code	ČSN	Description	Applicability date	Date of cessation of presumption of conformity of superseded standard	Publications in the Official Journal	Regulations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 556-1:2002 Oprava 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 (AIMD) 15.11.2006 (MDD) 15.11.2006 (IVDD)	30.04.2002 (AIMD) 30.04.2002 (MDD) 30.04.2002 (IVDD)	OJ-AIMD , OJ-MDD , OJ-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.
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 (AIMD) 13.05.2016 (MDD) 13.05.2016 (IVDD)	30.06.2016 (AIMD) 30.06.2016 (MDD) 30.06.2016 (IVDD)	OJ-AIMD , OJ-MDD , OJ-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 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)	OJ-AIMD , OJ-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 10993-1:2010 Oprava 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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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 A1-7.22 Oprava 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)		OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)	OJ-AIMD , OJ-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)		OJ-AIMD , OJ-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(Canceled (still harmonized))	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)	OJ-AIMD , OJ-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 10993-18:2020 Změna 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)		OJ-AIMD , OJ-MDD , OJ-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) 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)	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 11135-1:2008 Změna 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)	OJ-AIMD , OJ-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 11137-1:2007 Změna 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)	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 11137-2:2015 replaces EN ISO 11137-2:2013Canceled	ČSN EN ISO 11137-2:2016 Změna 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
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)	OJ-AIMD , OJ-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.