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Sector of: In vitro diagnostic medical devices (placed on the market to 26. 5. 2022)

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

Abbreviation:	IVDD
Publications in the Official Journal:	(EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4
Notified bodies (NANDO):	Notified bodies for Directive EP and Council 98/79/EC

ES/EU regulation	ČR regulation	SR regulation
Directive EP and Council 98/79/EC / will be partial repealed by Regulation (EU)2017/746 of the European Parliament and of the Council (text with amendment (EU)2024/1860 / Commission Implementing regulation No (EU)2017/2185 / Commission Decision No 2008/932/ES, 2010/227/EC
		nariadenie vlády SR č. 569/2001 Z.z. (consolidated text)
	nařízení vlády č. 56/2015 Sb. repealed by Law No 375/2022 Coll. / amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024 Decree No 377/2022 Coll.

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Standard code	ČSN	Description	Applicability date	Date of cessation of presumption of conformity of superseded standard	Publications in the Official Journal	Regulations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 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	20.07.2021 (IVDR) 13.05.2016 (AIMD) 13.05.2016 (MDD) 17.11.2017 (IVDD) 19.07.2021 (MDR)	30.06.2016 (AIMD) 30.09.2021 (MDD) 30.06.2016 (IVDD)	OJ-IVDR , OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR (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) (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)2017/746 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
A2:2019			20.07.2021 (IVDR) 25.03.2020 (MDD) 25.03.2020 (IVDD) 19.07.2021 (MDR)	30.09.2021 (IVDD)
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	08.03.2024 (IVDR) 13.05.2016 (AIMD) 13.05.2016 (MDD) 13.05.2016 (IVDD) 08.03.2024 (MDR)	30.06.2016 (AIMD) 30.06.2016 (MDD) 30.06.2016 (IVDD)	OJ-IVDR , OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR (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) (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)2017/746 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
EN ISO 11607-1:2020 replaces EN ISO 11607-1:2009Canceled	ČSN EN ISO 11607-1:2020 Změna A1-5.24 Změna A11-12.22 replaces ČSN EN ISO 11607-1:2010 Změna 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 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR)		OJ-IVDR , OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR (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) (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)2017/746 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
EN ISO 11607-2:2020 replaces EN ISO 11607-2:2006Canceled	ČSN EN ISO 11607-2:2020 Změna A1-5.24 Změna A11-12.22 replaces ČSN EN ISO 11607-2:2006 Změna 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)		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 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)		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 12322:1999	ČSN EN 12322:2000 Změna A1-7.02	In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media	31.07.2002 (IVDD)	30.04.2002 (IVDD)	OJ-IVDD (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	98/79/ES 569/2001 Z.z. 56/2015 Sb.
A1:2001
EN ISO 13408-1:2015 replaces EN ISO 13408-1:2011Canceled	ČSN EN ISO 13408-1:2016(Canceled (still harmonized)) is replaced ČSN EN ISO 13408-1:2011 Změna A1-12.13Canceled	Aseptic processing of health care products - Part 1: General requirements	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 ISO 13408-2:2018 replaces EN ISO 13408-2:2011Canceled	ČSN EN ISO 13408-2:2018 replaces ČSN EN ISO 13408-2:2011Canceled	Aseptic processing of health care products - Part 2: Sterilizing filtration	25.03.2020 (AIMD) 25.03.2020 (MDD) 25.03.2020 (IVDD)	30.09.2021 (AIMD) 30.09.2021 (MDD) 30.09.2021 (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 ISO 13408-3:2011 replaces EN 13824:2004Canceled	ČSN EN ISO 13408-3:2011	Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)	19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD)	31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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 ISO 13408-4:2011 replaces EN 13824:2004Canceled	ČSN EN ISO 13408-4:2012	Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)	19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD)	31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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 ISO 13408-5:2011 replaces EN 13824:2004Canceled	ČSN EN ISO 13408-5:2012	Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)	19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD)	31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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 ISO 13408-6:2011 replaces EN 13824:2004Canceled	ČSN EN ISO 13408-6:2012 Změna A1-9.13	Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)	19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD)	31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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 ISO 13408-7:2015	ČSN EN ISO 13408-7:2016	Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products	13.05.2016 (AIMD) 13.05.2016 (MDD) 13.05.2016 (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 ISO 13485:2016 replaces EN ISO 13485:2012Canceled	ČSN EN ISO 13485 ed. 2:2016 Změna A11-4.22 Oprava 1-7.17 replaces ČSN EN ISO 13485:2012 Oprava 1-1.13 Oprava 2-1.13 Změna Z1-12.16Canceled	Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)	17.11.2017 (AIMD) 17.11.2017 (MDD) 17.11.2017 (IVDD) 05.01.2022 (MDR) 07.01.2022 (IVDR)	31.03.2019 (AIMD) 31.03.2019 (MDD) 31.03.2019 (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
AC:2018			07.01.2022 (IVDR) 25.03.2020 (AIMD) 25.03.2020 (MDD) 25.03.2020 (IVDD) 17.05.2022 (MDR)	30.09.2021 (AIMD) 30.09.2021 (MDD) 30.09.2021 (IVDD)
EN 13532:2002	ČSN EN 13532:2002	General requirements for in vitro diagnostic medical devices for self-testing	17.12.2002 (IVDD)		OJ-IVDD (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	98/79/ES 569/2001 Z.z. 56/2015 Sb.
EN 13612:2002	ČSN EN 13612:2002 Oprava 1-7.03	Performance evaluation of in vitro diagnostic medical devices	02.12.2009 (IVDD)		OJ-IVDD (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	98/79/ES 569/2001 Z.z. 56/2015 Sb.
AC:2002
EN 13641:2002	ČSN EN 13641:2002	Elimination or reduction of risk of infection related to in vitro diagnostic reagents	17.12.2002 (IVDD)		OJ-IVDD (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	98/79/ES 569/2001 Z.z. 56/2015 Sb.
EN 13975:2003	ČSN EN 13975:2003	Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects	21.11.2003 (IVDD)		OJ-IVDD (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4	98/79/ES 569/2001 Z.z. 56/2015 Sb.