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Sector of: Medical devices

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

Abbreviation:	MDD
Publications in the Official Journal:	(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
Notified bodies (NANDO):	Notified bodies for Council Directive 93/42/EEC

ES/EU regulation	ČR regulation	SR regulation
Council Directive 93/42/EEC / repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable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 / Recommendations (EU)2021/1433 wiil gradually expire Recommendations (EU)2020/403 / Recommendations (EU)2020/403 without Corrigendum / Commission implementing decision No (EU)2019/1396 / Commission Desicion No (EU)2018/1617 / Commission Implementing regulation No (EU)2017/2185 / Regulation Commission No 722/2012 / Commission Desicion No 2010/227/EU / Agreement No 2017/2118
	nařízení vlády č. 54/2015 Sb. repealed by 89/2021 Coll. from 26th May 2021
		Government Regulation SR No 166/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.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Standard code	ČSN	Description	Applicability date	Date of cessation of presumption of conformity of superseded standard	Publications in the Official Journal	Regulations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 285:2006+A2:2009 replaces EN 285:2006+A1:2008Canceled	ČSN EN 285+A2:2009 Změna Z2-6.17 Změna Z1-7.16 zrušena(Canceled (still harmonized))	Sterilization - Steam sterilizers - Large sterilizers	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 455-1:2000 replaces EN 455-1:1993Canceled	ČSN EN 455-1:2001	Medical gloves for single use - Part 1: Requirements and testing for freedom from holes	30.09.2005 (MDD)	30.04.2001 (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 455-2:2009+A2:2013 replaces EN 455-2:2009+A1:2011 Canceled	ČSN EN 455-2+A2:2013(Canceled (still harmonized))	Medical gloves for single use - Part 2: Requirements and testing for physical properties	16.05.2014 (MDD)	31.10.2014 (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 455-3:2006 replaces EN 455-3:1999 Canceled	ČSN EN 455-3:2007(Canceled (still harmonized))	Medical gloves for single use - Part 3: Requirements and testing for biological evaluation	09.08.2007 (MDD)	30.06.2007 (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 455-4:2009	ČSN EN 455-4:2010	Medical gloves for single use - Part 4: Requirements and testing for shelf life determination	07.07.2010 (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 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)	(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)	(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 794-3:1998+A2:2009 replaces EN 794-3:1998Canceled	ČSN EN 794-3+A2:2010	Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators	07.07.2010 (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 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 1060-3:1997+A2:2009 replaces EN 1060-3:1997Canceled	ČSN EN 1060-3+A2:2013(Canceled (still harmonized))	Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems	07.07.2010 (MDD)	31.05.2010 (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 1060-4:2004	ČSN EN 1060-4:2005 Změna Z1-11.14(Canceled (still harmonized))	Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers	30.09.2005 (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 1135-4:2011 replaces EN ISO 1135-4:2010 Canceled	ČSN EN ISO 1135-4:2012(Canceled (still harmonized))	Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)	27.04.2012 (MDD)	30.04.2012 (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 1282-2:2005+A1:2009 replaces EN 1282-2:2005Canceled	ČSN EN 1282-2+A1:2010	Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)	07.07.2010 (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 1422:1997+A1:2009 replaces EN 1422:1997 Canceled	ČSN EN 1422+A1:2009 Změna Z1-12.14(Canceled (still harmonized))	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods	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 1618:1997	ČSN EN 1618:1998(Canceled (still harmonized))	Catheters other than intravascular catheters - Test methods for common properties	09.05.1998 (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 1639:2009 replaces EN 1639:2004Canceled	ČSN EN 1639:2010	Dentistry - Medical devices for dentistry - Instruments	07.07.2010 (MDD)	30.04.2010 (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 1640:2009 replaces EN 1640:2004Canceled	ČSN EN 1640:2010	Dentistry - Medical devices for dentistry - Equipment	07.07.2010 (MDD)	30.04.2010 (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 1641:2009 replaces EN 1641:2004Canceled	ČSN EN 1641:2010	Dentistry - Medical devices for dentistry - Materials	07.07.2010 (MDD)	30.04.2010 (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 1642:2011 replaces EN 1642:2009Canceled	ČSN EN 1642:2012	Dentistry - Medical devices for dentistry - Dental implants	27.04.2012 (MDD)	30.04.2012 (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 1707:1996	ČSN EN 1707:1998 Změna Z1-12.17	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings	17.05.1997 (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.