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| Standard code | ČSN | Description | Applicability date | Date of cessation of presumption of conformity of superseded standard | Publications in the Official Journal | Regulations |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) | OJ-MD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-PED | 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) | OJ-MDD | 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) | OJ-AIMD , OJ-MDD | 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 | 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) | OJ-AIMD , OJ-MDD | 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) | OJ-AIMD , OJ-MDD , OJ-MDR | 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 A1-5.24Změna 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) | OJ-AIMD , OJ-MDD , OJ-IVDD | 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 A1-5.24Změna 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) | OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR | 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 A1-5.24Změna 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) | OJ-MDD | 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 A1-5.24Změna 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) | OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR | 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) | OJ-AIMD , OJ-MDD , OJ-IVDD | 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) | OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR | 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) | OJ-MDD | 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 ÄSN 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-MDD | 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-old) | OJ-PPE-old | 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) | OJ-AIMD , OJ-MDD | 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) | OJ-MDD , OJ-IVDD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-IRS | (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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-EMC | 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) | OJ-EMC , OJ-RTTED | 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) | OJ-EMC | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-LVD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-MDD | 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) | OJ-LVD | 148/2016 Z.z. 2014/35/EU 118/2016 Sb. | |
|
A1:2013 IEC 61535:2009/A1:2012 |
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| 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) | OJ-LVD | 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) | OJ-LVD | 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) | OJ-LVD | 148/2016 Z.z. 2014/35/EU 118/2016 Sb. |
| EN ISO 80601-2-55:2018 | ČSN EN ISO 80601-2-55 ed. 2:Změna A1-6.24 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | 15.04.2021 (MDD) | OJ-MDD | 93/42/EHS 54/2015 Sb. 166/2020 Z.z. |