Information system Product regulation

Updates | Období : 01.03.2024 - 31.03.2024

Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations
EN 455-3:2023 EN 455-3.....připravuje se Medical gloves for single use - Part 3: Requirements and testing for biological evaluation 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN ISO 10088:2023 Concurrent concurrent validity with EN ISO 10088:2017 ČSN EN ISO 10088:2023 replaces ČSN EN ISO 10088:2018Canceled (still harmonized) Small craft - Permanently installed fuel systems 12.01.2024 (RCD) 12.07.2025 (RCD) OJ-RCD 77/2016 Z.z. 96/2016 Sb. 2013/53/EU
EN ISO 10993-15:2023 ČSN EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-17:2023 ČSN EN ISO 10993-17....připravuje se Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances 08.03.2024 (MDR) OJ-MDR (EU)2017/745
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 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) 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 11607-1:2020 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 11607-2:2020 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 13232-3:2003+A1:2011 ČSN EN 13232-3+A1:2012(Canceled (still harmonized)) Railway applications - Track - Switches and crossings - Part 3: Requirements for wheel/rail interaction 21.11.2023 (IRS) OJ-IRS (EU)2016/797 513/2009 Z.z. zákon č. 266/1994 Sb
EN ISO 17664-2:2023 ČSN EN ISO 17664-2:2024 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices Part 2: Non-critical medical devices 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN 60335-2-14:2006 replaces EN 60335-2-14:2003Canceled ČSN EN 60335-2-14 ed. 3:2007Změna A1-5.09Změna Z1-3.24Změna A11-9.12Oprava 1-1.14 Household and similar electrical appliances - Safety -- Part 2-14: Particular requirements for kitchen machines OJ-LVD 148/2016 Z.z. 2014/35/EU 118/2016 Sb.
AC:2007        
A1:2008        
A11:2012        
A12:2016        
A11:2012/AC:2013        
A11:2012/AC:2016        
EN 60670-23:2008 ČSN EN 60670-23:2009Změna A1-3.24Změna A11-3.24 Boxes and enclosures for electrical accessories for household and similar fixed electrical installations -- Part 23: Particular requirements for floor boxes and enclosures 08.07.2016 (LVD) OJ-LVD 148/2016 Z.z. 2014/35/EU 118/2016 Sb.
A11:2023     23.04.2024 (LVD)    
EN 60730-2-5:2015 replaces EN 60730-2-5:2002Canceled ČSN EN 60730-2-5 ed. 3:2015Změna A2-11.21Oprava 1-3.24Změna A1-10.19 replaces ČSN EN 60730-2-5 ed. 2:2002Změna A1-7.05Změna A11-12.05Změna A2-2.11Změna Z1-8.15Canceled Automatic electrical controls - Part 2-5: Particular requirements for automatic electrical burner control systems 08.07.2016 (LVD) 17.11.2017 (LVD) OJ-LVD 148/2016 Z.z. 2014/35/EU 118/2016 Sb.
EN 60811-201:2012 ČSN EN 60811-201:2013Změna A1-3.18Změna A2-5.24 Electric and optical fibre cables - Test methods for non-metallic materials -- Part 201: General tests - Measurement of insulation thickness 08.07.2016 (LVD) 13.06.2025 (LVD) OJ-LVD 148/2016 Z.z. 2014/35/EU 118/2016 Sb.
EN 62020:1998 ČSN EN 62020:2000Změna A1-12.05Změna Z1-10.21(Canceled (still harmonized)) Electrical accessories - Residual current monitors for household and similar uses (RCMs) 08.07.2016 (LVD) 13.05.2016 (EMC) OJ-LVD , OJ-EMC 148/2016 Z.z. 2014/35/EU 118/2016 Sb. 117/2016 Sb. 2014/30/EU 127/2016 Z.z.
A1:2005
IEC 62020:1998/A1:2003 (Modified) 		       
EN IEC 62040-1:2019 replaces EN 62040-1:2008Canceled ČSN EN IEC 62040-1 ed. 2:2019Změna A1-3.24Oprava 1-3.20Změna A11-8.21 replaces ČSN EN 62040-1:2009Změna A1-9.13Změna Z1-12.19Canceled Uninterruptible power systems (UPS) - Part 1: Safety requirements 21.12.2021 (LVD) 21.06.2023 (LVD) OJ-LVD 148/2016 Z.z. 2014/35/EU 118/2016 Sb.
A11:2021        
EN 62053-23:2003 Canceled is replaced EN IEC 62053-23:2021 ČSN EN 62053-23:2003Změna Z1-8.21Změna A1-8.17Oprava 1-11.18(Canceled) is replaced ČSN EN IEC 62053-23 ed. 2:2021Změna A11-12.21 Electricity metering equipment (a.c.) - Particular requirements -- Part 23: Static meters for reactive energy (classes 2 and 3) 13.05.2016 (EMC) OJ-EMC 117/2016 Sb. 2014/30/EU 127/2016 Z.z.
We use cookies that make this site work. By using our services you agree to use them.More here I agree