Detail

The area of medical technology remains very volatile: This year alone, 15 standards from the IEC 60601 series were changed. It is still very unclear when these changes will appear in the EU Official Journal. This will probably further complicate the already difficult transition of medical device approval to the new MDR.

The standard series IEC 60601 defines safety and usability requirements for electrical medical devices and medical systems. The following standards were updated in 2020:

• IEC 60601-1:2005+AMD1:2012+AMD2:2020
  Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

• IEC 60601-1-2:2014+AMD1:2020    
  Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests  

• IEC 60601-1-6:2010+AMD1:2013+AMD2:2020
  Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

• IEC 60601-1-8:2006+AMD1:2012+AMD2:2020
  Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

• IEC 60601-1-9:2007+AMD1:2013+AMD2:2020
  Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

• IEC 60601-1-10:2007+AMD1:2013+AMD2:2020
  Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

• IEC 60601-1-11:2015+AMD1:2020
  Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

• IEC 60601-1-12:2014+AMD1:2020
  Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

• IEC 60601-2-1:2020
  Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV

• IEC 60601-2-19:2020
  Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

• IEC 60601-2-20:2020
  Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

• IEC 60601-2-21:2020
  Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers  

• IEC 60601-2-31:2020
  Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

• IEC 60601-2-35:2020   
  Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use

• IEC 60601-2-50:2020Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

In our standards management system GLOBALnorm you can set up monitoring for your standards and be notified automatically about changes like these. You can also order the changed standards directly. Feel free to contact us for more information or guidance on that.