A new list of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) was published in the Official Journal on May 13, 2016 – OJ C173

9 new standards have been added:

  • EN 556-2:2015 (new) Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices
  • EN 1865-1:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment
  • EN 1865-2:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher
  • EN ISO 3826-4:2015 (new) Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
  • EN ISO 11137-1:2015 (new) Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
  • EN ISO 11137-2:2015 (new) Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
  • EN ISO 13408-1:2015 (new) Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
  • EN ISO 13408-7:2015 (new) Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
  • EN 60601-1-2:2015 (new) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral
    Standard: Electromagnetic disturbances – Requirements and tests

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