Our experience makes us leader in the branding market of active medical devices for several applications: Diagnosis and Therapy, Surgery, Rehabilitation and Physiotherapy and Odontology.

Kiwa’s laboratory supports Companies during the whole process, from the initial “Risk Analysis” phase up to the “Compliance” one, through all trials and testing needed to assess conformity with active requirements.

Electrical Safety

  • Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (EN 60601-1)
  • Medical Electrical Equipment - Part 2-52: Particular Requirements for Basic Safety and Essential Performance of Medical Beds (CEI EN 60601-2-52)
  • Medical Electrical Equipment – Part 2-57: Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use (EN 60601-2-57)
  • Photobiological Safety Of Lamps And Lamp Systems (EN 62471)

Electromagnetic Compatibility

  • Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests (EN 60601-1-2)
  • Electrical Equipment For Measurement, Control and Laboratory Use - EMC Requirements Part 1: General Requirements (EN 61326-1)