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Medical devices - Product Testing and Certification

SLG is a notified body (reg.-no. 0494) for active medical devices carrying out tests for safety and essential performance characteristics according to DIN EN 60601-1 and further particular standards.

General active medical devices

  • Respiratory devices, devices for oxygen therapy including hyperbaric chambers, inhalation anaesthesia
  • Devices for stimulation or inhibition
  • Surgical devices
  • Ophthalmologic devices
  • Dental devices
  • Devices for disinfection and sterilisation
  • Rehabilitation devices and and active prostheses
  • Devices for patient positioning and transport
  • Software

Devices for imaging

  • Imaging devices utilising ionising radiation
  • Imaging devices utilising non-ionising radiation

Monitoring devices

  • Monitoring devices of non-vital physiological parameters
  • Montioring devices of vital physiological parameters

Devices for radiation therapy and thermotherapy

  • Devices utilising ionising radiation
  • Devices utilising non-ionising radiation
  • Devices for hyperthermia / hypothermia

Manufacturers are required to ensure that every new medical device meets "basic requirements" according to the Medical Devices Directive 93/42/EEC before introducing the product to the market. Our experts are entitled to carry out necessary conformity assessment procedures for active medical devices.