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.
