Active Medical Devices

Testing of the electrical safety of medical devices according to the medical devices directive 93/42/EEC

This covers:

  • active medical devices
  • active therapeutic medical devices
  • active diagnostic medical devices

What is an Active Medical Device?

An „Active Medical Device“ is a medical device, which operates with an electrical energy source or any source of power (other than the directly generated energy by the human body or gravity).

Product examples:

  • Electrical instruments for the operating theatre (circulating pumps, imaging systems, light sources, surgical tools, insuflation pumps)
  • Devices for patient monitoring (monitoring systems, medical sensors)
  • Devices for emergency medical care (adjustable thermal blankets)
  • Diagnostic devices (ECG-Recorder, EMG-Recorder, sphygmomanometer, sonographic units)
  • Therapeutic devices (electromyostimulation, respiration, magnetic field stimmulation, massagetherapy, infusion pumps)
  • Electrical powered wheelchairs, medical beds and stair climbers
  • Coordination of tests to establish the electromagnetic compability (EMC)

Description of the scope of our services and its limits

Our service includes:

  • Electrical safety testing according to DIN EN 60601-1:2006
  • Electrical safety testing according to DIN EN 60601-1:1996
  • Coordination of the tests according to DIN EN 60601-1-2:2007 (EMC)
  • Coordination of the tests according to DIN EN 60529:2014 (IP-Classification)
  • Coordination of the tests according to DIN EN 10993 (biological evaluation of medical products)
  • Coordination of the tests according to DIN EN 60086-4 and DIN EN 62133 (Li-Ion batteries/accus)
  • Coordination of the tests according to IEC 60825-1 and DIN EN 62471 (Safety of lasers)
  • Coordination of the tests according to DIN EN 62471 (Safety of lamps)
  • Test based on norms or internal standarts of Berlin Cert in agreement with the client
  • Detailed list of our services see: list of service

Duration

Testing of a product takes between 8 and 12 weeks.

About the process

Information are gathered through an initial conversation (by phone, e-mail or, should you prefer this, in person)

  • detailed quote is put together
  • product is sent / made available
  • tests are conducted
  • test report is established

Which information are required for the establishment of a quote?

  • Details about the name, function, classification and dimensions of the test sample
  • Further technical information (e.g. datasheets, service manual, photos)