Risk Assessment of a Medical System

In Germany, the processing of the standard IEC 80001-1 in the German Electrotechnical Commission (DKE) in the GAK 811.3.2 takes place under the moderation of NSF’s Mr. Oliver Christ.

IEC 80001-1 applies if there is no single medical device manufacturer who has overall responsibility for the conformity and risk assessment of a medical system (for the IT network and medical devices).
The standard applies after the first placing on the market of medical devices and applies to:

  • Operators of medical IT networks
  • Medical device manufacturers
  • Providers of other IT technologies

It describes tasks and responsibilities for the safe operation of a medical IT net-work and calls for a risk management process for its entire life cycle. We provide practical support during the implementation of IEC 80001-1.