The standard IEC 80001-1 was edited in Germany by the German Commission for Electrical, Electronic & Information Technologies (DKE) in the workgroup GAK 811.3.2 under the moderation of Mr. Oliver P. Christ, PROSYSTEM. The IEC 80001-1 applies if there is no single medical device manufacturer who claims responsibility for conformity and risk evaluation of a medical system (consisting of an IT network and medical devices).
This standard applies after placing the medical device on the market for the first time and is directed to:

  • “medical IT network” operators
  • medical device manufacturers
  • IT technology providers

The standard describes tasks and responsibilities for the safe operation of a “medical IT network” and demands a risk management process for the whole lifecycle.
PROSYSTEM offers to accompany and support you during implementation of the IEC 8001-1 at hospitals and medical practices (pilot projects).