DIN EN 80001-1 VDE 0756-1:2011-11

This international standard defines the roles, responsibilities and activities that are necessary for risk management of IT-networks incorporating medical devices to address safety, effectiveness and data and system security (the key properties). This standard applies after a medical device has been acquired by a responsible organization and is a candidate for incorporation into an IT-network. This standard applies where there is no single medical device manufacturer assuming responsibility for addressing the key properties of the IT-network incorporating a medical device. This standard does not address regulatory or legal requirements.