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DIN EN IEC 80001-1 VDE 0756-1:2023-02

Application of risk management for IT-networks incorporating medical devices

Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

(IEC 80001-1:2021); German version EN IEC 80001-1:2021
Class/Status: Standard, valid
Released: 2023-02
VDE Art. No.: 0701438

The implementation and use of connected medical devices or health software to support health IT systems and services entails risk. This international standard provides general requirements for applying risk management to Health Information Technology (HIT) systems by addressing the key properties of safety, effectiveness and both data and system security (including privacy) while engaging appropriate stakeholders. In this context, "implementation" refers to the technology lifecycle phases and activities that are required after health software or medical devices have been released and made available to the market and are being prepared for connection and use.