Consolidates and upgrades IEC TR 80001-2-2:2012 and IEC TR 80001-2-8:2016 from TR to TS. Strengthens alignment with MDS2 (Manufacturer Disclosure Statement for Medical Device Security). Specifies guidance for disclosure, communication and implementation of security needs, risks and controls. SBOM handling is treated separately from MDS2.

Withdraws and replaces IEC TR 80001-2-2. Provides guidance for communication of security needs, risks and controls for health software connected to IT networks.

Establishes a common framework for secure health software life cycle processes. Defines security activities and tasks to increase cybersecurity of health software.

Specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety.

Applies to health software intended to be operated on general-purpose computing platforms. Covers product safety requirements for the complete life cycle.

Defines life cycle requirements for software in medical devices and in vitro diagnostic medical devices. Applies to development and maintenance of medical device software.