IEC TS 81001-2-2:2025
Clause 4: How security capabilities are used, communicated and fed into risk management – IEC TS 81001-2-2:2025

IEC TS 81001-2-2:2025 4.3: Select capabilities as risk control options from intended use and environment

What does 4.3 require?

Every capability is a potential security risk control option, chosen once the need to mitigate a security risk has been identified: the capability goal lists the risks it can address and the user need lists the aspects that must be considered when it is applied. How the software is intended to be used, and in what environment, within the health IT infrastructure inform which capabilities are selected and at what level, for instance authentication on network-connected products holding patient data. Security requirements for a particular intended use and environment are never adopted or tailored without considering their effect on the safety and effectiveness of the product.

Maintained by Gerard Blokdyk

Other controls in Clause 4: How security capabilities are used, communicated and fed into risk management – IEC TS 81001-2-2:2025

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.