IEC TS 81001-2-2:2025
Clause 5: The seventeen security capabilities – IEC TS 81001-2-2:2025

IEC TS 81001-2-2:2025 5.14: Third-party components in product life cycle roadmaps (RDMP)

What does 5.14 require?

The manufacturer plans security support for third-party components across the product life cycle so that HDOs understand security throughout the life of the software and products stay sustainable under the quality management system (ISO 13485 is an example) and regulation. The impact of component life cycles, including operating systems, databases, report generators and other commercial or third-party software and internal suppliers' components, is managed proactively, for instance the ability to patch components analysed under IEC 81001-5-1, 4.3, hardware obsolescence being assumed covered by existing product change processes. HDO contracts, policy and regulation oblige the vendor to maintain and support the system for its life; when platform components become obsolete, updates and upgrades are expected; HDOs and service providers irreversibly erase health data before storage products are decommissioned, discarded, reused, resold or recycled, logging and auditing the activity; and sales and service staff are informed of the security support offered per product over its life.

Maintained by Gerard Blokdyk

Other controls in Clause 5: The seventeen security capabilities – 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.