IEC TR 60601-4-5 (2021)

IEC TR 60601-4-5:2021 is a technical report published by the International Electrotechnical Commission (IEC) that provides security (cybersecurity) requirements and guidance for medical electrical equipment and medical electrical systems. Rather than acting as a certifiable requirements standard, it maps and adapts the security concepts of the IEC 62443 series to the specific context of medical devices, translating security levels and technical controls into terms relevant to healthcare technology.

The report is aligned with the IEC 60601 family of medical equipment standards and supports manufacturers, integrators and healthcare providers in specifying and evaluating device security. As a technical report (TR) it carries an informative rather than normative status, offering a common reference that can be cited alongside broader risk management and safety requirements.