Cybersecurity - Related International Standards
The following non-harmonised international standards are related to Cybersecurity for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 81001-5-1:2021 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle | active | 17, 17.1, 17.2, 17.3, 17.4, 18, 18.8 | Link |
| IEC TR 60601-4-5:2021 | Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications | active | 17, 17.1, 17.2, 17.4, 18 | Link |
| IEC 80001-1:2021 | 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 | active | 17, 17.4, 18, 18.8 | Link |
| IEC 62443-4-1:2018 | Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements | active | 17, 17.2, 17.4 | Link |
| AAMI TIR57:2016/(R)2022 | Principles for medical device security - Risk management | active | 17, 17.4, 18 | Link |
| IEC TS 81001-2-2:2025 | Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the communication of medical device security needs, risks and controls | withdrawn | 17, 17.4 | Link |