Software & Usability - Related International Standards
The following non-harmonised international standards are related to Software & Usability for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 62304:2006+AMD1:2015 | Medical device software - Software life cycle processes | active | Link | |
| IEC 82304-1:2016 | Health software — Part 1: General requirements for product safety | active | 17, 17.1, 17.2, 14 | Link |
| AAMI TIR57:2016/(R)2022 | Principles for medical device security—Risk management | active | 17, 17.1, 17.2, 17.3 | Link |
| IEC TR 80002-1:2009 | Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software | active | 17, 17.1 | 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 | 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medical devices - Part 2-2: Guidance for the communication of medical device security needs, risks and controls | withdrawn | 17, 17.4 | Link |
| IEC 62443-4-1:2018 | Security for industrial automation and control systems - Part 4-1: Secure product development lifecycle requirements | active | 17 | Link |
| ISO 11073-10101:2020 | Health informatics - Device interoperability - Part 10101: Nomenclature | active | 14, 17 | Link |
| ISO/IEEE 11073-10207:2019 | Health informatics - Device interoperability - Part 10207: Domain information and service model for point-of-care medical device communication | active | 14, 17 | Link |
| ISO/IEC TR 24028:2020 | Information technology - Artificial intelligence - Overview of trustworthiness in artificial intelligence | active | 17 | Link |
| ISO/IEC 23894:2023 | Information technology - Artificial intelligence - Guidance on risk management | active | 3, 17 | Link |