Digital Health & Wearables - Related International Standards
The following non-harmonised international standards are related to Digital Health & Wearables for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 62304:2006+AMD1:2015 | Medical device software - Software life cycle processes | active | 1, 3, 14, 17 | Link |
| ISO/IEEE 11073-10101:2020 | Health informatics - Device interoperability - Part 10101: Nomenclature | active | 14, 17 | Link |
| ISO/IEEE 11073-10417:2017 | Health informatics - Device interoperability - Part 10417: Personal health device communication - Device specialization - Glucose meter | active | 14, 17 | Link |
| IEC 60601-1-11:2015+AMD1:2020 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | active | 1, 3, 5, 9, 14 | Link |
| ISO/TS 82304-2:2021 | Health software - Part 2: Health and wellness apps - Quality and reliability | active | 1, 3, 14, 17 | Link |