Home Healthcare - Related International Standards
The following non-harmonised international standards are related to Home Healthcare for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | 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 | 14, 18, 22 | Link |
| IEC 60601-1-12:2014+AMD1:2020 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment | active | 14, 18 | Link |
| ISO 80601-2-72:2023 | Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients | active | 14, 18 | Link |
| ISO 80601-2-78:2019 | Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation | active | 14, 18 | Link |