Cardiology - Related International Standards
The following non-harmonised international standards are related to Cardiology for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-47:2012 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems | active | 14, 14.1 | Link |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | active | 14, 14.1 | Link |
| IEC 60601-2-31:2020 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source | active | 14, 14.2 | Link |
| ISO 25539-1:2017 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses | active | 1, 3, 5, 10 | Link |
| ISO 25539-2:2020 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents | active | 1, 3, 5, 10 | Link |
| ISO 5840-1:2021 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements | active | 1, 3, 5, 10 | Link |
| IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment | active | 1, 3, 14 | Link |
| IEC 60601-2-34:2024 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment | active | 1, 3, 14 | Link |