Electrical Safety & EMC - Related International Standards
The following non-harmonised international standards are related to Electrical Safety & EMC for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance | active | 14, 14.1, 14.2, 14.6 | Link |
| IEC 60601-2-2:2017+AMD1:2023 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | active | 14, 18, 20 | Link |
| IEC 60601-2-4:2010+AMD1:2018 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators | active | 14, 18, 19 | Link |
| IEC 60601-2-6:2012+AMD1:2016+AMD2:2022 | Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy and hyperthermia equipment | active | 14, 16, 18 | Link |
| IEC 60601-2-10:2012+AMD1:2016+AMD2:2023 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | active | 14, 18, 19 | Link |
| IEC 60601-2-16:2025 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | active | 14, 18, 21 | Link |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers | active | 14, 18, 21 | 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, 15, 18 | 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 | 14, 15, 18 | 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 | 14, 15, 18 | Link |
| IEC 60601-2-37:2024 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | active | 14, 16, 18 | Link |
| IEC 80601-2-49:2018+AMD1:2024 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment | active | 14, 15, 18 | Link |
| IEC 80601-2-52:2026 | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds | active | 14, 18, 20 | Link |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | active | 18 | Link |
| IEC 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | active | 14, 18 | Link |