Diagnostic Imaging - Related International Standards
The following non-harmonised international standards are related to Diagnostic Imaging for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | active | 14, 16 | Link |
| IEC 60601-2-33:2022 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | active | 14, 16 | Link |
| IEC 60601-2-43:2022 | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | active | 14, 16 | Link |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography | active | 14, 16 | Link |
| IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | active | 14, 16 | Link |
| IEC 60601-2-54:2022 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | active | 14, 16 | Link |
| IEC 62563-1:2009+AMD1:2016+AMD2:2021 | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods | active | 14, 14.1 | Link |
| IEC 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging | active | 14, 16 | Link |
| IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography | active | 14, 16 | Link |
| IEC 62220-1-3:2008 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging | active | 14, 16 | Link |
| IEC 61223-3-5:2019 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment | active | 14, 16 | Link |
| IEC 62464-1:2018 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters | active | 14, 16 | Link |