Radiation Protection - Related International Standards
The following non-harmonised international standards are related to Radiation Protection for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-1:2020 | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV | active | 16, 18 | Link |
| IEC 60601-1-3:2008+AMD1:2013+AMD2:2021 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment | active | 16 | Link |
| IEC 60601-2-8:2010+AMD1:2015 | Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV | active | 14, 16 | Link |
| IEC 60601-2-11:2013 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment | active | 14, 16 | Link |
| IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment | active | 14, 16 | Link |
| IEC 60601-2-29:2008 | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators | active | 14, 16 | Link |
| IEC 60601-2-64:2025 | Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment | active | 14, 16 | Link |
| IEC 60601-2-68:2025 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment | active | 14, 16 | Link |
| IEC 60731:2011+AMD1:2016 | Medical electrical equipment - Part 2-9: Particular requirements for the basic safety and essential performance of equipment with dosimetric instruments as used in radiotherapy | active | 14, 16 | Link |