Endoscopy - Related International Standards
The following non-harmonised international standards are related to Endoscopy for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | active | 14, 14.1 | Link |
| ISO 8600-1:2025 | Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements | active | 1, 3, 5 | 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 | 1, 3, 5, 9, 14 | Link |
| ISO 16571:2024 | Systems for evacuation of plume generated by medical devices | active | 1, 3, 5, 9 | Link |
| ISO 8600-3:2019 | Endoscopes - Medical endoscopes and endotherapy devices - Part 3: Determination of field of view and direction of view of endoscopes with optics | active | 1, 3 | Link |
| ISO 8600-5:2020 | Endoscopes - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics | active | 1, 3 | Link |