Robotic Surgery - Related International Standards
The following non-harmonised international standards are related to Robotic Surgery for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 80601-2-77:2019+AMD1:2023 | Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | active | 1, 3, 5, 9, 14, 17 | Link |
| IEC 80601-2-78:2019 | Medical electrical equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation | active | 1, 3, 5, 9, 14, 17 | Link |
| ISO 13482:2014 | Robots and robotic devices - Safety requirements for personal care robots | active | 1, 3, 5, 9 | Link |
| IEC 62443-4-2:2019 | Security for industrial automation and control systems - Part 4-2: Technical security requirements for IACS components | active | 17, 17.2, 17.4 | Link |
| ISO/TS 15066:2016 | Robots and robotic devices - Collaborative robots | active | 1, 3, 5, 9 | Link |