Neurology - Related International Standards
The following non-harmonised international standards are related to Neurology for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 80601-2-26:2019+AMD1:2024 | Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs | active | 14, 14.1 | Link |
| IEC 60601-2-40:2024 | Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment | active | 14, 14.1 | Link |
| IEC 80601-2-71:2025 | Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (fNIRS) equipment | active | 14, 14.1 | Link |
| ISO 7197:2024 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components | active | 1, 3, 5, 10 | Link |