Lithotripsy - Related International Standards
The following non-harmonised international standards are related to Lithotripsy for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-36:2014 | Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy | active | 14, 14.1 | Link |
| IEC 61846:2025 | Ultrasonics - Pressure pulse lithotripters - Characteristics of fields | active | 14, 18 | Link |
| IEC 61847:2025 | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics | active | 14, 18 | Link |