Surgical Instruments - Related International Standards
The following non-harmonised international standards are related to Surgical Instruments for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 7151:2024 | Surgical instruments - Non-cutting, articulated instruments - General requirements and test methods | active | 1, 3, 5, 11 | Link |
| ISO 13402:2025 | Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure | active | 1, 3, 5, 11 | Link |
| ISO 7153-1:2016 | Surgical instruments - Materials - Part 1: Metals | active | 1, 3, 5, 10 | Link |
| ISO 7740:1985 | Surgical instruments - Scalpels with detachable blades - Fitting dimensions | active | 1, 3, 5 | Link |
| ISO 13404-1:2024 | Prosthetics and orthotics - External orthoses and orthotic components - Part 1: Uses, functions, classification and description of lower limb orthoses | withdrawn | 1, 3 | Link |
| ISO 16571:2024 | Systems for evacuation of plume generated by medical devices | active | 1, 3, 5, 9 | Link |
| ISO 10334:1994 | Implants for surgery - Malleable wires for use as sutures and other surgical applications | active | 1, 3, 5, 10 | Link |