Drug-Device Combination - Related International Standards
The following non-harmonised international standards are related to Drug-Device Combination for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 11608-1:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems | active | 10, 14, 14.7 | Link |
| ISO 11608-2:2022 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles | active | 10, 14 | Link |
| ISO 20072:2009 | Aerosol drug delivery device design verification - Requirements and test methods | active | 14, 18 | Link |