Urogenital - Related International Standards
The following non-harmonised international standards are related to Urogenital for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 7439:2023 | Copper-bearing contraceptive intrauterine devices - Requirements and tests | active | 1, 3, 5, 10 | Link |
| IEC 60601-2-41:2021 | Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis | active | 1, 3, 5, 9, 14 | Link |
| ISO 8009:2014 | Mechanical contraceptives - Reusable natural rubber latex diaphragms - Requirements and tests | active | 1, 3, 5, 10 | Link |
| ISO 25841:2017 | Female condoms - Requirements and test methods | active | 1, 3, 5, 10 | Link |
| ISO 23409:2011 | Male condoms - Requirements and test methods for condoms to be used with condom-compatible lubricants | active | 1, 3, 5, 10 | Link |