Dental - Related International Standards
The following non-harmonised international standards are related to Dental for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 60601-2-63:2012+AMD1:2017+AMD2:2021 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment | active | 14, 16 | Link |
| IEC 60601-2-65:2012+AMD1:2017+AMD2:2021 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment | active | 14, 16 | Link |
| ISO 14801:2016 | Dentistry - Implants - Dynamic loading test for endosseous dental implants | active | 14, 17 | Link |
| ISO 1942:2020 | Dentistry - Vocabulary | active | 23 | Link |
| ISO 6872:2024 | Dentistry - Ceramic materials | active | 10, 14 | Link |
| ISO 7405:2025 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | active | 10 | Link |