Ophthalmic - Related International Standards
The following non-harmonised international standards are related to Ophthalmic for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| IEC 80601-2-58:2024 | Particular requirements for lens removal devices and vitrectomy devices for ophthalmic surgery | active | 14, 14.1 | Link |
| ISO 11979-1:2026 | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary | active | 10, 14, 15 | Link |
| ISO 11979-2:2024 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods | active | 14, 18 | Link |
| ISO 11979-7:2024 | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia | active | 14, 18, 20 | Link |
| ISO 15004-1:2020 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments | active | 14, 18 | Link |
| ISO 15004-2:2024 | Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection | active | 14, 18 | Link |
| ISO 12870:2025 | Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024) | active | 10, 10.1, 10.3, 10.4 | Link |