Implant Materials - Related International Standards
The following non-harmonised international standards are related to Implant Materials for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 5832-2:2025 | Implants for surgery - Metallic materials - Part 2: Unalloyed titanium | active | 10, 10.1 | Link |
| ISO 5832-4:2024 | Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy | active | 10, 10.1 | Link |
| ISO 5832-5:2022 | Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy | active | 10, 10.1 | Link |
| ISO 5832-6:2022 | Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy | active | 10, 10.1 | Link |
| ISO 5832-7:2024 | Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy | active | 10, 10.1 | Link |
| ISO 5832-9:2019 | Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel | active | 10, 10.1 | Link |
| ISO 5832-11:2024 | Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy | active | 10, 10.1 | Link |
| ISO 5832-12:2019 | Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy | active | 10, 10.1 | Link |
| ISO 5832-14:2019 | Implants for surgery - Metallic materials - Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy | active | 10, 10.1 | Link |
| ISO 14602:2010 | Non-active surgical implants - Implants for osteosynthesis - Particular requirements | active | 10, 10.1, 14 | Link |
| ISO 21534:2007 | Non-active surgical implants - Joint replacement implants - Particular requirements | active | 10, 10.1, 14 | Link |
| ASTM F136-26 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications | active | 10, 10.1 | Link |
| ASTM F75-23 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants | active | 10, 10.1 | Link |
| ASTM F138-19 | Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants | active | 10, 10.1 | Link |