Dental implant standards
The international standards that cover how implants are made and tested.
| Standard | Topic | In plain English |
|---|---|---|
| ISO 13485 | Quality management for medical devices | Shows the manufacturer runs a controlled quality system. Almost every serious implant maker holds it. |
| ISO 14801 | Fatigue testing of dental implants | A standard lab test that repeatedly loads an implant to see how much force it survives over millions of cycles. |
| ISO 5832-2 | Unalloyed titanium for implants | Specifies the pure titanium (Grades 1–4) used for implants. |
| ISO 5832-3 | Titanium alloy Ti-6Al-4V for implants | Specifies the Grade 5 alloy used by many brands. |
| ISO 13356 | Zirconia ceramics for implants | Specifies the ceramic used for zirconia implants. |
| ISO 10993 | Biocompatibility testing | A series of tests to show a material is safe inside the body. |
| ISO 11137 / 11135 | Sterilisation | Sterilisation by radiation or gas, ensuring implants arrive sterile. |
| ISO 22803 | Membranes for bone regeneration | Covers membrane materials used in bone grafting. |
| ISO 14971 | Risk management | How manufacturers identify and reduce risks of their devices. |
| ISO 16498 | Dental implant terminology | Common vocabulary for dental implant systems. |
| ASTM F67 / F136 | US titanium specifications | American material standards for pure titanium and Ti-6Al-4V. |
| ISO 7405 | Biocompatibility of dental materials | Dental-specific biological safety tests. |