Standards
The ISO and ASTM standards that actually appear in dental implant documentation — what each one tests, why it matters, and what it does not tell you.
A standard is not a certificate, and ISO does not certify anybody. ISO and ASTM write the documents; independent certification bodies issue certificates against them, and regulators decide which ones a device must meet. Where a manufacturer names a specific standard, that is more informative than any amount of general quality language. How certificates work →
11 standards documented
Product testing
Tests performed on the implant itself. The closest thing to comparable performance data.
Materials
What the implant is made of, specified precisely enough to be checked.
- ASTM F136 The American specification for extra-low-interstitial Ti-6Al-4V titanium alloy used in surgical implants.
- ASTM F67 The American materials specification covering four grades of unalloyed titanium for surgical implants, of which Grade 4 is the strongest and most used for implant fixtures.
- ISO 5832-2 Specifies the composition and mechanical properties required of unalloyed (commercially pure) titanium used to make surgical implants.
- ISO 5832-3 Specifies the composition and properties of the Ti-6Al-4V titanium alloy used in surgical implants.
- ISO 6872 Classifies dental ceramics by flexural strength and intended clinical use, covering the zirconia used in ceramic implants and restorations.
Biocompatibility
How the body responds. Expected of every marketed implant, so a floor rather than a distinction.
Quality systems
Certifies the company and its processes — not the implant.
Risk management
The process behind CE marking and FDA submissions.
Vocabulary
Agreed terminology, without which comparison is impossible.