ASTM F67 Medical Grade 1 Titanium
May 20, 2026
Medical grade titanium is different from industrial titanium. The material looks the same. The chemistry looks similar. But the certification, traceability, and process control are not the same.
ASTM F67 covers unalloyed titanium for surgical implant applications. Grade 1 is the softest and most formable of the commercially pure grades.
What is ASTM F67 Grade 1?
ASTM F67 is the specification for unalloyed titanium for surgical implant applications. Grade 1 is commercially pure titanium with controlled oxygen content.
| Property | Value |
|---|---|
| Standard | ASTM F67 |
| Grade | Grade 1 (also called CP Ti Grade 1) |
| Type | Unalloyed titanium |
| Application | Surgical implants |
The same ASTM F67 specification also covers Grade 2, Grade 3, and Grade 4. Grade 1 has the lowest oxygen and highest ductility. Grade 4 has the highest oxygen and highest strength.
For medical use, Grade 1 is chosen when formability matters more than strength.
How is medical grade different from industrial GR1?
| Element | ASTM F67 Grade 1 (medical) | ASTM B348 Grade 1 (industrial) |
|---|---|---|
| Oxygen | 0.18% max | 0.18% max |
| Iron | 0.20% max | 0.20% max |
| Carbon | 0.10% max | 0.08% max |
| Nitrogen | 0.03% max | 0.03% max |
| Hydrogen | 0.012% max | 0.015% max |
| Titanium | Balance | Balance |
| Requirement | Medical grade | Industrial grade |
|---|---|---|
| Traceability | Full, from ore to finished product | Heat number level |
| Process control | ISO 13485 certified | ISO 9001 typical |
| Surface inspection | Strict, no surface defects | Standard mill finish |
| Biocompatibility testing | Required for certification | Not required |
| Packaging | Clean room or medical grade | Standard industrial |
| Documentation | Full lot history, sterilization available | Mill certificate only |
What are the mechanical properties?
| Property | ASTM F67 Grade 1 |
|---|---|
| Tensile strength | 240 MPa minimum |
| Yield strength (0.2% offset) | 170 MPa to 310 MPa |
| Elongation | 24% minimum in 50mm |
| Reduction of area | 30% minimum |
| Hardness | 120 to 200 HV |
Low modulus (105 GPa) is closer to bone than stainless steel or cobalt chrome
High elongation allows forming of thin wall implants and components
Low hardness reduces wear on opposing materials
What are the applications for ASTM F67 Grade 1?
Common applications:
Craniofacial plates and screws
Mesh for bone reconstruction
Dental implants (non-load-bearing components)
Spinal cages (certain designs)
Pacemaker casings
Surgical instruments
Orthopedic cable and wire
Finger and toe implants (small joints)
What Grade 1 is not used for:
Hip stems (use Grade 4 or Ti-6Al-4V)
Knee components (use Ti-6Al-4V)
High stress spinal rods (use Grade 4 or Ti-6Al-4V)
Bone screws for weight bearing (use Grade 4 or Ti-6Al-4V)
What forms are available in ASTM F67 Grade 1?
| Product form | Typical sizes | Common applications |
|---|---|---|
| Sheet | 0.2mm to 6.0mm thick | Craniofacial mesh, plates |
| Plate | 6.0mm to 25mm thick | Small plates, blocks for machining |
| Rod and bar | 3mm to 50mm diameter | Screws, pins, surgical tools |
| Wire | 0.5mm to 6mm diameter | Cerclage wire, cables |
| Tube | 3mm to 25mm OD | Surgical instruments, implants |
What testing is required for ASTM F67?
Chemical analysis:
Oxygen, iron, carbon, nitrogen, hydrogen
Each element must be within specified limits
Test method: ASTM E1409, E1941, E2371
Tensile testing:
Ultimate tensile strength
Yield strength (0.2% offset)
Elongation in 50mm
Reduction of area
Hardness testing:
Vickers (HV) or Rockwell (HRB/HRE)
Flattening and flaring tests:
Required for tube products only
Surface inspection:
Visual inspection for surface defects
No cracks, seams, laps, or scale
Specified surface roughness (Ra)
What additional requirements apply to medical grade?
Traceability:
Each lot must have a unique heat number. The manufacturer must maintain records from raw material to finished product. Every piece must be traceable back to the original heat.
Process control:
The manufacturer should have ISO 13485 certification (medical devices quality management). Process validation is required for critical steps. Cleanliness standards apply to packaging.
Biocompatibility:
The material must pass ISO 10993 biocompatibility testing. This includes cytotoxicity, sensitization, and irritation tests. Industrial grade titanium is not tested for biocompatibility.
How does ASTM F67 Grade 1 compare to other medical titanium grades?
| Grade | Tensile strength (MPa) | Elongation (%) | Typical use |
|---|---|---|---|
| F67 Grade 1 | 240 | 24 | Craniofacial, non-load-bearing |
| F67 Grade 2 | 345 | 20 | General implant use |
| F67 Grade 3 | 380 | 18 | Higher strength pure titanium |
| F67 Grade 4 | 550 | 15 | High strength pure titanium, hip stems |
| F136 Ti-6Al-4V | 860 | 10 | Most common alloy for load-bearing |
F67 Grade 1 has the lowest strength and highest ductility. Use it when you need formability. Use higher grades for strength.
What is the difference between ASTM F67 and ASTM F136?
| Spec | Material | Applications |
|---|---|---|
| ASTM F67 | Unalloyed titanium (Grades 1-4) | Pure titanium implants |
| ASTM F136 | Ti-6Al-4V ELI alloy | High strength load-bearing implants |
F136 is the more common spec for orthopedic implants. F67 Grade 4 is used for some high strength pure titanium applications. F67 Grade 1 is for specific low-load or formed parts.
FAQ
1. What is ASTM F67 Grade 1 titanium?
ASTM F67 Grade 1 is unalloyed commercially pure titanium for surgical implant applications. It has 0.18% oxygen maximum and 240 MPa minimum tensile strength.
2. What is the difference between medical grade and industrial GR1?
Medical grade has tighter traceability, ISO 13485 process control, biocompatibility testing, and specific documentation. Industrial GR1 is not certified for implant use.
3. Can I use industrial GR1 for medical implants?
No. Industrial grade titanium is not tested for biocompatibility. It does not meet FDA or regulatory requirements for implants. You cannot certify an implant made from industrial material.
4. What is the oxygen limit for ASTM F67 Grade 1?
0.18% maximum. Same as industrial GR1. The difference is in process control and certification, not the chemical limit.
5. Is ASTM F67 Grade 1 used for hip stems?
No. Hip stems require higher strength. Grade 4 or Ti-6Al-4V (ASTM F136) are used for hip stems.
6. What is ASTM F67 Grade 1 used for?
Craniofacial plates and mesh, dental implants (non-load-bearing), pacemaker casings, surgical instruments, orthopedic wire, and small joint implants.
7. Does medical grade titanium require biocompatibility testing?
Yes. The material must pass ISO 10993 testing for cytotoxicity, sensitization, and irritation. Industrial grade titanium is not tested for biocompatibility.
8. What documentation comes with medical grade titanium?
Mill certificate showing ASTM F67 compliance, heat number, chemical analysis, tensile results. Additional documentation includes ISO 13485 certification and biocompatibility test reports.
9. Can ASTM F67 Grade 1 be welded?
Yes. Use GTAW (TIG) with ERTi-1 filler. Pure argon shielding. No post-weld heat treatment required. Weld must be free of contamination and color should be silver or light straw.
10. What is the hardness of medical grade GR1?
120 to 200 HV (Vickers). This is softer than other implant grades and reduces wear on opposing materials.
11. What is the difference between ASTM F67 Grade 1 and Grade 4?
Grade 1 has lower oxygen (0.18% vs 0.40%), lower strength (240 MPa vs 550 MPa), and higher elongation (24% vs 15%). Grade 4 is much stronger and harder.
12. Can medical grade titanium be sterilized?
Yes. Autoclave, gamma radiation, EtO, and electron beam are all acceptable. No degradation in properties after standard sterilization cycles.
13. What surface finish is available for medical grade?
Sheet and plate: annealed and pickled, bright annealed, or ground. Rod and bar: turned, polished, or ground. Custom surface roughness (Ra) can be specified.
