Biocompatibility testing
AKSOPEEK® Performance and characteristics
AKSOPEEK® Passed biocompatibility testing, the material has no cytotoxicity, mutagenicity, carcinogenicity, and does not cause allergies.
The elastic modulus is similar to that of cortical bone, with physical properties similar to human bones. The texture is sturdy, and the stress borne by the bone is not entirely borne by the implant, making the bone healthier.
Corrosion resistance, radiation transparency, no artifacts on X-ray images, and the ability to perform surgery with the assistance of CT scanning or magnetic resonance imaging.
| Product name | Testing standards | Testing items | Detection result |
| AKSOPEEK® Medical implant grade materials | ISO 10993-3 | Genetic toxicity test | Adopt |
| Ames test | Adopt | ||
| In vitro Mammalian Chromosome Aberration Test | Adopt | ||
| ISO 10993-4 | Blood compatibility | Adopt | |
| ISO 10993-5 | Cytotoxicity test | Adopt | |
| ISO 10993-6 | Bone Implantation Test (26 weeks) | Adopt | |
| ISO 10993-10 | Skin sensitization test | Adopt | |
| Intradermal reaction test | Adopt | ||
| ISO 10993-11 | Pyrogen test | Adopt | |
| Acute systemic toxicity test | Adopt | ||
| Subchronic systemic toxicity test | Adopt | ||
| ISO 10993-17 | Toxicology | Adopt | |
| ISO 10993-18 | Chemical characterization | Adopt |
AKSOPEEK® | Properties
| Performance | Reference standards | Unit | Standard value | Actual measurement results |
| Colour | 一 | 一 | Khaki | Khaki |
| Glass transition temperature Tg | ISO 11357-2 | ℃ | 125-165 | 147 |
| Crystallization temperature Tc | ISO 11357-3 | ℃ | 260-320 | 286 |
| Melting point Tm | ISO 11357-3 | ℃ | 320-360 | 340 |
| Melt index | ISO 1133 | g/10 min | 6-15 | 8 |
| Melt viscosity | ISO 11443 | Pa·s | >200~400 | 389 |
| Infrared spectrum | YY/T 0660 | 一 | The main absorption peaks of the infrared spectrum of PEEK polymer are consistent with the characteristic absorption peaks of the standard control spectrum of the material | Pass |
| Total heavy metal content, calculated as lead, maximum value/% | YY/T 0660 | % | <0.1 | 0.00 |
| Density | ISO 1183 | kg/m³ | 1280-1320 | 1308 |
| Tensile strength (yield) | ISO 527 | MPa | ≥90 | 101 |
| Tensile strength (fracture) | ISO 527 | MPa | ≥70 | 73 |
| Elongation at break | ISO 527 | % | ≥5 | 15 |
| Bending strength | ISO 178 | MPa | ≥110 | 166 |
| Bending modulus | ISO 178 | GPa | ≥3 | 4.0 |
| Notch impact strength | ISO 180 | kJ/m² | ≥4 | 6 |
| In vitro cytotoxicity | ISO 10993-5 | 一 | Pass | Pass |
1. Moisture tested during packaging due to AKSOPEEK® It has hygroscopicity, so it needs to be dried before use.
2. Each batch needs to be tested for infrared (FTIR) to ensure compatibility with AKSOPEEK® The spectrum is consistent.
3. 0.001-0.003% calcium stearate can be added as a lubricant.