Biocompatibility Testing

Product name Testing standards Testing items Detection result
AKSOPEEK®
Medical implant grade materials		 ISO 10993-3 Genetic toxicity test Pass through
Ames test Pass through
In vitro Mammalian Chromosome Aberration Test Pass through
ISO 10993-4 Blood compatibility Pass through
ISO 10993-5 Cytotoxicity test Pass through
ISO 10993-6 Bone Implantation Test (26 weeks) Pass through
ISO 10993-10 Skin sensitization test Pass through
Intradermal reaction test Pass through
ISO 10993-11 Pyrogen test Pass through
Acute systemic toxicity test Pass through
Subchronic systemic toxicity test Pass through
ISO 10993-17 Toxicology Pass through
ISO 10993-18 Chemical characterization Pass through

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.

AKSOPEEK® | Properties

Performance Reference standards Unit Standard value Actual measurement results
Colour — — 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 — 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 — 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.

Performance Unit Test Methods Value (XY direction)
After thermal treatment
(200℃/4 hrs)		 Value (z direction)
After thermal treatment
(200℃/4 hrs)
Mechanical behavior
Stretch MPa ISO 527 2700 2590
Yield stress MPa ISO 527 72 /
Symbol extension rate % ISO 527 6 /
Fracture stress MPa ISO 527 63 51
Fracture extension % ISO 527 13 /
Bending modulus MPa ISO 178 2590 2480
Jianzhiliang impact intensity kJ/m² ISO 179 No Break /