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Desde 2008 fabricante chino de estándares PEEK
El nuevo filamento PEEK se basa en ARKPEEK, un material de grado de implante altamente viscoso fabricado por PEEKChina. El producto, que exhibe una impresionante biocompatibilidad, bioestabilidad y transparencia a los rayos X, es fácil de procesar y se ha establecido durante años como un material de alto rendimiento en aplicaciones de tecnología médica como implantes espinales, medicina deportiva y cirugía maxilofacial.
Properties Information | ||||||
Property | Reference Standard | Test Method | Unit | Specification | Result | |
Physical Properties | Glass Transition | ASTM F2026 | ASTM D3418 | °C | 125-165 | 147 |
Temperature, Tg | ||||||
Melt Temperature, Tm | ASTM F2026 | ASTM D3418 | °C | 320-360 | 338 | |
Recrystallization | ASTM F2026 | ASTM D3418 | °C | 260-320 | 289 | |
Temperature, Tc | ||||||
Viscosity | ASTM F2026 | ISO 11443 | Pa·s | 400-480 | 437 | |
Infrared Spectrum | ASTM F2026 | ASTM F1579 | / | See Appendix X1 | See Appendix X2 | |
Density | ASTM F2026 | ASTM D1505 | kg/m3 | 1280-1320 | 1294 | |
Chemical Properties | Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max | ASTM F2026 | US Pharmacopeia, | ppm | <100 | <10 |
Test 233 | ||||||
Mechanical Properties | Tensile Strength at Yield (zero slope), min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | MPa | 90 | 105 |
Tensile Strength at Break, min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | MPa | 70 | 80 | |
Elongation at Break, min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | % | 5 | 18 | |
Flexural Strength, min | ASTM F2026 | ASTM D790 | MPa | 110 | 163 | |
Flexural Modulus, min | ASTM F2026 | ASTM D790 | GPa | 3 | 4 | |
Impact Strength, | ASTM F2026 | ISO 180 | kJ/m2 | 4 | 9 | |
Notched Izod, min | ||||||
Biological Properties | Genotoxicity | ISO 10993-3 | ISO 10993-3 | / | Negative | Negative |
Animal Intracutaneous (Intradermal) Reactivity | ISO 10993-10 | ISO 10993-10 | / | ≤1 | 0 | |
Skin Sensitization | ISO 10993-10 | ISO 10993-10 | / | ≤1 | 0 | |
Acute Systemic Toxicity | ISO 10993-11 | ISO 10993-11 | / | No Acute Systemic Toxicity | No Acute Systemic Toxicity | |
Subchronic Systemic Toxicity | ISO 10993-11 | ISO 10993-11 | / | No Subchronic Systemic Toxicity | No Subchronic Systemic Toxicity | |
local Effects After Implantation | ISO 10993-6 | ISO10993-6 | / | No obvious difference between the test sample and the control sample | No obvious difference between the test sample and the control sample | |
In Vitro Cytotoxicity | ISO 10993-5 | ISO10993-5 | / | ≤1 | 1 | |
Evaluation of Haemolytic Properties | ISO 10993-4 | ISO10993-4 | % | <5 | 1 | |
Material Mediated Pyrogens | ISO 10993-11 | ISO 10993-11 | / | No Pyrogenic Responses | No Pyrogenic Responses | |
Extractables of The Material | ISO 10993-18 | ISO 10993-18 | μg/g | The contents of Phenyl Sulfone≤300 | The contents of Phenyl Sulfone<0.09 |