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Certificaciones
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ISO 13485
Descripción
Bioabsorbable Evolvemer™ TCP30PLGA is a biocompatible composite of bioabsorbable 85L/15G PLGA base polymer and beta-tri-calcium phosphate (β-TCP).
The β-TCP particle size distribution is optimized in this high-quality composite. This makes its processing easier and improves the mechanical properties of the final products.
Biocompatibility of the Evolvemer™ Composite has been evaluated according to ISO 10993-1:2009 (“Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”). Based on the evaluation, Evolvemer™ Composite presents no risk of systemic toxicological effects.
Cytotoxicity and Plastic Class V tests have been conducted for Evolvemer™ Composite to support the biocompatibility statement of the composite. However, it is the sole responsibility of the manufacturer of the final end-use product to determine the biocompatibility of the final product.
Especificaciones
| Marca | arctic biomaterials, evolvemer™ |
| Usos / Aplicaciones | orthopedics, sports medicine, veterinary, dental |
| Materiales | plga + β-tcp |
| Designación química | - no especificado - |
| Densidad | - no especificado - |
| Porosidad | - no especificado - |
| Manufacturabilidad | - no especificado - |
| Biodegradabilidad | - no especificado - |
| Reabsorbibilidad | - no especificado - |
| Refuerzo (compuesto) | - no especificado - |
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