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来自invibio生物材料解决方案的peek-optima图像对比化合物为植入物制造商提供了peek-optima聚合物的所有优点,现在具有量身定制的辐射能力。这些化合物包括指定水平的图像对比度添加剂,为X射线、CT和MRI成像方式的最佳可视化提供了广泛的对比度范围。PEEK-OPTIMA图像对比度等级是一种安全、生物相容的材料,适用于植入式医疗和制药设备以及需要30天以上的血液、骨骼或组织接触的应用。这些化合物提供了一个独特的功能和好处的组合,包括:定制的辐射能力使植入物的可见性得到优化peek-optima聚合物提供了强度、刚度和韧性的卓越组合,即使在灭菌后,生物相容性也确保了安全、长期的植入加工方法允许广泛的设计。gn和制造灵活性美国FDA药品和设备主文件可以帮助满足不同于金属的监管要求,peek-optima图像对比度等级提供了根据特定应用定制植入物可见性的可能性。因此,在不出现伪影或散射的情况下,可以实现植入物、骨骼和组织可视化的适当平衡。PEEK-OPTIMA图像对比度等级有多种粘度(标准、中、低),可通过传统方法(包括注塑和挤压)进行处理,并可进行机加工,从而使医疗设备制造商具有广泛的设计和制造灵活性。根据ISO 10993标准对peek-optima化合物进行的广泛测试表明,没有细胞毒性、全身毒性或刺激性的证据。结果已提交给美国食品药品监督管理局,可以减少审批过程的时间和费用。 PEEK-OPTIMA® image contrast compounds, from Invibio® Biomaterial Solutions, offer implant manufacturers all the benefits of PEEK-OPTIMA polymer, now with tailored radiopacity. These compounds comprise an image contrast additive at specified levels, providing a broad contrast range for optimal visualization with x-ray, CT and MRI imaging modalities. PEEK-OPTIMA image contrast grades are safe, biocompatible materials intended for implantable medical and pharmaceutical devices and applications requiring blood, bone or tissue contact of more than 30 days. These compounds provide a unique combination of features and benefits, including: Tailored radiopacity allows implant visibility to be optimized PEEK-OPTIMA polymer provides a superior combination of strength, stiffness and toughness, even after sterilization Biocompatibility ensures safe, long term implantation Processing methods allow broad design and manufacturing flexibility US FDA Drug and Device Master files can assist with regulatory requirements Unlike metals, PEEK-OPTIMA image contrast grades provide the possibility of tailoring the visibility of an implant to suit a particular application. It is therefore possible to achieve an appropriate balance of implant, bone and tissue visualization without artifacts or scatter. Available in a range of viscosities (standard, medium and low), PEEK-OPTIMA image contrast grades can be processed by conventional methods, including injection molding and extrusion, and can be machined, allowing medical device manufacturers broad design and manufacturing flexibility. Extensive testing of PEEK-OPTIMA compounds to ISO 10993 standards demonstrated no evidence of cytotoxicity, systemic toxicity or irritation. Results have been lodged with the US FDA and can reduce the time and expense of the approval process. |
技术参数 Technical Data | |||
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物理性能 PHYSICAL |
额定值 Nominal Value |
单位 Units |
测试方法 Test Method |
密度 Density |
1.49 | g/cm³ | ISO 1183 |
机械性能 MECHANICAL |
额定值 Nominal Value |
单位 Units |
测试方法 Test Method |
拉伸强度 tensile strength |
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屈服 yield |
90.0 | MPa | ISO 527-2 |
拉伸应变 Tensile strain |
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断裂 fracture |
15 | % | ISO 527-2 |
弯曲模量 Bending modulus |
4500 | MPa | ISO 178 |
弯曲强度 bending strength |
150 | MPa | ISO 178 |
冲击性能 IMPACT |
额定值 Nominal Value |
单位 Units |
测试方法 Test Method |
悬臂梁缺口冲击强度 Impact strength of cantilever beam notch |
kJ/m² | ISO 180 |
备注 |
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1 一般属性:这些不能被视为规格。 |
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【免责声明】 广州搜料信息技术有限公司保留所有权利。 此数据表中的信息由搜料网soliao.com从该材料的生产商处获得。搜料网soliao.com尽最大努力确保此数据的准确性。 但是搜料公司对这些数据值及建议等给用户带来的不确定因素和后果不承担任何责任,并强烈建议在最终选择材料前,就数据值与材料供应商进行验证。 |
电邮一份说明书
PDF文档名:搜料网-PEEK-OPTIMA® Image Contrast (High radiopacity)证书
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