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PEEK-OPTIMA® Image Contrast (Low radiopacity)

聚醚醚酮

Invibio Inc.

产品说明:

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.

特性	纯度高 毒性低 刚性，高 高强度 韧性良好 生物兼容性 阻射
用途	人体植入物 牙齿应用领域 医疗/护理用品
机构评级	DMF 未评级 FDA 未评级
形式	颗粒
加工方法	机器加工 挤出 注射成型

物理性能	额定值	单位制	测试方法
密度	1.36	g/cm³	ISO 1183

机械性能	额定值	单位制	测试方法
拉伸应力 (屈服)	13800	psi	ISO 527-2
拉伸应变 (断裂)	20	%	ISO 527-2
弯曲模量	551000	psi	ISO 178
弯曲应力	21800	psi	ISO 178
冲击性能	额定值	单位制	测试方法
悬壁梁缺口冲击强度

东莞永大塑胶原料长期供应塑胶原料,货源充足，可为客户提供相应有效的报告证明、品质保证及有关性能测试报告，如：无毒证明，COA，UL黄卡，MSDS、SGS，COC。如有需要，欢迎新老客户来电咨询，

联系人：邓生 13694934262

订购热线：0769-89914118

传       真： 0769-82058794

Q        Q： 1762887032

 

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