13549213581 肖生

 

纯度高, 毒性低, 韧性良好, 阻射, 生物兼容性, 人体植入物, 牙齿应用领域, 医疗/护理用品, DMF 未评级, FDA 未评级, 机器加工, 挤出, 注射成型

PEEK-OPTIMA® Image Contrast (Low radiopacity)

聚醚醚酮

 

Invibio Inc.

 

Technical Data

 

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.

 

总体

 

材料状态 • 已商用：当前有效

•  Processing - Machining (English)

资料 1 •  Processing - PEEK-OPTIMA (English)

•  Technical Datasheet (English)

供货地区 • 北美洲 • 欧洲

• 纯度高 • 高强度 •

特性 • 毒性低 • 韧性良好 阻射

• 刚性，高 • 生物兼容性

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(英制) 额定值(公制) 测试方法

密度 1.36g/cm³ 1.36g/cm³ ISO 1183

机械性能 额定值(英制) 额定值(公制) 测试方法

拉伸应力 (屈服) 13800psi 95.0MPa ISO 527-2

拉伸应变 (断裂) 20% 20% ISO 527-2

弯曲模量 551000psi 3800MPa ISO 178

弯曲应力 21800psi 150MPa ISO 178

冲击性能 额定值(英制) 额定值(公制) 测试方法

悬壁梁缺口冲击强度 3.3ft•lb/in² 7.0kJ/m² ISO 180

 

 

 

 

 

聚醚醚酮,PEEK PEEK-OPTIMA® Image Contrast (Low radiopacity)是东莞市双帮塑胶原料有限公司常年销售的塑料，因为塑料价格行情每天都有新变化前天的报价不等于今天的报价。本公司销售的所有原料保证是原厂原包,随料可以提供生产厂商提供的物性表、SGS报告，COA原料出厂报告,REACH报告,SVHC报告,UL黄卡,提供原料注塑加工工程中可能出现的各种异常现象解决方法，塑料牌号太多，本网站没有提供的本公司也有代理，详情请咨询本公司相关业务人员0769-87795123 

13549213581 肖生