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二类医疗生物兼容USP 第 VI 热塑性弹性体, 二类医疗生物兼容USP 第 VI热塑性弹性体,三类医疗生物兼容ISO 10993热塑性弹性体,三类医疗生物兼容ISO 10993 TPE ChronoPrene™ 75A东莞市双帮塑胶原料有限公司常年供应一类二类生物兼容三类生物兼容医疗器械用料，二类生物兼容三类生物兼容辐射消毒医疗器械用料,二类生物兼容三类生物兼容环氧乙烷消毒医疗器械用料,二类生物兼容三类生物兼容抗伽马辐射医疗器械用料,随料提供食品药监局注册必需的资料：中英语物性表，COA出厂报告，生物兼容USP Class VI (USP 第 VI 类)报告，MSDS(SDS)报告，ISO 10993生物兼容报告(10993-3 ,ISO 10993-4 , ISO 10993-5,ISO 10993-10, ISO 10993-11, ISO 10993-12)

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二类医疗生物兼容USP 第 VI 类TPE, 三类医疗生物兼容ISO 10993 TPE, 生物兼容性, ISO 10993

二类医疗生物兼容USP 第 VI 类TPE, 三类医疗生物兼容ISO 10993 TPE, 生物兼容性, ISO 10993, USP 第 VI 类

ChronoPrene™ 75A

热塑性弹性体

AdvanSource Biomaterials Corp.

Technical Data

产品说明

This biocompatible elastomer may be considered as a substitute for rubber, latex and silicone materials. Soft and compliant, the ChronoPrene resins offer a high flexural modulus, as well as a superior combination of tensile strength and elongation.

An easy molding, high-flow material, ChronoPrene can be processed using conventional extrusion, injection molding and blowmolding methods. Its physical properties make it an optimal material for applications requiring elastic characteristics, such as compliant/ non-compliant balloons, endoscopic and laparoscopic inflation bags.

ChronoPrene can be processed at low temperatures, resulting in excellent surface smoothness and superior elasticity. ChronoPrene exhibits high abrasion resistance, durability and UV stability and is available in hardnesses ranging from 5 Shore A to 75 Shore A.

AdvanSource Biomaterials synthesizes and manufactures medical grade materials offering the ability to tailor physical and mechanical characteristics to support and enhance your end product design.

These mechanical characteristic's, critical to the design and development of medical devices, can incorporate a wide range of physical and chemical properties while maintaining core characteristics such as biodurability and biocompatibility. In most materials, specialized characteristics such as the addition of colorant agents or antimicrobial properties (where applicable) can be added to the polymer to provide a homogenous material and limit secondary processing steps.

In addition, radiopaque agents may also be incorporated into the formula to provide additional product enhancements and may contain up to 40%, by weight, of a radiopaque agent thus allowing varied-scale visibility options.

With an expanding range of secondary operations including custom solution development, prototype coating capabilities, and project management services, ASB's expert team of chemists, scientists, engineers and industry professionals assist in every stage of customers' projects, from concept initiation through full-scale manufacture.

总览

材料状态 • 已商用：当前有效

资料 1 • Technical Datasheet (English)

供货地区 • 北美洲

• Hydrophobic • 耐磨损性，良好 • 生物兼容性

特性 • 良好的成型性能 • 耐用性 • 无动物源性成分

• 流动性高 • 耐紫外光性能，良好 • 延高的拉伸率

• 耐化学品性能，良好 • 柔软 • 优良外观

用途 • 医疗/护理用品

机构评级 • ISO 10993 Part 5 • USP 第 VI 类

形式 • 粒子

加工方法 • 吹塑成型 • 挤出 • 注射成型

物理性能额定值单位制测试方法

熔流率（熔体流动速率） (200°C/5.0 kg) 2.0 到 26g/10 min ASTM D1238

机械性能额定值单位制测试方法

抗张强度 ASTM D638

断裂 8.27 到 9.65MPa

50% 应变 5.69 到 6.72MPa

100% 应变 6.72 到 7.58MPa

200% 应变 7.58 到 8.96MPa

300% 应变 8.96 到 9.65MPa

伸长率 (断裂) 250 到 350% ASTM D638

硬度额定值单位制测试方法

肖氏硬度 (邵氏 A) 75 ASTM D2240

注射额定值单位制

干燥温度 - 热风干燥机 71 到 93°C

干燥时间 - 热风干燥机 3.0 到 4.0hr

Dew Point -40°C

建议的最大水分含量 0.050%