生物兼容二类三类医疗USP 第 VI 类共聚多酯, 生物兼容二类三类医疗共聚多酯, USP 第 VI 类

 

生物兼容二类三类医疗USP 第 VI 类共聚多酯, 生物兼容二类三类医疗共聚多酯, USP 第 VI 类，ISO 10993,, 电子束消毒, 辐射消毒, 环氧乙烷消毒, 生物兼容性

 

Eastar™ 6763

共聚多酯

Eastman Chemical Company

Technical Data

 

产品说明

Eastar™ 6763 copolyester meets ISO 10993 and/or USP Class VI biocompatibility requirement; Food Contact Status compliant. Eastar 6763 is a clear, amorphous material that can be molded and extruded with ease. Its excellent performance properties include clarity, toughness, good melt strength, no dusting, no stress whitening, good heat sealability, easy cutting and thermoforming. Eastar 6763 may be colored using color concentrates, dry colors, or liquid colorants. Eastar 6763 can be safely sterilized with proper ethylene oxide, radiation, or electron beam methods without property loss or color shift.

 

Eastar 6763 provides:

• Superior, long-term clarity provides easy identification of instruments 

• Excellent puncture resistance and impact toughness ensure package integrity 

• Excellent ability to be subjected to several methods of sterilization, providing flexibility and security to the device manufacturer 

• Excellent optical and physical property stability post sterilization 

• Good melt strength offers wide processing latitude and ease in thermoforming 

 

The production and trimming of rigid medical trays made from sheet of Eastar 6763 results in little or no dust or particulates. After the thermoformed trays are made, they are put in polybags. The polybags of trays are then placed in protective boxes for storage or shipment. As long as the polybags in the protective boxes are intact and no outside contamination is evident, the thermoformer or medical device manufacturer should not need to clean the tray prior to packaging a device and sealing the package. If contamination is found on the medical trays and cleaning is required, use a lint-free towel. Blowing the tray out with filtered, deionized, non-lubricated air is also acceptable, assuming this does not stir up dust from the surrounding area. Using alcohol, which could cause crazing, or water, which would not evaporate, is not recommended.

 

This product has received a Platinum level Material Health Certificate from the Cradle to Cradle Products Innovation Institute. A Material Health Certificate is awarded to products that meet the Material Health requirements of the multi-attribute Cradle to Cradle Certified™ Product Standard. The Cradle to Cradle Products Innovation Institute is a nonprofit organization that administers the publicly available Cradle to Cradle Certified™ Product Standard, which provides designers and manufacturers with criteria and requirements for continually improving product materials and manufacturing processes. The Material Health Certificate provides manufacturers with a trusted way to communicate their efforts to identify and replace chemicals of concern in their products. For more information about Cradle to Cradle certification and to obtain printable certificates for Eastman copolyesters, visit www.c2ccertified.org. Search for Eastman Chemical Company in the Material Health Certificate Registry.

 

Key Attributes

• Easy primary & secondary operations 

• Excellent clarity 

• Excellent toughness 

• Gamma, ebeam, ETO sterilization stable 

 

Applications

• Flexible medical device packaging 

• Pharmaceutical packaging 

• Rigid medical packaging 

 

总览

材料状态 • 已商用：当前有效

资料 1 • Technical Datasheet (English)

UL 黄卡 2 • E118289-101981969

搜索 UL 黄卡 •  Eastman Chemical Company

• Eastar™

供货地区 • 北美洲 • 拉丁美洲 • 亚太地区

• 非洲和中东 • 欧洲

• 电子束消毒 • 抗应力发白 • 清晰度，高

• 辐射消毒 • 可热封 • 韧性良好

特性 • 好的消毒性 • 良好的熔体强度 • 生物兼容性

• 环氧乙烷消毒 • 良好的稳定性 • 食品接触的合规性

• 抗穿孔性 • 良好的着色性 • 无定形的

• Thermoforming Applications • 片材 • 医用包装

用途 • Trays • 药品包装

• 包装 • 医疗/护理用品 • 硬包装

• 薄膜 • 医疗器械

机构评级 • ISO 10993 • USP 第 VI 类

 

Eastar™ 6763

共聚多酯

Eastman Chemical Company

总览

外观 • 清晰/透明

形式 • 粒子

加工方法 • 薄膜挤出 • 片材挤出成型

• 挤出 • 热成型

物理性能 额定值单位制 测试方法

密度 / 比重

-- 1.27g/cm³ ASTM D792

ASTM D1505

23°C 1.27g/cm³ ISO 1183/D

吸水率

24 hr, 23°C, 50% RH 0.13% ASTM D570

24 hr, 23°C 0.13% ISO 62

机械性能 额定值单位制 测试方法

拉伸模量 (23°C) 2100MPa ASTM D638

ISO 527-1

抗张强度 ASTM D638

屈服, 23°C 50.0MPa ISO 527-2

断裂, 23°C 28.0MPa

伸长率

断裂, 23°C 130% ASTM D638

断裂, 23°C 100% ISO 527-2

弯曲模量

23°C 2100MPa ASTM D790

23°C 2000MPa ISO 178

弯曲应力

23°C 68.0MPa ISO 178

屈服, 23°C 70.0MPa ASTM D790

撕裂阻力 ASTM D2582

MD : 23°C, 250.0 µm 93N

TD : 23°C, 250.0 µm 93N

薄膜 额定值单位制 测试方法

薄膜厚度 - 经测试 250µm ASTM D374

割线模量 ASTM D882

MD : 250 µm 1900MPa

TD : 250 µm 1900MPa

抗张强度 ASTM D882

MD : 屈服, 250 µm 52.0MPa

TD : 屈服, 250 µm 52.0MPa

MD : 断裂, 250 µm 59.0MPa

TD : 断裂, 250 µm 55.0MPa

伸长率 ASTM D882

MD : 屈服, 250 µm 4.0%

TD : 屈服, 250 µm 4.0%

MD : 断裂, 250 µm 400%

TD : 断裂, 250 µm 400%

落锤冲击 4 ASTM D1709A

-18°C, 250 µm 500g

23°C, 250 µm 400g

埃尔曼多夫抗撕强度 ASTM D1922

MD : 250 µm 1400g

TD : 250 µm 1700g

 

Eastar™ 6763

共聚多酯

Eastman Chemical Company

薄膜 额定值单位制 测试方法

裤型撕裂耐性 5 ISO 6383-1

MD 36.0N/mm

TD 36.0N/mm

透氧率 (23°C, 250 µm, 50% RH) cm³•mm/m²/atm/24 ASTM D3985

10hr

水气透过率 (38°C, 100% RH, 250 µm) 7.0g/m²/24 hr ASTM F1249

Carbon Dioxide Permeability (23°C, 250.0 µm) cm³•mm/m²/atm/24 ASTM D1434

49hr

抗撕裂蔓延性 6 ASTM D1938

MD : 23°C, 250.0 µm 36kN/m

TD : 23°C, 250.0 µm 36kN/m

冲击性能 额定值单位制 测试方法

悬壁梁缺口冲击强度

-40°C 37J/m ASTM D256

23°C 100J/m ASTM D256

-40°C 4.2kJ/m² ISO 180

23°C 6.2kJ/m² ISO 180

无缺口悬臂梁冲击

-40°C, 3.20 mm 无断裂 ASTM D4812

-30°C, 3.20 mm 无断裂 ASTM D4812

-20°C, 3.20 mm 无断裂 ASTM D4812

23°C, 3.20 mm 无断裂 ASTM D4812

-40°C 7 无断裂 ISO 180/1U

-30°C 7 无断裂 ISO 180/1U

-20°C 7 无断裂 ISO 180/1U

23°C 7 无断裂 ISO 180/1U

装有测量仪表的落镖冲击

-40°C, 2.50 mm, Energy at Peak Load 41.0J ASTM D3763

-40°C, 3.20 mm, Energy at Peak Load 50.0J ASTM D3763

23°C, 2.50 mm, Energy at Peak Load 28.0J ASTM D3763

23°C, 3.20 mm, Energy at Peak Load 33.0J ASTM D3763

-40°C, 2.50 mm, 能量到力量峰值 8, 9 35.0J ISO 6603-2

-40°C, 3.20 mm, 能量到力量峰值 8, 9 36.0J ISO 6603-2

23°C, 2.50 mm, 能量到力量峰值 8, 9 40.0J ISO 6603-2

23°C, 3.20 mm, 能量到力量峰值 8, 9 44.0J ISO 6603-2

硬度 额定值单位制 测试方法

洛氏硬度

R 级, 23°C 106 ASTM D785

R 计秤, 23°C 109 ISO 2039-2

热性能 额定值单位制 测试方法

载荷下热变形温度 ASTM D648

0.45 MPa, 未退火 70.0°C

1.8 MPa, 未退火 64.0°C

玻璃转化温度 80.0°C DSC

维卡软化温度 85.0°C ASTM D1525

线形热膨胀系数 - 流动 (-30 到 40°C) 5.1E-5cm/cm/°C ASTM D696

比热 DSC

60°C 1300J/kg/°C

100°C 1760J/kg/°C

150°C 1880J/kg/°C

200°C 1970J/kg/°C

250°C 2050J/kg/°C

 

Eastar™ 6763

共聚多酯

Eastman Chemical Company

热性能 额定值单位制 测试方法

导热系数 (23°C) 0.21W/m/K ASTM C177

电气性能 额定值单位制 测试方法

表面电阻率 (23°C) 1.0E+17ohms ASTM D257

体积电阻率 (23°C) 1.0E+16ohms•cm ASTM D257

介电强度 10 (23°C, 方法 A（短时间）) 16kV/mm ASTM D149

介电常数 ASTM D150

23°C, 1 kHz 2.60

23°C, 1 MHz 2.40

耗散因数 ASTM D150

23°C, 1 kHz 5.0E-3

23°C, 1 MHz 0.020

耐电弧性 158sec ASTM D495

光学性能 额定值单位制 测试方法

光泽度 (45°, 250 µm) 108 ASTM D2457

透射率 11 ASTM D1003

常规, 250 µm 89.0%

总计, 250 µm 91.0%

透明度 (250 µm) 85.0 ASTM D1746

雾度 (250 µm) 0.800% ASTM D1003

注射 额定值单位制

干燥温度 65°C

干燥时间 4.0 到 6.0hr

加工（熔体）温度 249 到 271°C

模具温度 16 到 38°C

 

 

 

 

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