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POM N2320 003 PRO 医疗级POM

POM N2320 003 PRO 医疗级POM

BASF Ultraform POM N2320 003 PRO 特点:生物兼容性。应用:药物,医疗/护理领域的应用。
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BASF Ultraform POM N2320 003 PRO 特点:生物兼容性。应用:药物,医疗/护理领域的应用。

Ultraform® POM N2320 003 PRO

聚甲醛(POM)共聚物

BASF Corporation

 

产品说明

Preliminary Datasheet

 

Rapidly solidifying standard grade for injection molding.

 

Ultraform® PRO offers a comprehensive service package, which supports customers in product development for the medical technology market.

 

Ultraform® PRO is in compliance with Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultraform PRO to show compatibility of the material in general. The biocompatibility-tests listed below are not part of any continuous production control.

 

European Pharmacopoeia, Japanese Pharmacopoeia:The composition of the product complies with the requirements of the European Pharmacopoeia 7th Edition, Chap. 3.2.2.

"Plastic Containers and Closures for Pharmaceutical Use" and with the requirements of the Japanese Pharmacopoeia, 15th Edition, General Information, "17. Plastic Containers for Pharmaceutical Products".

However, suitability for the end application concerned including observation of given limitations and toxicological thresholds have to be ensured on the final article by the producer.

 

US Pharmacopoeia: Biological Reactivity Tests, USP Plastic Class VI (USP VI)

 

ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Test for Cytotoxicity

 

DMF: A Drug Master File (DMF) has been registered at FDA for Ultraform® PRO.

 

Food Contact: Ultraform® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.

 

For notice:However, BASF has not designed or tested its plastics with respect to all of the special requirements related to their use in medical devices (defined in risk classes I to III according to the European and US Medical Device legislation) and pharmaceutical applications. Therefore BASF makes no warranties, express or implied, concerning the suitability of any BASF plastics for use in any medical device and pharmaceutical applications.

 

材料特点:生物兼容性

材料应用:把手,连接器,药物,医疗/护理领域的应用

产品形式:颗粒料

加工方法:注射成型

塑料牌号:POM N2320 003 PRO

定属记号:聚甲醛(POM)共聚物

 

物料数据

物理性能

额定值

单位制

测试方法

密度

1.40

g/cm³

ISO 1183

溶化体积流率(MVR)(190/2.16 kg)

7.50

cm³/10min

ISO 1133

吸水率

 

 

ISO 62

饱和,23

0.80

%

平衡,23,50% RH

0.20

%

硬度

额定值

单位制

测试方法

球压硬度

145

MPa

ISO 2039-1

机械性能

额定值

单位制

测试方法

拉伸模量(23)

2700

MPa

ISO 527-2

拉伸应力(屈服,23)

65.0

MPa

ISO 527-2

拉伸应变(屈服,23)

9.4

%

ISO 527-2

标称拉伸断裂应变(23)

27

%

ISO 527-2

拉伸蠕变模量

 

 

ISO 899-1

1 hr

1800

MPa

1000 hr

1400

MPa

冲击性能

额定值

单位制

测试方法

简支梁缺口冲击强度

 

 

ISO 179

-30

5.5

kJ/m²

23

6.0

kJ/m²

简支梁无缺口冲击强度

 

 

ISO 179

-30

190

kJ/m²

23

210

kJ/m²

热性能

额定值

单位制

测试方法

热变形温度(1.8 MPa,未退火)

100

ISO 75-2/A

溶融温度(DSC

167

ISO 3146

线形热膨胀系数 - 流动

1.1E-4

cm/cm/

 

电气性能

额定值

单位制

测试方法

表面电阻率

1.0E+13

ohms

IEC 60093

体积电阻率

1.0E+15

ohms·cm

IEC 60093

介电常数(1 MHz)

3.80

 

IEC 60250

耗散因数(1 MHz)

5.0E-3

 

IEC 60250

漏电起痕指数

600

V

IEC 60112

注射

额定值

单位制

干燥温度

80.0 110

干燥时间

2.0 4.0

hr

建议的最大水分含量

0.15

%

加工(熔体)温度

190 230

模具温度

60.0 120

注塑压力

3.50 7.00

MPa

 

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