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POM N2320 003 PRO 医疗级POM

添加时间:2013-09-30  信息来源:http://www.xzslw.com/  作者:苏州希普能塑料
Ultraform POM N2320 003 PRO
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
代理销售:苏州希普能工程塑料 185 5121 3137 谭经理
 
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 到 110
干燥时间 2.0 到 4.0 hr
建议的最大水分含量 0.15 %
加工(熔体)温度 190 到 230
模具温度 60.0 到 120
注塑压力 3.50 到 7.00 MPa
苏州希普能工程塑料
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