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 complies with the basic requirements of Pharmacopoeia and Biocompatibility-Tests in Europe, United States and Japan respectively as specified below. However, the biocompatibility tests were recorded on tests specimens of Ultraform PRO to show compatibility and potential suitability of the material in general. The biocompatibility-tests and the other tests listed below are not part of any continuous production control.
European Pharmacopoeia, Japanese Pharmacopoeia:
The composition of the product complies with the basic requirements of the European Pharmacopoeia 8th Edition, Chap. 3.2.2. "Plastic Containers and Closures for Pharmaceutical Use" and with the basic requirements of the Japanese Pharmacopoeia,16th 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.
Additional compliances may also be available. Please contact your local representative or the Ultraplaste Infopoint (E-Mail: ultraplaste.infopoint@basf.com, Telefon: +49 621-60-78780, Fax: +49 621-60-78730).
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.
Abbreviated designation according to ISO 1043-1: POM
Designation according to ISO 29988-POM-K,,M-GNR,4-2
| 原厂资料 | 物性表(英文) | |||
| 树脂缩写 | POM | |||
| 产品特性 | 短周期成型食品接触级医疗级生物相容 | |||
| 成型方式 | 注塑 | |||
| 法规认证 | DMF(药品主控文件)EP(欧洲药典)ISO10993(生物相容性)USP Class VI(美国药典) | |||
| 曲线坐标点 | 应力-应变(Yield)正割模量-应变(Yield)比容-温度(pvT) | |||
| 物理性能 | 值/单位 | 测试标准 | 测试条件 |
|---|---|---|---|
密度 | 1.41 g/cm³ | ISO 1183 | |
熔体体积流动速率(MVR) | |||
190℃/2.16 kg | 7.5 cm³/10min | ISO 1133 | |
收缩率 | |||
纵向(Flow) | 2.1 % | ISO 294-4 | |
横向(Across Flow) | 2.1 % | ISO 294-4 | |
吸水率 | 0.9 % | ISO 62 | equilibrium in water at 23°C |
吸湿率 | 0.2 % | ISO 62 | equilibrium 23°C/50% r.h. |
| 机械性能 | 值/单位 | 测试标准 | 测试条件 |
拉伸强度 | |||
屈服(yld) | 64 Mpa | ISO 527-1/-2 | 50 mm/min |
拉伸延伸率 | |||
屈服(yld) | 10.7 % | ISO 527-1/-2 | 50 mm/min |
标称断裂伸长率 | 32 % | ISO 527-1/-2 | 50 mm/min |
弯曲模量 | 2500 Mpa | ISO 178 | |
拉伸模量 | 2700 Mpa | ISO 527-1/-2 | |
拉伸蠕变模量 | |||
1000h | 1400 Mpa | ISO 899-1 | strain ≤ 0.5%, 23°C |
| 冲击性能 | 值/单位 | 测试标准 | 测试条件 |
简支梁缺口(Charpy Notched) | |||
-30℃ (-22℉) | 5.5 kJ/m² | ISO 179/1eA | |
23℃ (73℉) | 6.5 kJ/m² | ISO 179/1eA | |
简支梁无缺口(Charpy Unnotched) | |||
-30℃ (-22℉) | 250 kJ/m² | ISO 179/1eU | |
23℃ (73℉) | 270 kJ/m² | ISO 179/1eU | |
悬臂梁缺口(Izod Notched) | |||
-30℃ (-22℉) | 5.5 kJ/m² | ISO 180/A | |
23℃ (73℉) | 6 kJ/m² | ISO 180/A | |
| 硬度性能 | 值/单位 | 测试标准 | 测试条件 |
球压硬度 | 135 Mpa | ISO 2039-1 | 358 N and 30 s |
| 热学性能 | 值/单位 | 测试标准 | 测试条件 |
热变形温度(HDT) | |||
1.8 Mpa (264 psi)（18.6kg/cm²） | 95 °C | ISO 75-1/-2 | |
线性膨胀系数(CLTE) | |||
纵向(Flow) | 110 E-6/K | ISO 11359-1/-2 | (23-55)°C |
熔融温度(Tm) | 166 °C | ISO 11357-1/-3 | DSC |
短周期使用温度 | 100 °C | - | |
加工温度 | 190~230 °C | - | Injection moulding/Extrusion |
模具温度 | 60~120 °C | - | Injection moulding |
| 燃烧性能 | 值/单位 | 测试标准 | 测试条件 |
UL 防火等级 | |||
HB | 1.5 mm | IEC 60695-11-10 | |
FMVSS | + pass | FMVSS 302 | thickness d ≥ 1mm |
燃烧速率 | 100 mm/min | ISO 3795 | d < 1 mm |
| 电学性能 | 值/单位 | 测试标准 | 测试条件 |
体积电阻率 | 1.0E+11 Ohm-m | IEC 62631-3-1 | |
表面电阻率 | 1.0E+13 Ohm | IEC 62631-3-2 | |
介电常数(DK) | |||
1MHz | 3.8 - | IEC 62631-2-1 | |
耗散因数(DF) | |||
1MHz | 50 E-4 | IEC 62631-2-1 | |
相对漏电起痕指数(CTI ) | |||
溶液A | 600 V | IEC 60112 |
此物性表中的信息由阿技材料库从该材料的生产商处获得。阿技材料库尽最大努力确保此数据的准确性。 但是阿技材料库对这些数据值不承担任何责任，并强烈建议在最终选择材料前，就数据值与材料供应商进行验证。
