Ultraform H 4320 PRO is an unfilled injection molding POM grade, which supports customers in product development for the medical technology market. This grade complied with 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 and Food Contact: Ultraform® PRO is in compliance with multiple regional food contact regulations, especially for Europe and United States.
Applications
This material can be used for functional parts in devices such as insulin pens or powder inhalers as well as for plug in connectors or medical device handles.
| Original Document | Technical Datasheet-ISO(English) | |||
| Features | Food ContactMedical Application/Health CareBiocompatible | |||
| Processing | Injection | |||
| Compliance | Drug Master FileEU 2011/10/ECFDAISO10993REACH (EC 1907/2006)USP Class VI | |||
| Physical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
|---|---|---|---|
Density/Specific Gravity | *** g/cm³ | ISO 1183 | |
Melt Volume Flow Rate(MVR) | |||
190℃/2.16 kg | *** cm³/10min | ISO 1133 | |
Water Absorption | *** % | ISO 62 | 50% RH |
Water Absorption | *** % | ISO 62 | Saturation |
| Mechanical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Tensile Modulus | *** Mpa | ISO 527 | 23℃ |
Tensile Strength | |||
Yield | *** Mpa | ISO 527 | 23℃ |
Tensile Elongation | |||
Yield | *** % | ISO 527 | 23℃ |
Tensile Creep Modulus | |||
1000h | *** Mpa | ISO 899 | |
| Impact | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Charpy Notched Impact Strengh | |||
-30℃ (-22℉) | *** kJ/m² | ISO 179 | |
23℃ (73℉) | *** kJ/m² | ISO 179 | |
Charpy Unnotched Impact Strengh | |||
-30℃ (-22℉) | *** kJ/m² | ISO 179 | |
23℃ (73℉) | *** kJ/m² | ISO 179 | |
| Hardness | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Ball Indentation Hardness | *** Mpa | ISO 2039-1 | |
| Thermal | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Heat Deflection Temperature(HDT) | |||
1.8 Mpa (264 psi)（18.6kg/cm²） | *** °C | ISO 75 | |
Coefficient of Linear Thermal Expansion | |||
Flow | *** E-6/°C | Internal | |
Melt Temperature(Tm) | *** °C | ISO 3146 | |
| Electrical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Volume Resistivity | *** Ohm-cm | IEC 60093 | |
Surface Resistivity | *** Ohm | IEC 60093 | |
Dielectric Constant(Permittivity) | |||
1MHz | *** - | IEC 60250 | |
Dissipation Factor | |||
1MHz | *** E-4 | IEC 60250 | |
Comparative Tracking Index (CTI) | |||
- | *** V | IEC 60112 |
The information presented on this datasheet was acquired by AjiEng.com from the producer of the material. AjiEng.com makes substantial efforts to assure the accuracy of this data. However, AjiEng.com assumes no responsibility for the data values and strongly encourages that upon final material selection, data points are validated with the material supplier.
