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
| Original Document | Technical Datasheet(English) | |||
| Resin ID | POM | |||
| Features | Fast Cycle TimeFood ContactMedical Application/Health CareBiocompatible | |||
| Processing | Injection | |||
| Compliance | Drug Master FileEuropean PharmacopoeiaISO10993USP Class VI | |||
| Diagrams | Stress-strain(Yield)Secant modulus-strain(Yield)Specific volume-temperature (pvT) | |||
| 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 | |
Mold Shrinkage | |||
Flow | *** % | ISO 294-4 | |
Across Flow | *** % | ISO 294-4 | |
Water Absorption | *** % | ISO 62 | equilibrium in water at 23°C |
Moisture /Humidity Absorption | *** % | ISO 62 | equilibrium 23°C/50% r.h. |
| Mechanical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Tensile Modulus | *** Mpa | ISO 527-1/-2 | |
Tensile Strength | |||
Yield | *** Mpa | ISO 527-1/-2 | 50 mm/min |
Tensile Elongation | |||
Yield | *** % | ISO 527-1/-2 | 50 mm/min |
Nominal Tensile Strain at Break | *** % | ISO 527-1/-2 | 50 mm/min |
Flexural Modulus | *** Mpa | ISO 178 | |
Tensile Creep Modulus | |||
1000h | *** Mpa | ISO 899-1 | strain ≤ 0.5%, 23°C |
| Impact | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Charpy Notched Impact Strengh | |||
-30℃ (-22℉) | *** kJ/m² | ISO 179/1eA | |
23℃ (73℉) | *** kJ/m² | ISO 179/1eA | |
Charpy Unnotched Impact Strengh | |||
-30℃ (-22℉) | *** kJ/m² | ISO 179/1eU | |
23℃ (73℉) | *** kJ/m² | ISO 179/1eU | |
Izod Notched Impact Strengh | |||
-30℃ (-22℉) | *** kJ/m² | ISO 180/A | |
23℃ (73℉) | *** kJ/m² | ISO 180/A | |
| Hardness | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Ball Indentation Hardness | *** Mpa | ISO 2039-1 | 358 N and 30 s |
| 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 75-1/-2 | |
Coefficient of Linear Thermal Expansion | |||
Flow | *** E-6/K | ISO 11359-1/-2 | (23-55)°C |
Melt Temperature(Tm) | *** °C | ISO 11357-1/-3 | DSC |
Temperature at Short Circle Operation | *** °C | - | |
Processing Temperature | ***~*** °C | - | Injection moulding/Extrusion |
Mould temperature | ***~*** °C | - | Injection moulding |
| Flammability | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Flame Rating | |||
HB | *** mm | IEC 60695-11-10 | |
FMVSS | *** pass | FMVSS 302 | thickness d ≥ 1mm |
Burning Rate | *** mm/min | ISO 3795 | d < 1 mm |
| Electrical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Volume Resistivity | *** Ohm-m | IEC 62631-3-1 | |
Surface Resistivity | *** Ohm | IEC 62631-3-2 | |
Dielectric Constant(Permittivity) | |||
1MHz | *** - | IEC 62631-2-1 | |
Dissipation Factor | |||
1MHz | *** E-4 | IEC 62631-2-1 | |
Comparative Tracking Index (CTI) | |||
Solution A | *** 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.
