A soft, colorable, specialty thermoplastic vulcanizate (TPV) in the thermoplastic elastomer (TPE) family. It is designed for use in medical and healthcare applications. This grade of Santoprene TPV is sheardependent and can be processed on conventional thermoplastics equipment for injection molding or extrusion. It is polyolefin based and recyclable within the manufacturing stream.
Key Features
• Based on a series of biocompatibility tests conducted on representative grades, this grade should meet the USP (U.S. Pharmacopeia) Class VI requirements for plastics.
• Additionally some ISO 10993 tests have been conducted.
• Each medical grade undergoes annual testing for cytotoxicity and heavy metals.
• Drug master file maintained with the FDA.
| Original Document | Technical Datasheet(English) Technical Datasheet(Chinese) | |||
| Features | Medical Application/Health CareBiocompatibleSoft | |||
| Appearance | Pellets/GranulesNatural Color | |||
| Processing | InjectionExtrusionSheet ExtrusionProfile ExtrusionCo-extrusion | |||
| Compliance | Drug Master FileFDAISO10993RoHSUSP Class VI | |||
| Physical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
|---|---|---|---|
Density/Specific Gravity | *** g/cm³ | ISO 1183 | |
Density/Specific Gravity | *** g/cm³ | ASTM D792 | |
| Mechanical | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Tensile Strength | |||
Break | *** Mpa | ASTM D 412 | Across Flow, 23°C |
Break | *** Mpa | ISO 37 | Across Flow, 23°C |
at 100% strain | *** Mpa | ASTM D 412 | Across Flow, 23°C |
at 100% strain | *** Mpa | ISO 37 | Across Flow, 23°C |
Tensile Elongation | |||
Break | *** % | ASTM D 412 | Across Flow, 23°C |
Break | *** % | ISO 37 | Across Flow, 23°C |
Compression Set | *** % | ASTM D 395 | 100°C, 168 hr, Type 1 |
Compression Set | *** % | ASTM D 395 | 23°C, 168 hr, Type 1 |
Compression Set | *** % | ISO 815 | 100°C, 168 hr, Type A |
Compression Set | *** % | ISO 815 | 23°C, 168 hr, Type A |
Tensile Set | *** % | ASTM D 412 | 23°C |
Tensile Set | *** % | ISO 2285 | 23°C |
| Hardness | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Shore A hardness | *** A | ISO 868 | 15 sec, 23°C |
| Aging | Value/Unit(Sign in to View) | Test Standard | Test Condition |
Tensile Strength(Heat Aging) | *** % | ISO 188 | Change in Air, 100°C, 168 hr |
Tensile Strength(Heat Aging) | *** % | ASTM D573 | Change in Air, 100°C, 168 hr |
Elonggation(Heat Aging) | *** % | ISO 188 | Change in Air, 100°C, 168 hr |
Elonggation(Heat Aging) | *** % | ASTM D573 | Change in Air, 100°C, 168 hr |
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.
