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USP Class VI and ISO 10993-compliant for biocompatibility testing
Latex-free, phthalate-free, and heavy-metal-free formulation
Excellent processability via injection molding, extrusion, and overmolding
Soft-touch surface with consistent Shore A hardness (e.g., 40–80 Shore A grades available)
Good resistance to sterilization methods including steam autoclaving, gamma, and EtO
Medical tubing and catheters
Seals, gaskets, and diaphragms for drug delivery devices
Overmolded grips for surgical and diagnostic instruments
Respiratory masks and patient interface components
Disposable wearable sensors and monitoring patches
| Chemical Type | Thermoplastic Elastomer (TPE), SEBS-based |
| Product Form | Pellets |
| Appearance | Opaque to translucent, colorable |
| Primary Applications | Class I–III medical devices requiring biocompatibility |
| Key Features | Soft-touch, low extractables, low odor |
| Benefits | Regulatory-ready; supports accelerated time-to-market |
| Compliance | ISO 10993-5/-10, USP Class VI, RoHS, REACH SVHC compliant |
Q1: What is the primary intended application for Kraiburg TM4MED TPE?
A: Kraiburg TM4MED TPE is specifically developed for medical device components requiring soft-touch performance, biocompatibility support, and ease of processing—such as tubing connectors, overmolded grips, seals, and non-invasive patient interface parts.
Q2: Is TM4MED TPE suitable for sterilization?
A: Yes, TM4MED TPE is formulated to withstand common low-temperature sterilization methods including ethylene oxide (EtO) and gamma irradiation, maintaining mechanical integrity and surface quality post-processing.
Q3: Does TM4MED TPE require drying before processing?
A: Yes, like most thermoplastic elastomers, TM4MED TPE benefits from pre-drying at 70–80 °C for 2–4 hours to minimize moisture-related defects during injection molding or extrusion.
Q4: Can TM4MED TPE be overmolded onto common medical-grade substrates?
A: Yes, TM4MED TPE exhibits good adhesion to a range of engineering thermoplastics used in medical devices—including polypropylene, polyethylene, and certain grades of polycarbonate—when appropriate mold temperature and processing parameters are applied.
Q5: How does TM4MED TPE support regulatory compliance for medical applications?
A: TM4MED TPE is manufactured under ISO 13485-certified conditions and is supplied with comprehensive documentation supporting biocompatibility evaluation pathways, including cytotoxicity, sensitization, and irritation testing per ISO 10993 series guidelines.
Contact With Us:
E-mail: wangxingqiang@ericwchem.com
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Building A1, Jiete Industrial Park, Huangpu District, Guangzhou City, Guangdong Province, China
