- TPE Products
Medical TPE Components
- Product Details
Product Description
Biocompatibility data according to ISO 10993 or USP Class VI reports may be available for selected medical TPE grades. Suitability must be assessed for the finished medical device based on contact type, contact duration and sterilization method. DEHP-free and latex-free grades are available.
- Properties
Properties & Advantages
- ✅ ISO 10993 data for selected compounds
- ✅ USP Class VI evidence on request
- ✅ DEHP-free and latex-free grades available
- Technical Data
Technical Specifications
| Biocompatibility data | Scope depends on grade, contact and intended use |
| Sterilization | EtO, gamma or limited autoclaving only as stated in the grade data sheet |
| Temperature | Family- and grade-dependent; see data sheet |
| Hardness | Grade-dependent; see data sheet |
Chemical Resistance TPE
| Medium | Resistance |
|---|---|
| Water (cold/warm) | ✅ Good to very good |
| Diluted acids & alkalis | ✅ Good |
| UV radiation | ✅ Good (with stabilizers) |
| Mineral oils / greases | ⚠️ Varies (TPE-V good) |
| Ketone / Ester | ❌ Not resistant |
| Food contact | ✅ FDA/EU-compliant compounds |
- Applications
Typical Application Areas
- ✅ Medical Technology — Hoses, wearables
- ✅ Medical Technology — Infusion lines, wearables, pump tubing
- FAQ
Frequently Asked Questions
Can TPE replace silicone in medical applications?
TPE may be suitable for selected uses such as tubing, wearables or short-term skin contact. Implants and long-term body contact require a separate material and risk assessment.
Which ISO 10993 tests are required?
The endpoints depend on the finished device, contact type and contact duration. Available compound reports must be checked against the intended use.
Who is responsible for regulatory clearance?
The medical-device manufacturer is responsible for regulatory assessment and clearance of the finished device.
See Also
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