Medical-grade TPE color masterbatch
TPE-MB Series
Medical-grade color masterbatch complying with ISO 10993 biocompatibility requirements, suitable for medical devices.

Product introduction
This medical-grade TPE color masterbatch complies with ISO 10993 biocompatibility standards and is designed for medical and pharmaceutical applications, providing stable coloring while meeting stringent medical safety regulations.
Product features
- Compliant with ISO 10993 (biocompatibility)
- USP Class VI certification available
- Autoclave and EtO sterilizable
- Non-phthalate formula
- Batch traceability
Typical applications
- Medical catheters
- IV set components
- Syringe pistons
- Medical device handles
- Pharmaceutical packaging
Physical properties
| Performance | Test method | Value |
|---|---|---|
| Carrier resin | — | Medical-grade SEBS-based TPE |
| Pigment content | — | 15-40% |
| Melt index (190°C/5 kg) | ISO 1133 | 5-25 g/10 min |
| Density | ISO 1183 | 1.0-1.5 g/cm³ |
| Biocompatibility | ISO 10993 | Depends on grade |
Recommended processing conditions
| Parameter | Value |
|---|---|
| Drying | 60-70°C, 2-3 hours |
| Processing temperature | 160-200°C |
| Let-down ratio | 2-4% |
| Mold temperature | 30-50°C |
Coloring performance
| Performance | Test method | Value |
|---|---|---|
| Color difference Delta E (CIE Lab) | ISO 7724 | < 1.0 |
| Sterilization tolerance (EtO/steam) | Internal method | Delta E < 2.0 |
| Light fastness | ISO 105-B02 | 6-8 |





