Medical-grade TPE color masterbatch

TPE-MB Series

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

Medical-grade TPE color masterbatch

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

PerformanceTest methodValue
Carrier resin—Medical-grade SEBS-based TPE
Pigment content—15-40%
Melt index (190°C/5 kg)ISO 11335-25 g/10 min
DensityISO 11831.0-1.5 g/cm³
BiocompatibilityISO 10993Depends on grade

Recommended processing conditions

ParameterValue
Drying60-70°C, 2-3 hours
Processing temperature160-200°C
Let-down ratio2-4%
Mold temperature30-50°C

Coloring performance

PerformanceTest methodValue
Color difference Delta E (CIE Lab)ISO 7724< 1.0
Sterilization tolerance (EtO/steam)Internal methodDelta E < 2.0
Light fastnessISO 105-B026-8