MC/HE Series

THERMOLAST® M

The MC/HE series is your material solution for applications requiring basic medical approvals such as ISO 10993-5. The series is characterized by its elasticity and transparency at high hardness plus its adhesion to PP. The compounds are transparent and can be colored in many different ways. The compounds are produced exclusively on a special medical unit.

Processing Method: Injection Molding
Color / RAL DESIGN: Transparent

Typical applications

  • Squeeze bottles
  • Luer lock
  • Drip chamber
  • Closure caps

 

Material features

  • Adhesion to PP
  • Elasticity
  • Transparency
  • Stiffness
  • Sterilizable (autoclave 134°C, ß-/y-radiation 2x35 kGy, EtO)
  • Weldable (Ultrasonic)
  • Free from animal ingredients
  • US DMF listed
  • KRAIBURG TPE Medical Service Package
  • ISCC PLUS ready (mass balance approach)

 

Regulations / Approvals *

  • Regulation (EU) No 10/2011
  • US FDA CFR 21 (raw material conformity)
  • VDI 2017
  • ISO 10993-4 (Hemolysis)
  • ISO 10993-5 (Cytotoxicity)
  • ISO 10993-10 (Intracutaneous injection)
  • ISO10993-11 (Acute systemic toxicity)
  • USP <88> (Biological Reactivity, Class VI)

 

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Compound name
Color / RAL DESIGN
Hardness
DIN ISO 48-4
Shore D
Hardness
DIN ISO 48-4
Shore A
Density
DIN EN ISO 1183-1
g/cm3
Tensile Strength 1
DIN 53504/ISO 37
MPa
Elongation at Break 1
DIN 53504/ISO 37
%
Tear Resistance
ISO 34-1 Method B (b) (Graves)
N/mm
CS 72 h/23 °C
DIN ISO 815-1 Method A
%
CS 24 h/70 °C
DIN ISO 815-1 Method A
%
TM0HET Transparent 52 97 0.900 18.0 550 100.0 52 79
TM9HET Transparent 40 94 0.900 18.5 750 73.5 48 86
1Deviating from ISO 37 standard test piece S2 is tested with a traverse speed of 200 mm/min.
All values published in this data sheet are rounded average values.
The expected shelf life of the TPE granules is a minimum of 24 months from the date of delivery, provided that the storage instructions are followed and the product is kept in the unopened original KRAIBURG TPE packaging. Dry conditions at room temperature (below 40 °C/ 104 °F), away from heat sources and direct sunlight, must be maintained for proper storage. Contact with nitrogen oxides during storage should be avoided.
For further information and individual custom solutions please contact our customer service.
* Regulations a compound complies with and approvals granted are displayed here. Please note: All regulations and approvals for all compounds of a series are collectively shown in the overview of the respective product series, i.e. not all regulations and approvals shown in the overview apply to each individual compound.