BioSpan® Segmented Polyether Urethane

property (dry)

procedure
ASTM

BioSpan®
SPU

Initial Modulus (psi)

D-1708

1833

Tensile Strength (psi)

D-1708

6162

Ultimate Elongation (%)

D-1708

875

Hardness

D-2240

70A

Glass Transition Temperature (°C)

D-3418

-65

Water Absorption (%)

D-570

1.5

Mw (Daltons)

D-3593

180,000

Appearance

NA

Translucent

Solution Concentration by Weight (%)

NA

24

Note: Typical physical property values are not to be construed as sales specifications.


Representative Biological Test Results

biological test

results

Primary Skin

Primary Mucosal

Non-irritant

Non-irritant

Kligman's Maximuzation-CSO extract

Kligman's Maximization-NaCl extract

Weak allergic potential

Weak allergic potential

USP Cytotoxicity (MEM Elution)

Non-cytotoxic

USP Acute Systemic

Intracutaneous Injection

Non-toxic

Non-toxic

Hemolysis

Lee White Clotting

Non-hemolytic

No effect on the clotting time of whole blood

USP Pyrogen

Non-pyrogenic

USP Muscle Implantation (14 days/rats)

Macroscopic-not significant tissue contact irritation

Microscopic-Non-irritant

Ames Mutagenicity Assay

Chromosome Aberation

Balb/c-3T3 Cell Transformation

Non-mutagenic

Non-clastogenic

Does not induce morphological cell transformation in activated or    non-activated test systems

Repeat Dose IV Study

Non-toxic

USP Muscle Implantation (120 days/rats)

Macroscopic-not significant tissue contact irritation

Microscopic-slight irritant

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