Bionate® Thermoplastic Polycarbonate Urethane

property

procedure

ASTM

Bionate® PCU

80A

90A

55D

65D

75D

Color

NA

Clear, colorless to slightly yellow

Hardness, Durometer

D-2240

83A

91A

56D

66D

73D

Density, g/cm3

D-792

1.19

1.2

1.21

1.22

1.22

Tear Strength, Die 'C', pli

D-624

370

550

780

NA

1350

Ultimate Tensile Strength (psi)

D1708

6765

7993

8782

9015

9171

Ultimate Elongation (%)

D1708

531

406

365

281

241

Tensile Stress at

  50% (psi)

  100% (psi)

  300% (psi)

D1708

 

634

871

2453

 

1159

1604

5345

 

1772

2467

6963

 

3683

4601

NA

 

5188

5825

NA

Flexural Modulus, psi

   1% Secant Modulus

D790

4160

6030

7000

NA

260,000

Flexural Stress, psi

   at 5% Deflection

D790

180

275

300

NA

10,200

Water Absorption (%)

D-750

1.2

NA

0.9

NA

0.8

Dielectric Strength (V/mil)

D-149

430

480

530

NA

>625

Dielectric Constant, k', 60 hz

D-150

5

4.8

4.5

NA

3.7

Coefficient of Friction (Kinetic)

D1894

1.52

NA

0.81

NA

0.64

Taber Abrasion, 1000g wt.
Wear Index, mg/1000 cycles

D1044
H-18 wheel

5.7

9.1

7.4

NA

31

Vicat Softening Temp.

°C

°F

D-1525

 

78

173

 

88
190

 

98
208

 

NA

 

56
133

Coefficient of Linear

Thermal Expansion

   x 10-6/°C

   x 10-6/°F

 

 

E-831

E-1545

 

 

160.2

89

 

 

160.7

89.3

 

 

137.1

76.2

 

 

NA

 

 

93.2

51.8

Approximate Melt Index
g/10 min at 224°C

D-1238

(1200g)

22

(1200g)

14

(2160g)

20

(2160)

10

(5000g)

14

Mold Shrinkage, %

  4.0" Disk

  Flame Bar

D-955

 

1.2

0-3.0

 

1.2

0-3.0

 

1.2

0.5-2.0

 

NA

 

1.2

0.5-2.0

Optimum Extrusion Conditions

°F

°C

 

 

350-410

180-210

 

350-410

180-210

 

370-428

190-220

 

370-428

190-220

 

370-450

190-232

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


Representative Biological Test Results

The scope of Bionate PCU's tests-encompassing Histology, Carcinogenicity, Biostability, and Tripartite Biocompatiblity Guidance for Medical Devices-reassures medical device and implant manufacturers of the material's biocompatibility. Below is a representative summary.

biological test

results

Ames Mutagenicity

Non-mutagenic

Chronic Toxicity: USP Muscle Implantation

Macroscopic reaction not significant

Compliment Activation

Less activation of the compliment system than ePTFE

USP Cytotoxicity (MEM Elution)

Non-toxic

Hemolysis

Non-hemolytic

Humoral Immunological Study

No humoral (serological) immune response

USP Pyrogenicity

Non-pyrogenic

Platelet Deposition (ex vivo shunt)

No difference in thrombogenicity when compared to ePTFE control

Sensitization: Magnusson and Kligman

No dermal sensitization

Acute Systemic Toxicity

No significant systemic toxicity

USP Implantation Test: 7 days in rabbits

Macroscopic reaction not significant

Intracutaneous Toxicity

No significant irritation or toxicity

Carcinogenicity: 2 years in rats

Non-carcinogenic

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