Bionate

Thermoplastic Polycarbonate Polyurethane (PCU)

A proven family of highly biocompatible medical

grade polymers with outstanding physical and
mechanical properties
Bionate PCU is an industry-leading medical grade
polymer for use in long-term implants. It has been used
in chronically implanted medical devices for nearly two
decades. The Bionate PCU family is one of the most
extensively tested families of biomedical polymers and
is backed by a comprehensive FDA Master File. Both
Bionate PCU and Bionate II PCU are tough, biostable
and biocompatible polymers with exceptional performance
characteristics.
Widely Used
The Bionate PCU family is currently being used in a
wide range of applications, including neurostimulation,
vascular, artificial heart, cardiac assist and diagnostic
devices. Because of its exceptional load-bearing capability
and biostability, it is also used extensively in orthopedic
applications such as hip and knee joints and spinal
motion preservation devices. Due to its biostability,
flexibility, electrical properties and tensile strength,
the Bionate PCU family is an excellent candidate for
lead insulation.

Tailor Made
Bionate PCU can be modified with SME technology
to incorporate end groups that can enhance device
performance. Bionate II PCU also offers a wide range of
potential surface characteristics by using DSMs patented
SAME technology.
Summary of Product Benefits
Biostable and biocompatible
Extensively tested
Backed by a comprehensive FDA Master File
In use for nearly two decades
Exceptional abrasion resistance, flexibility
and tensile strength
Adaptable with SME and SAME technology

Bionate PCU Physical Properties

Bionate II PCU Physical Properties

Bionate PCU
55D

Bionate II PCU
90A

Typical Property

Test Method

Color
Hardness, Durometer
Density, g/cm3
Ultimate Tensile Strength
Ultimate Elongation (%)
Tensile Stress
at 50% elongation
at 100% elongation
at 300% elongation
Flexural Modulus, 1% Secant Modulus

Visual
ASTM D2240
ASTM D792
ASTM D1708
ASTM D1708

Flexural Stress, at 5% Deflection

Tear Strength, Die C, pli
Coefficient of Linear Thermal Expansion
x 10-6/C
x 10-6/F
Water Absorption (%)

80A

90A

65D

75D

83A
1.19
6765 psi / 46.6 MPa
531

Clear to amber colored pellets

91A
56D
66D
1.2
1.21
1.22
7993 psi / 55.1 MPa 8782 psi / 60.5 MPa 9015 psi / 62.2 MPa
406
365
281

ASTM D790

634 psi / 4.4 MPa

871 psi / 6.0 MPa
2453 psi / 16.9 MPa
4160 psi / 28.7 MPa

1159 psi / 8.0 MPa

1604 psi / 11.1 MPa
5345 psi / 36.9 MPa
6030 psi / 41.6 MPa

1772 psi / 12.2 MPa

2467 psi / 17.0 MPa
6963 psi / 48.0 MPa
7000 psi / 48.3 MPa

ASTM D790

180 psi / 1.2 MPa

275 psi / 1.9 MPa

300 psi / 2.1 MPa

NA

10,200 psi / 70.3 MPa

ASTM D624

370

550

780

NA

ASTM E831
ASTM E1545
ASTM D750

160.2
89
1.2

160.7
89.3
NA

137.1
76.2
0.9

Dielectric Strength (V/mil)

ASTM D149

430

480

530

Dielectric Constant, k, 60 hz

ASTM D150

4.8

4.5

NA

3.7

Coefficient of Friction (Kinetic)

Taber Abrasion, 1000g wt.
Weight Loss, mg/1000 cycles
Vicat Softening Temp.
C
F
Melt Flow Rate
g/10 min at 224C
Mold Shrinkage, %
4.0 Disk
Flame Bar
Recommended Extrusion Conditions
F
C

ASTM D1894
ASTM D1044
H-18 wheel

1.52

NA

0.81

NA

0.64

5.7

9.1

7.4

NA

31

ASTM D1525

78
173
(1200g)
22

88
190
(1200g)
14

98
208
(2160g)
20

NA

56
133
(5000g)
14

1.2
0-3.0

1.2
0-3.0

1.2
0.5-2.0

NA

1.2
0.5-2.0

350-410
180-210

350-410
180-210

370-428
190-220

370-428
190-220

370-450
190-232

ASTM D1708

ASTM D1238
ASTM D955

73D
1.22
9171 psi / 63.2 MPa
241

Color

Test Method

80A

Visual

Hardness, Durometer

ASTM D2240

84A

92A

56D

Ultimate Tensile Strength

ASTM D1708

7966 psi / 54.9 MPa

8615 psi / 59.4 MPa

8960 psi / 61.8 MPa

ASTM 1708

501

385

372

1358 psi / 9.4 MPa

1909 psi / 13.2 MPa
6518 psi / 44.9 MPa
6540 psi / 45.1 MPa

1927 psi / 13.3 MPa

2635 psi / 18.2 MPa
7105 psi / 49.0 MPa
13800 psi / 95.1 MPa

ASTM D1708
ASTM D790

596 psi / 4.1 MPa

852 psi / 5.9 MPa
3504 psi / 24.2 MPa
2780 psi / 19.2 MPa

Flexural Stress at 5% Deflection

ASTM D790

137 psi / 0.9 MPa

314 psi / 2.2 MPa

511 psi / 3.5 MPa

1350

Water Absorption (%)

ASTM D750

0.74

0.72

0.54

ASTM D149

425

423

420

Dielectric Constant, k, 60hz

ASTM D150

4.16

3.97

3.71

NA

93.2
51.8
0.8

Dielectric Strength (V/mil)

0.43

0.46

>625

ASTM D1894
ASTM D4060
H-18 wheel

0.41

NA

Coefficient of Friction (Kinetic)

Taber Abrasion, 1000gram wt.
Weight Loss, mg/1000 cycles
Vicat Softening Temp.
C
F
Melt Flow Rate
g/10 min at 224C
Glass Transition Temperature, Tg (C)

ASTM D1525

82.5
180.5
(1200g)
23

ASTM E1356

-8

Melting Point, Tm (C)

ASTM E1356

162

177

180

Mold Shrinkage (%)

Recommended Extrusion Conditions
C
F
Recommended Injection Molding Conditions
C
F

ASTM D955

.24-3.86

.83-2.71

.8-2.31

3683 psi / 25.4 MPa

5188 psi / 35.8 MPa
4601 psi / 31.7 MPa
5825 psi / 40.2 MPa
NA
NA
NA
260,000 psi / 1792.6 MPa

NA

(2160g)
10

ASTM D1238

11

PCU Representative Biological Test Results

225 230
440 450

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

Biological test

Results
Non-mutagenic

Biological test

Results

Biological test

Results

Genotoxicity

Ames Mutagenicity
Chronic Toxicity: USP Muscle
Implantation

Non-mutagenic

USP Pyrogenicity

Non-pyrogenic
No difference in thrombogenicity when
compared to ePTFE control

Hemocompatibility

Non-hemolytic

Cytotoxicity

Non-cytotoxic

No dermal sensitization

Systemic Toxicity

No evidence of systemic toxicity

Irritation

No significant irritation or toxicity

No significant systemic toxicity

Pyrogenicity

Non-pyrogenic

Macroscopic reaction not significant

Sensitization

No evidence of sensitization; not considered a sensitizer

Implantation

Non-irritant

Complement Activation
USP Cytotoxicity (MEM Elution)
Humoral Immunological Study
Hemolysis

Platelet Deposition (ex vivo shunt)

Less activation of the complement system

than ePTFE
Non-cytotoxic
No humoral (serological) immune
response
Non-hemolytic

Sensitization: Magnusson and

Kligman
Acute Systemic Toxicity
USP Implantation Test: 7 days
in rabbits
Intracutaneous Toxicity
Carcinogenicity: 2 years in rats

No significant irritation or toxicity

Non-carcinogenic

94.7
202.5
(1200g)
18
-2

180 210
350 410

Bionate II PCU Representative Biological Test Results

Macroscopic reaction not significant

55D

clear to amber colored pellets

Ultimate Elongation (%)

Tensile Stress
at 50% elongation
at 100% elongation
at 300% elongation
Flexural Modulus, 1% Secant Modulus

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

Bionate

Typical Property

106.9
224.4
(2160g)
35
1

Bionate PCU Physical Properties

Bionate II PCU Physical Properties

Bionate PCU
55D

Bionate II PCU
90A

Typical Property

Test Method

Color
Hardness, Durometer
Density, g/cm3
Ultimate Tensile Strength
Ultimate Elongation (%)
Tensile Stress
at 50% elongation
at 100% elongation
at 300% elongation
Flexural Modulus, 1% Secant Modulus

Visual
ASTM D2240
ASTM D792
ASTM D1708
ASTM D1708

Flexural Stress, at 5% Deflection

Tear Strength, Die C, pli
Coefficient of Linear Thermal Expansion
x 10-6/C
x 10-6/F
Water Absorption (%)

80A

90A

65D

75D

83A
1.19
6765 psi / 46.6 MPa
531

Clear to amber colored pellets

91A
56D
66D
1.2
1.21
1.22
7993 psi / 55.1 MPa 8782 psi / 60.5 MPa 9015 psi / 62.2 MPa
406
365
281

ASTM D790

634 psi / 4.4 MPa

871 psi / 6.0 MPa
2453 psi / 16.9 MPa
4160 psi / 28.7 MPa

1159 psi / 8.0 MPa

1604 psi / 11.1 MPa
5345 psi / 36.9 MPa
6030 psi / 41.6 MPa

1772 psi / 12.2 MPa

2467 psi / 17.0 MPa
6963 psi / 48.0 MPa
7000 psi / 48.3 MPa

ASTM D790

180 psi / 1.2 MPa

275 psi / 1.9 MPa

300 psi / 2.1 MPa

NA

10,200 psi / 70.3 MPa

ASTM D624

370

550

780

NA

ASTM E831
ASTM E1545
ASTM D750

160.2
89
1.2

160.7
89.3
NA

137.1
76.2
0.9

Dielectric Strength (V/mil)

ASTM D149

430

480

530

Dielectric Constant, k, 60 hz

ASTM D150

4.8

4.5

NA

3.7

Coefficient of Friction (Kinetic)

Taber Abrasion, 1000g wt.
Weight Loss, mg/1000 cycles
Vicat Softening Temp.
C
F
Melt Flow Rate
g/10 min at 224C
Mold Shrinkage, %
4.0 Disk
Flame Bar
Recommended Extrusion Conditions
F
C

ASTM D1894
ASTM D1044
H-18 wheel

1.52

NA

0.81

NA

0.64

5.7

9.1

7.4

NA

31

ASTM D1525

78
173
(1200g)
22

88
190
(1200g)
14

98
208
(2160g)
20

NA

56
133
(5000g)
14

1.2
0-3.0

1.2
0-3.0

1.2
0.5-2.0

NA

1.2
0.5-2.0

350-410
180-210

350-410
180-210

370-428
190-220

370-428
190-220

370-450
190-232

ASTM D1708

ASTM D1238
ASTM D955

73D
1.22
9171 psi / 63.2 MPa
241

Color

Test Method

80A

Visual

Hardness, Durometer

ASTM D2240

84A

92A

56D

Ultimate Tensile Strength

ASTM D1708

7966 psi / 54.9 MPa

8615 psi / 59.4 MPa

8960 psi / 61.8 MPa

ASTM 1708

501

385

372

1358 psi / 9.4 MPa

1909 psi / 13.2 MPa
6518 psi / 44.9 MPa
6540 psi / 45.1 MPa

1927 psi / 13.3 MPa

2635 psi / 18.2 MPa
7105 psi / 49.0 MPa
13800 psi / 95.1 MPa

ASTM D1708
ASTM D790

596 psi / 4.1 MPa

852 psi / 5.9 MPa
3504 psi / 24.2 MPa
2780 psi / 19.2 MPa

Flexural Stress at 5% Deflection

ASTM D790

137 psi / 0.9 MPa

314 psi / 2.2 MPa

511 psi / 3.5 MPa

1350

Water Absorption (%)

ASTM D750

0.74

0.72

0.54

ASTM D149

425

423

420

Dielectric Constant, k, 60hz

ASTM D150

4.16

3.97

3.71

NA

93.2
51.8
0.8

Dielectric Strength (V/mil)

0.43

0.46

>625

ASTM D1894
ASTM D4060
H-18 wheel

0.41

NA

Coefficient of Friction (Kinetic)

Taber Abrasion, 1000gram wt.
Weight Loss, mg/1000 cycles
Vicat Softening Temp.
C
F
Melt Flow Rate
g/10 min at 224C
Glass Transition Temperature, Tg (C)

ASTM D1525

82.5
180.5
(1200g)
23

ASTM E1356

-8

Melting Point, Tm (C)

ASTM E1356

162

177

180

Mold Shrinkage (%)

Recommended Extrusion Conditions
C
F
Recommended Injection Molding Conditions
C
F

ASTM D955

.24-3.86

.83-2.71

.8-2.31

3683 psi / 25.4 MPa

5188 psi / 35.8 MPa
4601 psi / 31.7 MPa
5825 psi / 40.2 MPa
NA
NA
NA
260,000 psi / 1792.6 MPa

NA

(2160g)
10

ASTM D1238

11

PCU Representative Biological Test Results

225 230
440 450

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

Biological test

Results
Non-mutagenic

Biological test

Results

Biological test

Results

Genotoxicity

Ames Mutagenicity
Chronic Toxicity: USP Muscle
Implantation

Non-mutagenic

USP Pyrogenicity

Non-pyrogenic
No difference in thrombogenicity when
compared to ePTFE control

Hemocompatibility

Non-hemolytic

Cytotoxicity

Non-cytotoxic

No dermal sensitization

Systemic Toxicity

No evidence of systemic toxicity

Irritation

No significant irritation or toxicity

No significant systemic toxicity

Pyrogenicity

Non-pyrogenic

Macroscopic reaction not significant

Sensitization

No evidence of sensitization; not considered a sensitizer

Implantation

Non-irritant

Complement Activation
USP Cytotoxicity (MEM Elution)
Humoral Immunological Study
Hemolysis

Platelet Deposition (ex vivo shunt)

Less activation of the complement system

than ePTFE
Non-cytotoxic
No humoral (serological) immune
response
Non-hemolytic

Sensitization: Magnusson and

Kligman
Acute Systemic Toxicity
USP Implantation Test: 7 days
in rabbits
Intracutaneous Toxicity
Carcinogenicity: 2 years in rats

No significant irritation or toxicity

Non-carcinogenic

94.7
202.5
(1200g)
18
-2

180 210
350 410

Bionate II PCU Representative Biological Test Results

Macroscopic reaction not significant

55D

clear to amber colored pellets

Ultimate Elongation (%)

Tensile Stress
at 50% elongation
at 100% elongation
at 300% elongation
Flexural Modulus, 1% Secant Modulus

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

Bionate

Typical Property

106.9
224.4
(2160g)
35
1

Data on file at DSM Biomedical Inc.

Bionate, SME and SAME are registered trademarks of DSM.

Product Disclaimer

The description by DSM Biomedical of the characteristics and properties of its products and services as contained in this brochure is for general information purposes only, and may not be relied
upon in individual situations. Not all properties are included in the certificate of analysis. All materials offered by DSM Biomedical are supplied under a contract containing detailed product
specifications, and the user shall be exclusively responsible for, and shall bear full responsibility for the consequences of, (i) whether or not the product is suitable for use in the devices (or for
any other (authorized) use that customer may wish to make of the product), and (ii) whether the product specifications are sufficient and sufficiently well defined in order for the product to be fit
and suitable for use by user. User undertakes to keep itself actively informed as to developments in the relevant fields of its applications.

North America
DSM Biomedical Inc.
2810 Seventh Street
Berkeley, CA 94710
Phone: 510-841-8800
Fax: 510-841-7800

Europe/Asia

Email: [email protected]
2012 DSM. All rights reserved.

DSM Biomedical B.V.

Koestraat 1, 6167 RA Geleen
The Netherlands
Trade Register Limburg: 14093470
Phone: +31 (0)46 4760248
Fax: +31 (0)46 4763563