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Medical Devices & Catheters

Elastomeric and semi-rigid polyamide solutions for catheters, tubes, masks, bags and chemically resistant surfaces.  

Graphical Representation of a Balloon Catheter

Typical Applications - by product range

Pebax® MED Elastomers:

  • Catheters (angioplasty, stent delivery, diagnostic, ablation)
  • Balloons
  • Tubing
  • Cannula
  • Hearing Aid Components

Rilsan® MED and Rilsamid® MED Semi-Rigid Polyamides:

  • Catheters
  • Tubing

Rilsan® Clear MED Transparent Semi-Rigid Polyamides:

  • Breathing Masks
  • Fittings

Pebax® MED Range

Medical grade Pebax® polymers are plasticizer-free thermoplastic elastomers with a wide range of physical and mechanical properties achieved by varying the monomeric block types and ratios.


Grades within the product range extend from soft, flexible and elastomeric to those with mechanical properties approaching semi-rigid polyamides. 
The remarkable processing ease of medical grade Pebax® elastomers make them an excellent choice for extrusion of medical grade tubing or film applications. They are often compounded by our customers for additional lubricity or radiopaque properties.

 

Their lightness and tremendous durability makes them very good candidates for wearable applications such as straps and fasteners.

 

Typical properties include:


USP Class VI* certification
Sterilization resistance
• Bondable by adhesives or RF welding
• Easily blended with other polymers and compounded with additives
• High torque transference, maneuverability and kink resistance
• Excellent impact resistance and low rigidification at low temperature
Consistent durometer and flexibility at room and body temperatures
• Good resistance to many harsh chemicals

• Lightweight and high maneuverability

• Pebax® MV 1074 SA 01 MED: hydrophilic grade with inherent antistatic properties (surface resistivity 3 x 109 Ω / sq.)

 

Breathable Pebax® MV 1074 SA 01 MED is often considered for breathable wound care, surgical garments (disposable) and bedding materials. (Datasheet US/SI)

 

* Pebax® MED grades have undergone testing in accodance with certain portions of the USP Class VI and/or ISO 10993 standards. Contact us for details.

Respiratory mask with blue straps and an attached hose.

Rilsan® MED and Rilsamid® MED Semi-Rigid Polyamides

Medical grades Rilsan® MED polyamide 11 and Rilsamid® MED polyamide 12 are used in applications that require the strength and performance characteristics of a true thermoplastic, yet still offer sufficient flexibility and elongation approaching that of some elastomers. Rilsan® and Rilsamid® MED polymers are easy to process by most traditional methods, including extrusion, extrusion blow molding, injection molding and rotomolding. Exceptional properties of these polyamide products include:

 

• High strength and mechanical properties
• Excellent resistance to chemicals (particularly hydrocarbons)
• Ease of processing

• Wide range of application temperatures [ -40°—130°C (-40°F—266°F) ]
• High dimensional stability and low density
• Very low gas permeation

When High Transparency is Required

Rilsan® Clear MED grades offer an outstanding combination of transparency, light weight, chemical resistance and flexibility used in applications like BPA free and BPS free breathing masks, tubing, and storage containers.

 

Rilsan® Clear G170 MED polyamide offers an excellent combination of transparency, light weight, and flexibility of transparent polymers commonly used in medical applications. It is more transparent than glass and more flexible than polycarbonate.

 

Transparent: Light transmittance of 91% - exceeding that of glass and polycarbonate

 

Light Weight: Specific gravity of 1.05, Rilsan® Clear G170 MED is about 15% lighter than traditional transparent medical plastics such as acrylics, polycarbonates or PSU.

 

Flexible: Flexural modulus of 1,980 MPa (287,000 psi), representing an approximate18% improvement in flexibility compared to polycarbonate.

 

Durable: High temperature resistance (Tg = 168°C), good surface and wear resistance, good chemical resistance.

 

Rilsan® Clear G170 MED is BPA and plasticizer free, and is sterilizable (contact us for information on Steam, ETO and gamma sterilizations). 

 

 

Chemical Resistance - Common Grades (All)

Pebax® Grades

Hydrocarbon

Lipids

IPA

Saline water

Hydrogen Peroxide

Bleach

2533 SA 01 MED

P

F

F

G

F

G

3533 SA 01 MED

P

F

F

G

F

G

4033 SA 01 MED

F

G

G

G

G

G

4533 SA 01 MED

F

G

G

G

G

G

5533 SA 01 MED

G

G

G

G

G

G

6333 SA 01 MED

G

G

G

G

G

G

7033 SA 01 MED

G

G

G

G

G

G

 

Rilsan® Clear Grades

Hydrocarbon

Lipids

IPA

Saline water

Hydrogen Peroxide

Bleach

G170 MED

G

G

G

G

G

G

G850 Rnew MED

G

G

G

G

G

G

 >view Arkema's Product Disclaimer


 

 

Rilsan® and Rilsamid® Grades

Polyamide

Type

Hydrocarbon

Lipids

IPA

Saline water

Hydrogen Peroxide

Bleach

Rilsan®

BMNO MED

PA11

G

G

G

G

G

G

Rilsan®

BESNO MED

G

G

G

G

G

G

Rilsan®

BESVOA MED

G

G

G

G

G

G

Rilsamid®

AMNO MED

PA12

G

G

G

G

G

G

Rilsamid®

AESNO MED

G

G

G

G

G

G

 G: Good  F:Fair  P:Poor    >view Arkema's Product Disclaimer

Typical Physical Properties - Pebax® MED Range - Common Grades

Property Description Test Method Units 2533 SA 01 MED 3533 SA 01 MED 4033 SA 01 MED 4533 SA 01 MED 5533 SA 01 MED 6333 SA 01 MED 7033 SA 01 MED 7233 SA 01 MED 7433 SA 01 MED
Density   ISO 1183 g/cm3 1 1 1.01 1.01 1.01 1.01 1.01 1.01 1.01
Water Absorption @20ºC, 50% RH ISO 62 % 0.4 0.4 0.5 0.4 0.6 0.7 0.7 0.7 -
  @23ºC, 24hrs in water   1.2 1.2 1.2 1.2 1.2 1.1 1.1 0.9 -
Melting Point   ISO 11357 ºC 134 144 160 147 159 169 172 174 174
Vicat Point Under 1 daN ISO 306 ºC 58 77 131 111 142 157 164 164 -
Shrinkage Flow direction, after 24hrs, 4mm, mold @20ºC Internal Method % 0.5 0.5 0.4 0.4 1.2 1.2 1.2 1.2 0.2
  Transverse direction, after 24hrs, 4mm, mold @20ºC     0.8 0.8 1.1 1.1 1.4 1.4 1.5 1.5 0.7
Hardness* Instantaneous ISO 868 Shore D 27 33 42 46 54 64 69 69 73
  After 15sec 22 25 35 41 50 58 61 61 66
Tensile Test* Stress @ break ASTM D 638 MPa 32 39 40 42 52 53 54 56 46
  Strain @ break % >750 >600 >450 >450 >450 >350 >350 >300 >250
Flexural Modulus   ISO 178 MPa 12 21 77 86 170 285 390 513 610
Charpy Impact* Unnotched 23ºC ISO 179 kJ/m2 NB NB NB NB NB NB NB NB NB
  Unnotched -30ºC     NB NB NB NB NB NB NB NB NB
  V-notched 23ºC     NB NB NB NB NB NB 120(p) 15(c) 19(c)
  V-notched -30ºC     NB NB NB NB NB 20(c) 20(c) 10(c) 6(c)

*Samples conditioned 15 days at 23oC 50% RH Typical properties only. Not to be considered as specifications.

>view Arkema's Product Disclaimer

Typical Physical Properties - Rilsan® Clear MED Range

Description

Test method

Units

G170

MED

G850 Rnew®

MED

Hardness

ISO 868

Shore D

84

78

Tensile strength at break

ISO 527

Mpa

58

55

Tensile strain at break

ISO 527

%

>100

>50

Flexural modulus

ISO 178

MPa

1980

1630

Glass transition temperature

ISO 11 357

°C

168

150

Moisture absorption at equilibrium

(At 23°C and 50% R.H.)

ISO 62

%

1,3

1,7

Shrinkage

(after 24h, 4mm, mold at 40°C)   

Parallel

Internal

method

%

0,69

0.6

Perpendicular   

Internal

method

%

0,72

0,8

 

>view Arkema's Product Disclaimer

Typical Physical Properties - Rilsan® MED and Rilsamid® MED Range - Common Grades

        Rilsan® PA11 MED Range Rilsan® PA11 MED Range Rilsan® PA11 MED Range   Rilsamid® PA12 MED Range Rilsamid® PA12 MED Range
Property Description Test Method Units BMNO MED BESNO MED BESVOA MED   AMNO MED AESNO MED
Nature & designation   ISO 1874   PA11 PA11 PA11   PA12 PA12
Bio-based content Calculation ASTM 6866 % 100 100 100   - -
Density   ISO 1183 g/cm3 1.03 1.02 1.02   1.02 1.01
Water Absorption @20ºC, 50% RH ISO 62 % 0.75 0.75 0.75   0.7 0.7
  @23ºC, 24hrs in water     0.95 0.95 0.95   0.9 0.9
Melting Point ISO 11357 °C 189 186 186 172   180
Heat Deflection Temperature (HDT) Under 0.45 MPa ISO 75 °C 145 145 145   130 130
  Under 1.80 MPa     50 50 50   50 50
Shrinkage Flow direction, after 24hrs, 2mm, mold @30ºC Internal Method % 0.4 N/A N/A   0.8 N/A
  Transverse direction, after 24hrs, 2mm, mold @30ºC     0.8 x x   0.8 x
Hardness Instantaneous ISO 868 Shore D 75 76 76   - 75
After 15sec 68 71 71 62 72 69
Tensile Test Stress @ Yield ISO 527 MPa 41 40 36   38 43
  Strain @ Yield   % 5 6 5   7 5
  Stress @ Break   MPa 58 50 52   64 50
  Strain @ Break   % >200 >200 >200   >250 >200
Tensile Modulus   ISO 527 MPa 1280 1200 1180   1170 1440
Flexural Modulus   ISO 178 MPa 1140 1130 1100   1200 1180
Charpy Impact Unnotched 23ºC ISO 179 kJ/m2 NB NB NB   NB NB
  Unnotched -30ºC     NB NB NB   NB NB
  V-notched 23ºC     20 15 15   9 11
  V-notched -30ºC     10 13 13   5 6

 

>view Arkema's Product Disclaimer

Permanent Antistatic Additive Properties - Pebax® MV 1074 SA 01 MED

Host Polymer Pebax® grade Additive Level   Surface resistivity (Ohms/sq)
PE MV 1074 MED 15 to 25%   1011 to 1012
PP MV 1074 MED 15 to 25%   1011 to 1012
PS or HIPS MV 1074 MED 10 to 20%   1011 to 1012
ABS MV 1074 MED 10 to 15%   1010 to 1011
PC/ABS MV 1074 MED 10 to 20%   1010 to 1012
PMMA MV 1074 MED 10 to 15%   1011 to 1012
PBT MV 1074 MED 10%   1013
PETG MV 1074 MED 10 to 20%   1010 to 1012
POM MV 1074 MED 10%   1012
PA MV 1074 MED 10 to 20%   1011 to 1012

 *Arkema products. Visit lotader.com 

For more complete information on our wider range of permanent antistatic additives, visit here.

>view Arkema's Product Disclaimer

 

Let's Run Together

Our range of materials is constantly growing.  As the market demands higher performance materials we will continue to develop innovative solutions.  

 

Contact our team today to learn more about our product offerings.

 

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Contact Our Medical Devices and Catheters Team

 
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