Medical grade soft silicone elastomers for realistic, comfortable and durable prostheses

Prosthetics manufacturers use silicone for their unique properties to manufacture various parts of the prostheses, aiming at improving the quality of life of amputees. Medical grade soft silicone elastomers (RTVs) are used most widely in prosthetics because they are chemically inert, do not absorb sweat and are more durable than other soft materials. 

Medical grade silicone RTVs are particularly used for the manufacturing of prosthetic liners, which is the part of the limb prosthesis in direct contact with the skin. Its role is to maintain a tight fit with the body while redistributing weight in order to reduce pain at pressure points. 

Elkem Silicone’s range of Silbione™ RTVs provide the following benefits for the manufacturing of prosthetic liners :

  • Wide range of hardness available
  • Biocompatible according to ISO 10993
  • Excellent mechanical properties for a longer durability
  • Low viscosity for a trouble-free and high productivity manufacturing operation
  • Silicone glue technology available to bond with the external fabric
  • Custom grades available on demand

 Silbione™ Reference

Color

Hardness ShA (Sh00)

Viscosity Pa.s at 23°C

Maximum working time 23°C

Tear strength N/mm

Cytotoxicity
Skin sensitization
Skin Irritation
(ISO 10993)

Comment

RTV 4528

Translucent

(28)

4

70’

3

♦ ♦ ♦

Textile liners

RTV 4404

Translucent

4

0.9

40’

9

♦ ♦ ♦

Multi-purpose

RTV 4408

Translucent

4

0.9

40’

9

♦ ♦ ♦

Multi-purpose

RTV 4410

Skin or Trans

10

1.9

70’

15

♦ ♦ ♦

Multi-purpose

RTV 4411

Translucent

11

7.5

60’

12

♦ ♦ ♦

Multi-purpose

RTV 4418 ADH

Translucent

18

10.5

55’

 

♦ ♦ ♦

Adhesive for liner

 

Beyond liners, medical grade RTVs can also be used to make realistic, life-like artificial limbs such as hands and feet. By using various grades and colors pigments, prosthetists can make tailor-made individual prostheses in a process called cosmetic restoration.  Thanks to the unique viscoelastic properties of silicone elastomers, the end product can have a touch and feel which is very close to human skin. Typical products include :

 Silbione™ Reference

Color

Hardness ShA

Viscosity Pa.s at 23°C

Maximum working time 23°C

Tear strength N/mm

Cytotoxicity
Skin sensitization
Skin Irritation
(ISO 10993)

Comment

RTV 4420

Translucent

20

4

50’

15

♦ ♦ ♦

Multi-purpose

RTV 4428

Translucent

28

20

90’

20

♦ ♦ ♦

Multi-purpose

RTV 4439

Translucent

40

7

25’

2.5

♦ ♦ ♦

Multi-purpose

 

Learn more about our Silbione™ RTVs on the dedicated product page or by downloading our brochure.

At Elkem silicones, we are dedicated people located around the globe, committed to your success. Whether you are looking for a product recommendation, for customized silicone solutions, or for regulatory support, we have the people in place when and where you want them. If you have a medical device project, contact us and our experts will be there to help.