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USP Class VI Adhesives
USP Class VI Approved Adhesives for Medical Device Applications
Master Bond’s biocompatible adhesives are designed to meet the needs of medical device manufacturers. Compounds withstand various types of sterilization methods.

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Wacker Silpuran® 8461/60 Silicone Rubber
Categories: Polymer; Thermoset; Silicone; Silicone Rubber

Material Notes: Product description: SILPURAN® 8461/60 is a peroxide cure two part high consistency silicone rubber optimized for extrusion. Vulcanizates are noted for their good tear resistance and high transparency.

Special features: SILPURAN® 8461/60 is packaged in accordance with class 8 clean room standards (DIN EN ISO 14644). SILPURAN® 8461/60 meets selected test requirements of ISO 10993 and United States Pharmacopoeia (USP) Class VI. Postcured parts can be used for food contact applications and are suitable for use under the Recommendation "XV. Silicones" of the BfR and FDA § 177.2600 under observance of any given limitations on extractable and volatile substances.

Application: SILPURAN® 8461/60 is designed for medical applications including implantation for < 30 days.

Information provided by Wacker Chemie AG.

Vendors: No vendors are listed for this material. Please click here if you are a supplier and would like information on how to add your listing to this material.
 
Physical PropertiesOriginal ValueComments
Density 1.18 g/ccDIN 53479
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 60DIN 53505
Tensile Strength at Break 10.5 MPaDIN 53505 S1
Elongation at Break 480 %DIN 53505 S1
Rebound 48 %DIN 53512
Tear Strength 33.0 kN/mASTM D624B
Compression Set 31 %
@Temperature 175 °C,
Time 79200 sec
DIN ISO 815-B
 
Optical PropertiesOriginal ValueComments
Transmission, Visible 90 %"Transparent" but manufacturer does not quantify.
 
Processing PropertiesOriginal ValueComments
Cure Time 10.0 min
@Treatment Temp. 135 °C
postcuring 4h/200°C
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
Colortransparent

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PWACK9519 / 205048

USP Class VI adhesives

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