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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.

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 PropertiesMetricEnglishComments
Density 1.18 g/cc0.0426 lb/in³DIN 53479
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 6060DIN 53505
Tensile Strength at Break 10.5 MPa1520 psiDIN 53505 S1
Elongation at Break 480 %480 %DIN 53505 S1
Rebound 48 %48 %DIN 53512
Tear Strength 33.0 kN/m188 pliASTM D624B
Compression Set 31 %
@Temperature 175 °C,
Time 79200 sec
31 %
@Temperature 347 °F,
Time 22.0 hour
DIN ISO 815-B
 
Optical PropertiesMetricEnglishComments
Transmission, Visible 90 %90 %"Transparent" but manufacturer does not quantify.
 
Processing PropertiesMetricEnglishComments
Cure Time 10.0 min
@Treatment Temp. 135 °C
0.167 hour
@Treatment Temp. 275 °F
postcuring 4h/200°C
 
Compliance PropertiesMetricEnglishComments
USP Class VI YesYes
 
Descriptive Properties
Colortransparent

Some of the values displayed above may have been converted from their original units and/or rounded in order to display the information in a consistent format. Users requiring more precise data for scientific or engineering calculations can click on the property value to see the original value as well as raw conversions to equivalent units. We advise that you only use the original value or one of its raw conversions in your calculations to minimize rounding error. We also ask that you refer to MatWeb's terms of use regarding this information. Click here to view all the property values for this datasheet as they were originally entered into MatWeb.

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PWACK9519 / 205048

USP Class VI adhesives

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