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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® 6400/60 A/B Liquid Silicone Rubber
Categories: Polymer; Thermoset; Silicone; Silicone Rubber; Liquid Silicone Rubber (LSR)

Material Notes: Liquid silicone rubber of the SILPURAN® 6400 series is a paste-like, easily-pigmentable two-component compound with short curing times. Their vulcanizates are noted for their high transparency and excellent mechanical and electrical properties. Especially they are noted for an excellent tear resistance according to ASTM D 624 B and DIN ISO 34-1 Method A (DIN 53507).

Properties: SILPURAN® 6400/60 A/B 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.

Special features: A master file has been filed with the U.S. Food and Drug Administration.

Application: SILPURAN® 6400/60 A/B is particularly suitable for the economical production of large series of injection-moulded articles. SILPURAN® 6400/60 A/B is designed for medical and pharmaceutical 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 1.13 g/ccDIN EN ISO 1183-1 A
Viscosity 430000 cP
@Shear Rate 10.0 1/s
DIN 53019
 1.30e+7 cP
@Shear Rate 1.00 1/s
DIN 53019
 
Mechanical PropertiesOriginal ValueComments
Hardness, Shore A 60DIN 53505
Tensile Strength at Break 8.80 MPaDIN 53505 S1
Elongation at Break 350 %DIN 53505 S1
Rebound 65 %DIN 53512
Tear Strength 14.0 kN/mDIN ISO 34-1 method A
 43.0 kN/mASTM D624B
Compression Set 19 %
@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 5.00 min
@Treatment Temp. 165 °C
postcuring for 4 h/200 °C in ventilated air.
 5.00 min
@Treatment Temp. 165 °C
postcuring for 6 h/200 °C in ventilated air.
 
Compliance PropertiesOriginal ValueComments
USP Class VI Yes
 
Descriptive Properties
Colortransparent

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PWACK9494 / 205023

USP Class VI adhesives

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