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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.

Momentive Performance Materials Silopren™ LSR 4660 Liquid Silicone Rubber - Healthcare
Categories: Polymer; Thermoset; Rubber or Thermoset Elastomer (TSE); Silicone; Silicone Rubber; Liquid Silicone Rubber (LSR)

Material Notes: LSR elastomers are a two-component, platinum (addition/heat) curable, and pumpable silicone elastomer that can be molded and cured with very fast cycle times, at elevated temperatures. The molding process allows for complex part geometry and exact dimensions. LSR elastomers are generally suitable for short cycle time injection and full automatic flash-less processing. Color pastes are available to pigmenting addition cure productions of LSR's.

All LSR grades are platinum cured materials which are mixed in a 1:1 ratio by weight.

The distinctive properties of silicone elastomers - purity, clarity, strength - coupled with ease of processability, have resulted in their use in a broad range of medical device applications. Silicone materials exhibit exceptional stability over a wide range of temperatures, lending themselves to use in applications requiring repeated sterilization performance.

Typical applications include, but are not limited to:

  • Dental / surgical devices
  • Diagnostics / imaging
  • Fluid and drug delivery devices
  • Orthopedics / prosthetics
  • Scar management
  • Septa / stoppers / laboratory accessories
  • Medical tubing
  • Wound drains and bulbs
  • Sterilization mats
  • Pharmaceutical closures
  • Instrument grips
  • Dialysis o-rings
  • Positioning devices
  • Catheters
  • Seals / o-rings / valves
  • Respiratory / anesthesia
  • Medical equipment keypads

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Physical PropertiesMetricEnglishComments
Specific Gravity 1.13 g/cc1.13 g/cc
Linear Mold Shrinkage 0.027 cm/cm0.027 in/invulcanized 10 sec at 200°C; Without post-cure
 0.035 cm/cm0.035 in/invulcanized 10 sec at 200°C then post-cured
 
Mechanical PropertiesMetricEnglishComments
Hardness, Shore A 6262
Tensile Strength 9.00 MPa1310 psi
Elongation at Break 400 %400 %
Tear Strength 45.0 kN/m257 pliDie B
Compression Set 20 %20 %Post cured
 
Optical PropertiesMetricEnglishComments
Transmission, Visible 80 %80 %transparent; thickness unknown
 
Processing PropertiesMetricEnglishComments
Nozzle Temperature 20.0 °C68.0 °Fcool nozzle and cylinder to prevent premature vulcanization
Mold Temperature 140 - 230 °C284 - 446 °Fshort vulcanization time required (a few seconds)
Injection Pressure 5.00 - 15.0 MPa725 - 2180 psidepends on feed channel
Hold Pressure 5.00 MPa725 psi
 
Compliance PropertiesMetricEnglishComments
FDA YesYesFDA Indirect food contact - Rubber articles intended for repeated use - FDA Reg 21CFR177.2600
USP Class VI YesYesUSP Class VI methods: Intramuscular implantation, intracutaneous injection, & systematic injection
 
Descriptive Properties
AppearanceTransparent
BfRproduct is compositionally compliantRecommendation XV Silicones; post cured (4h/200°C)
ISO10993yes7 ISO 10993 tests applicable to "wet" chemicals

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PGE8V752 / 109012

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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