Applied Silicone's Implant Grade High Consistency Addition Cure Extrudable (HCRA) 4700 Series are two part platinum catalyzed silicone elastomers designed for use in processes where high strength extruded or molded parts are desired.  This material is specially formulated for rapid vulcanization in short dwell cure ovens.  HCRA 4700 Series contains 100% by weight of dimethyl silicone elastomer when cured.  This product is supplied in two components consisting of equal amounts of Part A and Part B.

Our medical grade products are manufactured under a fully traceable quality system that is ISO 9001 Certified.  The stringent biocompatibility requirements imposed upon these materials make this series of elastomers ideally suited for use in critical implantable medical devices.  Important characteristics include:

▪ Good potlife
▪ Good extrudability
▪ No cure by-products
▪ Non-tacky surface
▪ Non-blooming
▪ No peroxide residues
▪ Tested under FDA protocol

This material is developmental and is intended for long term medical contact or implantation.  Our medical implant products are designed and tested to meet many of the ISO 10993 biocompatibility test requirements for long term implantable materials which an create substantial savings in product development testing and time-to-market.  As a developmental material, all bio-testing for this material may not be completed.  The user of this material must independently determine that any medical product incorporating this material is safe and effective. 

Applied Silicone recommends that product designers using this material contact Applied Silicone Corporation's Regulatory Affairs to determine what test results are available before incorporating this material into a medical device.   

This product was designed to be mixed in equal parts using standard rubber processing techniques such as two roll milling.  Care must be taken to work in a clean area with clean equipment, as traces of foreign materials can poison the catalyst, and inhibit the cure.  For optimum results, freshen both parts separately on a two roll mill before mixing them.  Do not allow material temperature to exceed 30°C during the milling.  Mixed material should be used within four hours to prevent structuring and premature crosslinking.  Store mixed material in a freezer to extend the working time.  HAV cure is typically achieved in three seconds at 593°C.  Post cure is recommended to stabilize physical properties.  Typical postcure is one hour at 165°C.

Accurate measuring and complete mixing are important factors in obtaining consistent results.  Contamination by trace amounts of compounds containing sulfur, amines, and organometallic salts can result in an unreliable cure of the material.  Organic rubbers and tin catalyzed silicones often contain compounds which can interfere with the cure of this material and should be avoided.  HCRA begins to cure in about 120 minutes at room temperature.  Mix components and use promptly for best results.  Clean equipment thoroughly to avoid cured residue which may result in crumbs of elastomer being picked up by the next lot causing "gels " and imperfections.

Mix only what is intended for use.  Mixed shelf life at room temperature is approximately four hours.  Mixed material can be stored at lower temperatures to extend pot life.

Packaging is available in 50 pound kits.  This material should be stored under cool and dry conditions.  Containers should be sealed to avoid contamination.

Suggested retest is at six months from the date of shipment.

DISCLAIMER 
 
Applied Silicone Corporation warrants that this product meets applicable descriptions and specifications for a period of six months from shipment.  No other warranties, expressed or implied, are intended.  This product was designed for sophisticated users.  The user must carefully review literature for uses where adverse effects are reported for certain applications of silicone in medical devices.  The user of this material must independently determine that any product incorporating this material is safe and effective.  The user of this material must thoroughly test any application consistent with industry requirements and/or standards.  Applied Silicone Corporation disclaims any expressed or implied warranty against the infringement of any patent.  Any suggestion of use by Applied Silicone should not be taken as inducement to infringe on any particular patent. 

 Revised 02.25.03