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IMPLANT GRADE HIGH CONSISTENCY SILICONE
ELASTOMER, ADDITION CURE, HCRA 4750
PN 40115
DESCRIPTION
Applied Silicone Implant Grade High Consistency Silicone Elastomer (HCR) 40115 is a two-part, platinum-catalyzed
dimethyl silicone elastomer designed for use in extrusion processes where greater productivity and dimensional control are
desired. HCRA 4750 is optimized for long, catalyzed table life, high plasticity, and rapid vulcanization in short dwell cure
ovens delivering increased output and reduced scrap.
FEATURES
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Excellent table life after mixing
Excellent extrudability and dimensional control
Non-tacky surface
No cure by-products
Reduced scrap rate
High strength, high elongation, high tear
Tested per ISO 10993-1 for long term implantation
Compendium to support regulatory submissions for long -term implantation is available
TYPICAL PROPERTIES
These values are not intended for use in preparing specifications
Test
Results
40115
UNCURED PROPERTY:
Appearance
Consistency
Colorless, Translucent Gum
Non-flowable Gum
CURED PROPERTY*
Durometer, Shore A
Tensile Strength, psi
Elongation, %
Tear Strength, ppi
Specific Gravity
Linear Shrinkage, %
Cytotoxicity
Trace Metals Analysis
50
1550
900
250
1.16
3.0
Non-Toxic
Meets Specification
*Compression molded 10 minutes @ 116°C
*Extended post cure may alter physical properties
APPLICATIONS
Applied Silicone Implant Grade High Consistency Addition Cure HCRA 4750 is mixed in equal parts using standard two-roll
mill rubber processing techniques. Care must be taken to work in a clean area with clean equipment. 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 the components together. Do not allow material temperature to exceed 35°C during the milling. Mixed material
should be used within 6-8 hours after mixing to prevent structuring and premature crosslinking. Post cure is recommended to
stabilize physical properties. Typical post-cure is 2-4 hours at 175°C.
PRECAUTIONS
A Material Safety Data Sheet (MSDS) is supplied with each shipment. 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 that can interfere with the cure of this material and should be avoided. Latex gloves should never be used while
fabricating or handling products or components utilizing this product.
Mix only what is intended for use. Mixed shelf life at room temperature is approximately 6-8 hours. Mixed material can be
stored at lower temperatures to extend pot life. To avoid “gels” and imperfections in final product, clean mixing and
processing equipment thoroughly of cured residue to avoid becoming incorporated into subsequent batches.
Accurate measuring and complete mixing are important factors in obtaining consistent results. Contamination can result in an
unreliable cure. Avoid sulfur or amine containing materials that can poison the platinum catalyst.
BIOCOMPATIBILITY
This material was designed and tested to meet ISO 10993 requirements for long-term implantation. Master Access Files,
including formulation, manufacturing methods, testing, and toxicology have been filed with the U.S. Food and Drug
Administration. A sample from each manufactured lot is subjected to MEM Tissue Culture testing. A Compendium
Summary of physiochemical testing to support regulatory submission for long term implantation is available upon request.
TRACE METALS ANALYSIS
Trace Metals Analysis Testing meets the following specification criteria of elements set forth in the ISO 14949 STANDARD:
Al < 200 ppm Na, Mg, Ca < 100 ppm P, Ti, Fe < 50 ppm Sb, Ge, Mn, Mo, Pb, Sn, Cr, Bi, V, Ag, Co, Ni, Cu, Zr Ba, As, Zn,
Se, Cd, Hg, Tl < 10 ppm. This product is neither designed to nor does it comply with the ISO 14949 standard.
LOT TESTING
Each production lot is certified as having met specifications for durometer, tensile, elongation, tear resistance, specific gravity,
trace metals analysis, and Cytotoxicity screening.
PACKAGING AND STORAGE
Packaging is available in 44-pound (20-kg) kits. This material should be stored under cool and dry conditions. Containers
should be sealed to avoid contamination. Material should be stored in original, unopened containers at ambient conditions
below 43°C (110°F) to maintain product integrity.
Applied silicone does not specify shelf life. Suggested retest date is six months from date of shipment. Retested materials
found to conform to quality specifications and user’s retest criteria will be suitable for continued use.
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.
U.S. (805) 525-5657 EMAIL siliconesales@appliedsilicone.com
EUROPE +353 (0) 86 8953049 WEB www.appliedsilicone.com