Restricted Healthcare Materials Selection Guide
Restricted Healthcare Materials Selection Guide
Restricted Healthcare Materials Selection Guide
Biological Data
The following table lists the biological testing conducted on most materials found in this selection guide. These materials meet or exceed
all USP Class VI and many ISO-10993 test requirements.
Warranty Statement
NuSil Technology’s warranty period is product-specific and is provided
on the Product Profile and Material Certification. The warranty
period begins on the date of shipment when stored below 40° C in
original unopened containers. Unless NuSil Technology provides you
with a specific written warranty of fitness for a particular use, NuSil
Technology’s sole warranty is that the product will meet our current
specification. It is the sole responsibility of each purchaser to ensure
that any use of these materials is safe and complies with all applicable
laws and regulations. It is the user’s responsibility to adequately test
and determine the safety and suitability for their applications and
NuSil Technology makes no warranty concerning fitness for any use
or purpose.
1
Improving Adhesion
NuSil Technology specializes in helping our customers solve
complex problems related to the processing and adhesion of
silicones. In general, silicones adhere quite well to substrates
such as ceramics, glass, metals, urethanes, and other silicones.
Substrates with low surface energy, such as plastics, are difficult
to bond with silicone adhesives. Modification of the surface of
the substrate allows the adhesive to spread well, allowing both
chemical and mechanical interactions. Many substrates need
to have the surface “activated” to enhance the adhesive’s bond
to the substrate. Common techniques can be used to improve
the adhesive bond such as: primers, plasma, corona, flame
treatment or abrasion of the substrate’s surface. These surface
treatments enhance the adhesive bond; however, the type of
treatment is dependent on configuration complexity, silicone
adhesive and substrates. Adhesion is a very complex subject
that incorporates principles from several scientific disciplines.
For more information on adhesion, please review our White
Papers at www.nusil.com/whitepapers.
Inhibition
NuSil Technology’s adhesives, gels, and elastomers are designed
to provide optimal mechanical and physical properties. Some
ingredients commonly found in certain adhesives, plastics, and
elastomers adversely affect the cure in these products. NuSil
recommends analyzing adhesives, plastics and elastomers
for cure inhibition prior to selecting the silicone material for
use. This evaluation includes materials used in any transfer
containers, dispensing hoses, or utensils that come in direct
contact with the silicone materials. Please visit our website to
find listings of common silicone inhibitors at www.nusil.com/
whitepapers/resources.
2
Storage and Handling of Primers
SILICONE ADHESIVES, SEALANTS AND PRIMERS The following procedures are recommended for best bonding results with
HCARE MA primers:
TERIALS 1. Decant the amount of primer needed for use into a secondary container.
2. Containers should remain sealed when not in use. Silicone
primers will react with atmospheric moisture and hydrolyze.
Precautions should be taken to minimize exposure to moisture.
Note: The formation of moderate amounts of precipitate as a result
of hydrolyzation is inherent in this material and will not adversely
affect the performance of the material.
Silicone adhesives are elastomers or pressure sensitive adhesive systems that are designed to bond silicone surfaces to each other and to other 3. It is recommended to fill empty space in container with a dry gas such
substrate surfaces such as metals and plastics. There are one-part and two-part adhesives, ranging in consistency from flowable to non-flowable as nitrogen or argon.
(non-slump). Silicone primers are specially formulated silanes supplied in a solvent that are used to improve the bond strength between a silicone 4. Discard primer from the secondary container once finished using this
elastomer or adhesive and another substrate surface (silicone, metals, and certain plastics). amount of primer. Do not return the primer from the secondary container
to the original container.
NuSil’s Work Time Certified Durometer Tensile Elongation Tear Specific Stress @ Strain
Restricted Cure Mix Cure Rheology
Comments @ 25 °C Type A psi (MPa) % ppi (kN/m) Gravity psi (MPa) @ %
Product System Ratio Schedule**
Numbers Typical Time / °C Certified Typical Certified Typical Certified Typical Certified Typical Typical Typical Typical
NuSil’s
Work Time Certified Cure Durometer Tensile Elongation Tear Specific Extrusion Stress @ Strain
Restricted Cure
Comments @ 25 °C Mix Ratio Schedule** Type A psi (MPa) % ppi (kN/m) Gravity Rate psi (MPa) @ %
Product System
Time / °C
Numbers Typical Certified Typical Certified Typical Certified Typical Certified Typical Typical Typical Typical
5 6
HIGH PLATINUM CURE
CONSISTENCY
RUBBERS
High consistency rubber, or HCR, consists of high molecular weight polymer combined with silica to produce a material that can be molded,
extruded, or calendared into a useful end product. An HCR has the consistency of clay and is primarily formulated in a one or two part system Vulcanization
(peroxide and platinum catalysts respectively). Although a set cure time is achieved with the pre-measured
catalyst, the cure of a blended elastomer can be accelerated with
Important Properties of Platinum Cure High Processing heat. Attempting to change molding times by mixing the two
Consistency Rubbers components in any other than the specified ratio, will change the
Most platinum cure high consistency rubbers are two component When mixing platinum cure HCRs on a two-roll mill, to avoid properties of the elastomer. To vary the rate of cure, only adjust the
systems with an easy-to-work-with 1:1 mix ratio. Features of inhibiting the cure, work in a meticulously clean area with no temperature.
platinum cure high consistency rubbers include the following: organic rubbers used on the same equipment. Traces of foreign
• Two part (typically) materials can poison the catalyst, thus inhibiting the cure. Cure Inhibition
• Heat accelerated
Blending The cure may be inhibited by traces of amines, sulfur, nitrogen
• No byproducts
oxide, organotin compounds, and carbon monoxide, often found
• Post cure optional To blend, separately soften Parts A and B on a cooled two-roll mill, in organic rubbers. Catalyst residues from silicone RTV elastomers
• Low percent shrinkage then combine both components in equal portions on the mill. For and peroxide-cured silicone elastomers may also inhibit the cure.
maximum table life, keep the temperature of the blended material
as low as possible. Carefully wrapped blended material may be Post-Curing
stored in a freezer for up to 7 days. Before unwrapping, heat the
material to room temperature so as to avoid condensation, which No byproducts are present and post cure is not required for many
may cause voids in molded or extruded parts. applications. The user must confirm that press molding or short
oven-cures are suitable for any specific application.
NuSil’s Work Certified Durometer Tensile Elongation Tear Specific Plasticity Stress @ Strain
Restricted Cure Time @ Mix Cure Post Cure
Comments Type A psi (MPa) % ppi (kN/m) Gravity mils psi (MPa) @ %
Product System 25 ºC Ratio Schedule** Time / ºC
Numbers Typical Time / ºC Certified Typical Certified Typical Certified Typical Certified Typical Typical Typical Typical
Processing
Prior to use, soften the HCR on a two-roll mill. If the HCR base is
HCRs can be used for extrusion of tubing and profiles (rod or ribbon), in calendared sheeting for die-cutting, or in compression or transfer molded not catalyzed, add the peroxide catalyst after softening the base.
parts such as balloons, gaskets or o-rings. HCRs are clay-like in the uncured state and when cured generally exhibit very high mechanical properties A minimum of 10 passes on the two-roll mill should be used to
and low modulus. ensure the catalyst is uniformly mixed into the base.
Vulcanization
Important Properties of Peroxide Cure High Additional Features
The cure rates of HCRs with preblended peroxide catalyst can be
Consistency Rubbers • Green strength- ideal for extrusion processes
varied by adjusting the initial cure temperature. If the peroxide
HCRs with a peroxide cure system have a long history in implant • Low modulus compared to other elastomer systems
catalyst is added on the mill at the time of use, the amount of
applications. The cure mechanism can be vinyl specific or non vinyl • Wide range of available durometers
catalyst can be adjusted to vary the cure rate (Note this may also
specific. Non vinyl specific peroxide catalysts are more commonly affect the ultimate cured physical properties).
used with HCRs than vinyl specific peroxide catalysts. Features of
peroxide cure high consistency rubbers include the following:
Cure Inhibition
• One or two part
• Indefinite work time Depending on the peroxide catalyst used, cure inhibition may or
• Heat required may not be an issue. Understanding the chemistry of the specific
• Acid or alcohol byproducts peroxide catalyst to be used is needed to determine what, if
• Post cure required anything, will inhibit the cure.
• % shrinkage ~2 -5%
Post-Curing
Post cure is dependant on the peroxide catalyst used. Consult
catalyst specific literature to determine the appropriate post cure
time and temperature.
9 10
HCARE MA
TERIALS
LOW CONSISTENCY ELASTOMERS
Low consistency elastomers (LCEs) are useful alternatives to liquid silicone rubber (LSR) and high consistency rubber (HCR) for end users who need
Mixing and De-airing
a low viscosity elastomer which provides other unique properties. When mixing by hand or with a propeller-type mixer, scrape
the container’s sides and corners to ensure the Part A and B are
homogeneously mixed. Using Planetary and Dual Asymmetric
Important Properties of Low Consistency Processing LCEs
Centrifugal mixers is another method for mixing materials
Elastomers One advantage of LCEs is their adjustable cure schedule, which rapidly and thoroughly. With these types of mixers, heat can be
LCEs lend themselves to applications that require a pourable, self- allows curing at various temperatures. In some applications, generated through shear caused by the mixing process and can
leveling silicone. Applications include: encapsulating a device, due to equipment limitations or heat sensitive materials within have an adverse effect on the pot life of the silicone. Adjust mixing
backfilling a void, potting an electronic component that cannot the assembly, higher temperatures can not be used and a low times and speed to minimize heat. To enable airless mixing and
withstand exposure to high heat, or prototyping a mold. Features curing temperature is required. Another advantage of curing at dispensing, most low consistency elastomers are available in
of low consistency elastomers may include the following: lower temperatures is avoiding common defects such as bowing, convenient side by side kit packaging.
• Optically clear warping and delamination caused by heating bonded materials
• Self-leveling with different coefficients of thermal expansion (CTE). Yet these While very low viscosity materials may not require de-airing, NuSil
• Low and high temperature cure same silicones are also designed to allow the engineer to accelerate recommends slowly applying vacuum up to approximately 28
• Low viscosity the cure time with heat and allow more efficient processing times inches of mercury (0.95 Barr). Hold vacuum until bubbles are no
• Easy to process and reduce production cost. Contact NuSil Technology for more longer observed. Periodically release the vacuum to allow bubbles
information on the recommended cure schedules of different to burst and subsequently expedite the de-airing process. This
products. process can be accomplished with an industry standard vacuum
chamber and vacuum pump. A standard centrifuge is also an
adequate tool for removing air in low consistency elastomer.
DISPERSIONS
MED-2014 ONE PART, IN XYLENE PLATINUM N/A 1 PART *1 31-45 35 1200 (8.3) 1800 (12.4) 700 800 100 (17.6) 185 (33.6) 1.10 3,500 150 (1.0) @ 200
MED10-6400 1.43 R.I. IN XYLENE PLATINUM 24 h 1:1 *2 20-35 30 950 (6.6) 1500 (10.3) 600 775 130 (22.8) 150 (26.3) 1.08 600 350 (2.4) @ 300
MED10-6600 1.46 R.I. IN XYLENE PLATINUM 24 h 1:1 *2 15-30 25 700 (4.8) 1200 (8.3) 550 750 80 (14.1) 125 (22.0) 1.10 400 325 (2.2) @ 300
MED11-6604 ONE PART, SMOOTH FINISH IN THF ACETOXY N/A 1 PART 1 d / R.T. 10-25 15 45 (0.3) 75 (0.5) 150 375 5 (0.88) 12 (2.1) 0.99 250 -
MED10-6605 ONE PART, IN XYLENE ACETOXY N/A 1 PART 5 d / R.T. 20-30 25 1000 (6.9) 1425 (9.8) 550 950 50 (8.8) 125 (22.0) 1.09 700 160 (1.1) @ 300
MED16-6606 ONE PART ADHESIVE, IN HEPTANE ACETOXY N/A 1 PART 3 d / R.T. 10-30 20 870 (6.0) 1250 (8.6) 450 900 52 (9.1) 115 (20.3) 1.11 95 50 (0.34) @ 100
MED10-6607 ONE PART, IN NAPHTHA OXIME N/A 1 PART 7 d / R.T. 35-45 40 600 (4.1) 1250 (8.6) 500 650 80 (14.1) 95 (16.8) 1.11 6,000 -
MED10-6640 ULTRA HIGH TEAR, IN XYLENE PLATINUM 24 h 1:1 *2 30-50 40 1500 (10.3) 1700 (11.7) 750 1000 240 (42.0) 300 (52.9) 1.12 3,500 155 (1.0) @ 100
MED10-6655 100M% FLUOROSILICONE ACETOXY N/A 1 PART 3 d / R.T.,H 30-45 35 600 (4.1) 775 (5.3) 200 425 - 45 (7.9) - 700 -
SPECIALTY DISPERSIONS
MED-4159 LOW CROSSLINK DENSITY AMINE N/A 1 PART 7 d / R.T. - - - - - - - - 0.87 200 -
MED10-4161 AMINO FUNCTIONAL SILICONE COATING AMINE N/A 1 PART 5 d / R.T. 10 - 40 (00) 25 (00) - - - - - - 0.87 140 -
MED-4162 LUBRICIOUS COATING IN XYLENE NON-CURING N/A 1 PART - - - - - - - - - - 27,000 -
MED10-6670 LOW COEFFICIENT OF FRICTION COATING PLATINUM 24 h 1:1 5 m / 150 - - - - - - - - 0.96 - -
INKS
MED-6608-X RTV INK AVAILABLE IN WHITE & BLACK OXIME N/A 1 PART 7 d / R.T. - 30 - 300 (2.1) - 200 - - - 1,150 -
MED8-6608-2 RTV BLACK INK, INCREASED HIDING POWER OXIME N/A 1 PART 7 d / R.T. - - - - - - - - 1.83 800 -
MED-6613-X HEAT CURABLE INKS IN VARIOUS COLORS PLATINUM N/A 1:1 5 m / 150 - - - - - - - - - 2,000 -
** Test specimen cure parameters d = days *1) 1h / 50°C + 1h / 150°C
h = hours *2) 30m / 25°C + 45m / 75°C + 135m / 150°C
m = minutes
R.T. = Room temperature
13 H = Humidity
14
SILICONE FLUIDS AND GREASES
HCARE MA
TERIALS
Fluids are non-curing, stable silicone polymers typically used as lubricants. Fluids are available in a variety of viscosities. Depending on the
viscosity, fluids can be applied by spraying, dipping, wiping, or brushing. For optimal performance, the chemistry of the fluid should not match
the chemistry of the substrate being lubricated. If unsure of the compatibility of the substrate and lubricant, contact the supplier of each material
for assistance.
FLUIDS
MED-361 DIMETHYL POLYMER 1 PART 0.97 100 - 100,000
MED-400 FLUOROSILICONE POLYMER 1 PART 1.26 350 - 100,000
MED-420 METHYL FLUORO COPOLYMER (LOW FLUORO) 1 PART 1.05 100 - 100,000
MED-460 METHYL FLUORO COPOLYMER (HIGH FLUORO) 1 PART 1.21 250 - 12,500
GREASES
MED-6731 HEAVY CONSISTENCY METHYL FLUORO GREASE 1 PART 1.22 2,000,000
MED-9011 LOW CONSISTENCY GREASE 1 PART 1.03 100,000
MED-9021 MEDIUM CONSISTENCY GREASE 1 PART 1.08 350,000
MED-9031 HEAVY CONSISTENCY GREASE 1 PART 1.10 1,000,000
15
Blending Fluids
Polydimethylsiloxane fluids of different viscosities can be mixed together to create a fluid with an intermediate viscosity. The chart featured here is
a guide to blending fluids depending on the desired viscosity. Follow the directions below to determine the right amount of each fluid to mix:
1. Know the viscosities of the fluids to be blended.
2. Find the lower viscosity on the scale at the left side of the chart (e.g. “500”).
3. Find the higher viscosity on the scale at the right side of the chart (e.g. “4,500”).
4. Draw a straight line between these two points, as shown below.
5. Find the desired viscosity (e.g. “3,800”) on the chart and draw another straight line between the two points (Scale is the same on both left
and right).
6. At the point where the desired viscosity intersects with the line you constructed, draw another straight line down to the bottom of
the chart.
7. Find the percent of the higher viscosity fluid to be blended. This is indicated on the scale at the bottom of the chart (e.g. 83%).
To achieve a viscosity of 3,800 cP as shown in the example, mix 83% of 4500 cP and 17% of 500 cP fluids. The percentages of the two fluids
to be blended will add up to 100%.
This method is reasonably accurate in yielding the necessary blend ratio when the difference in viscosity is one magnitude (one power of ten) or
smaller. If the fluids have a greater difference in viscosity, the desired viscosity will most likely not appear on the line drawn between the viscosities
of the fluids to be blended.
Fluid Solubility
Different silicone fluids may be more easily dispersed in some solvents compared to others. The following chart features a list of common solvents
and the general solubility of silicone fluids to them.
16
HCARE MA
TERIALS
SILICONE GELS
Tacky Gels
Silicone tacky gels are ideal for processing into sheets or pads
for various topical applications requiring a temporary adhesive.
Some key examples include:
• Wound care
A silicone gel is an unreinforced, loosely crosslinked network of polymers. Due to the lack of reinforcing filler, gels tend to be low in viscosity in the • Scar management therapies
uncured state, allowing flexibility for various processing techniques. Not only can the crosslink density of the silicone polymers be designed to yield • Transdermal therapeutic systems
a very firm or soft gel, but the work time and cure profile can also be modified. Accordingly, gels can be used in a variety of applications, including • Face masks
sheeting and encapsulating sensors or electronic devices. Additionally, NuSil’s restricted tacky gels can be used as temporary adhesives. • Ostomy and incontinence care products
GELS
MED-6340 LOW PENETRATION, LOW TACK GEL PLATINUM 3h 1:1 30 m / 140 - - - 3 (0.1) - - - - 0.97 8,000
51 g / 3.2 mm / 15 s
MED-6342 LOW PENETRATION, HIGH TACK GEL PLATINUM 10 h 1:1 45 m / 135 - - - 1.25 (0.05) - - - - - 8,000
19.5 g / 6.35 mm / 5 s
MED-6345 MEDIUM PENETRATION, MEDIUM TACK GEL PLATINUM 30 m 1:1 3 h / 60 - - - 5 (0.2) - - - - 0.97 12,750
19.5 g / 6.35 mm / 15 s
MED-6350 LOW PENETRATION, MEDIUM TACK GEL PLATINUM 2h 1:1 30 m / 100 - - - 1.7 (0.07) - - - - - 22,000
19.5 g / 6.35 mm / 15 s
MED12-6381 FIRM RTV GEL CONDENSATION N/A 97:2.5:0.5 30 m / 25 24 h / 25 65 (00) 75 (00) - 45 (0.3) 70 (0.48) - 125 0.98 10,000
** Test specimen cure parameters h = hours s = seconds
m = minutes mm = millimeters
in = inches
g = grams
17 18