Product Information

Healthcare DOW CORNING®Class VI

Elastomers (C6-530, C6-540, C6-550
C6-560, C6-570) Parts A & B

FEATURES Liquid Silicone Rubber for device and component fabrication

in the healthcare industry
• Contains no peroxides, peroxide by-
products, chlorophenyls or PCBs
APPLICATIONS
• No organic plasticizers, phthalates or • DOW CORNING Class VI Elastomers (C6-530, C6-540, C6-550, C6-560, C6-570)
latex additives
Parts A & B are platinum-catalyzed materials designed for part fabrication and medical
• Solventless devices, including those intended for implantation in humans for up to 29 days.
• Non-blooming
• Can be post-cured DESCRIPTION HOW TO USE
DOW CORNING Class VI Elastomers These elastomers are supplied as two-
• Pigmentable
(C6-530, C6-540, C6-550, C6-560, component kits (Parts A and B) that
C6-570) Parts A & B are a series of must be thoroughly mixed in equal
BENEFITS portions, by weight, prior to use.
two-part platinum-catalyzed silicone
• Qualified to meet or exceed the test elastomers. Each elastomer is supplied
requirements of: as a two-part kit (Part A and Part B), Airless mixing, metering and
dispensing equipment are
o United States Pharmacopeia equal portions of which must be
recommended for production
(USP) Class VI thoroughly blended together prior to
operations. Information is available
use. The elastomer is thermally cured
o European Pharmacopoeia (Ph. from Dow Corning on the suppliers of
Eur. or EP ) Silicone Elastomers via an addition-cure (platinum- suitable pumping, mixing, and
for Closures and Tubing- catalyzed) reaction. When blended and molding equipment.
Substances soluble in hexane and cured as indicated, the resulting
Volatile matter elastomer consists of crosslinked If hand mixing, a vacuum of 711 to
o ISO 10993-1 Surface devices: dimethyl and methyl-vinyl siloxane 737mm Hg (28 to 29 inches of
cytotoxicity, sensitization and copolymers and reinforcing silica. The mercury) should be sufficient to de-air
irritation/intracutaneous reactivity elastomers are available in a range of the material in 20 to 30 minutes. Use a
• Fast cure system nominal hardness from 30 to 70, container 3-4 times the volume of the
Durometer-Shore A. The elastomers mixture to allow for expansion.
• Easy processing can be used without any post-cure
• Batch-to-batch consistency although if necessary, this may be Cure
employed to stabilize final properties. Cure of the mixed elastomer is
• Cost-effective
Furthermore, the elastomers are heat accelerated by heat. Raising the
stable up to 204°C (400°F), can be temperature of the mixed material to
COMPOSITION autoclaved, and exhibit high gas 110°C (230°F) results in a rapid cure
• Two-part silicone elastomer permeability compared with most to a tough, elastomeric material. Cure
thermoset elastomers and profiles for these products can be
thermoplastics. found in Figures 1 and 2. Please note
that mixing parts A & B at anything
other that a 1:1 ration, by weight, will
likey change the molding times, and
the resulting material's properties. Text
continuation
CAUTION: The cure may be inhibited QUALITY ASSURANCE HANDLING PRECAUTIONS
by traces of amines, sulfur, nitrogen DOW CORNING Class VI materials are Product safety information required for
oxide, organotin compounds and carbon manufactured using appropriate safe use is not included. Before
monoxide. Because organic rubbers principles of Good Manufacturing handling, read product and safety data
often contain these substances, they Practice (GMP) regulations. sheets and container labels for safe use,
should not come in contact with the Dow Corning is globally registered to the physical and health hazard information.
uncured elastomer. Catalyst residues ISO 9001 Quality Standard. Registration The material safety data sheet is
from some room temperature certificate number FM 10734 has been available on the Dow Corning website at
vulcanized and peroxide-cured silicone obtained through the British Standards www.dowcorning.com. You can also
elastomers may also inhibit the cure. Institution (BSI). Certification to ISO obtain a copy from your local
9001 through an independent third party Dow Corning sales representative or
Post-curing indicates that Dow Corning operates a Distributor or by calling your local
These materials crosslink via an quality management system in Dow Corning Global Connection.
addition-cure (platinum-catalyzed) accordance with the standard, ensuring
reaction. No organic residues such as full documentation and traceability. USABLE LIFE AND
peroxides or their by-products are STORAGE
present and post-cure is not normally REGULATORY STATUS When stored at or below ambient
required for most applications. The user DOW CORNING Class VI temperature in the original unopened
must confirm that quick molding or Elastomers, when fully cured and water containers, these products have a usable
short oven cures are suitable for any rinsed, meet the requirements of FDA life of 18 months from the date of
specific application. regulation 21CFR177.2600, “Rubber production.
Articles Intended For Repeated Food
The principal volatile components Contact.”
evolved during post-curing are low PACKAGING
molecular weight polydimethyl- DOW CORNING Class VI Elastomers
IMPORTANT INFORMATION (C6-530, C6-540, C6-550, C6-560, C6-
siloxanes and water vapor.
THE USER'S ATTENTION IS 570) are supplied in 36kg and 400kg (80
See Typical Properties chart (Table 1) IN PARTICULAR DRAWN TO lb and 900 lb) kits, containing equal
for specific post-cure information. THE FOLLOWING portions each of Parts A and B.
STATEMENT:
QUALIFICATION TESTING It is the User's responsibility to ensure
HEALTH AND
The results of selected qualification the safety and efficacy of these materials ENVIRONMENTAL
tests are shown in Table 2. Summaries for all intended uses. While these INFORMATION
of Qualification Data are available upon materials have passed screening tests To support Customers in their product
request. that are applicable to products intended safety needs, Dow Corning has an
to be implanted for up to 29 days, extensive Product Stewardship
ORDERING AND PRODUCT Dow Corning makes no end- use organization and a team of Product
INFORMATION representation based on such testing. Safety and Regulatory Compliance
For ordering and product information, These products are not designed for, (PS&RC) specialists available in each
contact your local Dow Corning Global tested for, intended for and therefore not area.
Connection. suitable for implantation greater than
29 days in the human body. For further information, please see our
website, www.dowcorning.com or
consult your local Dow Corning
representative.

We help you invent the future is a trademark of Dow Corning Corporation.

05/29/2008 Dow Corning is a registered trademark of Dow Corning Corporation.
Ref. No. 52-1027F-01 ©2008 Dow Corning Corporation. All rights reserved.
LIMITED WARRANTY
INFORMATION - PLEASE
READ CAREFULLY
The information contained herein is
offered in good faith and is believed to
be accurate. However, because
conditions and methods of use of our
products are beyond our control, this
information should not be used in
substitution for customer's tests to
ensure that Dow Corning's products are
safe, effective, and fully satisfactory for
the intended end use. Suggestions of
use shall not be taken as inducements to
infringe any patent.

Dow Corning's sole warranty is that the

product will meet the Dow Corning
sales specifications in effect at the time
of shipment.

Your exclusive remedy for breach of

such warranty is limited to refund of
purchase price or replacement of any
product shown to be other than as
warranted.

DOW CORNING SPECIFICALLY

DISCLAIMS ANY OTHER
EXPRESS OR IMPLIED
WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE OR
MERCHANTABILITY.

DOW CORNING DISCLAIMS

LIABILITY FOR ANY
INCIDENTAL OR
CONSEQUENTIAL DAMAGES.

We help you invent the future.™

www.dowcorning.com

We help you invent the future is a trademark of Dow Corning Corporation.

05/29/2008 Dow Corning is a registered trademark of Dow Corning Corporation.
Ref. No. 52-1027F-01 ©2008 Dow Corning Corporation. All rights reserved.
 We help you invent the future is a trademark of Dow Corning Corporation.
05/29/2008 Dow Corning is a registered trademark of Dow Corning Corporation.
Ref. No. 52-1027F-01 ©2008 Dow Corning Corporation. All rights reserved.
Table 1: TYPICAL PROPERTIES¹
Specification writers: These values are not intended for use in preparing specifications. Please contact your local Dow Corning
representative prior to writing specifications on this product.
CTM² ASTM³ Test Unit C6-530 C6-540 C6-550 C6-560 C6-570
No Post-cure
0022 D792 Relative density 1.13 1.13 1.14 1.10 1.15
0099 D2240 Durometer hardness, shore A 30 40 52 58 65
0137A D412 Tensile strength MPa 8.20 8.92 10.47 8.83 9.13
psi 1190 1394 1518 1280 1324
0137A D412 Elongation % 831 742 661 540 442
0137A D412 Modulus, 200% MPa 0.89 2.12 3.20 3.97 5.24
Psi 129 308 464 575 760
0159A D624 Tear strength - Die B kN/m 27.5 41.9 44.7 50.9 53.9
ppi 157 239 255 290 308
1057 Shrinkage, linear % 2.0 2.0 2.0 2.7 1.9
Post-cured - 2 hours at 177°C (350°F)
0099 D2240 Durometer hardness, shore A 31 43 54 58 66
0137A D412 Tensile strength MPa 9.09 8.73 9.23 8.8 8.92
psi 1318 1266 1339 1276 1294
0137A D412 Elongation % 833 642 530 503 380
0137A D412 Modulus, 200% MPa 1.15 2.70 3.92 4.27 5.78
psi 167 391 569 619 839
0159A D624 Tear strength - Die B kN/m 28.2 45.0 49.0 47.5 49.4
ppi 161 257 280 271 282
Post-cured - 4 hours at 177°C (350°F)
0099 D2240 Durometer hardness, shore A 32 42 54 59 67
0137A D412 Tensile strength MPa 8.51 8.72 9.04 8.79 9.05
psi 1235 1265 1311 1274 1313
0137A D412 Elongation % 793 659 522 518 394
0137A D412 Modulus, 200% MPa 1.05 2.48 3.92 4.21 5.67
psi 152 359 569 610 823
0159A D624 Tear strength - Die B kN/m 26.3 44.8 48.2 49.5 49.7
ppi 150 256 275 282 284
Post-cured - 8 hours at 177°C (350°F)
0099 D2240 Durometer hardness, shore A 33 44 55 59 67
0137A D412 Tensile strength MPa 8.30 9.48 9.11 8.55 9.12
psi 1204 1375 1322 1240 1323
0137A D412 Elongation % 796 660 508 492 386
0137A D412 Modulus, 200% MPa 1.10 2.85 4.12 4.29 5.83
psi 160 413 598 622 846
0159A D624 Tear strength - Die B kN/m 27.0 45.7 49.9 50.7 50.3
1. Properties obtained from 1.905mm (0.075 inch) thick ASTM slab cured 5 minutes at 150°C (302°F) and allowed to equilibrate a minimum of 3
hours at ambient conditions.
2. Corporate test method (CTM) procedures correspond to standard ASTM tests in most instances. Copies of CTMs are available upon request.
3. ASTM: American Society for Testing and Materials.

We help you invent the future is a trademark of Dow Corning Corporation.

05/29/2008 Dow Corning is a registered trademark of Dow Corning Corporation.
Ref. No. 52-1027F-01 ©2008 Dow Corning Corporation. All rights reserved.