https://www.avient.com/sites/default/files/resources/US_Avon%2520Lake%2520POC_RCMS%25202013.pdf
Microsoft Word - 55453- PolyOne Corporation RCMS 2013 Option 2.docx
ABS Quality Evaluations
Letter Of Conformity
Page 1 of 1
This is to confirm that the Environment, Health, Safety and Security Management System of:
PolyOne Corporation
33587 Walker Road
Avon Lake, OH 44012
U.S.A.
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
RCMS®:2013 (Option 2)
The Environment, Health, Safety and Security Management System is applicable to:
Responsible Care Management System activities and corporate supported processes
associated with the design and manufacture of plastic compounds, colorants,
thermoplastic elastomer compounds, color concentrates and compounding of
thermoplastic products.
https://www.avient.com/sites/default/files/resources/US_Terre%2520Haute_RCMS%25202013.pdf
Microsoft Word - 55543 Letter of Conformity RCMS Option 2 .docx
ABS Quality Evaluations
Letter Of Conformity
This is to confirm that the Environment, Health, Safety and Security Management System of:
PolyOne Corporation
3100 North 35th Street
Terre Haute, IN 47804
U.S.A.
WITH ADDITIONAL FACILITIES LISTED ON THE ATTACHED ANNEX)
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
RCMS®:2013 (Option 2)
The Environment, Health, Safety and Security Management System is applicable to:
Design and Manufacture of Plastic Compounds
Certificate No: 55543
Effective Date 21 December 2017
ABS Quality Evaluations, Inc. 16855 Northchase Drive, Houston, TX 77060, U.S.A.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-bt218-biopharmaceutical-tubing-case-study.pdf
MEDICAL TUBING
EXTRUDER
B I O P H A R M A C E U T I C A L
T U B I N G
• Low leachables & extractables
• Great tensile performance and kink resistance
• Good thermal weldability
• Excellent clarity and medical blue tint
• ISO 10993-4 & 5, USP Class VI & Animal Derivative Free
(ADF)
• Supplied drop-in material replacement to
overcome supply constraints of incumbent TPE
• Offered a lower extractable profile than
comparable materials in the market
• Enabled easy material transition without changes
in tooling or thermal welding machine settings
• Formulated solution with proprietary additives to
provide clarity and prevent yellowing after
sterilization
Versaflex™ HC BT218 Thermoplastic
Elastomer
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2023-12/Avient_ProdStewardship_Policy_Dec_18_2023.pdf
Consider environmental, health and safety impacts into product
design, manufacture, use, reuse, recycling and disposal
Promote openness and two-way communication with key
stakeholders regarding environmental, health and safety measures
and risks associated with use, storage, transportation and disposal
of our products.
https://www.avient.com/sites/default/files/2020-07/ISO 45001 14 March 2026.pdf
This is to certify that the Occupational Health and Safety Management of:
PolyOne Polymers India Pvt.
F-27, MIDC,
Ranjangaon, Shirur,
Pune, Maharashtra 412 220
India
ISO 45001:2018
The Occupational Health and Safety Management is applicable to:
Certificate No: 55689
Certification Date: 15 March 2017
Effective Date: 09 March 2023
Expiration Date: 14 March 2026
Revision Date: 15 March 2023 Dominic Townsend, President
DESIGN MANUFACTURE OF COLOR MASTER BATCHES, ADDITIVES CONCENTRATES AND SPECIALTY
COMPOUNDS.
https://www.avient.com/sites/default/files/2025-01/Stethoscope Dispersions Case Study Snapshot.pdf
MEDICAL DEVICE
MA NUFAC TURER
S T E T H O S C O P E S
• Provide a silicone paste colorant dispersion for liquid silicone
rubber (LSR) to use in stethoscope ear tips
• Create a custom-colored vinyl plastisol formulation for
stethoscope tubing
• Harmonize color across materials to meet specific process
and performance requirements
• Deliver effective communication and cross-functional
collaboration
• Offered dependable silicone paste colorants
that allowed for comfort and easy sterilization
• Provided a colored vinyl plastisol to reduce
tackiness and support product longevity
• Collaborated internally to align all materials and
provide color consistency across components
• Supported fast color changes and met quality
specifications through constant communication
and technical expertise
Silcopas Silicone Paste Colorants and
CORE Vinyl Plastisols for Healthcare
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare
https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber
Slide 1: Medical device manufacturer
https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
Fast, accurate and reliable results
aid medical professionals to understand the
illness and develop the strategy for an effective
treatment.
It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including
the suitability of all raw materials and components used for its manufacture.
https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
Common healthcare applications include medical tubing,
gaskets and stoppers, bags, bottles and films, grips, handles and medical devices.
VERSAFLEX™
HC MEDICAL
TUBING SERIES
• Improve extrusion
rates, achieve high
service temperature
performance or
increase clarity
in medical tubing
• Meet
biopharmaceutical
needs for weldability
and minimize
extractables during
processing
VERSALLOY™
HC SERIES
• Obtain better flow in
long, thin paths and
lower shrink rates
versus typical TPVs
with our alloys, made
with Santoprene™
TPV
• Color easily and
obtain a smooth
tactile feel
VERSAFLEX™
HC GASKETS &
STOPPERS SERIES
• Achieve no coring,
good puncture and
resealability in static
stoppers
• Meet low COF
and low stiction
requirements in
dynamic seals
VERSAFLEX™
CL E SERIES
• Increase clarity and
flexibility in bags,
bottles and films
• Mitigate risk with
plasticizer-free
formulations for
film extrusion
• Deliver excellent
odor & O
2
barrier
performance for
film extrusion
INDUSTRY BULLETIN
TPE HEALTHCARE PRODUCT SELECTOR GUIDE
Versaflex™ HC MT Series
Versaflex™ HC MT222 Clear 66A 0.88 14 - 334 2.30 629 4.34 898 6.19 430 220 36 ✔ ✔
High clarity,
without plasticizers
Versaflex™ HC MT224 Clear 75A 0.89 19 - 468 3.23 773 5.33 1360 9.40 530 321 56 ✔ ✔
Versaflex™ HC MT226 Clear 84A 0.88 20 - 606 4.17 885 6.10 1600 11.00 600 433 76 ✔ ✔
Versaflex™ HC MT317 Clear 68A 0.89 17 69 450 3.10 660 4.55 870 6.00 470 221 39 ✔ ✔ Very high service temperature
Versaflex™ HC BT218 Natural 67A 0.89 19 69 381 2.60 683 4.70 1186 8.20 608 - - ✔ ✔ Weldable, kink resistant
Versaflex™ HC Gaskets & Stoppers Series
Versaflex™ HC 2110-35N Natural 34A 0.90 19 47 145 1.00 261 1.80 400 2.76 620 97 17 ✔ ✔ Good resealing
Versaflex™ HC 2110-43N Natural 43A 0.98 12 46 134 0.92 368 2.54 723 4.98 710 - - ✔ ✔ Good compression set
Versaflex™ HC 2110-57B Black 59A 1.01 20 37 369 2.54 558 3.85 537 3.70 350 147 26 ✔ ✔ Low stiction
Versaflex™ CL E Series
Versaflex™ CL E85 Clear 84A 0.90 20 72 752 5.18 1160 8.00 1550 10.70 450 433 76 ✔ ✔
High clarity, without
plasticizers; E95 also offers
excellent odor & O
2
barrier
Versaflex™ CL E90 Clear 90A 0.90 27 73 1000 6.89 1230 8.50 1830 12.60 57 - - ✔ ✔
Versaflex™ CL E95 Clear 95A 0.90 38 71 1680 11.60 1730 11.90 2500 17.20 580 720 126 ✔ ✔
Versaflex™ HC 3810 Series
Versaflex™ HC 3810-20N Natural 20A 0.88 16 54 123 0.80 185 1.30 342 2.40 650 - - ✔ -
Formulated without
animal derivatives,
excellent colorability,
translucent
Versaflex™ HC 3810-30N Natural 30A 0.89 18 58 170 1.20 245 1.70 459 3.20 680 - - ✔ -
Versaflex™ HC 3810-40N Natural 40A 0.88 19 59 191 1.30 275 1.90 506 3.50 670 - - ✔ -
Versaflex™ HC 3810-50N Natural 50A 0.89 21 61 264 1.80 366 2.50 699 4.80 690 - - ✔ -
Versaflex™ HC 3810-60N Natural 60A 0.88 24 65 459 3.20 594 4.10 790 5.40 510 - - ✔ -
Versaflex™ HC 3810-70N Natural 70A 0.88 28 67 535 3.70 684 4.70 1000 6.90 570 - - ✔ -
Versaflex™ HC 3810-80N Natural 80A 0.88 30 67 689 4.80 869 6.00 1390 9.60 620 - - ✔ -
Versaflex™ HC 3810-90N Natural 90A 0.88 27 89 1087 7.50 1350 9.30 1890 13.00 570 - - ✔ -
Versalloy™ HC 9210 Series
Versalloy™ HC 9210-45N Natural 45A 0.89 19 39 160 1.10 320 2.20 484 3.33 480 100 18 - ✔
Smooth surface
aesthetics
Versalloy™ HC 9210-55N Natural 53A 0.89 20 44 208 1.44 335 2.31 580 4.00 610 120 21 - ✔
Versalloy™ HC 9210-70N Natural 70A 0.89 23 53 356 2.45 510 3.52 780 5.38 590 180 32 - ✔
Versalloy™ HC 9220 Series
Versalloy™ HC 9220-70 Natural 70A 0.95 17 51 453 3.12 - - 643 4.43 265 208 36 ✔ ✔
ExtrudableVersalloy™ HC 9220-80 Natural 80A 0.94 18 59 553 3.67 777 5.36 945 6.52 415 208 36 ✔ ✔
Versalloy™ HC 9220-90 Natural 90A 0.94 25 55 1030 8.13 1350 9.33 1945 13.45 620 400 70 ✔ ✔
Standard Healthcare Grades
Versaflex™ G2705N Natural 60A 0.88 - - - - 528 3.64 670 4.62 470 - - ✔ ✔ Natural, high strength
Versaflex™ CL 2242 Clear 43A 0.89 23 - 152 1.05 294 2.02 731 5.00 780 124 22 ✔ ✔
High clarity, boilable
Versaflex™ CL 2250 Clear 50A 0.89 20 - 220 1.52 337 2.32 827 5.70 770 140 25 ✔ ✔
Versaflex™ OM Series
Versaflex™ OM 1040X Natural 42A 0.92 22 - 180 1.24 301 2.08 504 3.47 580 100 18 ✔ ✔ ABS/PC
overmoldVersaflex™ OM 3060 Clear 59A 0.90 33 - 420 2.90 360 2.48 500 3.45 480 180 32 ✔ ✔
Color Hardness Specific Gravity
Compression Set
@ 23°C
Compression Set
@ 100°C
100% Modulus 300% Modulus Tensile Strength Elongation Tear Strength
ISO
10993
USP VI
Special
Characteristics
ASTM Shore A ASTM/ISO ASTM % ASTM % ASTM psi Mpa ASTM psi Mpa ASTM psi ISO Mpa ASTM % ASTM pll ISO kN/m
GENERAL PROPERTIES TENSILE PROPERTIES OTHER
For further information on specific grades, review technical data sheets.
https://www.avient.com/sites/default/files/2022-03/Avient 2021 Annual Report.pdf
Environmental, Health and Safety 4.
Safety and Health
The top priority at Avient is the safety and health of our associates, and our ultimate goal is to operate injury free.
Environmental, Health and Safety 4.