https://www.avient.com/sites/default/files/2024-03/QF-02 QMS Global Standard Response.PDF
Avient Colorants Sweden AB in Malmoe and Avient Colorants USA LLC in Lewiston, Maine are Medical
Centers of Competence with an external ISO 13485 certification.
Validation
Avient Colorants Sweden AB and Avient Colorants
Lewiston, ME follow the Global Harmonization Task
Force guideline GHTF/SG3/N99-10 to define the
procedure for process validation.
https://www.avient.com/resources/safety-data-sheets?page=3624
GREEN ABS 348C
693177 MILANI GOLD ABS
LT BLUE PE
https://www.avient.com/sites/default/files/2023-04/Advanced simulation captures part performance for fibre reinforced thermoplastics_Case_Study.pdf
© 2022 Hexagon AB and/or its subsidiaries and affiliates.
https://www.avient.com/sites/default/files/2020-07/tpes-for-healthcare-industry-bulletin.pdf
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
CL E SERIES
• Increase clarity and
flexibility in bags,
bottles and films
• Mitigate risk with
plasticizer-free
formulations for
film extrusion
• Deliver excellent
odor & O2 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 plasticizersVersaflex™ 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 & O2 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
aestheticsVersalloy™ 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/2025-03/65536-Certificate-05MAR2024.pdf
Certificate Avient Corporation
This is to certify that the Responsible Care Management System of:
Avon Lake Corporate
33587 Walker Road
Avon Lake OH
44012
United States
(WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the
requirements set forth by:
The Responsible Care Management System is applicable to:
CORPORATE SUPPORT ACTIVITIES, DESIGN, MANUFACTURE AND DISTRIBUTION OF COLOUR
AND ADDITIVE CONCENTRATES, THERMOPLASTIC RESINS AND PELLETS, SPECIALTY
COMPOUNDS AND COLORANTS.
https://www.avient.com/sites/default/files/2025-02/31307-Certificate-17JUL2024.pdf
Certificate Avient Corporation
S
E
s
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation
33587 Walker Road, Building 428
Avon Lake OH
44012
United States
has been assessed by ABS Quality Evaluations, Inc. and found to be in
conformance with the requirements set forth by:
ISO 9001:2015
The Quality Management System is applicable to:
Manufacture of plastic compounds, color and performance additives, engineered
thermoplastics, vinyl resins, custom mixed plastic materials, custom and commodity colorants
for plastics, polyurethane systems, and plasticizers with design and sampling support at
Suwanee, GA, and purchasing, customer service, logistics, quality, design and sampling
support at PolyOne Corporate Headquarters at Avon Lake, OH, and distribution of resins
Certificate No: 31307
Certification Date: 12 OCT 1995
Effective Date: 11 JUL 2024
Expiration Date 07 OCT 2025
Revision Date: 17 JUL 2024
Dominic Townsend, President
Page 1 of 4
S
E
s
ISO 9001:2015
Certificate Of Conformance
ANNEX
Certificate No.: 31307
Avient Corporation
At the below facilities
The Manufacture of Pultruded and Filament wound components Pultrusion and CRTM 3943, Valley East Industrial
Drive, Buildings 1,2,3,4
Birmingham - AL 35217 United
The Manufacture of Pultruded and Filament wound components Pultrusion and Filament Wound
Tubing
3968, Valley East Industrial
Drive, Building 5 Birmingham -
AL 35217 United States
The Manufacture of Pultruded and Filament wound components Pultrusion 3950, Valley East Industrial
Drive, Building 6 Birmingham -
AL 3517 United States
Corporation
Management of QMS.
https://www.avient.com/products/engineered-polymer-formulations/general-engineered-formulations/artisan-pre-colored-thermoplastics-premium-finishes
Additionally, ABS formulations expand customizable colors to include metallic effects and offer enhanced scratch and chemical resistance for use in electronics, home appliances, and cosmetic packaging.
ABS grades offering good scratch and chemical resistance with the ability to retain as high as 94% gloss.
Artisan™ high-gloss, metallic effect ABS formulation provided paint replacement solution to meet electronic applications needs
https://www.avient.com/resources/safety-data-sheets?page=3352
COOL GRAY 3C ABS
COOL GRAY 1C ABS
BLUE ABS MB
https://www.avient.com/resources/safety-data-sheets?page=5645
WHITE HELMET ABS
DARK GREEN HELMET ABS
ROYAL BLUE HELMET ABS
https://www.avient.com/resources/safety-data-sheets?page=5958
ABS 75% LIGHT DIFFUSER CMPD
ABS 50% LIGHT DIFFUSER CMPD
ABS AQUA BLUE 7711C