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/2023-12/Avient_ResponsibleCarePolicy_Dec_18_2023.pdf
AVIENT RESPONSIBLE CARE POLICY
Avient Corporation conducts its operations in a manner that is protective
of the environment, and the health, safety and security of associates,
customers, and all our stakeholders, including the communities in which
we operate.
We further define these commitments with individual Policies on
Environment, Safety & Health, Security and Product Stewardship.
https://www.avient.com/sites/default/files/2021-08/avient-cdp-climate-change-questionnaire-2021.pdf
Other, please specify
Environmental, Health and
Safety Committee of the
Board of Directors (Chair
of the Committee)
The Company’s Environmental, Health and Safety Committee (EH&S
Committee) is also tasked with exercising oversight with respect to
the Company’s environmental, health, safety, physical security and
product stewardship policies and practices and the Company’s
compliance with related laws and regulations.
Avient is leading an internal directional movement
to implement digital science and data methods to reduce
our environmental impact.
In 2019, Avient directed $7.87 MM towards environmental, health and
safety capital improvements.
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
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/2021-06/vinod-purayath-bio.pdf
Purayath has achieved
global success in materials development, with a particular emphasis on semiconductor
and digital memory applications.
https://www.avient.com/sites/default/files/2021-06/chemical-resistance-technical-bulletin.pdf
MEDICAL DEVICE DISINFECTION—HOW TO PREVENT
CRACKING AND CRAZING
Understanding polymer performance is key to minimizing
disinfectant-related failures
DISINFECTANT-RELATED DAMAGE
ON POLYMER HOUSINGS
Strong chemicals used to reduce hospital-
acquired infections can damage equipment
and result in material failures, such as:
• Stress cracking
• Crazing
• Discoloration
CHEMICAL RESISTANCE REQUIREMENTS
VARY BY ENVIRONMENT
• Patient/exam rooms
• Operating and radiology rooms
• Reception areas
• Home (patient equipment & devices)
Healthcare devices must perform flawlessly in a myriad of challenging environments and engineers must
be certain their devices can withstand increasingly potent disinfectants, which have begun to outstrip
the performance of traditional polymers.
Additionally, the wide variability of environments that medical
devices might see, which can range from home to hospital, mean devices must be able to withstand varying
disinfectant strengths, exposure levels and frequencies.
Whether you are designing for a medical device housing or a surgical device in the operating room, we offer
solutions to meet a wide variety of performance specifications and application needs.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
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/2022-12/Mevopur Colors for Ophthalmic Closures Application Bulletin_A4.pdf
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/2022-12/Mevopur Healthcare Functional Additives Pharma Pkg Application Bulletin.pdf
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.