https://www.avient.com/sites/default/files/2023-10/ISO13485 -2016 - 2021.2.20~2024.2.19 -EN.pdf
China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤) For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴;舞蒸;撇蒸 (non-implantable) :护、::于b入沙黔娜;舞睡莎:器器舞蟒檬非拟拐称群亘爸竺舀‘。
https://www.avient.com/sites/default/files/2020-10/case-study-one-pager-trilliant-xr-xray-glasses.pdf
MEDICAL EQUIPMENT MANUFACTURER S U R G I C A L X - R A Y G L A S S E S • Replace lead while providing uniform shielding performance • Radiation shielding up to 140KeV • Improve glasses design • Compliance with Radiation Protection Regulation: Adult eye exposure must be below 20 mSv per calendar year • Conducted extensive testing to ensure comparable and uniform shielding performance • Improved geometric flexibility • Lowered shielding component costs 30-50% by eliminating machining and assembly steps (associated with lead) • Reduced weight of the glasses and enabled a more ergonomic design • Eliminated disposal concerns associated with lead Trilliant™ XR Lead Replacement Thermoplastics KEY REQUIREMENTS WHY AVIENT?
All Rights Reserved. https://www.avient.com/products/engineered-polymer-formulations/conductive-signal-radiation-shielding-formulations/trilliant Medical equipment manufacturer
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
SPECIALTY ENGINEERED MATERIALS FOR HEALTHCARE PRODUCT SELECTION GUIDE Careful consideration must be given to materials used for medical devices and their impact on patient safety.
Common applications include medical device overmolds, medical and biopharma tubing, and gaskets and stoppers.
MATERIAL DESCRIPTION BASE RESIN Trilliant™ HC2020 Copolyester Trilliant™ HC8910/8920 Polyketone/ABS blend Trilliant™ HC2120 Tritan Trilliant™ HC3120 PC Trilliant™ HC5210 PP Trilliant™ HC6010 PA6 Trilliant™ HC6610 PA66 Trilliant™ GRV-NP-110-W PA12 TRILLIANT™ HC THERMOPLASTICS • Chemically resistant replacement for FR PC/ABS, FR PC/PET & FR COPE, providing UL 94 Yellow Card V-0 flame rating at 1.5 mm, V-1 at 0.75 mm thicknesses for a broad color spectrum • Outperforms PC/ABS, PC/PET and COPE in resistance to common disinfectants • Retains tensile strength after 72-hour exposure to common hospital disinfectants, and shows better long-term chemical resistance as compared to PC blends and COPE • Exhibits good impact and temperature resistance • Available in natural grades, standard medical colors, or custom pre-colored products Applications: • Medical device housings • MRI, X-ray, CT scanner components • Surgical instruments such as staplers, dissectors, scissors • Auto-injector pen TRILLIANT™ HC ELECTRICALLY CONDUCTIVE FORMULATIONS • Consistent conductivity ensures repeatable part performance and minimizes failures related to inconsistent electrical conductivity • High flow and easy processing facilitate filling of thin wall parts and multiple cavity tools, which enable faster cycle times and lower per-unit part costs • Superior durability reduces breakage and resultant scrap related costs • Less tendency to flash results in improved appearance and less fluid retention in or on the tip, thus driving greater accuracy and less potential for cross-contamination • High strength produces parts with greater stiffness and warp resistance, again minimizing scrap-related costs Applications: • Conductive pipette tips TEST TEMS SPECIFIC GRAVITY MELT FLOW RATE (230OC, 2.16KG) TENSILE STRENGTH FLEXURAL STRENGTH FLEXURAL MODULUS IMPACT STRENGTH NOTCHED, IZOD SURFACE RESISTIVITY Method ASTM D-792 ASTM D-1238 ASTM D-638 ASTM D-790 ASTM D-790 ASTM D-256 ASTM D-257 Unit -- g/10min MPa MPa MPa J/m Ohms/sq.
https://www.avient.com/resource-center/knowledge-base/article/selecting-and-molding-high-performance-thermoplastics
Recently, high-performance thermoplastics have been tapped for specialized 3D printed applications in aerospace and medical markets.
https://www.avient.com/sites/default/files/2024-11/Stan-Tone HC Plus Product Bulletin_0.pdf
These USP-compliant colorants are available in liquid silicone rubber (LSR) and high consistency silicone rubber (HCR) forms and can be customized for specific medical uses.
These high-quality silicone dispersions excel in sterilization capabilities while maintaining low toxicity, making them ideal for medical applications.
KEY CHARACTERISTICS • Meets USP Class VI standards • Biocompatible • Provides lightfastness, chemical resistance, and heat stability • Available in standard single pigment or custom multi-pigment colors • LSR and HCR options available TARGET APPLICATIONS Stan-Tone HC Plus silicone dispersions are suitable for a variety of healthcare applications including: • Catheters and medical tubing • Medical and surgical equipment • Labware and diagnostic devices • Specialty medical devices and wearables Product Code Pigment Type % Pigment (approx.)
https://www.avient.com/sites/default/files/2023-07/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 GRADES • Improve extrusion rates, achieve high service temperature performance or increase clarity in medical tubing • Traditional and bio- based formulations specifically for biopharmaceutical tubing to meet the 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 • 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 & O2 barrier performance for film extrusion INDUSTRY BULLETIN TPE HEALTHCARE PRODUCT SELECTOR GUIDE Versaflex™ HC Medical Tubing Grades 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 Versalfex™ HC BIO BT218 Natural 70A 0.88 18 58 416 2.87 668 4.60 1190 8.20 630 - - ✔ ✔ Weldable, kink resistant, contains 40% bio-derived content (Gen 1 biomass) 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 ✔ ✔ Versaflex™ OM 8940X-1 Clear 42A 0.91 - - 233 - 311 - 1573 - 1059 - - - - PK, COPE overmold Versaflex™ OM 4052 Natural 56A 1.01 27 - 271 - 557 - 1680 - 670 - - ✔ - Excellent chemical resistance; PK, PC, ABS, PC/ABS overmoldVersaflex™ OM 4063 Natural 54A 1.12 30 - 365 - 580 - 1640 - 670 - - ✔ - 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/2023-06/AVIENT_TPEs and LSR eBook.pdf
These properties make TPEs useful in medical applications such as disposable gloves that serve as a guard against biohazards and pathogens without concern for latex allergies.
WE’VE GOT YOU COVERED. http://www.art.canaco.org https://www.avient.com/sites/default/files/2020-11/gls-acqua-plose-case-study.pdf 1http://store.elsevier.com/Handbook-of-Polymer-Applications-in-Medicine- and-Medical-Devices/isbn-9780323221696/ Tear Resistance PERFORMANCE COMPARISON In Handbook of Polymer Applications in Medicine and Medical Devices,1 Laurence W.
Medical-grade TPEs can rival LSR in biocompatibility performance, depending on their chemistry.
https://www.avient.com/industries/packaging/beverage-packaging/water
Medical Tubing
Medical Packaging
Medical Packaging
https://www.avient.com/sites/default/files/2024-09/Chemical Resistance Technical Bulletin %281%29.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/2023-05/Mevopur Healthcare Colorants and Formulations Amber for Pharma 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.