https://www.avient.com/sites/default/files/2021-medical-devices-selection-guide.pdf
Copolyester, Polyester & PC/Polyester Blends Copolyester Eastman Tritan™ (Copolyester) High chemical resistance to a wide variety of hospital disinfectants; excellent toughness and impact resistance after disinfection; retains color and gloss after sterilization and disinfection; does not contain BPA, BPS or halogens Polybutylene Terephthalate (PBT) DuPont™ Crastin® & Rynite® (FR-PBT) 30% glass reinforced; flame retardant; good mold flow and electrical properties; high strength, stiffness, dimensional stability and heat resistance Polyester (PC/PET) & Polybutylene Terephthalate (PC/PBT) Covestro Makroblend® (FR-PC/PET) & (FR-PC/PBT) Strength; toughness; chemical resistance; flame retardant Covestro Makroblend® (Non-FR PC/PBT) Strength; toughness; chemical resistance; limited biocompatibility Trinseo EMERGE™ (FR-PC/PET) Chemical resistance; ignition resistance; limited biocompatibility PA, PVC, PC & PMMA Polyamide (Nylon, PA) Avient Trilliant™ XR Radiation Shielding (PA) Radiation shielding; green alternative for lead replacement; enhanced design freedom vs. lead; available in hard and soft durometers Arkema Rilsan® MED (PA11) & Rilsamid® MED (PA12) Chemical resistance; transparent and opaque; easy processing; creep resistance; temperature resistance; BPA-free; sterilizable by gamma, EtO and steam Polyvinyl Chloride GEON Performance Solutions Resilience™ HC (PVC) Excellent chemical resistance; good strength and stiffness; very good surface quality; inherently flame resistant; available in all medical colors; excellent solvent bonding to PVC Polycarbonate (PC) Trinseo EMERGE™ (PC) Ignition resistant; transparent and opaque; glass-filled also available PolyMethyl Methacrylate (PMMA) Trinseo Plexiglas® Acrylics (PMMA) Clarity; easy processing; chemical resistance; BPA free; ideal for light piping and lenses Styrenics & FR-PC/ABS Blends Styrenics Trinseo MAGNUM™ (ABS) Opaque; custom colors; excellent impact and flow; low residuals; full biocompatibility INEOS Styrolution Terlux® HD (MABS) Good clarity; good heat and overall chemical resistance; good impact strength; good solvent bonding to PVC; outstanding surface quality INEOS Styrolution Lustran® & Novodur® HD (ABS) Opaque appearance; outstanding chemical resistance; high impact strength; excellent balance of properties; ease of processability; bondable FR- Polycarbonate/ ABS (FR-PC/ABS) Covestro Bayblend® (FR-PC/ABS) Flame retardant; good impact resistance; dimensional stability; toughness Trinseo EMERGE™ (FR-PC/ABS) Ignition resistant; limited biocompatibility; high flow; easy processing; glass-filled also available RIGID COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, Applications include: • Housings • Covers • Monitor bezels • Body panels • Handles • Access panels • Battery enclosures • Wands • Coils Rigid Component Solution Needs: • Materials compliant with ISO 10993 & USP Class VI, if required • UL approved resins to meet flammability requirements • Housings with toughness & good impact resistance • Enclosures & components that withstand repeated cleanings • High-flow materials for components with complex designs FLEXIBLE COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, Applications include: • O-rings • Gaskets • Wheels • Soft touch grips/handles • Keypads/displays • Diaphragms • Seals Flexible Component Solution Needs: • Comfortable handles & grips • Water-tight seals • Durable feet or casters • Durable keypads • Flow control TPE, TPC-ET, TPU, TPV & Flexible PVC Thermoplastic Avient Versaflex™ HC Overmolding Series Proven healthcare solutions with hardness ranges 42–65 Shore A; autoclave, radiation and EtO sterilizable; bondable to many substrates; customizable haptics Arkema Pebax® MED Sterilizable by gamma and EtO; low energy return; soft touch; chemical resistance; overmolding material Thermoplastic Polyester DuPont™ Hytrel® Wide range of flexibility, stiffness, and processing options; Shore D between 30-82; BPA-free; excellent flex fatigue and toughness; low temperature flexibility; good chemical resistance Thermoplastic Polyurethane Covestro Texin® Biocompatible; soft touch; sterilizable; good chemical resistance; overmold for grips and handles; excellent bonding to polar substrates like PC; 70A to 95A Thermoplastic Vulcanizate Avient Versalloy™ Proven healthcare solutions with hardness ranges 45–90 Shore A; autoclave, radiation and EtO sterilizable; natural and colorable; smooth texture; bonds to PP Exxon Mobil Santoprene™ Durable sealing performance; elastic recovery; excellent chemical resistance; compliance with medical standards Flexible Polyvinyl Chloride GEON Performance Solutions Geon™ Flexible PVC Engineered exclusively for the healthcare market; transparent and opaque colors; radiopaque grades available; durometer ranges from 55A to 40D; gamma and EtO sterilizable Thermoset Silicone Elastomers Thermoset Silicone Elastomers/ Liquid Silicone Rubber (LSR) DuPont™ Liveo™ Silicone Elastomers (LSR) Biocompatible; non-irritating and non-sensitization; sterilizable; made without plasticizers, phthalates or latex PVC Polyvinyl Chloride GEON Performance Solutions Geon™ Flexible PVC Inherent flame resistance; halogen-free; excellent chemical resistance; non-yellowing; proven safety record in wire and cable applications; high temperature grades available TPE, TPC-ET, TPU & POE Thermoplastic Polyester Arkema Pebax® Flexibility; chemical resistance; easy processing; abrasion resistance; low coefficient of friction Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® REACH, RoHS and WEEE compliant; wide range of flexibility, stiffness, and processing options; 30D-82D; BPA-free; excellent flex fatigue and toughness; low temperature flexibility; good chemical resistance Thermoplastic Polyurethane Covestro Texin® RoHs, WEEE, and REACH compliant; excellent memory and recoil; abrasion resistance; Texin® Rx Series - medical grade Polyether TPU – 70A to 80D Polyolefin Elastomer (POE) Avient ECCOH™ Non-halogenated flame retardant; high flexibility; environmental stress cracking resistance (ESCR); good electrical properties PA Polyamide (Nylon, PA) Arkema Rilsan® (PA) Chemical resistance; easy processing; abrasion resistance; low coefficient of friction; dimensional stability WIRE & CABLE: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, Applications include: • Plug molding • Flexible jacket • Heater cable insulation • Flexible cords • Coil cords & cable Wire & Cable Component Solution Needs: • Materials compliant with UL, RoHS, REACH & WEEE, if needed • Materials with good chemical, moisture & abrasion resistance • Low smoke & non-halogen materials CUSTOM AVIENT SOLUTIONS FOR MEDICAL EQUIPMENT Custom Solution Needs Avient™ Custom Solutions Specialized materials to meet unique application requirements Avient Trilliant™ Healthcare products are a line of customized solutions specific for regulated medical devices; color branding expertise FDA-registered pre-colored resins and masterbatch options; color coding for safety and brand recognition Avient collaborates with key material suppliers to provide FDA-approved pre-colored resins Avient OnColor™ HC Plus offers customizable color masterbatch solutions pre-certified for biocompatibility using ISO 10993 and USP Class VI test protocol Reduced growth of microbes Avient WithStand™ additive technologies inhibit growth of microbes that often cause odor, staining and loss of mechanical properties AVIENT DISTRIBUTION Healthcare Supplier Line Card You face a unique set of challenges when designing parts for the healthcare industry.
https://www.avient.com/sites/default/files/2021-02/2021-medical-devices-selection-guide.pdf
RIGID COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, & MONITORING EQUIPMENT (housings & covers, monitor bezels, body panels, handles, battery enclosures, access panels, wands, coils) Rigid Component Materials compliant with ISO 10993 & USP Class VI, if required UL approved resins to meet flammability requirements Housings with toughness & good impact resistance Enclosures & components that withstand repeated cleanings High-flow materials for components with complex designs Copolyester, Polyester & PC/Polyester Blends Copolyester Eastman Tritan™ (Copolyester) High chemical resistance to a wide variety of hospital disinfectants; excellent toughness and impact resistance after disinfection; retains color and gloss after sterilization and disinfection; does not contain BPA, BPS or halogens Polybutylene Terephthalate (PBT) DuPont™ Crastin® & Rynite® (FR- PBT) 30% glass reinforced; flame retardant; good mold flow and electrical properties; high strength, stiffness, dimensional stability and heat resistance Polyester (PC/PET) & Polybutylene Terephthalate (PC/PBT) Covestro Makroblend® (FR-PC/PET) & (FR-PC/PBT) Strength; toughness; chemical resistance; flame retardant Covestro Makroblend® (Non-FR PC/PBT) Strength; toughness; chemical resistance; limited biocompatibility Trinseo EMERGE™ (FR-PC/PET) Chemical resistance; ignition resistance; limited biocompatibility PA, PVC, PC & PMMA Polyamide (Nylon, PA) Avient Trilliant™ XR Radiation Shielding (PA) Radiation shielding; green alternative for lead replacement; enhanced design freedom vs. lead; available in hard and soft durometers Arkema Rilsan® MED (PA11) & Rilsamid® MED (PA12) Chemical resistance; transparent and opaque; easy processing; creep resistance; temperature resistance; BPA-free; sterilizable by gamma, EtO and steam Polyvinyl Chloride GEON Performance Solutions Resilience™ HC (PVC) Excellent chemical resistance; good strength and stiffness; very good surface quality; inherently flame resistant; available in all medical colors; excellent solvent bonding to PVC Polycarbonate (PC) Trinseo EMERGE™ (PC) Ignition resistant; transparent and opaque; glass-filled also available PolyMethyl Methacrylate (PMMA) Altuglas Plexiglas® Acrylics (PMMA) Clarity; easy processing; chemical resistance; BPA free; ideal for light piping and lenses Styrenics & FR-PC/ABS Blends Styrenics Trinseo MAGNUM™ (ABS) Opaque; custom colors; excellent impact and flow; low residuals; full biocompatibility INEOS Styrolution Terlux® HD (MABS) Good clarity; good heat and overall chemical resistance; good impact strength; good solvent bonding to PVC; outstanding surface quality INEOS Styrolution Lustran® & Novodur® HD (ABS) Opaque appearance; outstanding chemical resistance; high impact strength; excellent balance of properties; ease of processability; bondable FR- Polycarbonate/ ABS Covestro Bayblend® Flame retardant; good impact resistance; dimensional stability; toughness Trinseo EMERGE™ Ignition resistant; limited biocompatibility; high flow; easy processing; glass-filled also available Flexible Component Solution Needs: Comfortable handles & grips Water-tight seals Durable feet or casters Durable keypads Flow control TPE, TPC-ET, TPU, TPV & Flexible PVC Thermoplastic Avient Versaflex™ HC Overmolding Series Proven healthcare solutions with hardness ranges 42–65 Shore A; autoclave, radiation and EtO sterilizable; bondable to many substrates; customizable haptics Arkema Pebax® MED Sterilizable by gamma and EtO; low energy return; soft touch; chemical resistance; overmolding material Thermoplastic Polyester DuPont™ Hytrel® Wide range of flexibility, stiffness, and processing options; Shore D between 30-82; BPA-free; excellent flex fatigue and toughness; low temperature flexibility; good chemical resistance Thermoplastic Polyurethane Covestro Texin® Biocompatible; soft touch; sterilizable; good chemical resistance; overmold for grips and handles; excellent bonding to polar substrates like PC; 70A to 95A Thermoplastic Vulcanizate (TPV) Avient Versalloy™ (TPV) Proven healthcare solutions with hardness ranges 45–90 Shore A; autoclave, radiation and EtO sterilizable; natural and colorable; smooth texture; bonds to PP Exxon Mobil Santoprene™ (TPV) Durable sealing performance; elastic recovery; excellent chemical resistance; compliance with medical standards Flexible Polyvinyl Chloride GEON Performance Solutions Geon™ Flexible PVC Engineered exclusively for the healthcare market; transparent and opaque colors; radiopaque grades available; durometer ranges from 55A to 40D; gamma and EtO sterilizable Thermoset Silicone Elastomers Thermoset Silicone Elastomers/ Liquid Silicone Rubber DuPont™ Liveo™ Silicone Elastomers (LSR) Biocompatible; non-irritating and non-sensitization; sterilizable; made without plasticizers, phthalates or latex FLEXIBLE COMPONENTS: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, MONITORING EQUIPMENT (o-rings, gaskets, wheels, soft touch grips/handles, keypads/displays, diaphragms, seals) WIRE & CABLE: DIAGNOSTIC, IMAGING, LIFE SUPPORT, LABORATORY, & MONITORING EQUIPMENT (plug molding, heater cable insulation, flexible jacket, flexible cords, coil cords & cable) Wire and Cable Component Solution Needs: Materials compliant with UL, RoHS, REACH & WEEE, if needed Materials with good chemical, moisture & abrasion resistance Low smoke & non- halogen materials PVC Polyvinyl Chloride GEON Performance Solutions Geon™ Flexible PVC Inherent flame resistance; halogen-free; excellent chemical resistance; non-yellowing; proven safety record in wire and cable applications; high temperature grades available TPE, TPC-ET, TPU & POE Thermoplastic Polyester Arkema Pebax® Flexibility; chemical resistance; easy processing; abrasion resistance; low coefficient of friction Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® REACH, RoHS and WEEE compliant; wide range of flexibility, stiffness, and processing options; 30D-82D; BPA-free; excellent flex fatigue and toughness; low temperature flexibility; good chemical resistance Thermoplastic Polyurethane Covestro Texin® RoHs, WEEE, and REACH compliant; excellent memory and recoil; abrasion resistance; Texin® Rx Series - medical grade Polyether TPU – 70A to 80D Polyolefin Elastomer (POE) Avient ECCOH™ Non-halogenated flame retardant; high flexibility; environmental stress cracking resistance (ESCR); good electrical properties PA Polyamide (Nylon, PA) Arkema Rilsan® (PA) Chemical resistance; easy processing; abrasion resistance; low coefficient of friction; dimensional stability CUSTOM AVIENT SOLUTIONS FOR MEDICAL EQUIPMENT Custom Solution Needs Avient™ Custom Solutions Specialized materials to meet unique application requirements Avient Trilliant™ Healthcare products are a line of customized solutions specific for regulated medical devices; color branding expertise FDA-registered pre-colored resins and masterbatch options; color coding for safety and brand recognition Avient collaborates with key material suppliers to provide FDA-approved pre-colored resins Avient OnColor™ HC Plus offers customizable color masterbatch solutions pre-certified for biocompatibility using ISO 10993 and USP Class VI test protocol Reduced growth of microbes Avient WithStand™ additive technologies inhibit growth of microbes that often cause odor, staining and loss of mechanical properties AVIENT DISTRIBUTION Healthcare Supplier Line Card You face a unique set of challenges when designing parts for the healthcare industry.
https://www.avient.com/sites/default/files/2020-12/sem-tri-fold-selection-guide.pdf
a wholly-owned subsidiary of Avient Corporation NAME BASE RESIN(S) AVAILABLE FEATURES1 Trilliant™ ABS, LCP, PA, PC, ABS, PA 6, PA 66, PC/ABS, PC/PSU, PEBA, PEEK, PES, POM, PPA, PSU Certified to USP Class VI Formulations locked down Drug master file submissions by product stewardship Pre-colored, small lot production down to 50 lb–250 lb Sterilization, chemical resistance, and secondary process guidance Adherence to FDM-GMP manufacturing standards Antimicrobial technologies Materials for radiation shielding protection NEU™ Specialty Materials2 PEBA, TPU, PA 11, PA 12, PP, PE, TPE Radiopacifiers, stabilizers, and surface modifiers Antimicrobial technologies Pre-colored formulations Small lot capabilities Short lead times Versaflex™ HC TPE Overmolding Clear and heat resistant Ultra clear grades Ultra soft TPE gels, 30 shore OO FDA, USP Class VI, ISO 10993 approved grades Sterilizable under autoclave, radiation, and EtO gas HEALTHCARE SPECIALTY THERMOPLASTICS reSound™ R Recycled Formulations PA6, PA66, PC Transportation, Consumer, Household Appliance, Electrical & Electronics, PA grades: Up to 100% recycled content PC grades: Up to 70% recycled content PIR and PCR grades available Support the circular economy Comparable performance to prime grades Customizable solution Surround™ ABS, PP, PBT, PC, PA 66 Transportation, Electrical Integrated EMI/RFI shielding Long fiber technology Conductive properties Galvanic corrosion protection Lightweighting and ease of processing Stat-Tech™ ABS, PA, PC, PC/ABS, PC/PSU, PEEK, PEI, PES, PP, PPA Transportation, Electrical Integrated EMI/RFI shielding Conductive properties Anti-static/dissipative properties Corrosion resistance Lightweighting and ease of processing Clean room materials for semiconductors available Therma-Tech™ LCP, PA, PEEK, PP, PPA, PPS Consumer, Transportation Thermally conductive Low coefficient of thermal expansion SPECIALTY ENGINEERED THERMOPLASTICS Barricade™ Elastomers with Fortrex™ Technology Barricade™ high-performance elastomers bring next genera- tion technology to market to bridge the gap between tradi- tional TPEs and silicone Healthcare, Industrial Aerospace, Appliances, Electronics High temperature compression set Processes on thermoplastic injection molding and extrusion equipment Customizable and colorable Process simplicity CROSSLINKABLE ELASTOMERS Barricade formulations leverage licensed Fortrex™ technology. Consumer, Packaging, Healthcare, Electrical & Electronics, Appliance Clear and heat resistant TPEs Ultra clear grades Ultra soft TPE gels, 30 shore OO FDA, USP Class VI, ISO 10993 approved grades NSF and UL listings Sterilizable under autoclave, radiation, and EtO gas GLS™ THERMOPLASTIC ELASTOMERS * Commercially available in North America only NAME BASE RESIN(S) AVAILABLE FEATURES1 ECCOH™ Polyolefin Flame retardant, low smoke and fume, zero halogen (LSFOH) Cross-linkable grades Chemical, oil, and gel resistant Flexible, low friction, easy-peel, and high speed processing Compatible with Avient additives and color masterbatches FireCon™ CPE, CPE Alloy Low and medium voltage cable jacketing Flame retardant and 90°C deformation resistance Oil resistance RoHS grades available Maxxam™ FR PE, PP UL Yellow Card for plenum applications Halogen-free flame retardant grades available Maxxam™ SY Foamable PP co-polymer Easy processing Variety of final densities available Syncure™ XLPE High performance moisture cure technology UL bulletinized XHHW2 and VW1 Temperature, abrasion, and oil resistant WIRE AND CABLE SPECIALTY THERMOPLASTICS To learn more, please visit avient.com or call +1.844.4AVIENT (+1.844.428.4368).
https://www.avient.com/sites/default/files/2023-11/AS9100 REV D_Hatfield PA.pdf
AS9100 Certication DEKRA CERTIFICATE Certificate Number: 131789.01 The Aerospace Quality Management System and implementation of: Fiber-Line, LLC With Central Functions At: 3050 Campus Drive Hatfield, PA 19440 United States The certification has been performed in accordance with the requirements of AS9104/1:2012, including its implementation, and meets the requirements of the standard: AS9100D (Based on and including ISO 9001:2015) Scope: The value added design and development of synthetic fiber products for use in public and private sectors.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%25209001_2015%2520EXP%25202021.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain 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: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
https://www.avient.com/sites/default/files/resources/Polyone%2520Barbastro_ISO%252014001_2015_EXP%25202021_0.pdf
Industrial Valle del Cinca s/n Apartado 18 22300 Barbastro, Huesca Spain has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: ISO 14001:2015 The Environment Management System is applicable to: DEVELOPMENT, PRODUCTION & DISTRIBUTION OF TECHNICAL THERMOPLASTICS.
https://www.avient.com/sites/default/files/2024-05/Avient Zertifikat deutsch - 2024.pdf
Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.
https://www.avient.com/sites/default/files/2021-04/versaflex-hc-3810-covid-19-containment-tube-screw-caps-case-study.pdf
DIAGNOSTICS MANUFACTURER C O V I D - 1 9 C O N T A I N M E N T T U B E S C R E W C A P S • Wide range of durometers with consistent raw materials • Processing consistencies across the durometer ranges for an easy transition between materials • Materials formulated without animal derivatives at a competitive cost • Offered a comprehensive range of solutions to accommodate specific application demands such as barrier, flexibility, and sealing performance • Provided materials manufactured in an ISO 13485 certified facility • Delivered a series of medical-grade TPEs that could be extruded and injection molded Versaflex™ HC 3810 Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?
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/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
Certificate Number: Certificate expiration date: Effective date: 31-10-2022 30-10-2025 Expiry date of previous cycle: 30-10-2022 31-10-2016 ES133794 Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRY ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.