https://www.avient.com/sites/default/files/2020-07/versaflex-cpap-tubing-film.pdf
Versaflex - CPAP tubing film CPAP TUBING C O R R U G A T E D T U B I N G F I L M • Replacement for polyolefins • Good spring-back • Bondable cuffs • Clear & clean look • Minimize humidity and condensation within the tube • No noticeable odor • FDA, ISO 10993 & USP VI compatible • Provided TPE solution to meet market expectations for improved user comfort & aesthetics • Reduced tube noise and improved drape compliance with new material solution versus polyolefins • Offered solution with improved thermal properties to combat humidity Versaflex™ CL2250 KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2023-12/Versaflex OM TPEs for Sealing Ring of Blood Lancet.pdf
BLOOD LANCET MANUFACTURER S E A L I N G R I N G • Compliance with strict regulations for medical materials • Excellent sealing performance • Good compression set • Provided a recycled TPE solutions compared to silicone without increasing system cost • Delivered a TPE that complied with ISO 10993-4 & -5 and USP Class VI • Supported a change to an injection molded material to ease production and enhance assembly capabilities Versaflex™ HC TPEs – OM1040-1 Grade KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2023-11/Versaflex HC -Syringe tip cap-Case study snapshot.pdf
PRE-FILLED SYRINGE COMPANY S Y R I N G E T I P C A P • Excellent sealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliant with ISO 10993-4&5 and USP Class VI • Formulated a solution that met rigorous medical application requirements • Leveraged global footprint to ensure supply continuity • Increased process efficiency by replacing previous thermoset material with a TPE Versaflex™ HC Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2022-11/Versaflex CL-Serum collection cartridge-Application Snapshot.pdf
A LIFE SCIENCE COMPANY S E R U M C O L L E C T I O N C A R T R I D G E • Excellent clarity • Good bonding and peel strength onto PP • Heat resistance • Meet sterilization needs • Easy processing • Formulated transparent Shore 50A TPE with excellent adhesion onto PP and good sealing performance • Met regulatory requirements for USP Class VI and ISO 10993-4,5 • Provided a short lead time and on-site technical service Versaflex™ CL Thermoplastic Elastomers KEY REQUIREMENTS WHY AVIENT?
https://www.avient.com/sites/default/files/2024-01/308701_en_46090.pdf
View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Germany GmbH Kornkamp 50 22926 Ahrensburg Germany Scope Production of Color- and Additives Concentrates, Compounds and Foaming Agents Normative base ISO 50001:2018 Energy Management System Reg. no. 46090 Page 1 of 1 Validity 20. 01. 2024 – 19. 01. 2027 Issue 20. 01. 2024 A.Grisard, President SQS F.
https://www.avient.com/sites/default/files/2023-10/308659_en_46154.pdf
Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 46154 Validity 12.01.2022 – 11.01.2025 Issue 12.01.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland F.
https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 45484 Validity 01.03.2022 – 28.02.2025 Issue 01.03.2022 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.
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 Polycarbonate/ Polyester (PC/PET) & Polycarbonate/ 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 (PVC) 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, & MONITORING EQUIPMENT 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, & MONITORING EQUIPMENT 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 Elastomers (TPE) Avient Versaflex™ HC Overmolding Series (TPE) Proven healthcare solutions with hardness ranges 42–65 Shore A; autoclave, radiation and EtO sterilizable; bondable to many substrates; customizable haptics Arkema Pebax® MED (TPE) Sterilizable by gamma and EtO; low energy return; soft touch; chemical resistance; overmolding material Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® (TPC-ET) 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 (TPU) Covestro Texin® (TPU) 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 (PVC) 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 (PVC) 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 (TPE) Arkema Pebax® (TPE) Flexibility; chemical resistance; easy processing; abrasion resistance; low coefficient of friction Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® (TPC-ET) 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 (TPU) Covestro Texin® (TPU) 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, & MONITORING EQUIPMENT 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 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 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 Polycarbonate/ Polyester (PC/PET) & Polycarbonate/ 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 (PVC) 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 (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 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 Elastomers (TPE) Avient Versaflex™ HC Overmolding Series (TPE) Proven healthcare solutions with hardness ranges 42–65 Shore A; autoclave, radiation and EtO sterilizable; bondable to many substrates; customizable haptics Arkema Pebax® MED (TPE) Sterilizable by gamma and EtO; low energy return; soft touch; chemical resistance; overmolding material Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® (TPC-ET) 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 (TPU) Covestro Texin® (TPU) 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 (PVC) 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 (PVC) 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 (TPE) Arkema Pebax® (TPE) Flexibility; chemical resistance; easy processing; abrasion resistance; low coefficient of friction Thermoplastic Polyester Elastomers (TPC-ET) DuPont™ Hytrel® (TPC-ET) 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 (TPU) Covestro Texin® (TPU) 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/2024-07/TPE Whitepaper_0.pdf
In addition, the formulation meets ISO 15759 requirements for medical infusion equipment and is manufactured in an ISO 13485 facility.