KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.

Versaflex™ OM3060 PP包覆成型 硬度 法规 灭菌 特性 28A 环氧乙烷 柔软的半透明材料，粘性好 43A 环氧乙烷 高度可着色的解决方案， 粘性好，不易压缩变形 42A/ 50A 环氧乙烷 透明的耐高温级材料； ABS、PC可粘合 60A 环氧乙烷/蒸汽 弹性高，不易压缩变形 20A-90A 环氧乙烷 用途广泛，无填充 ABS，PC包覆成型 硬度 法规 灭菌 特性 40A USP VI级，ISO 10993 环氧乙烷 半透明 60A USP VI级，ISO 10993 环氧乙烷 透明 VERSAFLEX™ CL与DYNAFLEX™ 包覆成型，符合人体 工程学设计 触感柔软，有利于形成良好的表面 有多种颜色效果和纹理可供选择 提高抓握力、缓冲力和舒适度 提高性能表现，如密封性能、减震、隔氧、 耐刮擦和耐磨性能 降低装配成本，加工性能良好 可牢固包覆于各种基材上 血糖仪 医用工具包覆成型 注射笔 分析仪器 Dynaflex™ G2706 Dynaflex™ G2711 Versaflex™ CL2242 & CL2250 Versaflex™ G2705 N Versaflex™ HC3810 Versaflex™ OM1040 US食品接触 USP VI级，ISO 10993 材料描述 硬度 法规 灭菌 特性 45A USP VI级 55A USP VI级 70A USP VI级 43A 环氧乙烷 34A USP VI级， ISO 10993-4/5 FDA，USP VI级， ISO 10993 57A 挤出级，耐高温 再密封，压缩变形性能提高 摩擦低 Versalloy™ HC 9210-55N Versalloy™ HC 9210-70N Versalloy™ HC 9220-43N Versaflex™ HC 2110-35N Versaflex™ HC 2110-57B FDA，USP VI级， ISO 10993 环氧乙烷 加工性能良好，表面光洁、美观 环氧乙烷 环氧乙烷 加工性能良好，表面光洁、美观 加工性能良好，表面光洁、美观 高压灭菌、环氧乙烷、 高压灭菌、环氧乙烷、 VERSALLOY™ HC与VERSAFLEX™ HC 密封和再密封 柔软的橡胶质感 无抽芯，静态推塞被刺穿后再密封性良好 满足动态密封的低摩擦系数要求 可萃取物含量低 适合在聚烯烃上包覆成型 密封和密封隔膜 密封件和卫生垫圈 注射器推塞和塞头 Versalloy™ HC 9210-45N 材料描述 硬度 法规 灭菌 特性 65A/ 75A/ 84A 54A 67A 高压灭菌器 透明度高，不含增塑剂，无油 工作温度高，可高温灭菌 环氧乙烷、辐射灭菌 Versaflex™ HC MT555 Versaflex™ HC BT218 VERSAFLEX™ CL与DYNAFLEX™ 高透明度级，不含增塑剂 无色透明级，配方不含邻苯二甲酸酯增塑剂 符合医疗法规USP VI级和ISO 10993-4、5的 要求 食品接触用并符合FDA标准 可高压灭菌和辐射灭菌 可萃取物含量低 透明度高（雾度50 4.1, 100 4.5, 100 4, 70 6, 70 拉伸模量（MPa） 2200 2700 2600 2350 1820 1820 挠曲强度（MPa） 80 90 104 86 68 68 挠曲模量（MPa） 2500 2700 2500 2300 1980 1590 HDT：0.45、1.8（MPa） 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70 UL-94等级，3.0mm 5VA V-0 5VA V-0 HB V-0 UL-94等级，1.5mm V-0 V-0 5VB V-0 HB V-0 UL-94等级，0.75mm V-1 V-2 V-0 无 无 V-2 竞争材料对比 医疗保健特种工程聚合物配方 TRILLIANT™ HC热塑性塑料 Trilliant™ HC高性能热塑性弹性体系列配方是专为应对日趋严苛的医疗器械和设备而开发的。

MATERIAL BRIEF DESCRIPTION FR PC/ABS Flame retardant, chemical resistance, high ESCR FR PC/PET Flame retardant, impact modified, chemical resistant FR PC/PBT Skin-contact biocompatible, flame retardant, high chemical resistance FR Copolyester Flame retardant, chemical resistant, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8910 Unfilled PK blend, BPA-free, high chemical resistance, may incorporate agency-rated materials to meet USP Class VI or ISO 10993 requirements Trilliant™ HC8920 FR Non-halogenated flame retardant PK blend, BPA-free, high chemical resistance, may incorporate agency rated materials to meet USP Class VI or ISO 10993 requirements Edgetek™ ET8900 CR Unfilled PK blend, high chemical resistance Edgetek™ ET8900 HI CR High impact PK blend, high chemical resistance Edgetek™ ET8920 FR CR Non-halogenated flame retardant PK blend, high chemical resistance Table 2.

Homepage // News Center // Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei). ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.

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?

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?

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?

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?

ORTHOPEDIC PARTS MANUFACTURER O R T H O P E D I C S O L E I N S E R T • A super soft TPE (

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Available as additive concentrates, ready-to-use additive formulations or ready-to-use additive/ colorant formulations for different polymers REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request; exceptions may occur Healthcare use limitations apply—see below.