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).

主要特性 可用于聚乙烯、聚丙烯、ABS、聚碳酸酯和苯 乙烯 树脂载体的生物含量从70%到100%不等，具 体取决于聚合物⸺按照ASTM D6866标准计 算 由四家通过ISO 13485认证的工厂生产，稳定 的供应链覆盖全球，品质始终如一 变更控制记录的级别高于CAS编号级别，降低 变更风险 可以像加工化石基聚合物般在普通注塑机和挤 出设备上进行产品加工的嵌入式解决方案 可以以即用型预着色或添加剂配方的形式提供 法规支持 原材料根据以下标准检测： - ISO 10993-1 - 美国药典和（包括VI类） - 欧洲药典，各论3.1.3/3.1.5（聚烯烃包装材 料） - 美国药典（聚乙烯） - 杂质元素符合ICH Q3D要求 注册药品管理档案（III类）和/或器械主文件 食品接触声明符合美国FDA和EU规范 适用医疗保健使用限制—见下文。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

GLOBAL ISO 13485 MANUFACTURING FOOTPRINT Avient’s certified sites are located on three continents and offer manufacturing support, project transfer and back-up supply to reduce supply chain risk. COMPREHENSIVE REGULATORY TESTING AND DOCUMENTATION Raw materials tested to: • ISO 10993-1 and USP , (biological evaluation) • European Pharmacopeia 3.1.3/3.1.5 (polyolefin —materials used for the manufacture of containers) • USP (polyethylene—plastic materials of construction) • ICH Q3D (elemental impurities) We provide Drug Master File (Type III) documentation and other supporting regulatory declarations that are relevant for the application. They are manufactured at ISO 13485 certified sites with bio-compatible raw materials and documented change control.

主要特性 在三个经ISO 13485认证的生产设施生产，在 全球范围内提供质量稳定一致的产品，并增加 供应稳定性 变更控制记录的级别高于CAS编号级别，降低 变更风险 不含动物源性物质和邻苯二甲酸盐 可用作预着色配方或母粒，用于不同的聚合物 注册药品管理档案（III类）和/或医疗器械主 文件 食品接触符合FDA/EU**要求 法规支持 原材料根据以下标准检测： - ISO 10993-1和美国药典 生物学 评估 - 欧洲药典3.1.3/3.1.5（聚烯烃） - 美国药典（聚乙烯） - ICH Q3D 杂质元素 * 设计备注：选择效果颜色时需要仔细考虑零件设计和聚合物流动路径， 从而尽可能减少可见流线。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

法规支持 经过预测试的原材料： - ISO 10993-1 - USP 第、章（VI类） - USP （指南），6.2.3 可萃取元素； USP - ICHQ3D/USP 2 可萃取金属 - 欧洲药典 3.1 聚烯烃（如适用） FDA发布的注册药品管理档案（III类）和/或医 疗器械管理档案 食品接触符合FDA/EU*要求 主要特性 在三个通过ISO 13485认证的医疗生产线生产 全球统一的配方，提供全球一致性和供应链保 障 变更控制记录的不限于CAS编号级别，降低变 更风险 不含动物源性物质和邻苯二甲酸盐 标准母粒在PE载体中提供，可根据要求在PP 中提供 可以采用针对应用选择的特定树脂提供预着色 配方 药物类型 颜色说明 潘通色号参考 埃万特产品代码 （PE基） 肾上腺素能激动剂组合 浅绿色 373 C PE6M176349 肾上腺素能激动剂 紫色 2583 C PE4M176057 抗感染药 棕褐色 467 C PE8M176130 非甾体类抗炎药 灰色 冷灰色 4 C PE7M176184 甾体类抗炎药 粉色 197 C PE3M176237 免疫调节剂类抗炎药 橄榄绿 5763 C 按要求提供 β-受体阻滞剂 黄色 黄色 C PE1M176160 β-受体阻滞剂组合 深蓝色 281 C PE5M176272 碳酸酐酶抑制剂 橘黄色 1585 C PE2M176089 细胞毒素 黑色 6 C PL9M176008 缩瞳剂 深绿色 348 C PE6M176267 散瞳剂和睫状肌麻痹剂 红色 1797 C PE3M176236 前列腺素类似物 绿松石 326 C PE5M176273 适用医疗保健使用限制—见下文。 埃万特的产品不为以下目的或用途而设计，也不会宣传或预期用于以下目的或用途： (a) 被美国食品药品监督管理局（FDA）或国际标准化组织（ISO）归类为“植入”类器械的医疗器械；或美国药典（USP）或ISO标准定义的“永久”使用器械；或 (b) 经修订的欧盟指令90/385/EEC中定义的有源植入式医疗器械；或者 (c) 经修订的欧盟指令93/42/EEC中定义的“长期”使用的医疗器械。

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience 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 • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.

KEY CHARACTERISTICS • Can be formulated for PESU, PPSU, and PSU • 43 standard colors as well as custom colors available • Ultra-high heat resistance • Based on raw materials pretested per ISO 10993 • Range of brilliant, vibrant colors • Based on raw materials compliant with food contact • Customizable with functional additive solutions • Based in polysulfone resins for ultra-high performance; may be formulated for other resin types • Low minimum order quantities available MARKETS AND APPLICATIONS Transcend colorants are formulated specifically for the healthcare market, and ideal for applications such as: • Dental tools and equipment • Surgical robots • Surgical lighting • Diagnostic equipment PRODUCT BULLETIN & COLOR CARD Colors may vary from actual color shown.

GENERAL PURPOSE GLS TPES FOR PACKAGING SOFT TOUCH GRIPS BONDING TO POLAR SUBSTRATES GENERAL PURPOSE GLS TPES FOR PACKAGING SOFT TOUCH GRIPS BONDING TO NON POLAR SUBSTRATES Dynaflex™ G2711 Dynaflex™ G2780 Dynaflex™ G6713 Dynaflex™ G7960 Versalloy™ XL9045 Versaflex™ CL40 Aesthetics Grippy, 43A Low tack, 84A Extra soft, 13A Rubbery, 60A & opaque Matte, 45A & natural Grippy, 40A & water clear Special Characteristics Grippy medical grade PP & PE OM Extra soft General purpose High flow & fast setup Water clear Regulatory FDA, EU & USP VI FDA FDA & EU FDA FDA FDA & EU Overmolding Polypropylene Polypropylene & Polyethylene Polypropylene Polypropylene Polypropylene Polypropylene Versaflex™ CL 2250 Versaflex™ OM 3060 Versaflex™ CE 3120-65 Versaflex™ CE 3620 Versollan™ RU 2205 Aesthetics Grippy, 50A & clear Grippy, 59A & clear Silky feel, 65A Silky feel, 65A Grippy, 65A Special Characteristics Clear overmold Clear overmold Abrasion resistance & high strength Low compression set & high flow Abrasion resistance & high strength Regulatory FDA & USP VI FDA & USP VI UL 94 FDA & ISO 10993-10 — Overmolding Polycarbonate Polycarbonate & ABS Polycarbonate, ABS, Copolyester & Nylon 12 Polycarbonate, ABS, Copolyester & Nylon 12 1.844.4AVIENT www.avient.com Copyright © 2020, Avient Corporation.