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 可用作各种聚合物的母粒或即用型配方 为方便起见，可在一个产品中实现功能性和颜 色的组合 • • • 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发布的注册药品主文件（III类）和/或医疗 器械主文件 为符合（新）法规（如IVDR）的批准或过渡提 供文档支持 • • • 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。

质量管理体系认证认证 Certificate No.：04621E14082R0S We hereby certify that the organization: Fiber-Line Asia Pacific (Changzhou) Co., Ltd. Unified social credit code: 91320412MA1NMF5W4P is in conformity with Environmental Management System Standard: GB/T24001-2016 / ISO14001:2015 The certificate is valid to the following product(s)/service: Textile (Yarn), Glass Products (Yarn) Coating Processing and Related Management Activities Registration Address/ Physical Address: R&D Workshop 5, No. 8, Lanxiang Road, West Taihu Science and Technology Industrial Park, Changzhou City, Jiangsu Province, P.

AUTOMOTIVE OEM I N T E R I O R D O O R P A N E L • Available for multiple resins and approved OEM colors • Maintain performance characteristics of traditional raw materials that use conventional carbon black • Pass REACH and RoHS requirements • Retain color consistency and stability • Provide a Product Carbon Footprint (PCF) calculation that aligns with ISO 14067:2018 • Provided recycled content formulations that met all design and engineering goals while achieving sustainability targets • Provided effective alternative to materials using virgin carbon black • Achieved color stability under xenon arc and TUV methodology • Supplied necessary PCF calculation certified by TÜV Rheinland and aligning with ISO 14067 requirements OnColor™ REC Polymer Colorants KEY REQUIREMENTS WHY AVIENT?

FIBER MANUFACTURER T E X T I L E S & F A B R I C S • Provide a Product Carbon Footprint (PCF) calculation to align with ISO 14067:2018 and to help in meeting sustainability goals • Procure feedstock from renewable resources • Maintain comparative performance to conventional carbon black • Achieve color stability under xenon arc and TUV testing • Offer solutions for rPET, PP, PE, PBT, and PA6 where a desire for environmentally responsible products exists • Offered sustainable platform approach supported by extensive fiber expertise • Helped meet sustainability targets while attaining all design and engineering goals • Supplied necessary PCF calculation certified by TÜV Rheinland and aligning with ISO 14067 requirements • Provided effective alternative to virgin carbon black • Achieved reductions in CO2e emissions vs.

They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety. 

ISO 845

Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance

Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding

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.