主要特性 生产符合高于CAS编号级别的变更控制原则 （与MEVOPUR母粒类似），降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 • • • 注册药品主文件（III型） 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试： - ISO 10993-1 - USP第、章，包括VI级别，符合眼 科和鼻腔用药物要求 - 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 - USP和USP，透光率 • • • 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 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。

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 Validity 20. 01. 2021 – 19. 01. 2024 Issue 12. 04. 2021 Swiss Made Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103, 3052 Zollikofen, Switzerland sqs.ch F.

Martorell no.124 08740 Sant Andreu de la Barca Spain Scope Category I Production of customer specific Masterbatches for Food packaging materials on the dedicated extrusion lines Normative base ISO 22000:2018 Food Safety Management Systems Requirements for any organization in the food chain Reg. no. 46388 Validity 25. 02. 2021 – 24. 02. 2024 Issue 25. 02. 2021 Swiss Madesqs.ch F.

Surgical instrument oem SURGICAL INSTRUMENT OEM E N D O S C O P E C O M P O N E N T S • Functional differentiation • ISO 10993 compliance • Excellent resistance to steam sterilization • Excellent chemical resistance • Delivered a variety of bright, distinguishing color choices for functional differentiation • Minimized color deviation • Provided a biocompatible solution • Offered low MOQ with flexible supply Transcend Premier PPSU Healthcare Pre- colored Solutions KEY REQUIREMENTS WHY AVIENT?

SYRINGE MANUFACTURING D I S P O S A B L E S Y R I N G E T I P C A P • Excellent sealing and resealing performance • No DEHP or natural rubber latex added during processing • Can be sterilized by EtO • Compliance with ISO 10993-4&5, USP Class VI Dynaflex™ Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?

EUROPEAN MEDICAL DEVICE MANUFACTURER F A C E M A S K V E N T I L A T I O N V A L V E • ISO 9001 and USP VI compliant • Compatible with overmolding onto PP • Translucent and highly colorable • Soft touch • Provided valuable regulatory support and documentation, enabling faster internal trials and material qualification for this customer • Worked together with customer to select the best material from a broad portfolio of medical TPE grades • Trusted as a polymer supplier for multiple healthcare applications Dynaflex™ G2711 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?

Versaflex - BVM Resuscitator Bag BAG-VALVE-MASK (BVM) MANUFACTURER R E S U S C I T A T O R B A G • Compatible gamma sterilization process • Achieve desired elastomeric properties • PVC-free formulation • FDA, ISO 10993, USP VI compliant • Repeatable injection molding process • Complemented customer expertise with technical support in material selection, part & tool design, and process development • Customized TPE offered customer an alternative to vinyl without sacrificing performance • Improved process efficiency and overall system costs through injection molding method Customized Versaflex™ TPE KEY REQUIREMENTS WHY AVIENT?

FAMOUS UNDERWEAR BRAND U N D E R W I R E • Formulated a 40% bio-derived material to help meet customer’s sustainable goals with good rigidity and supporting strength • Improved comfort and softness compared to a normal steel underwire design • Passed ISO 105-X18 textile test with good chemical resistance, durability, and wash fastness Customized reSound™ BIO TPE WHY AVIENT?

Versaflex HC - Syringe Plunger - English SYRINGE MANUFACTURER D I S P O S A B L E S Y R I N G E P L U N G E R • USP VI and ISO 10993-4,5 compliant • Sterilize by gamma & EtO • Long-term sealing performance • Low coefficient of friction (COF) • Consistent performance across barrel sizes • Provided a formulated solution that met rigorous medical application requirements • Improved global supply continuity • Increased process efficiency by replacing previous thermoset material with TPE Versaflex™ HC 2110-57B KEY REQUIREMENTS WHY AVIENT?

PowerPoint Presentation MEDICAL DEVICE MANUFACTURER O S T O M Y B A G S E A L S • Comply with ISO 10993 and FDA Class II medical device regulations • Offer Good sealing performance • Provide technical supports for processing recommendations • Deliver a high compression set materials to improve comfort • Provided a medical-grade TPE to help the customer meet necessary regulatory specifications and gain market share • Provided technical support during design and the manufacturing process for EVA bonding • Delivered soft-touch feel and excellent sealing performance Versaflex HC Thermoplastic Elastomers - G2705 Formulation KEY REQUIREMENTS WHY AVIENT?