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。

Normative base ISO 22000:2018 Food Safety Management Systems - Requirements for any organization in the food chain Reg. no. 46389 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 20. 12. 2023  A.Grisard, President SQS 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 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS 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?

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?

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?

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?

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?

GLOBAL ELASTIC & RUBBER PRODUCT MANUFACTURER T O U R N I Q U E T B A N D • Hardness 45, shore A • Thickness 0.5mm and Tensile set

Normative base EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. 37081 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.