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。

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.

A RANGE OF WORLD-CLASS SERVICES COLOR TECHNOLOGY Custom matching, saturated colors, and special effects to fill market niches, eliminate secondary operations, and strengthen your brand PCR COLOR PREDICTION SERVICE Digital prediction tool illustrating color possibilities and limitations of post-consumer recycled (PCR) content to simplify decision making and shorten time to launch PRODUCT CARBON FOOTPRINT (PCF) CALCULATOR Methodology that evaluates the carbon footprint of Avient solutions, contributing a data point to your overall carbon footprint and supporting credible reporting AVIENT DESIGN A highly specialized group of industrial designers and project engineers that provides advanced design and detailed analysis to foster higher levels of innovation TESTING AND VALIDATION Fully accredited and in-house testing capabilities to generate data for insight into material behavior, environmental effects, and more REGULATORY SUPPORT Dedicated product stewardship team assisting with new product approvals to reduce regulatory overhead and minimize risk COLOR AND ADDITIVE DESIGN SERVICES Trend and color insights along with product development assistance from concept through commercialization to optimize design and gain speed to market RESEARCH AND DEVELOPMENT Long-term strategic solution development that addresses complex and unmet product innovation needs APPLICATION DEVELOPMENT TECHNICAL SUPPORT Technical experts specifically trained to work directly with your team to solve definitive application challenges with new or existing approaches FIELD TECHNICAL SERVICE Onsite support for tool design, startup, and production optimization to gain manufacturing efficiencies and help resolve technical issues Common compliance categories where we can assist: • UL • USP Class VI • ISO 10993 • ISO 1345 • REACH • RoHS • FDA • EU 10/2011 • China GB • MERCOSUR • USP • ISP • CPSIA • Prop 65 ColorWorks™ Design & Technology Centers Our global ColorWorks centers are focused on design, technology, and innovation for plastics.

These include: • Industrial – Conveyor belts (food production and pharmaceutical industries) and controls (joy sticks, machinery handles and knobs, corrugated bellows, tool grips) • Electrical and electronic devices – Seals and gaskets, radars and sensors • ADAS components – Camera systems, navigation systems, vehicle control systems, infotainment systems PRODUCT OVERVIEW STAT-TECH SOLUTIONS KEY TECHNICAL PROPERTIES Material Description Base Resin Color Hardness Range Surface Resistivity (Ω) Key Characteristics ST0100-5003 ESD FD White VN8904 GP0F025721 TPU White 85 ShA 108 to 109 High elongation, static conductive, FDA compliance ST0100-5006 ESD X2 Natural TPU Natural 85 ShA 107 to 109 High elongation, static conductive ST0200-5001 ESD Natural X1 TPE Natural 40 ShD 107 to 109 High elongation, permanent anti-static, static conductive SST0200-5004 ESD Black TPE Black 40 ShA 103 to 105 Electrically conductive, static dissipative, lower hardness ST0200-5002 EC ES Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation ST0200-5009 EC Black TPE Black 60 ShA 100 to 102 Electrically conductive, high elongation Property Unit Standard Test Methods ST0100-5003 ESD FD White VN8904 GP0F02571 ST0100- 5006 ESD X2 Natural 5001 ESD Natural X1 5004 ESD Black 5002 EC ES Black 5009 EC Black Base Resin TPU TPU TPE TPE TPE TPE Physical Properties Hardness Shore ISO 48-4 85A 85A 50D 40A 60 A 60A Density ISO 1183 1.19 1.15 1 1.01 0.965 1.21 Mechanical Properties Tensile Strength (Break) Mpa DIN 53404 10 15 15 4 5.7 2.5 Elongation, Break % DIN 53504 600 650 500 300 400 250 Electrical Properties Surface Resistivity Ω IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102 Volume Resistivity Ω.cm IEC 60093 108 to 109 107 to 109 107 to 109 103 to 105 100 to 102 100 to 102 Color White Natural Natural Black Black Black Copyright © 2023, Avient Corporation.

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.

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 Page 1 of 1 Validity 25. 02. 2024  – 24. 02. 2027 Issue 25. 02. 2024  A.Grisard, President SQS F.

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?

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?