© 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012

© 2022, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 ANTIMICROBIAL TECHNOLOGY, CUSTOM COLORS AND PERFORMANCE ADDITIVES IN ONE MASTERBATCH.

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.

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.

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?

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?

View PDF The SQS herewith attests that the organisation named below has a management system that meets the requirements of the normative base mentioned. 7 0 0 1 _1 /A p ri l 2 0 2 2 /V er si o n 2 .0 Certificate Avient Colorants Germany GmbH Hohenrhein 1 56112 Lahnstein Germany Scope Production of Color Concentrates and Compounds Normative base ISO 50001:2018 Energy Management System Reg. no. 46089 Page 1 of 1 Validity 17. 12. 2023  – 16. 12. 2026 Issue 17. 12. 2023  A.Grisard, President SQS F.

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.