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发布的注册药品管理档案（III类）和/或医 疗器械管理档案 食品接触符合FDA/EU*要求 • • • 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 变更控制记录的不限于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 标准母粒在PE载体中提供，可根据要求在PP 中提供 可以采用针对应用选择的特定树脂提供预着色 配方 • • • • • 药物类型 颜色说明 潘通色号参考 埃万特产品代码（PE基） 肾上腺素能激动剂组合 浅绿色 373 C PE6M176349 肾上腺素能激动剂 紫色 2583 C PE4M176057 抗感染药 棕褐色 467 C PE8M176130 非甾体类抗炎药 灰色 冷灰色 4 C PE7M176184 甾体类抗炎药 粉色 197 C PE3M176237 免疫调节剂类抗炎药 橄榄绿 5763 C 按要求提供 β-受体阻滞剂 黄色 黄色 C PE1M176160 β-受体阻滞剂组合 深蓝色 281 C PE5M176272 碳酸酐酶抑制剂 橘黄色 1585 C PE2M176089 细胞毒素 黑色 6 C PL9M176008 缩瞳剂 深绿色 348 C PE6M176267 散瞳剂和睫状肌麻痹剂 红色 1797 C PE3M176236 前列腺素类似物 绿松石 326 C PE5M176273 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。

Combined, these facilities have a total of 205 certifications to an ISO or Management System and standards. For our sensitive applications, in addition to ISO9001, we have implemented ISO 13485 and Good Manufacturing Processes (GMP). 100% of our facilities producing those sensitive applications and warehouses are GMP audited within a 3–year period. Our goal in 2021 is to develop processes and procedures and a position statement on critical customer information, and fully prioritize the product portfolio in all critical markets/materials. 75 ISO Certified Facilities ZERO Product Recalls Major Non-Conformances at ISO Sites 0 HOME | Contents | Message from the CEO | Who We Are | People | Products | Planet | Performance | Metrics | Index Sustainability Report | 2020 59Sustainability Report | 2020 59 Management Approach: Supplier Collaboration Avient’s value extends not only to consumers through specialty products, but beyond the boundaries of our own processes and operations.

ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 54139 Certification Date: 04 September 2019 Effective Date: 29 August 2022 Expiration Date: 01 September 2025 Revision Date: 29 August 2022 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).

Bergmann GmbH Adolf-Dambach-Str. 2-4 76571 Gaggenau die Einführung und Anwendung eines Managementsystems gemäß DIN EN ISO 50001:2018 für den Geltungsbereich: Entwicklung und Produktion von technischen Thermoplasten; an den Standorten gemäß Anlage.

ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 65567 Effective Date: 08 September 2023 Expiration Date: 07 September 2026 Revision Date: 08 September 2023 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).

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 Made sqs.ch F.

Park, Pudong, Shanghai, China, 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch

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 S U RG I C A L I N S T RU M E N T O E M 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 - Spanish FABRICANTE DE JERINGAS É M B O L O D E J E R I N G A D E S E C H A B L E • Cumplir con las normas USP VI e ISO 10993-4,5 • Esterilización con gamma y EtO • Rendimiento de sellado a largo plazo • Bajo coeficiente de fricción (COF) • Rendimiento uniforme en jeringas de diferentes diámetros • Ofreció una solución formulada que cumple con los requerimientos rigurosos de una aplicación médica • Mejoró la continuidad del suministro global • Aumentó la eficiencia del proceso al sustituir el material termoestable anterior con un TPE Versaflex™ HC 2110-57B REQUERIMIENTOS CLAVE ¿POR QUÉ AVIENT?