Avon Lake, OH for technical competence in the field of Chemical Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 30th day of March 2018. _______________________ Vice President, Accreditation Services For the Accreditation Council Certificate Number 0514.02 Valid to December 31, 2019 Revised October 08, 2019 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf

Purchasing, Customer Service, Logistics, Quality, Design and Sampling; Corporate HQ, Management of QMS Activity: Manufacture of Engineered Thermoplastics Page 3 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Manufacture of Colorants for Plastics Activity: Manufacture of thermoplastic compounds Page 4 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Manufacturing, Shipping and Receiving Activity: Compound and supply of thermoplastics for the medical device industry Page 5 of 7 ABS Quality Evaluations Avient Corporation ISO 9001:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

Is there an Environmental Management System (EMS or/and ISO 14001 certifications) in place? Varies by Site; refer to ISO Cert http://www.avient.com/company/policies-and- governance/global-iso-certificate-library How often are 3rd party audits conducted? IATF and ISO 13485 managed within ETQ Reliance.

主要特性 根据ISO 13485规定的程序生产 变更控制记录的级别高于CAS编号级别，降低 变更风险 可用于常规注塑机和挤出设备—由技术支持团 队提供设置支持 可用于聚烯烃、苯乙烯和共聚物 可与着色剂联用 • • • • • 注册药品管理档案（III类）和/或医疗器械主 文件 食品接触声明符合美国FDA和EU规范 法规支持 原材料根据以下法规测试： - ISO 10993-1 - USP第、章（包含VI级） - 欧洲药典，各论3.1.3/3.1.5章节（聚烯烃包 装材料） - 美国药典（聚乙烯） - 杂质元素符合ICH Q3D要求 • • • 轻量化 1.844.4AVIENT www.avient.com 版权所有© 2022埃万特公司。 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。

Page 1 of 5 https://abs.zertic.com https://abs.zertic.com ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Avient Corporation Avon Lake Corporate Responsible Care Corporate Support Activities in Sr. Toluca 2000 Toluca Estado de México 50200 Mexico ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc. Unit 3 Dodworth Business Park, Dodworth Barnsley South Yorkshire S75 3SP United Kingdom ISO 14001:2015 Certificate Of Conformance ANNEX Certificate No: 65537 Avient Corporation At the below facilities FACILITY NAME FACILITY ACTIVITY ADDRESS Copyright as of the Effective Date, ABS Quality Evaluations, Inc.

Color and functional additive masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased appeal and performance

Standard colors for needle hubs, cannula hubs, and wings matching ISO 6009 color coding

ISO 845

They are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety. 

B210614), in Pommerloch (LU) Garratt, Michael Alexander, amerikanischer Staatsangehöriger, in Luxemburg (LU) James, Robert Kenneth, amerikanischer Staatsangehöriger, in ohio (US) Merklein, Norbert, deutscher Staatsangehöriger, in Rheinfelden Gesellschafterin Gesellschafterin Vorsitzender der Geschäftsführung Geschäftsführer Geschäftsführer l:Mes Vefrüaltüngsrates l*itglie#es Venrattungsrates Mitg+ie#es Venvattungsrates Direktor Direktorin Direktor Vizedirektor Vizedirektor Vizedirektor Vizedirektor Vizedirektor Vizedirektor Vizedirektor Vizedirektor Revisionsstelle Einzelunterschrift Einzelunterschrift Einzelunterschrift Einzehrnffi Einzeh*nffi Einzehrntersehrifi Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschdft zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Kollektivunterschrift zu zweien Dieser Auszug aus dem kantonalen Handelsregister hat ohne die nebenstehende Originalbeglaubigung keine Gültigkeit.