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。

CERTIFICATE Signed for the certification body: Eric Louys Chairman Certification Committee CERTIFICATE EN ISO 50001 : 2018 Energy Management System VINÇOTTE nv Jan Olieslagerslaan 35, 1800 Vilvoorde, Belgium This is to certify that Avient Located at Rue Melville Wilson 2 5330 Assesse Belgium has established and maintains an energy management system according the requirements of EN ISO 50001 : 2018 “Energy Management System” for: Design and manufacture of colour and additive concentrates, thermoplastic resins and speciality compounds This certificate is based on the result of an energy audit documented in the audit report 61231731. Certificate number: 24 EN 47 Valid from 1 February 2024 to 31 January 2027 Further clarifications regarding the scope of this certificate and the applicability of EN ISO 50001 : 2018 requirements may be obtained by consulting the organization.

Customized color solutions are available on request • Production under ISO 13485 / GMP quality system with change control management • Fingerprinting of raw materials and routine batch testing • Extractability evaluated in hexane, isopropanol, and water according to ISO 10993 part 18 REGULATORY SUPPORT • Raw materials are pre-tested to biologically- evaluated raw materials using ISO 10993-1 and USP chapters , Class VI • DMF/MAF documentation filed with the FDA for all standard colors APPLICATIONS MEVOPUR LQ formulations can be applied in demanding applications including: • Medical devices such as catheter tubing & connectors, syringe tips, and needleless connectors • Skin contact devices such as wearables or soft-touch surfaces of medical devices PRODUCT BULLETIN MEVOPUR™-LQ YELLOW (PMS1205C) Product Code FZ1M415005 MEVOPUR™-LQ TRANS YELLOW Product Code FZ1M415006 MEVOPUR™-LQ BLUE (PMS292C) Product Code FZ5M415008 MEVOPUR™-LQ TRANS BLUE Product Code FZ5M415009 MEVOPUR™-LQ RED (PMS198C) Product Code FZ3M415008 MEVOPUR™-LQ TRANS RED Product Code FZ3M415009 MEVOPUR™-LQ GREEN (PMS346C) Product Code FZ6M415008 MEVOPUR™-LQ TRANS GREEN Product Code FZ6M415009 MEVOPUR™-LQ VIOLET (PMS2655C) Product Code FZ4M415003 MEVOPUR™-LQ TRANS VIOLET Product Code FZ4M415004 CUSTOM-MADE Individual options Customized colors are also available to meet your needs, please contact us. Avient products have not been designed for nor are they promoted or intended for use in: (a) medical devices categorized by either the United States Food and Drug Administration (FDA) or the International Standards Organization (ISO) as an “implant” device; or “Permanent” as defined under US Pharmacopoeia (USP) or ISO standards; or (b) active implantable medical devices as defined in EU Directive 90/385/EEC as amended; or (c) medical devices for “Long Term” use as defined in EU Directive 93/42/EEC as amended.

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

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 2019年12月31日 Revised 2019年10月8日 0514-02.pdf SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 Test Method or Standard: Test Description: 0514-02c.pdf

MARKETS AND APPLICATIONS ColorMatrix Optica is formulated for PC resins used in the production of: • Automotive interiors • Appliance housings • Consumer goods • Food packaging • Finished materials such as PC sheet • Electrical & Electronics REGULATORY • No heavy metals or restricted ingredients • In-house chemical testing and verification system compliant with ISO ISO/IEC 17025:2005 • Dedicated product stewardship team globally and locally

APPLICATIONS • Medical devices • Drug delivery devices • Labware KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change 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* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.