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。

Minimum requirements are adopted from the ISO 9001 standard. This document is property of Avient 3.0 Supplier Management 3.1 Supplier Quality Management System Avient expects its supply base to maintain a certified QMS at all of its locations and those of its affiliated companies in accordance with the requirements of ISO 9001, ISO 13485, or IATF 16949 (depending on supplier commodity), as applicable. Avient categorization for a “supplier” FDA Food & Drug Administration IATF International Automotive Task Force Interested Party Term referenced in ISO 9001.

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

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.

KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.

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

China has been assessed and certified as meeting the requirements of 麟 ISO 13485:2016 EN ISO 13485:2016 ’骥鑫馨瓤） For the foiowing actratEes Design and manufacture of medical grade thermoplastic elastomers for non-active medical devices and active medical devices 遴；舞蒸；撇蒸 (non-implantable) ：护、：：于b入沙黔娜；舞睡莎：器器舞蟒檬非拟拐称群亘爸竺舀‘。