For and on behalf of BSI: Carlos Pitanga, Chief Operating Officer Assurance – Americas Certification Date: 2018-07-11 Latest Issue: 2018-07-11 Expiry Date: 2021-07-10 BSI Certificate Number: 85585 IATF Number: 0315491 Page: 1 of 2 This certificate remains the property of BSI and shall be returned immediately upon request. An electronic certificate can be authenticated online. An electronic certificate can be authenticated online.

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。

Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 10 ABS Quality Evaluations Avient Corporation RC14001®:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. Activity: Design and Manufacture of Colorants and Additives for Plastics Page 6 of 10 ABS Quality Evaluations Avient Corporation RC14001®:2015 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.

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.

CERTIFICATE CONFIRMING INCORPORATION OF COMPANY AVIENT COLORANTS SINGAPORE PTE.

Certificate - IATF 16949 - Avient Corporation - 596306 - 2806569 (2).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.

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.

ECert.pdf Page 1 of 2 Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof. Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation. IATF 16949:2016 The Quality Management System is applicable to: Certificate No: 38223 Effective Date: 03 July 2018 Expiration Date: 02 July 2021 Issue Date: 03 July 2018 IATF No: 0313794 Alex Weisselberg, President DESIGN AND COMPOUNDING OF THERMOPLASTIC PRODUCTS (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) Certificate Of Conformance has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: Page 2 of 2 ABS Quality Evaluations PolyOne Corporation IATF 16949:2016 Certificate Of Conformance ANNEX At Below Facilities: Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.