Avient PCF values are determined using its PCF Calculator, which is certified by TÜV Rheinland and meets the ISO 14067:2018 standard.  

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.

Any translations of this document shall be used for reference only.) and the applicable customer specific requirements Revision:1 For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France None Bureau Veritas Certification Certificate N°: FR072877- IATF IATF Certificate N°: 442787 Date Of Expiration: 01-February-2025 Date Of Certification: 02-February-2022 PRODUCT(S) DELIVERED colour with additive concentrates for thermoplastic resins and speciality compounds obtained by mixing and extrusion PERMITTED EXCLUSION(S) SCOPE Design and manufacturing Bureau Veritas Certification certify that the Quality Management System of the above organisation has been audited and found to be in accordance with the requirements of Route de la Vavrette, 01250, TOSSIAT France PolyOne France Tossiat Awarded to Certificate of Approval https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L https://e-cer.bureauveritas.com/FMSNR3ILR1QPBBMGXNKFUDB2LWB28AYDXJNZADBZ8WDH3QYML73QK0B7L7V6CZQPGPGDYLG2UVXWEPJVT4Q0E4Z0DOKSEXCP0BNO7K2WUHCQB2Q9ORVVTV4F9DTN2UI35L REMOTE SUPPORT FUNCTION(S) (The official document is in English. Revision:1 For Bureau Veritas Certification Holding, Le Triangle de l'Arche, 8 Cours du Triangle - 92800 Puteaux - France Bureau Veritas Certification Certificate N°: FR072877- IATF IATF Certificate N°: 442787 Date Of Expiration: 01-February-2025 Date Of Certification: 02-February-2022 Route de la Vavrette, 01250, TOSSIAT France PolyOne France Tossiat Awarded to Appendix to the Certificate of Approval Name Address Scope AVIENT LUXEMBOURG ROUTE DE BASTOGNE, 19, 9836, POMMERLOCH Luxembourg Logistic, Supplier Management, Purchasing PolyOne Europe Logistics 7 rue Blériot, 4460, GRACE HOLLOGNE Belgium Warehousing Polyone Europe ul.

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。

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