MEVOPUR Colors for Needle Hubs Bulletin_CN * 可根据要求提供FDA/EU合规信息 应用公告 MEVOPUR™用于针头和导管座的 标准颜色 为了帮助我们的客户满足医疗行业标准要求，埃 万特开发了一系列符合ISO 6009标准颜色编码的 针座、导管座和翼梁的标准颜色。 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。 在不限制本声明的一般性的情况下，不得将埃万特的产品用于旨在用于以下目的的任何医疗器械应用： (1) 接触人体组织或体液长达30天或更长时间； (2)“整形”（整容或重建）手术； (3) 生殖植入物或任何节育器械；或者 (4) 用于支持或维持人类生命的永久性（超过30天）植入式医疗器械中的任何关键组件。

We offer a wide range of color concentrates for different polymer grades, from standard to engineering polymers, that fulfill the vertical burning (V-0; V-1; V-2) and horizontal burning (HB) tests. SUSTAINABILITY Avient’s color and additive manufacturing sites comply with ISO standards such as ISO 9001:2015 QMS, ISO 14001:2015 Environmental Management System and ISO 45001:2018*. EC) 1907/2006 and amendments) • UL94 file for MB (QMQS.E73454) and formulations (QMQS.E103015) • “Toys declaration” Directive 2009/48/EC • Waste Electrical & Electronic Equipment (WEEE) * Contact us for more detailed information about our ISO certifications.

Medical-grade colorant and functional additive masterbatches with robust bio-compatibility pre-testing to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce risk, increase appeal, and boost performance  Soft-touch, durable, and colorable TPEs that comply with USP Class VI, ISO 10993, and ISO 9001 for diverse overmolding needs, aesthetics, and haptics 

Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 1614-2000-AE-RGC-RvA Initial certification date: 23 May 2000 Valid: 24 May 2024 – 23 May 2027 This is to certify that the management system of PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z. Park, China (Shanghai) Pilot Free Trade Zone, Shanghai, China 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Colour and Additive Concentrates http://www.dnv.com/assurance

Get Help Now +1-866-737-2066 Raw materials tested to ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D

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Contiene normas alineadas mundialmente y está arraigado en la legislación internacional. Las repercusiones negativas en el medio ambiente y el clima deberán evaluarse para minimizarse o eliminarse en origen Cumpla con la Ley de Prácticas Corruptas en el Extranjero de EE.

Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications. Michelle Maniscalco Senior Manager, Marketing Communications PolyOne Corporation +1 440-930-1988 michelle.maniscalco@avient.com

OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified Michelle Maniscalco Senior Manager, Marketing Communications PolyOne Corporation +1 440-930-1988 michelle.maniscalco@avient.com