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.

Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard Solutions compliant with USP Class VI and ISO-10993 regulations

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint

They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need   Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring

Certificate of Registration 9001:2015 MSP 9001:2015–MSP-ANAB-US (2.0) Page 1 of 2 Certificate of Registration of Quality Management System to ISO 9001:2015 The National Standards Authority of Ireland certifies that: Colorant Chromatics Ab Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland has been assessed and deemed to comply with the requirements of the above standard in respect of the scope of operations given below: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Additional sites covered under this multi-site certification are listed on the Annex (File No. 19.2540/C) Approved by: Geraldine LarkinChief Executive Officer Approved by: Lisa Greenleaf Operations Manager Registration Number: 19.2540/C Certification Granted: May 15, 1997 Effective Date: Oct 20, 2018 Expiry Date: Oct 19, 2021 National Standards Authority of Ireland, 20 Trafalgar Square, Nashua, New Hampshire, NH 03063, USA T +1 603 882 4412 9001:2015–MSP-ANAB-US (2.0) Page 2 of 2 Annex to Certificate Number: 19.2540/C Scope of Registration: The Design, Manufacture and Sales of Fluoropolymer Color Concentrates and Compounds Activity Location Central Management Group, Design, Manufacture Colorant Chromatics Kroklundsvagen 346 AX-22 320 Odkarby Aland Finland File No.: 19.2540/C Headquarters, Sales, Distribution Colorant Chromatics Europe B.V. Hastelweg 269 - 273 NL-5652 CV Eindhoven The Netherlands File No.: 19.2540/B Sales, Distribution Colorant GmbH Justus-Staudt-Strasse 1 Limburg-Offheim Germany 65555 File No.: 19.2540/A Design, Manufacture, Sales, Distribution Chromatics, Inc. 19 Francis J.

Lima, Peru 1. Combined, these facilities have a total of 205 certifications to an ISO or Management System and standards. Sustainability Report | 2020 67Sustainability Report | 2020 67 https://endplasticwaste.org/en/news?

S’approvisionner de façon responsable en tantale, en étain, en tungstène et en or ou leurs dérivés (métaux 3TG). Systèmes de gestion • Se conformer à toutes les exigences légales et autres exigences applicables en mettant en œuvre, lorsque cela est possible, des systèmes de gestion internationalement reconnus Améliorer continuellement les performances en évaluant convenablement les risques et en mettant en œuvre des mesures d’atténuation.

Surgical instrument oem SURGICAL INSTRUMENT OEM E N D O S C O P E C O M P O N E N T S • Functional differentiation • ISO 10993 compliance • Excellent resistance to steam sterilization • Excellent chemical resistance • Delivered a variety of bright, distinguishing color choices for functional differentiation • Minimized color deviation • Provided a biocompatible solution • Offered low MOQ with flexible supply Transcend Premier PPSU Healthcare Pre- colored Solutions KEY REQUIREMENTS WHY AVIENT? All Rights Reserved https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants Slide 1: Surgical instrument oem

PowerPoint Presentation MEDICAL DEVICE MANUFACTURER O S T O M Y B A G S E A L S • Comply with ISO 10993 and FDA Class II medical device regulations • Offer Good sealing performance • Provide technical supports for processing recommendations • Deliver a high compression set materials to improve comfort • Provided a medical-grade TPE to help the customer meet necessary regulatory specifications and gain market share • Provided technical support during design and the manufacturing process for EVA bonding • Delivered soft-touch feel and excellent sealing performance Versaflex HC Thermoplastic Elastomers - G2705 Formulation KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers Slide 1: MEDICAL Device manufacturer