主要特性 生产符合高于CAS编号级别的变更控制原则 （与MEVOPUR母粒类似），降低变更风险 不含动物源性物质和邻苯二甲酸盐 适用于吹膜、注塑、吹塑和挤出 注册药品主文件（III型） 食品接触符合FDA/EU*要求 法规支持 原材料根据以下法规测试： - ISO 10993-1 - USP第、章，包括VI级别，符合眼 科和鼻腔用药物要求 - 欧洲药典3.1.3/3.1.5（聚烯烃） - 美国药典（聚乙烯） - ICH Q3D 杂质元素 - USP和USP，透光率 载体材料 耐光性 热稳定性 产品代码颜料含量/类型 HDPE 50% TiO2 8 300°C PH00075525 LLDPE 60% TiO2 8 300°C PL00075542 LLDPE 70% TiO2 8 300°C PL00075545 PP 50% TiO2 8 300°C PP00075717 适用医疗保健使用限制—见下文。 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。

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1616267 Certification Effective Date: April 1, 2021 Issue Date: March 30, 2021 Certificate Expiry Date: March 31, 2024 ________________________________________________________________________________ ISO 9001 Registered by: QMI-SAI Canada Limited (SAI Global), 20 Carlson Court, Suite 200, Toronto, Ontario M9W 7K6 Canada.

AS9100 Certication DEKRA CERTIFICATE Certificate Number: 131789.01 The Aerospace Quality Management System and implementation of: Fiber-Line, LLC With Central Functions At: 3050 Campus Drive Hatfield, PA 19440 United States The certification has been performed in accordance with the requirements of AS9104/1:2012, including its implementation, and meets the requirements of the standard: AS9100D (Based on and including ISO 9001:2015) Scope: The value added design and development of synthetic fiber products for use in public and private sectors.

DEVICE MANUFACTURER M E D I C A L D E V I C E H O U S I N G • Improved chemical resistance compared to PC/ABS, PC/PET & COPE • Flame retardant (FR) rating of V-1 at 0.75 mm • Zero BPA & non-halogenated FR material • Available in standard hospital grade pre-colors • Provided a cost-effective material with superior chemical resistance to traditional materials • Formulated a medical-grade, semi-crystalline blend to support regulatory testing and approvals • Demonstrated superior property retention and crack resistance after exposure to hospital- grade disinfectants, including Virex® Tb, helping to extend the device life Trilliant™ HC8900 Thermoplastics KEY REQUIREMENTS WHY AVIENT?

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