主要特性 在三个通过ISO 13485认证的医疗生产线生 产全球统一的配方，提供全球一致性和供应 链保障 变更控制记录不限于CAS编号级别，降低变 更风险 • • 不含动物源性物质和邻苯二甲酸盐 可用作各种聚合物的母粒或即用型配方 为方便起见，可在一个产品中实现功能性和颜 色的组合 • • • 法规支持 经过预测试的原材料： - ISO 10993-1 - USP 第、章（VI类） - USP （指南），6.2.3 可萃取元素； USP - ICHQ3D/USP 2 可萃取金属 - 欧洲药典 3.1 聚烯烃（如适用） FDA发布的注册药品主文件（III类）和/或医疗 器械主文件 为符合（新）法规（如IVDR）的批准或过渡提 供文档支持 • • • 适用医疗保健使用限制—见下文。 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。

Geon(TM) DB5261 Neutral TT Iso Stable

Global ISO Certificate Library

Medical-grade thermoplastic elastomers that meet various regulatory requirements, such as ISO 10993 and USP Class VI

Global ISO Certificate Library

White colorants for polyolefin containers and closures pre-tested to USP, EP, and ISO protocols

Avient’s Product Carbon Footprint (PCF) Calculator: a tool that is third-party-certified by TÜV Rheinland, developed to evaluate the carbon footprint of Avient’s specialized and sustainable material solutions to help companies address the growing demand to create and meet sustainability commitments, understand the environmental impact of products, and navigate the complex landscape of reducing carbon emissions, particularly for upstream materials, and aligns with the ISO 14067:2018 standard for quantifying and reporting the carbon footprint of a product  

Biomerics manufactures its materials in ISO 13485 and FDA registered facilities in Salt Lake City, UT.

⁴Certificates can be found at https://www.avient.com/company/policies-and-governance/global-iso-certificate-library

First, the Pune production site achieved GMP Certification in 2022 and became the first specialty formulator of polymer materials in India to become certified with an ISO 22000 Food Safety Management System.