Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

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  

Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: based on polysulfone and PEEK resins with the capability of withstanding up to 1,000 autoclave cycles and high-heat sterilization at 150°C, these colorants are formulated with ingredient materials that have been successfully tested for ISO 10993 biocompatibility and are available in a line of bright and vivid transparent or opaque shades

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.

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

Global ISO Certificate Library

Geon(TM) DB5261 Neutral TT Iso Stable

主要特性 可用于聚乙烯、聚丙烯、ABS、聚碳酸酯和苯 乙烯 树脂载体的生物含量从70%到100%不等，具 体取决于聚合物⸺按照ASTM D6866标准计 算 由四家通过ISO 13485认证的工厂生产，稳定 的供应链覆盖全球，品质始终如一 变更控制记录的级别高于CAS编号级别，降低 变更风险 可以像加工化石基聚合物般在普通注塑机和挤 出设备上进行产品加工的嵌入式解决方案 可以以即用型预着色或添加剂配方的形式提供 法规支持 原材料根据以下标准检测： - ISO 10993-1 - 美国药典和（包括VI类） - 欧洲药典，各论3.1.3/3.1.5（聚烯烃包装材 料） - 美国药典（聚乙烯） - 杂质元素符合ICH Q3D要求 注册药品管理档案（III类）和/或器械主文件 食品接触声明符合美国FDA和EU规范 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。