主要特性 在四个通过ISO 13485认证的医疗生产线生 产，拥有全球统一的配方，提供一致性和供 应链保障 变更控制记录的不限于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 不同的琥珀色色调，可根据要求定制—偏红色 或偏黄色，和/或颜色浅或深 适用于液体形式 法规支持 经过预测试的原材料： - ISO 10993-1和USP第、 部分（VI级） - 欧洲药典，，美国药典， 元素分析符合ICH Q3D - USP 溶液性状、颜色标准 FDA发布的注册药品主文件（III类） 食品接触符合FDA/EU*要求 符合YBB00102002-2015 (口服液体药用聚酯 瓶）标准 1.844.4AVIENT www.avient.com 适用医疗保健使用限制—见下文。

KEY CHARACTERISTICS • Meets critical need for thermal weldability and kink resistance • Minimizes extractables during processing • Provides excellent tensile strength • Complies with USP VI and ISO 10993-4, -5, -11 certifications • Suitable for gamma and autoclave sterilization methods • Bio-based grade option formulated with nearly 40% Gen 1 biomass content PRODUCT OVERVIEW 1.844.4AVIENT www.avient.com Copyright © 2023, Avient Corporation.

Geon(TM) DB5261 Neutral TT Iso Stable

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

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

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

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

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

This information sheet shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities. This information sheet shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. 33587 Walker Road Avon Lake, Ohio 44012 United States +1 800 438 2335 +1 440 930 1644 fax Polymer Diagnostics Inc. is a contract laboratory with accreditation to ISO/IEC 17025 by the American Association for Laboratory Accreditation (A2LA) for both chemical and mechanical capacities.