The white ABS plastic samples, produced with and without Cesa Light Additives, were exposed to simulated sunlight conditions using the weathering test ISO 4892- 2:2013.

Whether your application demands can be supported by the NEUSoft Express color palette or require customization, all our NEUSoft TPUs are designed with patient safety and regulatory specifications in mind, complying with ISO 10993 and USP Class VI standards.

KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.

Ltd Business Registration Number: 91320505799067336K Registered/ Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Environmental Management System has been awarded this certificate for compliance with the standard ISO 14001:2015 The Environmental Management System Applies in the following area: Production and Related Management Activities of Plastic Colorant & Additive (UV Blockers, Anti-Aging,Anti-Oxidation) Certified since: June 6, 2012 Valid from: January 17, 2024 Valid until: January 7, 2027 the expiry date of last certification cycle: January 7, 2024 the date ofrecertification audit: December 21, 2023 to December 22, 2023 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.

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.

Based on polysulfone resins and tested to ISO 10993, this line of opaque and transparent colorants is specifically formulated to achieve high heat resistance in healthcare applications.  Formulated with raw materials tested to ISO, USP, EP, and ICH Q3D protocols, the portfolio includes standard color ranges to speed up time to market and custom color solutions tailored to customer requirements. 

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。

In addition, Avient has externally certified EHS&S management systems, including ISO 9001 worldwide. ISO 14001, Responsible Care 14001, ISO 45001, ISO 50001, and OHSAS 18001, certification at 74% of facilities. In addition, Avient has ISO 9001 worldwide and ISO 14001 and ISO 50001 certification at many facilities.

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.

Composite panels for modular ISO shelters, transport containers and pallets TRANSPORTATION Rail car doors, floors and body panels, shipping containers, tractor trailer panels, large trucks, trailers, RVs, and mass transit vehicles MARINE Structural bulkheads, transoms, decks/soles, subflooring, and interior walls www.avient.com Copyright © 2020, Avient Corporation.