Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They can be customized to meet specific regulatory demands such as USP Class VI, FDA CFR, and ISO 10993.   Versaflex™ HC 2110-57B TPEs comply with ISO 10993-4, ISO 10993-5, and USP Class VI and are suitable for Ethylene Oxide (EtO) sterilization without residue or allergens.

Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).

Ranked as one of America’s Most Responsible Companies by Newsweek, 100 Most Sustainable Companies by Barron’s, and recognized on the USA Today’s America’s Climate Leaders List

Sourced and manufactured in the USA

Avient Site in Glendale, Arizona Earns ISO 13485 Certification The Avient facility in Glendale, AZ recently received ISO 13485 certification demonstrating the company’s commitment to providing healthcare solutio

KEY CHARACTERISTICS • Can be formulated for PESU, PPSU, and PSU • 43 standard colors as well as custom colors available • Ultra-high heat resistance • Based on raw materials pretested per ISO 10993 • Range of brilliant, vibrant colors • Based on raw materials compliant with food contact • Customizable with functional additive solutions • Based in polysulfone resins for ultra-high performance; may be formulated for other resin types • Low minimum order quantities available MARKETS AND APPLICATIONS Transcend colorants are formulated specifically for the healthcare market, and ideal for applications such as: • Dental tools and equipment • Surgical robots • Surgical lighting • Diagnostic equipment PRODUCT BULLETIN & COLOR CARD Colors may vary from actual color shown. NAME COLOR FAMILY COLOR CODE TRANSPARENTS Transparent Blue Violet Violet PPT6730-4005 Transparent Aquamarine Blue PPT6730-5018 Transparent Teal Green Green PPT6730-564C Transparent Optimal Yellow Yellow PPT6730-458C Transparent Energy Orange Orange PPT6730-150C Transparent Crimson Red PPT6730-2009 Transparent True Gray Gray PPT6730-7001 OPAQUES Linen White White PPO6730-9010 Hygienic White White PPO6730-9001 Ice Gray Gray PPO6730-5C True Gray Gray PPO6730-424C Shadow Gray PPO6730-446C Gunmetal Gray PPO6730-426C Black Black PPO6730-6C Powder Blue Blue PPO6730-2127C Smoky Blue Blue PPO6730-7682C Bright Azure Blue PPO6730-653C Cobalt Blue PPO6730-5002 Navy Blue PPO6730-5004 Aquamarine Blue PPO6730-7699C Blue Violet Violet PPO6730-7456C Emerald Green PPO6730-6016 Clover Green PPO6730-7723C Optimal Yellow Yellow PPO6730-459C Energy Orange Orange PPO6730-2000 Crimson Red PPO6730-3000 Colors may vary from actual color shown.

Manufactured across a global network of ISO 13485 facilities, they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, and ICH Q3D. Like other Mevopur formulations, they are manufactured in dedicated ISO 13485 facilities and supported by testing to ISO 10993-1, USP, European Pharmacopeia, and ICH Q3D guidelines. They are offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety.

After extensive testing, including mechanical testing to ISO 10328 standards and a six-month participant clinical trial, WillowWood introduced DuraWalk™, their most advanced low-activity foot. The DuraWalk foot, made in the USA with our Gordon Composites™ fiberglass laminate material, offers flexibility while walking without the “push-off” of a higher activity level foot, combined with the multiaxial stability needed for a low-activity amputee. © 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012

KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.

For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines. All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations. The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.