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.

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.

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.

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.

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.

These colorants and additives are pre-certified to meet USP Class VI or ISO 10993 biocompatibility testing for global healthcare applications, such as medical devices, pharmaceutical, and health & wellness products. We can now offer expanded resin families that incorporate biocompatible functional additives, in both masterbatch and compounded forms, that meet or exceed industry standards for USP Class VI or ISO 10993 biocompatibility testing.”

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).

Varies by Site; refer to ISO Cert http://www.avient.com/company/policies-and- governance/global-iso-certificate-library How often are 3rd party audits conducted? Procedures for requirements within ISO 9001 sites defined by business unit and Approved Corporate : Template/Form Document #: DOC-01879 Revision: 8 Document Owners: Brian Hoar Effective Date: May 13, 2022 Title: QF-02 Quality Standard Response Page 14 of 19 Only the electronic version of this document in ETQ is the controlled version of the document. IATF and ISO 13485 managed within ETQ Reliance.

All materials in this range are formulated to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS.   All the materials are manufactured in ISO 13485-2016 certified sites and supported by testing to ISO 10993-1, USP, EP, and ICH Q3D protocols.

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.