Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.  Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications. PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.

USP Class VI and ISO 10993-4/5 compliant ASTM ISO Shore A/D ASTM/ISO %

Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally. Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS

Standard colors for use in needle hubs (ISO 6009) Global network of ISO 13485 certified manufacturing sites ISO 6009 color range

9279-H-61 CERT.

CX-6180-B CERT.

Version / Date: 1 (no adjustments) / 30.12.2024 Page 1 of 2 ISCC PLUS Certificate Certificate Number: ISCC-PLUS-Cert-PL214-26100824 Bureau Veritas Polska Sp. z o.o. Version / Date: 1 (no adjustments) / 30.12.2024 Page 2 of 2 Annex I to the certificate: Sustainable materials handled by the certified site (This annex is applicable for all scopes except of Trader, Trader with storage, Warehouse, Logistic centres, MTBE and ETBE) This annex is only valid in connection with the certificate: ISCC-PLUS-Cert-PL214-26100824 issued on 30.12.2024 Input material Output material Add-ons (voluntary)1) Raw material category2) SAI FSA3) FEFAC4) Polypropylene (PP) Plastic Compounds (PP) NO Bio Bio-circular Circular N/A N/A Polyethylene (PE) Plastic Compounds (PE) NO Bio Bio-circular Circular N/A N/A 1) ISCC PLUS add-ons (voluntary application, see www.iscc-system.org for further information): • 202-04: Food Security Standard • 205-02: Consumables • 202-07: Low ILUC-risk feedstock • 205-03: Non GMO for food and feed • 205-01: GHG emission requirements • 205-04: Non GMO for technical markets 2) Bio raw materials complies with the ISCC Principles 1 – 6 for the cultivation and harvesting of sustainable biomass.

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).

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