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.

PolyOne Specialty Coatings and Inks Kennesaw, GA Plant Achieves ISO 9001-2008 Certification CLEVELAND – PolyOne today announced that its Specialty Coating and Inks plant in Kennesaw, GA recently achieved ISO 9001-2008 certification.

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).

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. ul. 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.

Global ISO Certificate Library

Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.   To access Avient’s news library online, please visit www.avient.com/news.

They provide comparable performance to 100% virgin equivalents and can help reduce product carbon footprint (PCF), which can be quantified on request using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067.    To access Avient's news library online, please visit www.avient.com/news.

¹Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.   To access Avient’s news library online, please visit www.avient.com/news.  

Developed with the rigorous demands of the healthcare industry in mind, these innovative pre-colored compounds are formulated with materials that have been successfully tested for ISO 10993 biocompatibility, supporting compliance with the highest standards for medical applications. To access Avient's news library online, please visit www.avient.com/news. 

Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety.  To access Avient’s news library online, please visit  www.avient.com/news.