https://www.avient.com/sites/default/files/2023-07/Versaflex HC _ Versaflex HC BIO - BT Series Product Overview.pdf
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.
https://www.avient.com/sites/default/files/2025-07/Avient 2024 Sustainability Report_6.pdf
To find more details about our certifications, visit the ISO Certifications Library on the Avient website.
The certification allows all locations on the certification to maintain a Responsible Care® Certification and ISO:14001 certification.
Avient has facilities certified to other ISO standards, including ISO:50001, ISO:22000, ISO:45001, ISO:9001.
https://www.avient.com/sites/default/files/2024-12/IATF16949 2016 Certificate for PolyOne shenzhen-EN2024.pdf
IATF Certificate Place and date: For the issuing office: Katy, TX, 10 December 2024 Revision 2 DNV - Business Assurance 1400 Ravello Drive, Katy, TX, 77449- 5164, USA Sherif Mekkawy Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ACCREDITED UNIT: DNV Business Assurance USA Inc., 1400 Ravello Drive, Katy, TX, 77449-5164, USA - TEL: +1 281-396-1000. www.dnv.com Page 1 of 2 MANAGEMENT SYSTEM CERTIFICATE Certificate no.: 273138-2018-AQ-RGC-IATF IATF Certificate No: 0558323 Valid: 10 December 2024 – 09 December 2027 This is to certify that the management system of Polyone - Shenzhen Co., Ltd.
No. 1, Qihang Industry Park, Haoxiang Road, Shajing Town, Baoan, Shenzhen, Guangdong, China 518104 (USI: C5M65R) and, if applicable, the remote supporting locations as mentioned in the Appendix accompanying this Certificate has been found to conform to the Quality Management System standard: IATF 16949:2016 This certificate is valid for the following scope: DESIGN AND MANUFACTURE OF PLASTIC COMPOUNDING MATERIAL EXCLUSION: NONE http://www.dnv.com Certificate no.: 273138-2018-AQ-RGC-IATF IATF Certificate No: 0558323 Place and date: Katy, TX, 10 December 2024 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/industries/healthcare/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions
https://www.avient.com/news/avient-showcase-newest-additions-its-healthcare-portfolio-mdm-west-2025
Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.
https://www.avient.com/news/avient-showcases-new-sustainable-solutions-and-recent-compliance-certifications-itma-2023
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Avient Showcases New Sustainable Solutions and Recent Compliance Certifications at ITMA 2023
The GRS standard is an international, voluntary, full-product standard that sets requirements for third-party certification of recycled content, chain of custody, social and environmental practices, and chemical restrictions.
Brand owners, yarn manufacturers, and chemical suppliers can apply for certification.
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-ep-white-colorants
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission
https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
https://www.avient.com/news/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
https://www.avient.com/news/polyone-features-more-materials-approach-medical-devices-mdm-west-2020
OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified