– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation. Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.

These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols. All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings. 

Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.  

Certificate Avient Corporation This is to certify that the Environmental Management System of: Avon Lake Corporate 33587 Walker Road Avon Lake OH 44012 United States (WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX) has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: The Environmental Management System is applicable to: Responsible Care Corporate Support Activities in Sr. Leadership, EHS&S-PS, Facility Services, Design & Development, Information Technology, Sourcing, Logistics, Legal, and Human Resources Certification Date: 29 SEP 2023 Effective Date: 27 FEB 2025 Expiration Date: 27 SEP 2026 Revision Date: 05 MAR 2025 Dominic Townsend, President Page 1 of 5 Avon Lake Corporate Responsible Care Corporate Support Activities in Sr.

Homepage // News Center // PolyOne Wilflex Screen Printing Inks Receive Key 2014 Regulatory Certifications KENNESAW, Georgia – PolyOne Corporation, a premier global provider of specialized polymer materials, services and solutions announced today that it has received several sustainability-related compliance and regulatory product certifications for Wilflex™ Textile Printing Inks. These certifications enable printers to meet regulatory and quality specifications, creating value for customers without sacrificing production performance.

Global network of ISO 13485 certified manufacturing sites ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D evaluations reduce risk of non-compliance during regulatory submission MEVOPUR™ ISO 6009 Standard/Customized Solutions met compliance requirements and improved quality for needle hub, cover and shield

Global ISO Certificate Library

Our PCF calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 Standard for quantifying and reporting the carbon footprint of a product. This certification confirms our tool meets defined criteria and safety-relevant aspects.

These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.