https://www.avient.com/news/polyone-develops-new-silicone-alternative-tpe-medical-tubing
Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.
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/resource-center/knowledge-base/article/medical-stoppers-improved
This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.
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/resources/safety-data-sheets?page=5116
DYNAFLEX(TM) G7940-9001-02 BLACK
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/resources/safety-data-sheets?page=6766
XB424.3 PPO6730-9001 PPSU WHT HC
Certificate of Analysis (COA) - labeled as "Material"
https://www.avient.com/company/policies-and-governance-0/copyright-legal-disclaimer
Global ISO Certificate Library
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-bio-based-polymer-solutions
Our site in Malmö, Sweden, received the ISCC PLUS certification for its bio-based concentrates and ready-to-use formulations manufactured following the mass balance chain-of-custody approach.
Raw materials tested to ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D
https://www.avient.com/company/sustainability/performance/eps-expansion
Global ISO Certificate Library
https://www.avient.com/news/polyone-wilflex-screen-printing-inks-receive-key-2014-regulatory-certifications
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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.