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/2023-10/31307-Certificate-20SEP2023.pdf
ECert - 2023-09-20T092923.129.pdf
Page 1 of 7
Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon
prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
This is to certify that the Quality Management System of:
Avient Corporation - HQ
33587 Walker Road
The Quality Management System is applicable to:
Certificate No: 31307
Certification Date: 12 October 1995
Effective Date: 20 September 2023
Expiration Date: 07 October 2025
Revision Date: 20 September 2023 Dominic Townsend, President
MANUFACTURE AND SUPPLY OF PLASTIC COMPOUNDS, COLOR AND PERFORMANCE ADDITIVES, ENGINEERED
THERMOPLASTICS, VINYL RESINS, CUSTOM MIXED PLASTIC MATERIALS, CUSTOM AND COMMODITY
COLORANTS FOR PLASTICS, POLYURETHANE SYSTEMS, AND PLASTICIZERS WITH DESIGN AND SAMPLING
SUPPORT AT SUWANEE, GA, AND PURCHASING, CUSTOMER SERVICE, LOGISTICS, QUALITY, DESIGN AND
SAMPLING SUPPORT AT AVIENT CORPORATE HEADQUARTERS AT AVON LAKE, OH, AND DISTRIBUTION OF
RESINS
This certificate may be found on the ABS QE Website (www.abs-qe.com).
For certificates issued in the People's Republic of China information may also be
verified on the CNCA website (www.cnca.gov.cn).
https://www.avient.com/company/sustainability/performance/eps-expansion
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/policies-and-governance-0/copyright-legal-disclaimer
Global ISO Certificate Library
https://www.avient.com/sites/default/files/2025-06/IATF16949 -2025.5.21~2028.5.20 EN -EM.pdf
IATF Certificate Place and date: For the issuing office: Katy, TX, 22 May 2025 Revision 10 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.: 11229-2006-CHN-IATF IATF Certificate No: 0573810 Valid: 21 May 2025 – 20 May 2028 This is to certify that the management system of PolyOne - Suzhou, China EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China 215024 (USI: CF4943) 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.: 11229-2006-CHN-IATF IATF Certificate No: 0573810 Place and date: Katy, TX, 22 May 2025 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 2 of 2 Appendix to Certificate PolyOne - Suzhou, China Remote Support Locations included in the certification are as follows: Site Name Site Address RSL Activities Certification Body Avient China Co., Ltd.
https://www.avient.com/sites/default/files/2021-08/20210802-certificate-of-incorporation.pdf
CERTIFICATE CONFIRMING INCORPORATION OF COMPANY AVIENT SINGAPORE PTE.
https://www.avient.com/sites/default/files/2024-02/ISO 14001吉力士-中英文%5B21%5D.pdf
https://www.avient.com/sites/default/files/2024-12/IATF16949 2016 Certificate for PolyOne shenzhen-CN2024.pdf
IATF Certificate CH-S
证书制作地点及日期: 证书认可签发机构:
Katy, TX, 2024年12月 10日 DNV - Business Assurance
1400 Ravello Drive, Katy, TX, 77449-5164, USA
Sherif Mekkawy
管理代表
未履行认证协议中规定条款会导致此证书失效,获证组织必须定期接受监督审核并经审核合格此证书方继续有效。
https://www.avient.com/products/vivo-formulations-healthcare/neu-custom-capabilities
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.