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/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.
https://www.avient.com/news/specialty-healthcare-polymer-solutions-be-showcased-avient-mdm-west-2024
All Mevopur formulations are manufactured across a global network of ISO 13485 facilities, and they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, European Pharmacopeia, and ICH Q3D.
They are available in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards.
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/news/avient-shares-customer-success-healthcare-high-temperature-pre-colored-solutions-k-2022
Because Transcend is fully bio-compatible per ISO 10993 standards, we’re helping customers speed up development and market introduction.
They are tested to ISO 10993 standards and can be customized with the addition of functional additives to enhance product performance.
https://www.avient.com/industries/healthcare/medical-devices-equipment/surgical-medical-instruments
Medical-grade colorant and functional additive masterbatches with robust bio-compatibility pre-testing to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce risk, increase appeal, and boost performance
Soft-touch, durable, and colorable TPEs that comply with USP Class VI, ISO 10993, and ISO 9001 for diverse overmolding needs, aesthetics, and haptics
https://www.avient.com/knowledge-base/article/regulatory-issues
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.
https://www.avient.com/resource-center/services/product-carbon-footprint-pcf-calculator
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.
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/2024-08/Avient-2023-Sustainability-Report_6.pdf
To find more details
about our certifications, visit our ISO Certifications Librar y.
Avient has 102 global manufacturing facilities. 96% of these sites are certified through independent third
parties to management system standards including ISO:14001, ISO:50001, ISO:22000, ISO:45001, ISO:9001, and
Responsible Care®.
The certification allows all locations on the certification to maintain a Responsible Care®
Certification and ISO:14001 certification.