https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations_Functional Additives for IVD Devices Bulletin.pdf
KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified manufacturing sites, providing global consistency and increased security of supply • Documented change control beyond CAS number, reducing risk of change • Non-phthalate and formulated without animal-derived substances • Available as concentrates or ready-to-use formulations in a wide range of polymers • Functionality and color can be combined in one product for convenience REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Documentation support for approval or transition to comply with (new) regulations such as IVDR APPLICATION BULLETIN Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-08/willowwood-prosthetics-case-study.pdf
After extensive testing, including mechanical testing to ISO 10328 standards and a six-month participant clinical trial, WillowWood introduced DuraWalk™, their most advanced low-activity foot.
https://www.avient.com/sites/default/files/2022-12/Cesa Fiber Additives Antimicrobials Product Bulletin.pdf
PRODUCT BULLETIN KEY BENEFITS Avient’s antimicrobial concentrates for fiber applications provide the following benefits: • High active-ingredient loading which translates to excellent efficacy at low let-down ratios • Easily withstand 50 washings in ISO 20743 standard tests • Also applicable for bi-component technology • Low levels of abrasiveness means higher process performance—reducing cost in the spinning phase • Can be combined with colors and with other additives (e.g., flame retardants) into a single combination concentrate for convenience • Product guidance and technical assistance from our experts Copyright © 2022, Avient Corporation.
https://www.avient.com/sites/default/files/2023-12/Cesa Light Additives for Injection Molding Product Bulletin.pdf
The white ABS plastic samples, produced with and without Cesa Light Additives, were exposed to simulated sunlight conditions using the weathering test ISO 4892- 2:2013.
https://www.avient.com/sites/default/files/2025-01/NEUSoft Product Selection Guide.pdf
Whether your application demands can be supported by the NEUSoft Express color palette or require customization, all our NEUSoft TPUs are designed with patient safety and regulatory specifications in mind, complying with ISO 10993 and USP Class VI standards.
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
ISO 10993 & USP Class VI compliant solutions
https://www.avient.com/sites/default/files/2022-08/ISO9001-2015 EN -EM.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance Certificate No: 2997-2006-AQ-RGC-RvA Initial certification date: 08 June, 2006 Valid: 11 April, 2022 – 11 April, 2025 This is to certify that the management system of Polyone - Suzhou, China EM Sector, 77 Shenggang Street, Suzhou Industrial Park, Suzhou, Jiangsu, China, 215024 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: GB/T 19001-2016/ISO 9001:2015 This certificate is valid for the following scope: Design and Manufacture of Plastic Compounding Material Certificate No: 2997-2006-AQ-RGC-RvA Place and date: Shanghai, 27 April, 2022 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2022-12/15719637-22-AVIENT ESPAÑA SL-INGLES.pdf
Certificate Number:Certificate Number: Certificate expiration date:Certificate expiration date: Effective date:Effective date: 31-10-202231-10-2022 30-10-202530-10-2025 Expiry date of previous cycle:Expiry date of previous cycle: 30-10-202230-10-2022 31-10-201631-10-2016 ES133794ES133794 Scope of certification:Scope of certification: MANUFACTURING OF MASTERBATCHES, ADDITIVESMANUFACTURING OF MASTERBATCHES, ADDITIVES AND COMPOUNDS FOR PIGMENTING THERMOPLASTICAND COMPOUNDS FOR PIGMENTING THERMOPLASTIC MATERIALS USED IN FOOD INDUSTRYMATERIALS USED IN FOOD INDUSTRY ISO 22000:2018ISO 22000:2018 POLIGONO INDUSTRIAL EZCABARTE, C/H, Nº3 - 31194 - ORICAIN - NAVARRA - ESPAÑA AVIENT ESPAÑA, S.L.AVIENT ESPAÑA, S.L.
https://www.avient.com/sites/default/files/2021-04/shanghai-9001.pdf
Park, Pudong, Shanghai China, 201203 and the sites as mentioned in the appendix accompanying this certificate has been found to conform to the Quality Management System standard: GB/T 19001-2016/ISO 9001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch Certificate No: 7071-1998-AQ-RGC-RvA Place and date: Shanghai, 19 March, 2021 Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
https://www.avient.com/sites/default/files/2024-12/ISO9001_English_Suzhou ColorMatrix.pdf
Ltd Business Registration Number: 91320505799067336K Registered I Operation Address: 13 Plant, No.855, Zhujiang Road, Suzhou New District, Jiangsu Province, China by reason of its Quality Management System has been awarded this certificate for compliance with the standard ISO 9001:2015 The Quality Management System Applies in the following area: Production Activities of Plastic Colorant & Additive (UV Blockers, Anti-Oxidation, Anti-Aging) Certified since: 2009年1月8日 Valid from: 2024年1月16日 Valid until: 2027年1月4日 the expiry date of last certification cycle: 2024年1月4日 the date of recertification audit: 2023年12月21日 to 2023年12月22日 After a surveillance cycle, the certificate is valid only when used together with an Acceptance Notice of Surveillance Audit issued by CQC.