https://www.avient.com/sites/default/files/2023-09/65567-Certificate-08SEP2023.pdf
ISO 13485:2016 The Quality Management System is applicable to: Certificate No: 65567 Effective Date: 08 September 2023 Expiration Date: 07 September 2026 Revision Date: 08 September 2023 Dominic Townsend, President This certificate may be found on the ABS QE Website (www.abs-qe.com).
https://www.avient.com/sites/default/files/2023-03/Mevopur Healthcare Functional Additives Antistatic Application Bulletin_0.pdf
APPLICATIONS • Medical devices • Drug delivery devices • Labware KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing risk of change 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 • Food contact established with FDA/EU* * FDA/EU compliance information available upon request Copyright © 2023, Avient Corporation.
https://www.avient.com/sites/default/files/2023-01/Mevopur Healthcare Functional Additives Chemical Foaming Agents Application Bulletin.pdf
KEY CHARACTERISTICS • Manufactured under ISO 13485 procedures • Documented change control beyond CAS number, reducing risk of change • Can be used on common injection molding and extrusion machines—set-up support by a technical assistance team • Available for use in polyolefins, styrenics and copolymers • Can be combined with colorants REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 - USP and (incl. class VI) - European Pharmacopeia, monograph 3.1.3/ 3.1.5 (polyolefin packaging materials) - USP (polyethylene) - Elemental impurities as per ICH Q3D • Registered Drug Master File (Type III) and/or Device Master File • Food contact according to USA FDA and EU norms APPLICATION BULLETIN Sustainability Spotlight Healthcare use limitations apply—see below.
https://www.avient.com/company/sustainability/planet/environmental-stewardship
ISO 14001 certifications follow intensive environmental audits of organizations, conducted by third-party ISO representatives. At present, multiple Avient facilities hold ISO 14001 Certification. Global ISO Certificate Library
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles
DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=6596
DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?pname[]=20342
DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?sust[]=1133
DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=6601
DIN EN ISO 105-B06 DIN EN ISO 105-C04 DIN EN ISO 105-P02 DIN EN ISO 105-X12
https://www.avient.com/sites/default/files/2024-03/Global Supplier Quality Manual_2024.pdf
Minimum requirements are adopted from the ISO 9001 standard. Avient shall communicate additional requirements regarding automotive (IATF 16949) and healthcare (ISO 13485) applications based on the raw material’s end-use application. This document is property of Avient 3.0 Supplier Management 3.1 Supplier Quality Management System Avient expects its supply base to maintain a certified QMS at all of its locations and those of its affiliated companies in accordance with the requirements of ISO 9001, ISO 13485, or IATF 16949 (depending on supplier commodity), as applicable.
