Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

Global ISO Certificate Library

CSA International is an independent product safety certification organization that helps achieve compliance with US and Canadian standards.  Avient currently has twenty-three facilities globally certified to the Corporation’s GMP program and two facilities certified to "ISO 13485, Medical Device - Quality Management Systems - Requirements for Regulatory Purposes." Global ISO Certificate Library

Mevopur™ Healthcare Colorants and Formulations: a range of medical grade concentrates and pre-colored formulations for a wide range of polymers used in applications such as remote patient monitoring, circulating blood contact, and invasive devices, with pre-tested biocompatibility according to ISO 10993, change control in place, production certified to ISO 13485-2016 and DMF/MAF files available Colorant Chromatics™ Transcend™ Premier Healthcare Colorants: high-temperature solutions offered in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards to provide ultra-high-heat resistance and performance without compromising safety

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993

Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards. Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.

Produced under rigorous cGMP and medical manufacturing protocols, the new amber color concentrates are made in three dedicated EN ISO 13485-2016 registered facilities using only medical-grade ingredients. They are formulated without animal-derived substances and phthalates, and have been pre-tested for compliance with: •    ISO 10993-1 and USP parts , (including class VI) •    European Pharmacopoeia, monograph 3.1.15 •    USP and •    elemental analysis, as per ICH Q3D

They are also certified to meet biocompatibility requirements for ISO 10993 and USP Class VI standards. Avient's Suzhou facility operates under ISO 13485 quality management system certification, complying with the leading standards in medical device manufacturing.