https://www.avient.com/news/avient-s-malm-sweden-site-earns-iscc-plus-certification-mevopur-healthcare-bio-based-polymer-solutions
Like other Mevopur products, the bio-based polymer solutions are formulated with raw materials pre-tested to ISO, USP, EP, and ICH Q3D protocols, supporting their compliance with safety and regulatory requirements for use in healthcare.
In Europe, Mevopur concentrates and ready-to-use formulations are manufactured in the ISO 13485-2016 certified site of Malmö, Sweden.
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/news/avient-launches-t-v-rheinland-certified-carbon-calculator-scope-3-emission-goals
Avient's PCF Calculator adheres to the globally recognized ISO 14067:2018 standard for calculating Product Carbon Footprint and has obtained additional third-party certification through TÜV Rheinland for ISO 14067 compliance.
https://www.avient.com/news/avient-announces-expansion-neusoft-tpu-manufacturing-china-medtec-china-2024-enhancing-service-apac-customers
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.
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/sites/default/files/2025-03/ISO 13485 2025.pdf
Normative basis
EN ISO 13485:2016 Medical devices – Quality Management System
Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025
29.02. 2028
Locations Scope Norm / Revision Reg. no.
EN ISO 13485:2016 H61173 01.03. 2025
29.02. 2028
Avient Colorants USA LLC
17 Foss Rd.
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/company/policies-and-governance/email-fraud-information
Global ISO Certificate Library
https://www.avient.com/company/sustainability/planet
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/candidate-privacy-notice
Global ISO Certificate Library
