https://www.avient.com/company/our-businesses
Global ISO Certificate Library
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/news/polyone-features-more-materials-approach-medical-devices-mdm-west-2020
OnColor™ HC Colorants for Healthcare: color concentrates developed to meet or exceed USP Class VI and ISO 10993 and formulated without heavy metals, phthalates and BPA or other requirements as specified
https://www.avient.com/news/polyone-launches-neu-view-technology-radiopaque-translucent-catheters
They are available in certified USP Class VI and ISO 10993 compositions.
https://www.avient.com/resource-center/knowledge-base/article/reduce-carbon-footprint-medical-plastics
Like all Mevopur products, Mevopur Healthcare Bio-based Polymer Solutions use raw materials pre-tested to ISO 10993-1, USP and , EP 3.1.3 / 3.1.5 (polyolefin packaging materials), USP (polyethylene) and ICH Q3D (elemental impurities).
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-ep-white-colorants
ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-bio-based-polymer-solutions
Raw materials tested to ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D
https://www.avient.com/news/avient-expands-production-nymax-rec-recycled-nylon-formulations-istanbul
PCF values are calculated using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067
https://www.avient.com/news/avient-launches-two-new-sustainable-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2021
MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/company/sustainability/performance/eps-expansion
Global ISO Certificate Library