https://www.avient.com/products/vivo-formulations-healthcare/neu-custom-capabilities
NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.
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Global ISO Certificate Library
https://www.avient.com/company/sustainability/planet/alliances-partnerships
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/global-policy-anti-bribery-and-anti-corruption
Global ISO Certificate Library
https://www.avient.com/idea/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/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/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/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/avient-launches-medical-tpe-grades-formulated-without-animal-derivatives
All eight grades in the new series are also ISO 10993-4 and -5, REACH SVHC, and RoHS compliant.
https://www.avient.com/idea/medical-stoppers-improved
This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.
