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/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/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/sites/default/files/2023-10/ISO 22000 Certificate.pdf
Certificate Number: 255 ISO2P Date First Registered: 03/04/2023 Issued on: 11/04/2023 Valid until: 10/04/2026 Awarded to AVIENT PAKISTAN (PVT) LTD 1A/1, Sector#20, Korangi Industrial Area, Sector 20 Karachi, Pakistan In recognition of the Organization´s Food Safety Management System which complies with : ISO 22000:2018 Food Category : I For the scope of activities described below: Manufacturing & Processing of Polymer Resins & Master batch F-3/22/ A 100 Issue date : 06/2022 Version:03 It is mandatory to carry out the surveillance audit on its time.
https://www.avient.com/industries/healthcare/labware-diagnostics/ivd-devices
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support
Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/home-care-monitors
They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard
Solutions compliant with USP Class VI and ISO-10993 regulations
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/company/sustainability/performance/eps-expansion
Global ISO Certificate Library