https://www.avient.com/news/avient-launches-new-bio-based-polymer-solutions-medical-and-pharmaceutical-applications-during-pharmapack-europe-2022
Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.
https://www.avient.com/news/bio-based-tpe-biopharmaceutical-tubing-added-avient-s-sustainable-healthcare-solutions
Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.
https://www.avient.com/products/polymer-colorants/high-temperature-color-concentrates/colorant-chromatics-transcend-premier-healthcare-colorants
Tested to ISO 10993
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-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/industries/healthcare/labware-diagnostics/laboratory-equipment
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
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/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/news/avient-unveils-high-temperature-vibrant-colorants-healthcare-mdm-west-2022
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/idea/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).
