https://www.avient.com/industries/healthcare/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions
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/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/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-announces-industry-first-carbon-negative-and-carbon-neutral-thermoplastic-elastomers
Avient follows the ISO 14067:2018 standard to calculate PCF values and utilizes global formulation expertise, green manufacturing processes, and sourcing & logistics competence to achieve such low or negative values.
https://www.avient.com/resource-center/knowledge-base/article/changing-regulations-ivdr
Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.
https://www.avient.com/company/sustainability/sustainability-report/products/product-stewardship-and-product-safety
Through this data, we create safety data sheets (SDS), customer certification statements for appropriate use and recommend product safety improvements
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance/avient-canada-ulc
TRA Plan Certifications
Global ISO Certificate Library
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.