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
https://www.avient.com/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/company/policies-and-governance-0/copyright-legal-disclaimer
Global ISO Certificate Library
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-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/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-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/sites/default/files/2023-12/ISO 9001 Englewood CO.pdf
PLATINUM REGISTRATION INC. 1040 South Gaylord Street, Suite 71, Denver, CO 80209 www.platinumregistration.com | info@platinumregistration.com Polystrand, Inc. 8375 Highfield Parkway, Englewood, CO, 80112 Is certified by PLATINUM REGISTRATION as a company that has developed, implemented and maintains a quality management system that conforms to the requirements of the following International Standards: ISO 9001:2015 (Requirements not applicable:8.5.5 Post-delivery activities.)
Certificate Number: 13132875 Certified Since: November 19, 2019 * Certificate Approval Date (Date Granted, Reduced, Extended, or Renewed): October 12, 2022 Current Certification Cycle Start Date: November 19, 2022 Current Certification Cycle Expiration Date: November 18, 2025 Rev: B This certification is subject to the organization maintaining its management system to the requirements of ISO 9001:2015 as well as the requirements of Platinum Registration, Inc.