https://www.avient.com/news/specialty-healthcare-polymer-solutions-be-showcased-avient-mdm-west-2024
All Mevopur formulations are manufactured across a global network of ISO 13485 facilities, and they meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661, European Pharmacopeia, and ICH Q3D.
They are available in pre-colored or concentrate form in a range of vivid opaque and transparent colors that are fully bio-compatible per ISO 10993 standards.
To access Avient’s news library online, please visit www.avient.com/news.
https://www.avient.com/resource-center/knowledge-base/article/securing-supplies-medical-plastic-solutions?ind%5B0%5D=6598
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.