Global ISO Certificate Library

Polymer technologies manufactured under controlled conditions and ISO 13485-certified sites to meet strict regulatory requirements

Global ISO Certificate Library

The materials are produced under a third-party certified ISO 13485:2016 quality management system and backed by comprehensive change control of raw materials, formulation, and manufacturing standards to enable consistent batch-to-batch quality.”

Mevopur™ Colorants represent a broad range of color concentrates and formulations, developed specifically for use in today’s complex healthcare applications, which meet or exceed requirements for regulations such as USP Class VI, ISO 10993, USP 661 and ICH Q3D.

Customer success story with a medical device company using Avient’s Colorant Chromatics™ Transcend™ Bio-compatible Premier Healthcare Colorants: Intended specifically for medical applications, the pre-colored solutions that are fully bio-compatible per ISO 10993 standards helped provide a customer that manufactures medical devices with ultra-high-heat resistance and performance for its orthopedic instruments without compromising safety. 

¹PCF values are calculated with Avient’s TÜV certified PCF-Calculator according to ISO 14067.  

Avient PCF values are determined using its PCF Calculator, which is certified by TÜV Rheinland and meets the ISO 14067:2018 standard.  

Mevopur™ formulations for PCR well plates prevent 'cross-talk' and minimize phosphorescence with optimally dispersed TiO2, while balancing melt flow and physical properties, and ensuring quality through ISO 13485:2016 certification.

Additionally, we request supplier self-assessments—aligned with ISO 9001/IATF 16949 standards—to gain insights into the core components of their Quality Management Systems (QMS).