Global ISO Certificate Library

Global ISO Certificate Library

This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.

Global ISO Certificate Library

NEU™ Custom Capabilities and NEUSoft™ Thermoplastic Polyurethanes are developed for short-term in-vivo applications that offer good elasticity, radiopacity, excellent UV stability and protection against moisture and oxygen while meeting ISO 10993 & USP Class VI standards.

We have composite pellet manufacturing in North America and Europe guided by the ISO 9001:2015 certified quality system. 

Normative basis EN ISO 13485:2016 Medical devices – Quality Management System Reg. no. EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Locations Scope Norm / Revision Reg. no. EN ISO 13485:2016 H61173 01.03. 2025 29.02. 2028 Avient Colorants USA LLC 17 Foss Rd.

ISO 13485 certified manufacturing sites ISO 10993 and USP Class VI compliant solutions

Mevopur™ Healthcare Colorants, Functional Additives, and Bio-based Formulations: Manufactured across a global network of ISO 13485 facilities, this broad portfolio is pre-tested to United States Pharmacopeia (USP) Class VI, ISO 10993, USP 661, European Pharmacopeia 3.1, and International Conference on Harmonization (ICH) Q3D protocols.

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint