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.

Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.

Geon(TM) DB5337 NEUTRAL ISO TT STAB FUNG

Additionally, Avient’s self-assessments, based on ISO 9001/IATF 16949, are requested of suppliers in order to provide insight into the core components of their Quality Management Systems (QMS) and subsequently used as approval criteria for Avient’s most sensitive end applications.

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.

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.  

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.”

These values were determined using Avient’s PCF Calculator, which is third-party certified by TÜV Rheinland and aligns with ISO-14067:2018 standards.