These expanded offerings add medical-grade LDPE, nylon, PEBA, PS and PVC to the globally available palette of specialty healthcare colorants, and are pre-certified to meet or exceed biocompatibility requirements for ISO 10993 and/or USP Class VI protocols. All thirteen medical-grade carrier materials in the portfolio are pre-certified to meet or exceed ISO 10993 and/or USP Class VI requirements for applications ranging from medical packaging to device housings. 

Avient’s PCF calculation method follows the ISO 14067:2018 standard and is certified by TÜV Rheinland.   Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is manufactured in the United States with global commercial availability.  

– June 24, 2014 – PolyOne GLS Thermoplastic Elastomers, a global leader in high-performance, custom-formulated thermoplastic elastomer (TPE) solutions, today announced that its Versaflex™ CE 3620 material meets all ISO 10993-10:2010 testing requirements with no signs of irritation. Several Versaflex CE materials have been used in wearable electronics applications without irritation for a number of years, and the recent ISO testing results underscore this track record.

Obtaining the RC14001® certification is unique as it encompasses security, product safety, and transportation elements, setting itself apart from the individual ISO 14001 and ISO 45001 certifications.”  

Biocompatibility: Our PEEK solutions have passed ISO 10993 biocompatibility testing, ensuring safety and reliability for medical applications. Passed ISO 10993 biocompatibility testing, suitable for medical use

PDI is accredited under ISO 17025 by A2LA (the American Association for Laboratory Accreditation) to perform testing as an independent laboratory body. Global ISO Certificate Library

Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for identification and differentiation Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICHQ3D protocols to reduce product carbon footprint Flexible, durable, and colorable TPEs for improved grips and gaskets that comply with USP Class VI and ISO 10993

Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards. Custom formulations can meet specific opacities, sealing requirements, impact performance, and align with ISO 6009 color standards.

MAUVE DOOR, ISO FIX COVER HAZEL DOOR, ISO FIX COVER V2

Geon(TM) DB5323 Neutral TT Imp-Iso No-Stab Geon(TM) DB5324 Neutral TT Imp-Iso Stab