CX-6187-A CERT.

Global ISO Certificate Library

Is there an Environmental Management System (EMS or/and ISO 14001 certifications) in place? Varies by Site; refer to ISO Cert https://www.avient.com/company/policies-and- governance/global-iso-certificate-library How often are 3rd party audits conducted? IATF and ISO 13485 managed within ETQ Reliance.

Global ISO Certificate Library

Global ISO Certificate Library

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.”  

Like other Mevopur formulations, they are produced in dedicated facilities according to ISO 13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

– 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.

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.