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

In addition, Avient can provide product carbon footprint (PCF) values for these and other products using our PCF calculator, which was developed in accordance with ISO 14067:2018 Standard and third-party certified by TÜV Rhineland. 

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

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.

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.

H Y P O D E R M I C N E E D L E M A N U FAC T U R E R N E E D L E H U B , C O V E R A N D S H I E L D • Compliance to ISO 6009 color coding for single use hypodermic needle • Biocompatibility of all component materials • Good mechanical and visual properties after sterilization (e.g. ETO / Gamma radiation) • Facilitated 510(k) submission with formulations registered under Device Master File MAF 1833 • Pre-tested raw materials to biocompatibility ISO10993, US and Eu Pharmacopeia, ICH-Q3D extractable metals • Enhanced stability with gamma stabilizing package • Minimized risk of change with change control beyond CAS number level • Ensured uninterrupted supply from multiple ISO 13485-2016 certified sites • MEVOPURTM ISO 6009 Standard / Customized Solutions KEY REQUIREMENTS WHY AVIENT?

They provide comparable performance to 100% virgin equivalents and can help reduce product carbon footprint (PCF), which can be quantified on request using Avient’s PCF Calculator, certified by TÜV Rheinland according to ISO 14067.   

Developed with the rigorous demands of the healthcare industry in mind, these innovative pre-colored compounds are formulated with materials that have been successfully tested for ISO 10993 biocompatibility, supporting compliance with the highest standards for medical applications.

Product Carbon Footprint values are calculated with Avient’s third-party certified PCF Calculator by TÜV Rheinland according to ISO 14067.