PFX Flex liners become the first medical device components to earn Intertek’s PFAS-free certification
Zeus, a global leader in advanced polymer solutions and catheter manufacturing, has announced that PFX Flex Sub-Lite-Wall liners have become the first medical device components to earn PFAS-free certification from Intertek, a leading Total Quality Assurance provider to industries worldwide.
Paddy O’Brien, Chief Executive Officer at Zeus said: “For nearly sixty years, Zeus has built its reputation on fluoropolymer innovation. As the medical device industry evaluates new material alternatives, we believe customers deserve objective, independent validation of the claims behind those technologies. That’s why third-party certification matters. It gives engineers confidence that they can make critical material decisions based on verified data.”
Intertek’s certification confirms that PFX Flex liners contain total organic fluorine levels below 20 ppm and targeted PFAS below 25 ppb, meeting Intertek’s published criteria for PFAS-free certification. PFAS-Free is Intertek’s certification designation for products that meet these thresholds. The certification covers the PFX Flex catheter liner portfolio, manufactured over either PEEK or silver-plated copper (SPC) mandrels.
Zeus says that as interest in non-fluorinated materials grows, manufacturers are evaluating a widening field of options, and the PFAS-free claims attached to those options vary widely in how they are defined and substantiated. Independent third-party validation brings greater consistency and transparency to those evaluations, helping establish a common benchmark for PFAS-free claims.
“Our PFAS-Free Certification combines Total Organic Fluorine and targeted PFAS testing with material documentation and ongoing oversight, giving manufacturers and their customers confidence that PFAS-free claims are supported by a rigorous, science-based evaluation.” said Faye Ricker, Sustainability Certification Manager at Intertek. “We’re pleased to recognize PFX Flex as the first medical device liner to earn this certification.”
Introduced in January 2026, Zeus says PFX Flex is engineered to deliver the performance catheter manufacturers expect from PTFE in a non-fluorinated construction. The liner combines PTFE-like lubricity, flexibility, direct covalent bond strength, exceptional abrasion resistance, and compatibility with multiple sterilisation methods based on test reports according to the compay, giving manufacturers greater design flexibility without compromising performance characteristics.
“The goal wasn’t just to create a PTFE-alternative catheter liner,” said Suresh Sainath, Chief Technology Officer at Zeus. “The challenge was finding a non-fluorinated material capable of matching the performance that has made PTFE the gold standard for catheter liners for decades. That required years of research and development, and independent verification through Intertek provides an objective validation of the technology we’ve developed.”
“Even if there’s no regulatory ban on the use of PFAS-based materials in medical devices today, our customers are already evaluating alternatives rather than waiting for one,” said Jim O’Connell, Chief Commercial Officer at Zeus. “Our aim is to give them options that perform, backed by testing and certification, no matter where regulations may land.”
