Confluent, Chattanooga, TN, has announced the offering of REACH and EU Medical Device Regulation (MDR) Compliant Polyimide Tubing.
REACH, an acronym for Registration, Evaluation, Authorization, and Restriction of Chemicals, is an EU regulation that imposes stringent limitations on the amount of restricted substances that can be contained in devices sold in the EU. The industry standard polyimide, a material used extensively in medical applications such as vascular catheters, contains one of the restricted solvents.
“Historically, ensuring REACH compliance required extensive post processing to remove the residual solvent and even after this processing, compliance is not guaranteed,” stated Jill Ellison, VP of site operations for Confluent’s Polymer Tubing Center of Excellence. “Confluent’s REACH Compliant Polyimide is made with no restricted substances, therefore, there are no restricted solvents to remove and no extensive and expensive testing is required.”
Confluent’s REACH Compliant Polyimide uses industry standard chemistry resulting in product that looks and performs like traditional polyimide while avoiding the historical hurdles of ensuring EU compliance. Confluent is offering their REACH Compliant Polyimide immediately with lead times of 4 weeks or less.
