Mediprene TPE Certified Against Skin Sensitization
Sensitization testing is recommended for all medical device categories according to the ISO 10993-1 guideline, since exposure or contact to even minute amounts of potential leachables can result in allergic or sensitization reactions. ELASTO can now offer their medical customers assurance that Mediprene thermoplastic elastomers have been classified as non-sensitizers.
LAB Research, Hungary, carried out an independent skin sensitization study on a representative Mediprene compound. The study was performed in accordance with EN ISO 10993 - 10 “Tests for Sensitization and Irritation.” The Mediprene compound was shown to have no sensitization potential and classified as a non-sensitizer, according to current EU regulations.
ELASTO has been supplying TPE for skin contact applications for many years and has never experienced sensitization reactions among customers or end-users. The fact that the tested Mediprene compound passed the ISO 10993-10 requirements further confirms the suitability of Mediprene thermoplastic elastomers in skin contact applications. “Close partnerships with our medical customers, a broad and deep understanding of medical device requirements, standards and functionality, this is what we offer our medical customers,” commented Niklas Ottosson, medical technical manager at ELASTO. “We have a strong heritage in the medical device market and are continuously working to expand our product offering. We support our customers by proving the performance of our products through carrying out relevant testing according to medical standards and pharmacopoeias.”
In addition to the sensitization test, representative Mediprene grades have already passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI.
Mediprene thermoplastic elastomers for medical device applications offer many advantages; they are sterilizable with gamma, EtO and steam. Mediprene thermoplastic elastomers are PVC, silicone and latex free, making them allergen free and a viable alternative to PVC based compounds. Applications include medical tubing, IV systems, catheters, intubation and respiratory equipment, resealable membranes, drip chambers and wound care products.
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