The medical device industry is facing increasing regulatory scrutiny regarding the use of PVC materials containing Di(2-ethylhexyl) Phthalate (DEHP), a known endocrine disruptor. This industry shift has prompted manufacturers to explore alternative flexible substrates like thermoplastic elastomers (TPEs). However, TPEs present unique challenges in assembly, as traditional methods such as solvent welding and existing adhesives are often ineffective, which is where LOCTITE® AA 3952and LOCTITE® SI 5057 come in.
The shift away from PVC materials has created a pressing need for adhesives capable of bonding effectively with TPE substrates. Many existing adhesives fail to achieve required strength or to maintain performance under heat and humidity aging, critical for medical device reliability. In addition, adhering to EU MDR regulations on CMR (carcinogenic, mutagenic, or toxic for reproduction) and endocrine substances is essential, further limiting material options.
Henkel addresses these challenges with the launch of two innovative light cure adhesives – LOCTITE® AA 3952 and LOCTITE® SI 5057. These adhesives are specifically designed to bond TPE substrates and overcome the limitations of traditional assembly methods, while also promising high performance under heat and humidity,
“At Henkel, we are dedicated to providing our customers in the medical industry with innovative adhesive solutions, pre-empting and complying with the respective safety standards,” says Dr Julia Kurtz, director marketing & strategy industrial adhesives at Henkel. “With the introduction of LOCTITE® AA 3952 and LOCTITE® SI 5057, we are addressing the growing need for safe and effective flexible substrates such as TPEs by providing innovative adhesives for their assembly. Our new products are ISO 10993 tested and formulated with patient safety and comfort in mind, ensuring their suitability for use in medical device bonding.”
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