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. Both the FDA’s Center for Devices and Radiological Health and the EU Medical Device Regulation (MDR) 2017 have emphasized minimizing DEHP exposure, prompting 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. 

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. The key benefits of the products include: 

• Enhanced bonding performance: Reliable adhesion to TPE materials, especially TPE-S and TPE-O, ensuring robust and durable device assembly. 
• Resistance to environmental factors: High performance under heat and humidity aging conditions. 
• Regulatory compliance: Formulated to meet EU MDR 2017 standards regarding CMR and endocrine substances. Both products are also ISO 10993 tested for biocompatibility, ensuring safety in medical device applications. 

“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,” said Dr. Julia Kurtz, Director Marketing & Strategy Industrial Adhesives at Henkel. “With the introduction of Loctite AA 3952 and 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.” 

Henkel’s extensive portfolio for medical devices includes adhesives for assembly, low-pressure molding technologies, skin bonding, circuit board assembly, and printable conductive inks. A comprehensive range of Loctite brand dispensing, curing and motion control equipment is available to ensure efficient and optimized assembly processes. As medical devices continue to evolve with advanced technologies, Henkel remains a trusted partner, delivering safe and innovative assembly solutions. 

Learn more at www.henkel.com.