Henkel Unveils New TPE Bonding Adhesives to Meet Regulatory and Performance Demands in Medical Devices

Henkel Unveils New TPE Bonding Adhesives to Meet Regulatory and Performance Demands in Medical Devices

(IN BRIEF) Henkel has launched two new light cure adhesives, Loctite AA 3952 and Loctite SI 5057, designed to address the challenges of bonding thermoplastic elastomers (TPEs) for medical devices. These adhesives ensure strong and reliable connections, meet stringent EU MDR 2017 regulations, and offer solutions to the increasing demand for safer, more effective alternatives to DEHP-based PVC materials in medical device assemblies.

(PRESS RELEASE) DÜSSELDORF, 30-Jan-2025 — /EuropaWire/ — In response to increasing regulatory scrutiny surrounding the use of DEHP-based PVC materials in medical devices, Henkel has introduced two advanced light cure adhesives – Loctite AA 3952 and Loctite SI 5057. These adhesives offer robust solutions for bonding thermoplastic elastomers (TPEs), which have become a critical alternative to PVC as manufacturers seek safer, more reliable materials for flexible medical device assemblies.

The medical device sector is currently navigating challenges related to regulatory demands aimed at minimizing DEHP exposure, a known endocrine disruptor. Both the FDA and EU Medical Device Regulations (MDR 2017) have emphasized the need for safer alternatives, driving the industry toward TPEs. However, while TPEs present a viable solution, traditional assembly methods, such as solvent welding, often fall short, and existing adhesives frequently struggle to meet performance standards.

Henkel’s new adhesives are designed to overcome these challenges, offering enhanced bonding performance with TPE-S and TPE-O materials, ensuring the durability and reliability required for medical device assembly.

Key benefits include:

• Superior Bonding: High-performance adhesion to TPE materials, delivering durable and strong bonds.
• Environmental Resistance: Reliable performance under heat and humidity aging conditions.
• Regulatory Compliance: Fully compliant with EU MDR 2017 standards on CMR (carcinogenic, mutagenic, or toxic for reproduction) substances and endocrine disruptors. Both adhesives are also ISO 10993 tested for biocompatibility, ensuring they meet the safety standards necessary for medical device applications.

Dr. Julia Kurtz, Director of Marketing & Strategy for Industrial Adhesives at Henkel, commented on the launch: “Henkel is committed to supporting our customers in the medical sector by offering innovative adhesive solutions that not only meet the evolving regulatory requirements but also improve patient safety and comfort. With Loctite AA 3952 and SI 5057, we are addressing the urgent need for reliable TPE bonding solutions in the medical device industry.”

Henkel’s comprehensive portfolio for medical device assembly also includes adhesives for low-pressure molding, skin bonding, circuit board assembly, and conductive inks, complemented by Loctite dispensing, curing, and motion control systems. Henkel continues to be a trusted partner, providing innovative and safe solutions for the evolving needs of the medical device sector.

Henkel to Showcase New Adhesives at MD&M West 2025
Attendees can explore Loctite AA 3952 and SI 5057 at Henkel’s booth (#2410) during the MD&M West exhibition from February 4–6, 2025, in Anaheim, California. Further details on the new adhesives are available on Henkel’s website.

About Henkel
With its brands, innovations and technologies, Henkel holds leading market positions worldwide in the industrial and consumer businesses. The business unit Adhesive Technologies is the global leader in the market for adhesives, sealants and functional coatings. With Consumer Brands, the company holds leading positions especially in laundry & home care and hair in many markets and categories around the world. The company’s three strongest brands are Loctite, Persil and Schwarzkopf. In fiscal 2023, Henkel reported sales of more than 21.5 billion euros and adjusted operating profit of around 2.6 billion euros. Henkel’s preferred shares are listed in the German stock index DAX.
Sustainability has a long tradition at Henkel, and the company has a clear sustainability strategy with specific targets. Henkel was founded in 1876 and today employs a diverse team of about 48,000 people worldwide – united by a strong corporate culture, shared values and a common purpose: “Pioneers at heart for the good of generations.”
More information at www.henkel.com

Media Contact:

Sebastian Hinz
Adhesive Technologies
Media Relations
+49-211-797-8594
press@henkel.com

SOURCE: Henkel AG & Co. KGaA