Tissue Medical Adhesive Testing

What Is Tissue Medical Adhesive Testing?

To make sure tissue medical adhesives like fibrin sealants or acrylic adhesives can be marketed, these have to be tested for strength properties under different load scenarios, all according to standards or customised protocols. The adhesive is first applied to skin-like substrates or skin grafts with a defined shape and then tested for stresses that occur in everyday life. This is the only way to ensure the safety and efficacy of the products and to verify that they do not cause adverse reactions in patients.

At Applus+ Laboratories we work with the goal of improving the products our clients develop through a comprehensive testing service for medical devices that helps verify the quality and efficiency of tissue medical adhesives.

What Tissue Medical Adhesive Testing Services Do We Offer?

To ensure safe use, the strength properties of tissue medical adhesives must be determined before product approval, clinical use, recertification, and during quality control processes. At Applus+ Laboratories, we offer accredited tissue medical adhesives testing services based on DIN EN ISO/IEC 17025, specifically adhering to the following standards: ASTM F2255, ASTM F2256, ASTM F2258, and ASTM F2458.

By doing so, our laboratories performing tissue medical adhesive testing can provide high-quality, reliable results that meet regulatory and industry standards, ensuring the safety and effectiveness of these products.

Static and Fatigue Testing for Tissue Medical Adhesive

We mainly use two methods for the tissue medical adhesive testing: static and fatigue testing, according to the ASTM standards we mentioned, as well as internal test procedures based on scientific publications and customer protocols.

The ASTM standards from the first are the following:

• ASTM F2255 tests the shear strength of tissue adhesives by applying tension in a lap-shear configuration to simulate performance under stress.
• ASTM F2256 evaluates the adhesive strength under peel stress, where bonded tissues are pulled apart in a T-shaped configuration.
• ASTM F2258 measures the tensile strength of adhesives by pulling bonded tissues directly apart to test their performance in closures.
• ASTM F2458 assesses wound closure strength, determining how well adhesives and sealants hold wounds closed under mechanical stress.

Our Testing Facilities and Equipment for Tissue Medical Adhesive Testing

Our team at Applus+ Laboratories is more than ready to perform tissue medical adhesive testing, using some of the most advanced equipment to evaluate different aspects of the tissue medical adhesive's performance, all to ensure that the products are safe, effective, and comfortable for users, complying with regulatory standards.

That's why at Applus+ Laboratories we offer a comprehensive service where, thanks to our state-of-the-art equipment, we can test their products simulating the effects of daily use.

Our team includes a multi-station simulator equipped with 5 controllable axes, allowing simultaneous testing of up to 8 different implants. This enables us to evaluate how the tissue medical adhesives respond to various fitting types, fixation methods, designs, and bearing combinations.

What Are the Benefits of Tissue Medical Adhesive Testing?

As mentioned earlier, conducting the necessary tests on all tissue medical adhesives helps us ensure these products meet standards and are safe, enabling them to be marketed promptly. Due to standardised quality tests, tissue medical adhesives can be compared to each other and results could be used for further improvements of the medical products.

Improving Safety and Efficacy for Tissue Medical Adhesive

Conducting thorough tests on tissue medical adhesives using advanced materials is a reliable approach to ensuring both safety and regulatory compliance. By assessing the safety and effectiveness of materials, these comprehensive evaluations foster innovation and ensure the delivery of safer products to patients.

Compliance with International Standards for Tissue Medical Adhesives

To get a broader market entry for your tissue medical adhesives, it is important to follow international standards, which will help you expand globally much faster with greater market access. By doing so you are also boosting your reputation and credibility in an increasingly competitive international market.

Why Choose Applus+ Laboratories for Your Tissue Medical Adhesive Testing Needs?

When you choose Applus+ Laboratories for your tissue medical adhesive testing you're choosing expertise, reliability, and commitment to safety and quality assurance from a leading authority in the testing of medical devices.

We specialise in delivering high-quality testing services that adhere to ASTM standards, making sure that your tissue medical adhesive products are precise and reliable. Our extensive range of testing capabilities and dedication to exceptional client care make us the ideal partner for your tissue medical adhesive testing needs.

Applus+ Laboratories is fully committed to serving as your comprehensive provider for medical device testing, offering a full spectrum of services designed to expedite your product's path to market, including:

• Consultation and developmental testing
• Comprehensive testing throughout the product lifecycle
• Product and process qualification with batch release testing

Having a global presence means that we are positioned to provide our testing solutions to clients worldwide, offering access to extraordinary tissue medical adhesive testing regardless of your location.

Choose Applus+ Laboratories as your trusted partner for all your tissue medical adhesive testing requirements and you’ll benefit from our expertise and exceptional service quality.