The biomedical industry uses tissue adhesives for applications such as bandages, secondary dressings, wound closure, and surgical sealants. The adhesive strength of these products must be clearly defined before using in a clinical setting. If the adhesive is not strong enough, the product may lead to infection or poor healing. If the adhesive is too strong, the underlying tissue may become damaged upon removal. This standard describes a test methodology for both development and characterization of these adhesives, as well as for quality control. When developing and characterizing the material properties of these adhesives in combination with soft tissue substrates, it is important to consider the environmental conditions.
The challenges of testing to this standard are:
- Testing in real world conditions
- Accurately recording adhesive strength
- Testing in real world conditions – For this application, we recommend the BioPuls™ Submersible Pneumatic Side Action Grips and Temperature Controlled Bath. The grip's features ensure the accuracy of results, as well as allow for easy loading of the delicate, compliant, and slippery specimens with both hands. The BioPuls Bath allows for the testing of specimens at in-vivo conditions with an adjustable temperature controller.
- Accurately recording adhesive strength – Bluehill® Universal allows the user to adjust the data sampling rate of the software up to 2.5 kHz in order to capture the critical data points, and to capture all peaks and valleys throughout the test.
It is important to review ASTM F2256-05(2015) to fully understand the test setup, procedure, and results requirements.