JIST

Abstract

The biocompatibility of medical devices is a requirement of many regulatory agencies since, used on the human body, these devices must do no harm. Therefore, the materials that come in contact must be evaluated and determined to be safe for use with the human body because while in use, substances may leach off of a device into adjacent tissue. Some leachables are not biologically safe and can harm the body after or during application. Sensitization studies help to determine whether materials cause adverse local or systemic effects after exposure.

Studies to involve sensitization potential most often are conducted using extracts of the test materials. For this, guinea pig maximization test (Magnusson- Kligman method) is used for the device externally applied to the body surface. Such a study has great importance before commercialization of product. In the present study, an attempt has been made to assess skin sensitization of a microporous pressure sensitive adhesive (PSA) tape made of polyurethane (PU) acrylate by electron beam (e-beam) irradiation process.