CYTOTOXICITY TESTING METHODS FOR HYGIENE PRODUCTS

摘要

Testing for cytotoxicity is a good first step toward ensuring the biocompatibility of a medical device. A negative result indicates that a material is free of harmful extractables or has an insufficient quantity of them to cause acute effects under exaggerated conditions with isolated cells. However, this result is certainly not, on its own merit, evidence that a material can be considered biocompatible; it is simply a first step. On the other hand, a positive cytotoxicity test result can be taken as an early warning sign that a material contains one or more extractable substances that could be of clinical importance. In such cases, further investigation is required to determine the utility of the material.