The Latest Topics of Irritation Test

Abstract

Assessment of irritation is an essential item of the biological evaluation of medical devices that has direct or indirect contacted with the body. Skin irritation test has typically been performed using in vivo models. Recently, alternative in vitro test method for assessing skin irritation potential in medical device extracts have been developed using a Reconstructed Human Epidermis (RhE) models to reduce in vivo test. The results of the in vitro method international round robin study show that it can be useful for correctly estimating the irritation potency of medical device extracts. Based on these results, the latest of MHLW Notification, an attachment “Guidance on test methods for biological safty evaluation of medical devices”, Part 5 “Irritation Test” has adopted the new in vitro test method for skin irritation test. It is an alternative to the primary skin irritation test. However, it is desired that the in vitro test will be improved to detect irritation response quantitatively, as the same with in vivo tests.