The Ministry of Food and Drug Safety (MFDS) said Friday that the homegrown skin irritation test method for medical devices using human skin models has won approval as an international standard test by the International Organization for Standardization (ISO).

According to the ministry, the validation results of the test method were presented at the ISO/TC194 expert committee meeting in the U.S. from Oct. 23 to 27. ISO unanimously approved the test method as an international standard for irritation testing.

ISO/TC194 is an ISO Technical Committee for standards in the biological evaluation of medical devices, with one Subcommittee (SC) and 17 Working Groups (WG).

The test method approved as an ISO standard is for evaluating the biosafety of medical devices. It is a test method for evaluating the skin irritation of medical device-derived substances using the human skin model called “KeraSkin,” which is biochemically and morphologically similar to human skin.

KeraSkin is a human tissue model developed by the Korean company Biosolution and is a 3D reconstructed human skin epidermis made of human epidermal tissue skin keratinocytes.

The test method has been validated by three domestic non-clinical testing laboratories under the initiative of the Korea Center for Validation of Alternative Methods (KoCVAM) and has proven its scientific validity.

"The approval of the test method using a domestically developed and manufactured human skin model as an ISO international standard test method is expected to save time and costs for non-clinical test laboratories and other industries when conducting skin irritation tests for medical devices," the ministry said.

The ministry will continue to do its best to develop internationally recognized animal alternative test methods by making the most of KoCVAM, it added.