What Tests Are Required To Add Sterilization Methods To The Registration Of Orthopedic And Oral Implants?

To increase the sterilization method by changing the registration of permission items, it is necessary to submit sterilization verification data and carry out sterility performance test.

In case of any other performance changes caused by the addition of sterilization methods, the test shall be conducted. For example, if the sterilization method of ethylene oxide is added, the sterility test item and residual amount of ethylene oxide shall be added.