|As interest in infections increases, the evaluation process and results of sterilization efforts and techniques have become more important. The sterilization validation procedure is concerned with evaluating whether safety and efficacy have been secured in accordance with the international standard of ISO 13485 in terms of the installation process, use process and result of sterilization.
Recently, the Korea Food and Drug Administration (KFDA) enacted regulations to ensure that mandatory sterilization is executed by companies manufacturing and utilizing medical devices. Proper compliance with these regulations can result in additional points for Hospital accreditation evaluation and JCI evaluation criteria. RENOSEM leads the field in sterilization validation and ensures customer satisfaction thanks to its expert staff and differentiated technology.