부산대학교 도서관

Reports on the validation of sterilization processes for a medical device by manufacturers in the U.S. Guidance from the Food and Drug Administration on the validation process; Application of validation methods developed by the Association for the Advancement of Medical Instrumentation (AAMI); Collaboration of the AAMI with the International Organization for Standardization and American National Standards Institute on the development of harmonized guidance for sterilization validation and testing methods.