ABSTRACT
This part introduction presents an overview of the key concepts discussed in the subsequent chapters. The part aims to help medical device manufacturers understand the international standards development process, its effect on sterilization practices in the United States and the Food and Drug Administration (FDA) use of standards in the regulation of the medical device industry. It shows that although the FDA has not formally endorsed any Advancement of Medical Instrumentation (AAMI) or International Organization for Standardization sterilization standard, the agency concedes that the standards represent state-of-the-art knowledge. All AAMI standards and recommended practices are developed by committees consisting of industry representatives. A standards document provides the manufacturer with information that should be considered in qualifying a device for clinical use. It spells out the measurement techniques that can be used to determine whether the device conforms to the safety and performance criteria and/or to compare the performance characteristics of different products.
