ABSTRACT
In 1990, the United States took the lead in the development of international sterilization standards with the formation of International Organization for Standardization (ISO)/Technical Committee (TC) 198, Sterilization of health care products. The American National Standards Institute designated Advancement of Medical Instrumentation (AAMI) as the Secretariat of this ISO TC, which includes 13 working groups. Existing national standards, such as the AAMI Sterilization Standards Committee standards, have provided an important starting point for international standards and have permitted faster development of the international standards. The Food and Drug Administration (FDA) Modernization Act of 1997 amended the Food, Drug and Cosmetic Act to allow formal FDA recognition of international and national consensus standards to satisfy certain identified device review requirements. The ISO sterilization standards have resulted in global harmonization of most requirements for industrial sterilization, because the ISO encourages members to adopt its standards.
