Standardization News

One example of regulatory flexibility is employed by the U.S. Food and Drug Administration. The Food and Drug Administration Modernization Act of 1997 authorized the FDA to recognize voluntary consensus standards developed in an open and transparent process, such as those employed by U.S. domiciled standards developing organizations and the International Organization for Standardization (ISO). These standards can also be developed in a U.S. standards-based organization and adopted as an ISO standard. One such example, which is based on an AAMI (Association for the Advancement of Medical Instrumentation) original document, is ANSI/AAMI/ISO 11137, Sterilization of Health Care Products – Radiation.