ISO Health Care Product Sterilization Standards Adopted By AAMI
A health care product is not sterile unless it is free of microorganisms. Sterilization is assured with these products and their materials and components through chemical or physical means. Common sterilization methods include liquid chemicals, moist heat, dry heat, ethylene oxide gas, and radiation.
Numerous international standards developed and published by the International Organization for Standardization (ISO) specify guidelines for the various sterilization methods of medical equipment and devices. As ANSI is the U.S. member body to ISO, the United States takes an active role in the development of many of these standards. The Association for the Advancement of Medical Instrumentation (AAMI) administers this participation.
AAMI has also adopted these documents as American National Standards, which generally are unchanged. The following international sterilization standards have been adopted:
ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products (You can read about this American National Standard in depth in our post on the Determination of a Population of Microrganisms on Products for Sterilization)
As each of these American National Standards originated as international ISO documents, each reflects an existing ISO standard with the same numeral designation. If you’d like to find the international versions of these standards, please refer to the AAMI Glossary of Equivalent Standards and search the ANSI Webstore. This list also notes if there are any technical variations with the national adoptions.
