AAMI TIR 7-99

This Technical Information Report (TIR) covers the selection and use of chemical sterilizingagents (except for ethylene oxide) that have been cleared for marketing by the Food and DrugAdministration (FDA). Topics specifically addressed include the general safety and performancecharacteristics of chemical sterilants and high-level disinfectants; the basic types of chemicalsterilants/high-level disinfectants and chemical sterilization techniques; the mechanisms by whichmanufacturers obtain FDA clearance for the marketing of their products; and questions that usersshould ask of manufacturers when choosing a product for use on a particular medical device.The TIR also provides general guidance on the use of chemical sterilants and high-leveldisinfectants, as well as a glossary, a bibliography, and informative annexes.