AAMI ST63:2002

This standard specifies requirements and guidance for the development, validation, and routinecontrol of dry heat sterilization processes for medical devices. Although the scope of thisstandard is limited to medical devices, it specifies requirements and provides guidance that mayapply to other health care products. This standard does not apply to processes that use infraredor microwaves as the heating medium and does not detail a specified requirement fordesignation of a medical device as ?sterile.?