Historical
ANSI/AAMI ST63-2002
Sterilization of health care products-Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices-Dry heat
Specifies requirements and guidance for the development, validation and routine control of a dry heat sterilization process for medical devices. Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. This standard does not apply to processes that utilize infrared or microwaves as the heating medium and does not detail a specified requirement for designation of a medical device as "sterile".
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
