• AAMI ST63:2002

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

Association for the Advancement of Medical Instrumentation , 10/01/2002

Publisher: AAMI

File Format: PDF

$55.00$110.00


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.?

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