规定了医疗器械工业干热灭菌过程的开发、验证和常规控制要求。本标准涵盖的干热灭菌过程包括但不限于强制空气循环和对流循环。虽然本标准主要针对干热灭菌，但也涵盖了脱热原过程。本标准不包括使用红外线或微波作为加热介质的工艺。

Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating medium.