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ANSI/AAMI/ISO 20857:2010 (R2015)

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

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.


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Association for the Advancement of Medical Instrumentation [aami]


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