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ANSI/AAMI/ISO 20857:2010/(R)2015

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

Summary

This standard 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. Annex 2

Technical characteristics

Publisher Association for the Advancement of Medical Instrumentation (AAMI)
Publication Date 01/01/2010
Confirmation Date 01/01/2015
Page Count 0
Themes Sterilization—Industrial
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