tes of change, and the duration of each change should be considered. Whenever the measured temperature exceeds the theoretical temperature calculated from measured pressure as described in Annex C, superheated steam may be present. The presence of superheated steam may be detrimental to the medical device and or its packaging and promise the sterilization process. Effective air removal from lumens, porous loads and plex designs incorporating enclosed spaces is difficult. The physical conditions required for effective air removal are influenced by length, width and shape of lumen, wall thickness, material of the product, mass, density, the packaging system and other items in the same packaging system. A sterilization process that removes air from the sterilizer chamber to a low level
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