Validating autoclaves


ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.Moist heat sterilization processes covered by ISO 17665-06 include but are not limited to: ISO 17665 covers sterilization of solid as well as liquid medical devices.

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Autoclaves come in a wide variety of sizes, from small bench-top laboratory autoclaves to large production autoclaves.A critical factor when validating autoclaves is the calibration of temperature sensors.It is essential that the user can demonstrate that the sensors were within an acceptable accuracy when they were used.According to the standard it is the manufacturer's responsibility to develop the process and provide guidelines/ instructions for operation and validation of the process.



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