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Cleaning and sterilization validation: ISO, ASTM, AAMI, FDA

Konmex Laboratories provide services of medical device cleaning, reprocessing, and sterilization validation in compliance with appropriate ISO and ASTM standards.

Cleaning validation

Cleaning validation of single use and reusable medical devices are necessary to confirm the procedures used to clean and disinfect are effective. We are developing cleaning and disinfection protocols according to the standards, such as: ISO 17664, ISO 15883, ASTM F3127, ASTM F2847, AAMI TIR 12, AAMI TIR 30, and the FDA guidance.

Sterilization validation

Sterilization validation process can be applied to medical devices that are cleaned and disinfected. We conduct steam and ethylene oxide sterilization validations in compliance with ISO 17665, ISO 11737, ISO 14937, ISO 11135, appropriate AAMI and FDA guidance.

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