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This International Standard describes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. This part of ISO 14698 specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used as a source of information.

Application-specific requirements are not given. Neither are fire and safety issues addressed; for these, see regulatory requirements and other national or local documentation.