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This European Standard specifies performance criteria for valves used in biotechnological processes with respect to the potential hazards to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the valves includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. This European Standard applies to the sterilizability and cleanability of valves and to microbial leaktigtness of valves breaching the physical containment of the intended closed system in an unwanted manner. NOTE This implies both leakage to the environment as well as within compartments of the process system.