This European Standard specifies performance criteria for pumps used in biotechnological processes, in which the release of microorganisms should be limited or prevented for reasons of safety. This standard applies if the intended use of the pump includes hazardous or potentially hazardous microorganisms. This standard applies to pumps with no auxiliary equipment, bordered by the connections on the unit of equipment. It also applies to pump systems equipped with all necessary auxiliary equipment necessary for operation of pumps and to accomplish cleaning and sterilization.