scope:

Specifies performance criteria for filter elements and filtration assemblies used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. Applies where the intended use of the filter elements or filtration assemblies includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety. Applies to sterilizability and cleanability of filter assemblies and to leakage of microorganisms through the housing of a filttration assembly and to leakage of microorganisms through filter elements for dead-end filtration and cross-flow filtration.