scope:

Specifies performance criteria for valves used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. Applies where the intended use of the valve 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. Applies to sterilizability and cleanability of valves and to microbial leaktightness of valves breaching the physical containment of the intended closed system in an unwanted manner.