CEN/TC 233/WG 4 - Equipment

This European Standard specifies performance criteria for vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment 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 specifies performance criteria for bioreactors used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of bioreactors 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 specifies performance criteria for pressure protection devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of pressure protection devices includes hazardous or potentially hazardous microorganisms used in biotechnological processes.

This European Standard specifies performance criteria for glass pressure vessels used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of glass pressure vessels 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 specifies performance criteria for chromatography columns used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of chromatography columns 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 specifies performance criteria for kill tanks used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of kill tanks 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 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.  This European Standard 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.

This European Standard specifies performance criteria for tubes and pipes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use. This European Standard applies where the intended use of the tubes and pipes 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 specifies performance criteria for sampling and inoculation devices used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the sampling and inoculation device 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 specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes 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 specifies performance criteria for piping and instrumentation used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment 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 specifies performance criteria for couplings used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the coupling 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 gives guidance to the manufacturer of sampling and inoculation devices on providing instructions in the manufacturer's documentation accompanying his products in accordance with prEN 13312-3. It has the purpose of pointing out to him, which hazards can occur during operation, s so that he can take these into account in an adequate way during construction and will be in a positive to formulate information for use giving adequate consideration of safety...

This European Standard specifies performance criteria for off-gas systems used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker and the environment. This European Standard applies where the intended use of the off-gas system 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.

This European Standard 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. This European Standard 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.

This European Standard specifies performance criteria for shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

This European Standard specifies performance criteria for centrifuges used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.

This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter 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.

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.

This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

This European Standard gives guidance on general testing procedures to assess the leaktightness for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the leaktightness of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.

This European Standard gives guidance on general testing procedures to assess the cleanability of equipment (components and units of equipment) used in biotechnological processes. This European Standard applies primarily if the intended use of equipment includes the use of potentially hazardous microorganisms. This European Standard also applies to non-hazardous micro- organisms and/or to residual soil which can adversely affect sterilization processes or which can cause cross-contamination of products or processes.