scope:

Gives guidance on general testing procedures to assess the leaktightness for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This 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 standard is applicable to plants or components such as valves and fittings, tanks, pumps, piping, separating and filling devices as well as instrumentation in contact with process fluids. This standard applies if the intended use of the equipment includes hazardous or potentially hazardous microorganisms.