scope:

Give guidance on the selection and risk analysis of biotechnological equipment and the subsequent assembly of these into a plant in order to attain the appropriate biosafety containment levels. This includes verification of installation, operation and maintenance. It also applies when a new process or significant changes are introduced into an existing plant. This European standard applies if the biotechnological process includes the use of hazardous or potentially hazardous microorganisms and/or if the emission of such microorganisms into the working place and/or environment are restricted. However this should be considered only as a part of the total safety approach required. Attention is drawn to relevant European and national regulations.