Paragraph 5
Safety assessment of the activities and the facility in order to—
(a)
identify ways in which potential exposures or accidental and unintended medical exposures could occur;
(b)
estimate, to the extent practicable, the probabilities and magnitude of potential exposures;
(c)
assess the quality and extent of protection and safety provisions, including engineering features, as well as administrative procedures;
(d)
define the operational limits and conditions of operation.