3.10. The following requirements apply for safety assessment:@@- “A safety assessment has to be carried out at the design stage for a new facility or activity, or as early as possible in the lifetime of an existing facility or activity. For facilities and activities that continue over long periods of time, the safety assessment needs to be updated as necessary through the stages of the lifetime of the facility or activity, so as to take into account possible changes in circumstances (such as the application of new standards or new scientific and technological developments), changes in site characteristics, and modifications to the design or operation, and also the effects of ageing” (para. 4.6 of Ref. [3]).@@- “The primary purposes of the safety assessment shall be to determine whether an adequate level of safety has been achieved for a facility or activity and whether the basic safety objectives and safety criteria established by the designer, the operating organization and the regulatory body, in compliance with the requirements for protection and safety as established in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources…, have been fulfilled” (Requirement 4, Ref. [3])6,7 @@6) The current edition of the International Basic Safety Standards is Ref. [19].@@7) It is recognized that radiation doses to individuals in the future, including those that may occur after institutional management of a waste disposal facility has ceased, can only be estimated.@@“Nevertheless, estimates of possible doses and risks for long time periods can be made and used as indicators for comparison with the safety criteria” (para. A.4 of Ref. [2]).@@- “The safety assessment has to address all radiation risks that arise from normal operation (that is, when the facility is operating normally or the activity is being carried out normally) and from anticipated operational occurrences and accident conditions (in which failures or internal or external events have occurred that challenge the safety of the facility or activity). The safety assessment for anticipated operational occurrences and accident conditions also has to address failures that might occur and the consequences of any failures” (para. 4.5 of Ref. [3]).@@- “It is determined in the safety assessment whether adequate measures have been taken to control radiation risks to an acceptable level. It is determined whether the structures, systems, components and barriers incorporated into the design fulfil the safety functions required of them. It is also determined whether adequate measures have been taken to prevent anticipated operational occurrences and accident conditions, and whether any radiological consequence can be mitigated if accidents do occur” (para. 4.9 of Ref. [3]). @@- “The safety assessment has to address all the radiation risks to individuals and population groups that arise from operation of the facility or conduct of the activity. This includes the local population and also population groups that are geographically remote from the facility or activity giving rise to the radiation risks, including population groups in other States, as appropriate” (para. 4.10 of Ref. [3]). @@- “The safety assessment has to address radiation risks in the present and in the long term. This is particularly important for activities such as the management of radioactive waste, the effects of which could span many generations” (para. 4.11 of Ref. [3]). @@- “The safety assessment has to include a safety analysis, which consists of a set of different quantitative analyses for evaluating and assessing challenges to safety in various operational states, anticipated operational occurrences and accident conditions, by means of deterministic and also probabilistic methods. The scope and level of detail of the safety analysis are determined by use of a graded approach, as described in Section 3. Determination of the scope and level of detail of the safety analysis is an integral part of the safety assessment” (para. 4.13 of Ref. [3]).