Class II Nuclear Facilities and Prescribed Equipment Regulations

11 The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act may certify a model of Class II prescribed equipment after receiving an application that includes the following information:

• (a) the applicant's name and business address;

• (b) the name and business address of the manufacturer of the equipment;

• (c) the name and model number of the equipment;

• (d) the design of the equipment and its components, including any standards used in the design;

• (e) the intended use of the equipment;

• (f) the name, quantity in becquerels and form of the nuclear substance to be incorporated into the equipment;

• (g) the method of incorporating the nuclear substance into the equipment;

• (h) the expected radiation dose rates around the equipment in all modes of operation, including the method, calculations and measurements used to establish them;

• (i) the maximum radiation dose rate that the equipment can deliver;

• (j) instructions for the use, transportation and storage of the equipment;

• (k) instructions for conducting leak tests on the equipment;

• (l) instructions for dealing with accidents involving the equipment;

• (m) a description of the labelling of the equipment;

• (n) the quality assurance program that was followed during the design of the equipment and that will be followed during the production of the equipment;

• (o) the type of package for and the procedures for packaging and transporting any equipment that may contain a nuclear substance, including the emergency response plan to be followed in case of a transportation accident involving the equipment;

• (p) the recommended inspection and servicing program for the equipment;

• (q) the type of beam producible by, and the maximum output energy and limits to the beam orientation of, any particle accelerator or radioactive source teletherapy machine;

• (r) the estimated maximum photon and neutron leakage during the use of any teletherapy machine;

• (s) the half-lives of activated components of any particle accelerator and the radiation dose rate at 30 cm from those components; and

• (t) at the request of the Commission, any other information that is necessary to enable the Commission or the designated officer to determine whether the equipment poses an unreasonable risk to the environment, the health and safety of persons or national security.