Class II Nuclear Facilities and Prescribed Equipment Regulations (SOR/2000-205)

Class II Prescribed Equipment

General Requirement

6 An application for a licence in respect of Class II prescribed equipment, other than a licence to service, shall contain a copy of or the number of any certificate relating to the equipment in addition to the information required by section 3 and, where applicable, section 4 of the General Nuclear Safety and Control Regulations.

Licence to Service

7 An application for a licence to service Class II prescribed equipment shall contain the following information in addition to the information required by section 3 of the General Nuclear Safety and Control Regulations:

• (a) the name, model number and characteristics of the equipment or the number of the certificate relating to the equipment;

• (b) a description of the nature of the servicing proposed to be carried on;

• (c) the proposed methods, procedures and equipment for carrying on the servicing;

• (d) the proposed qualification requirements and training program for workers; and

• (e) the proposed procedures to be followed after completion of the servicing to confirm that the equipment is safe to use.

Exemptions from Licence Requirement

Activities in Relation to Class II Nuclear Facilities

8 A person may carry on any of the following activities without a licence:

• (a) prepare a site for a Class II nuclear facility;

• (b) construct, operate, modify, decommission or abandon a Class II nuclear facility that includes a geophysical logging particle accelerator; or

• (c) decommission a Class II nuclear facility that includes a brachytherapy remote afterloader.

Activities in Relation to Class II Prescribed Equipment

9 A person may, without a licence to carry on an activity in relation to Class II prescribed equipment, possess, transfer or produce Class II prescribed equipment that does not contain a nuclear substance.

Certification of Class II Prescribed Equipment

Certification Requirement

10 No person shall use Class II prescribed equipment unless

• (a) it is a certified model; or

• (b) it is used in accordance with a licence that authorizes its use for development purposes or for scientific research that is not conducted on humans.

Application for Certification

• 11 (1) 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 brand 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; and

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

  • (t) [Repealed, SOR/2008-119, s. 9]

• (2) The Commission or the designated officer may request any other information that is necessary to enable the Commission or the designated officer to determine whether the equipment model in question poses an unreasonable risk to the environment, the health and safety of persons or national security and whether certification of the equipment model would be in conformity with measures of control and international obligations to which Canada has agreed.

Refusal to Certify

• 12 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person who has applied for the certification of a model of Class II prescribed equipment of a proposed decision not to certify the model, as well as the basis for the proposed decision, at least 30 days before refusing to certify it.

• (2) The notice shall include a description of the person's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.

Decertification

• 13 (1) The Commission or a designated officer authorized under paragraph 37(2)(a) of the Act shall notify a person to whom a certificate for a model of Class II prescribed equipment has been issued, and any licensee who is licensed in respect of that model, of a proposed decision to decertify the model, as well as the basis for the proposed decision, at least 30 days before decertifying it.

• (2) The notice shall include a description of the person's and the licensee's right to be provided with an opportunity to be heard in accordance with the procedure referred to in section 14.

Opportunity To Be Heard

• 14 (1) Where a person referred to in section 12 or 13 or a licensee referred to in section 13 has received a notice and has requested, within 30 days after the date of receipt of the notice, an opportunity to be heard either orally or in writing, the person or the licensee shall be provided with such an opportunity in accordance with the request.

• (2) On completion of a hearing held in accordance with subsection (1), every person and licensee who was notified in accordance with section 12 or 13 shall be notified of the decision and the reasons for it.

• (3) Where neither a person referred to in section 12 or 13 nor a licensee referred to in section 13 requests an opportunity to be heard within the period referred to in subsection (1), they shall be notified of the decision and the reasons for it.

Radiation Protection Requirements

Class II Nuclear Facilities

General Requirements

• 15 (1) This section applies to licensees who operate Class II nuclear facilities other than facilities that include brachytherapy remote afterloaders that incorporate pure beta emitters as their only nuclear substances or facilities that include particle accelerators used for geophysical logging.

• (2) Each entrance door to a room in which Class II prescribed equipment is located shall be

  • (a) equipped with a device that stops the equipment when the door is opened and prevents the equipment from being used when the door is open;

  • (b) equipped with a device that prevents the equipment from being used until a person activates the device from inside the room, leaves the room and closes the door within a preset time; and

  • (c) designed to prevent any person from being locked inside the room.

• (3) Each entrance, other than a door, to a room in which Class II prescribed equipment is located shall be equipped with

  • (a) a device that stops the equipment when a person passes through the entrance; and

  • (b) a device that prevents the equipment from being used until a person activates the device from inside the room and leaves the room within a preset time.

• (4) Every room in which Class II prescribed equipment that is used on persons is located shall be equipped with a viewing system that allows the operator to view the interior of the treatment room during operation of the equipment.

• (5) Each entrance to a room in which Class II prescribed equipment is located shall be equipped with a readily visible display that indicates the irradiation state of the equipment.

• (6) Every room in which Class II prescribed equipment — other than a particle accelerator — is located shall be equipped with an area radiation monitoring system that

  • (a) is independent of the Class II prescribed equipment;

  • (b) produces an audible alarm when a person enters the room while the equipment is delivering a dose of radiation; and

  • (c) has an independent back-up power supply.

• (7) Every room in which Class II prescribed equipment that is not used on persons is located shall be equipped with a device that, before the irradiation begins, provides a continuous audible alarm of sufficient duration to enable a person inside the room to operate one of the emergency stop buttons or other emergency stop devices referred to in subsection (8).

• (8) Every room in which Class II prescribed equipment is located shall be equipped with emergency stop buttons or other emergency stop devices located as specified in subsections (9) and (10) that, when any one of them is operated, cause all Class II prescribed equipment in the room to automatically revert to a safe state until the safety circuit is reset from inside that room and a switch on the control console of the equipment is operated.

• (9) The emergency stop buttons or other emergency stop devices shall be unobstructed, accessible and located at a minimum in each of the following places:

  • (a) on the control console of all Class II prescribed equipment;

  • (b) near each entrance to the room in which Class II prescribed equipment is located; and

  • (c) on both sides of all Class II prescribed equipment — other than a brachytherapy remote afterloader — or on the wall on both sides of the equipment.

• (10) In the case of a teletherapy machine, the emergency stop buttons or other emergency stop devices shall be unobstructed, accessible and located in accordance with paragraphs (9)(b) and (c) in places that are not in the machine’s direct beam.

• (11) Every licensee shall post and keep posted at every entrance to a Class II nuclear facility a visible, durable and legible sign that indicates the name or job title and the telephone number of a person who can initiate any required emergency procedure and who can be contacted 24 hours a day.

• (12) Class II prescribed equipment shall be equipped with a key switch or code-operated device that prevents persons who are not authorized by the licensee from operating the equipment.

• (13) After a device or system referred to in subsection (2), (3), (5), (6), (7) or (8) is serviced, the licensee shall not use the Class II prescribed equipment until the licensee performs a test or an inspection that establishes that the device is functioning as prescribed by those subsections.

• (14) Subsections (2), (3) and (7) and paragraphs (9)(b) and (c) do not apply in respect of a particle accelerator that meets at least one of the following criteria:

  • (a) its radiation dose rate at 30 cm is not greater than 200 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks, and it is located in a room that is equipped with a lock and that can be unlocked and entered only by persons who have been authorized by the licensee; or

  • (b) its radiation dose rate at 30 cm is not greater than 25 µSv per hour when it is being operated in the manner that produces the maximum dose rate as limited either by its characteristics or by its interlocks.

• (15) Paragraphs (2)(b), (3)(b) and (9)(b) do not apply in respect of a brachytherapy remote afterloader that contains a total quantity of nuclear substance that, if exposed, would produce a radiation dose rate in air of less than 10 mGy per hour at a distance of 1 m.

Radiation Safety Officers

Appointment and Certification

• 15.01 (1) Every licensee who operates a Class II nuclear facility shall appoint a radiation safety officer.

• (2) Every licensee who services Class II prescribed equipment shall appoint a radiation safety officer.

15.02 No person shall hold the position of radiation safety officer unless the person has been certified by the Commission or a designated officer authorized under paragraph 37(2)(b) of the Act.