333-123-0030 Facility Design Requirements for Therapeutic Radiation Machines (1) Grenz Ray. In addition to shielding adequate to meet the requirements of division 120, treatment rooms must be provided with warning lights, in a readily observable position (preferably at eye level) out side of all access doors to the Grenz Ray room. The warning lights must indicate when the useful beam is "ON" or when the room is being used for Grenz Ray purposes. (a) Except as provided in 333-106-0025, no individual other than the patient and operator must be in the treatment room during Grenz Ray radiation therapy treatment provided the operator is protected by a barrier sufficient to meet the requirements of division 120. (b) A method must be provided to secure the room where the Grenz Ray radiation machine is located, against unauthorized entry. (2) Therapeutic Radiation Machines 50 Kv To < 1 Mev. In addition to shielding adequate to meet requirements of division 120, the treatment room must meet the following design requirements: (a) Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel; and (b) There must be continuous observation of the patient during irradiation. The viewing system must be configured such that the operator can observe the patient from the control panel. (c) Treatment rooms that contain a therapeutic radiation machine capable of operating above 150 kV must meet the following additional requirements: (A) All protective barriers must be fixed except for entrance doors or beam interceptors; and (B) The control panel must be located outside the treatment room or in a totally enclosed booth. If within the treatment room, the booth must have a ceiling to provide total enclosure. The booth walls must meet the requirements of a protective barrier as specified in division 120; and (C) Interlocks must be provided such that all entrance doors, including doors to any interior booths, will be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, the machine must be incapable of resuming operation with manual reinitiation at the control panel, and the machine must remain inoperable until the door is closed; and (D) When any door, referred to in section (30)(2)(c)(C) of this rule, is opened while the x-ray tube is activated, the air kerma rate at a distance of 1 meter from the source must be reduced to less than 1 mGy (100 mRad) per hour. (3) Facility Design Requirements for Therapeutic Radiation Machines Operating > 1 Mv. Each therapeutic radiation machine subject to 333-123-0025 must be provided with such primary and/or secondary barriers as are necessary to ensure compliance with division 120; and (a) Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy must be submitted for Authority approval before actual installation of the therapeutic radiation machine. (b) In addition to shielding adequate to meet requirements of division 120, the following design requirements are made. (c) Protective Barriers. All protective barriers must be fixed, except for access doors to the treatment room or movable beam interceptors. (d) Control Panel. In addition to other requirements specified in this Division, the control panel must also: (A) Be located outside the treatment room; and (B) Provide an indication of whether electrical power is available at the control panel and if activation of the radiation is possible; and (C) Provide an indication of whether radiation is being produced; and (D) Include an access control (locking) device that will prevent unauthorized use of the therapeutic radiation machine. (e) Viewing Systems. Windows, mirrors, closed-circuit television or an equivalent viewing system must be provided to permit continuous observation of the patient following positioning and during irradiation and must be so located that the operator may observe the patient from the treatment control panel. The therapeutic radiation machine must not be used for patient irradiation unless at least one viewing system is operational. (f) Aural Communications. Provision must be made for continuous two-way aural communication between the patient and the operator at the control panel. The therapeutic radiation machine must not be used for irradiation of patients unless continuous two-way aural communication is possible. (g) Room Entrances. Treatment room entrances must be provided with warning lights in a readily observable position near the outside of all access doors, which will indicate when the useful beam is "ON" and when it is "OFF". (h) Entrance Interlocks. Interlocks must be provided such that all access controls are activated before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it must not be possible to restore the machine to operation without resetting the access control and reinitiating irradiation by manual action at the control panel; (i) Beam Interceptor Interlocks. If the shielding material in any protective barrier requires the presence of a beam interceptor to ensure compliance with division 120, locks must be provided to prevent the production of radiation, unless the beam interceptor is in place, whenever the useful beam is directed at the designated barrier(s); (j) Emergency Cutoff Switches. At least 1 emergency power cutoff switch must be located in the radiation therapy room and must terminate all equipment electrical power including radiation and mechanical motion. All emergency power cutoff switches must include a manual reset so that the therapeutic radiation machine cannot be restarted from the unit's control console without resetting the emergency cutoff switch; (k) Safety Interlocks. All safety interlocks must be designed so that any defect or component failure in the safety interlock system prevents or terminates operation of the therapeutic radiation machine. Statutory/Other Authority: ORS 453.605 – 453.807 Statutes/Other Implemented: ORS 453.605 – 453.807 History: PH 23-2006, f. & cert. ef. 10-19-06