reglab/statecodes huggingface dataset:
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 4 - Medical Diagnostic and Interventional X-Ray and Imaging Systems › Section 216-RICR-40-20-4.13 - Requirements for Use of Hand-Held Intraoral Dental Radiographic Unit

Current through June 14, 2024
A. In addition to the standards in this Part,
				  the following requirements are specifically applicable to intraoral dental
				  radiographic units designed to be operated as a hand-held device:
1. For All Uses:
a. The facility shall maintain documentation
				  that each operator of hand-held X-ray equipment has completed training as
				  specified by the manufacturer and approved by the Agency.
b. The use of a protective apron when
				  operating a hand-held intraoral dental radiographic unit shall be in accordance
				  with manufacturer' s specifications unless otherwise authorized by the Agency
				  or recommended by a health physicist or Qualified Medical Physicist.
c. A hand-held intraoral dental radiographic
				  unit shall be held with minimal motion during a patient examination. If the
				  operator has difficulty in holding the device stationary during the exposure,
				  the operator shall use a stand to immobilize the device.
d. A hand-held X-ray system shall be equipped
				  with a backscatter shield of not less than one quarter of one millimeter (0.25
				  mm) lead equivalent and fifteen and two tenths centimeters (15.2 cm) (six
				  inches (6")) in diameter that is positioned as close as practicable to the
				  distal end of the position indication device.
e. The operator shall ensure there are no
				  bystanders within a radius of six feet (6') from the patient being examined
				  with a hand-held intraoral radiographic unit.
f. Hand-held intraoral dental radiographic
				  units shall not routinely be used for patient examinations in hallways and
				  waiting rooms.
g. The registrant
				  shall comply with any facility-specific requirements established by the
				  Agency.
h. The facility shall adopt
				  and follow protocols provided by the manufacturer, and approved by the agency,
				  regarding the safe operation of the device.
i. The registrant shall secure the hand-held
				  device from unauthorized removal or use.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 4 - Medical Diagnostic and Interventional X-Ray and Imaging Systems › Section 216-RICR-40-20-4.14 - Requirements for Dental Facilities

Current through June 14, 2024
4.14.1
Applicability
In addition to the applicable requirements of §§
											4.3  and
					  4.4   of this Part, the
					 requirements of §
											4.14   of this Part apply to
					 dental facilities using intraoral, panoramic, and cephalometric X-ray
					 equipment. Dental facilities using cone beam computed tomography (CBCT)
					 technology shall follow applicable provisions of §4.7.8 of this
					 Part.
4.14.2
Warning
				  Label
A. On systems manufactured on or
				  before June 10, 2006, the control panel containing the main power switch shall
				  bear the following warning statement or the warning statement in §4.14.2(B)
				  of this Part, legible and accessible to view: "WARNING: This X-ray unit may be
				  dangerous to patient and operator unless safe exposure factors and operating
				  instructions are observed."
B. On
				  systems manufactured after June 10, 2006, the control panel containing the main
				  power switch shall bear the warning statement, legible and accessible to view:
				  "WARNING: This X-ray unit may be dangerous to patient and operator unless safe
				  exposure factors, operating instructions and maintenance schedules are
				  observed."
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.1 - Authority and Incorporation by Reference

Current through June 14, 2024
5.1.1
Authority
A. This Part is
				  promulgated pursuant to the authority conferred under R.I. Gen. Laws §
											23-1.3-5.
B. This Part establishes requirements, for
				  which a registrant is responsible, for use of therapeutic radiation machines.
				  The provisions of this Part are in addition to, and not in substitution for,
				  other applicable provisions of this Subchapter.
C. The use of therapeutic radiation machines
				  must be by, or under the supervision of, an Authorized Physician who meets the
				  criteria established by §5.3.3 of this
				  Part.
D. Provisions for Research
				  Involving Human Subjects. A registrant may conduct research involving human
				  subjects using therapeutic radiation machines provided that:
1. If the research will be conducted, funded,
				  supported, or regulated by a Federal Agency which has implemented the Federal
				  Policy for the Protection of Human Subjects ( 45 C.F.R. Part 46 ), the registrant
				  must, before conducting research:
a. Obtain
				  review and approval of the research from an "Institutional Review Board," as
				  defined and described in the Federal Policy; and
b. Obtain "informed consent," as defined and
				  described in the Federal Policy, from the human research subject; or
2. If the research will not be
				  conducted, funded, supported, or regulated by a Federal agency that has
				  implemented the Federal Policy, the registrant must, before conducting
				  research:
a. Apply for and receive approval
				  of a specific amendment to its Agency registration; and
b. Obtain review and approval of the research
				  from an "Institutional Review Board," as defined and described in the Federal
				  Policy; and
c. Obtain "informed
				  consent," as defined and described in the Federal Policy, from the human
				  research subject.
E. FDA, Other Federal and State Requirements.
				  Nothing in this Part relieves the registrant from complying with applicable
				  Agency, FDA, other Federal, and State requirements governing therapeutic
				  radiation machines or auxiliary devices.
F. Electronic brachytherapy devices are
				  subject to the requirements of §
											5.8   of this Part and are
				  exempt from the requirements of §
											5.6   of this Part.
G. Any notifications, reports or
				  correspondence required by this Part must be directed to the Agency using
				  contact information specified in §
											1.4   of this
				  Subchapter.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.3 - General Administrative Requirements for Facilities Using Therapeutic Radiation Machines

Current through June 14, 2024
5.3.1
Administrative Controls
The registrant must be responsible for directing the
					 operation of the therapeutic radiation machines which have been registered with
					 the Agency. The registrant or the registrant's agent must ensure that the
					 requirements of this Part are met in the operation of the therapeutic radiation
					 machine(s).
5.3.2
Prohibition on Use
A therapeutic radiation machine which does not meet the
					 provisions of this Part or has not received U.S. Food and Drug Administration
					 (FDA) clearance or premarket approval, must not be used for irradiation of
					 patients/human research subjects.
5.3.3
Qualification Requirements for
				  Therapeutic Radiation Machine Authorized Physicians
A. The registrant for any therapeutic
				  radiation machine subject to §§
											5.6,
				   5.7,
				   5.8,  5.12  or  5.13   of this
				  Part must require the Authorized Physician to be:
1. Currently certified in:
a. Radiation Oncology by the American Board
				  of Radiology (ABR); or
b. Radiation
				  Oncology by the American Osteopathic Board of Radiology(AOBR); or
c. Radiation Oncology by the Royal College of
				  Physicians and Surgeons of Canada.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.4 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines

Current through June 14, 2024
5.4.1
Shielding and Safety Designs Requirements
A. Each therapeutic radiation machine subject
				  to §§
											5.6,
				   5.7,
				   5.8,
				   5.12  or
				   5.13   of this Part must be
				  provided with such primary and/or secondary barriers as are necessary to ensure
				  compliance with Part 1 of this Subchapter.
1.
				  Facility shielding and safety designs must be performed in accordance with
				  current published recommendations from a recognized national professional
				  association with expertise in the use of therapeutic radiation technologies;
				  and
2. By, or under the direction
				  of, a Qualified Medical Physicist or a Medical Health Physicist.
3. Facility design information for all new
				  installations of a therapeutic radiation machine, or installations of a
				  therapeutic radiation machine of a different model with a different isocenter
				  or higher energy or workload into a room not previously approved for that
				  energy or isocenter or planned workload, must be submitted for Agency approval
				  prior to actual installation of the therapeutic radiation machine. The minimum
				  facility design information that must be submitted is contained in §
												5.14   of this Part.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.5 - Quality Management Program

Current through June 14, 2024
5.5.1
Scope
				  and Applicability
A. Each applicant or
				  registrant subject to §§
											5.6,
				   5.7  or
				   5.11   of this Part shall
				  develop, implement, and maintain a written quality management program to
				  provide high confidence that radiation will be administered as directed by the
				  Authorized Physician. The quality management program must address, as a
				  minimum, the following specific objectives:
1.
				  Written Directives:
a. A written directive
				  must be dated and signed by an Authorized Physician prior to the administration
				  of radiation;
b. Notwithstanding
				  §5.5.1(A)(1)(a)
				  of this Part, if, because of the patient's/human research subject's condition,
				  a delay in order to provide a written revision to an existing written directive
				  would jeopardize the patient's/human research subject's health, an oral
				  revision to an existing written directive must be acceptable, provided that the
				  oral revision is documented immediately in writing in the patient's/human
				  research subject's record and a revised written directive is signed by an
				  Authorized Physician within forty-eight (48) hours of the oral
				  revision;
c. The written directive
				  must contain the patient or human research subject's name, the type and energy
				  of the beam, the total dose, dose per fraction, treatment site, treatment
				  technique, treatment frequency, and number of fractions.
d. A written revision to an existing written
				  directive may be made provided that the revision is dated and signed by an
				  Authorized Physician prior to the administration of the therapeutic radiation
				  machine dose, or the next fractional dose.
e. The registrant must retain a copy of each
				  written directive, in an auditable form, for in accordance with medical record
				  retention requirements for comparable documents after the date of
				  administration.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.6 - Therapeutic Radiation Machines of Less Than 500 kV

Current through June 14, 2024
Documentation from the manufacturer and installer that the
					 therapeutic radiation machine was manufactured and installed in accordance with
					 most current applicable International Electrotechnical Commission (IEC)
					 standards in effect at the time of manufacturing/installation must be
					 sufficient to demonstrate compliance with the applicable requirements of
					 §§5.6.1 through
					 5.6.13 of this
					 Part.
5.6.1
Leakage
				  Radiation
A. When the X-ray tube is
				  operated at its maximum rated tube current for the maximum kV, the leakage air
				  kerma rate must not exceed the value specified at the distance specified for
				  that classification of therapeutic radiation machine:
1. Five to fifty (5 - 50) kV Systems. The
				  leakage air kerma rate measured at any position five (5) centimeters from the
				  tube housing assembly must not exceed one (1) mGy (one hundred (100) mrad) in
				  any one (1) hour.
2. Greater than
				  fifty (>50) and < five hundred (500) kV Systems. The leakage air kerma
				  rate measured at a distance of one (1) meter from the target in any direction
				  must not exceed one (1) cGy in any one (1) hour. This air kerma rate
				  measurement may be averaged over areas no larger than one hundred square
				  centimeters (100 cm2). In addition, the air kerma
				  rate at a distance of five (5) centimeters from the surface of the tube housing
				  assembly must not exceed thirty (30) cGy per hour.
3. For each therapeutic radiation machine,
				  the registrant must determine, or obtain from the manufacturer, the leakage
				  radiation existing at the positions specified in §§5.6.1(A)(1) and
				  (2) of this Part for the specified operating
				  conditions. Records on leakage radiation measurements must be maintained in an
				  auditable form at the installation for inspection by the Agency.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.7 - Therapeutic Radiation Machines - Photon Therapy Systems (500 kV and Above) and Electron Therapy Systems (500 keV and Above)

Current through June 14, 2024
Documentation from the manufacturer and installer that the
					 therapeutic radiation machine was manufactured and installed in accordance with
					 most current applicable IEC standards in effect at the time of
					 manufacturing/installation must be sufficient to demonstrate compliance with
					 the applicable requirements of §§5.7.2 through
					 5.7.16 of this
					 Part.
5.7.1
[RESERVED]
5.7.2
Leakage Radiation Outside the Maximum Useful Beam in Photon and Electron
				  Modes
A. For each therapeutic radiation
				  machine subject to §
											5.7   of this Part, the
				  registrant must determine, or obtain from the manufacturer, the leakage
				  radiation for the specified operating conditions. Records on leakage radiation
				  measurements must be maintained in an auditable form at the installation for
				  inspection by the Agency.
B. The
				  absorbed dose due to leakage radiation (excluding neutrons) at any point
				  outside the maximum-sized useful beam, but within a circular plane of radius
				  two (2) meters which is perpendicular to and centered on the central axis of
				  the useful beam at the nominal treatment distance (i.e. patient/human research
				  subject plane), must not exceed a maximum of two tenths of one percent (0.2%)
				  and an average of one tenth of one percent (0.1%) of the absorbed dose on the
				  central axis of the beam at the nominal treatment distance. Measurements must
				  be averaged over an area not exceeding one hundred square centimeters (100
				  cm2) at a minimum of sixteen (16) points uniformly
				  distributed in the plane.
C. Except
				  for the area defined in §5.7.2 of this Part, the
				  absorbed dose due to leakage radiation (excluding neutrons) at one (1) meter
				  from the electron path between the electron source and the target or electron
				  window must not exceed one half of one percent (0.5%) of the absorbed dose on
				  the central axis of the beam at the nominal treatment distance. Measurements
				  must be averaged over an area not exceeding one hundred square centimeters (100
				  cm2).
D.
				  The neutron absorbed dose outside the useful beam must be in compliance with
				  the appropriate manufacturer specifications; and
E. For each therapeutic radiation machine,
				  the registrant must determine, or obtain from the manufacturer, the leakage
				  radiation existing at the positions specified in §§5.7.2(A) through
				  (D) of this Part for the specified operating
				  conditions. Records on leakage radiation measurements must be maintained in an
				  auditable form at the installation for inspection by the
				  Agency.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.8 - Electronic Brachytherapy

Current through June 14, 2024
Documentation from the manufacturer and installer that the
					 therapeutic radiation machine was manufactured and installed in accordance with
					 most current applicable IEC standards in effect at the time of
					 manufacturing/installation must be sufficient to demonstrate compliance with
					 the applicable requirements of §§5.8.4 through
					 5.8.6 of this Part.
5.8.1
Applicability
A. Electronic brachytherapy devices must be
				  subject to the requirements of §
											5.8   of this Part, and must be
				  exempt for the requirements of §
											5.6   of this Part.
B. An electronic brachytherapy device that
				  does not meet the requirements of §
											5.8   of this Part must not be
				  used for irradiation of patients.
C. An electronic brachytherapy device must
				  only be utilized for human use applications specifically approved by the U.S.
				  Food and Drug Administration (FDA) unless participating in a research study
				  approved by the registrant's Institutional Review Board
				  (IRB).
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.9 - Shielding and Safety Design Requirements

Current through June 14, 2024
5.9.1
Primary and Secondary Barriers
Each therapeutic radiation machine subject to §§
											5.6,
					  5.7,
					  5.8,
					  5.12  or
					  5.13   of this Part must be
					 provided with such primary and/or secondary barriers as are necessary to ensure
					 compliance with §§1.7.1 and
					 1.8.1 of this Subchapter
					 and are in accordance with current published recommendations from a recognized
					 national professional association with expertise in the use of therapeutic
					 radiation technologies.
5.9.2
Facility Design
				  Information
Facility design information for all new installations of a
					 therapeutic radiation machine or installations of a therapeutic radiation
					 machine of different model with a different isocenter or higher energy or
					 workload into a room not previously approved for that energy or isocenter or
					 planned workload must be submitted for Agency approval prior to actual
					 installation of the therapeutic radiation machine. The minimum facility design
					 information that must be submitted is contained in §
											5.14   of this
					 Part.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.10 - Quality Assurance for Radiation Therapy Simulation Systems and Imaging Systems Used for Guidance During Therapeutic Radiation

Current through June 14, 2024
A.
				  Quality assurance for a conventional or virtual simulator and for imaging
				  systems used for guidance during therapeutic radiation must include acceptance
				  testing and periodic verification of system performance; and
B. Be performed in accordance with current
				  published recommendations from a recognized national professional association
				  with expertise in the use of therapeutic radiation technologies. In the absence
				  of a protocol published by a recognized national professional association, the
				  manufacturer's protocol or equivalent quality, safety, and security protocols,
				  must be followed.
C. Imaging
				  systems used exclusively for simulation or guidance of therapeutic radiation
				  must be exempt from the provisions of Part 4 of this Subchapter.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.11 - Calibration of Survey Instruments and Dosimetry Systems

Current through June 14, 2024
5.11.1
Survey Instruments
The registrant must ensure that the survey instruments used
					 to show compliance with this Part have been calibrated before first use, at
					 intervals not to exceed twelve (12) months, and following
					 repair.
5.11.2
Calibration Protocols
A. To
				  satisfy the requirements of §5.11.1 of this Part, the
				  registrant must:
1. Calibrate all required
				  scale readings up to ten (10) mSv (one thousand (1,000) mrem) per hour with an
				  appropriate radiation source that is traceable to the National Institute of
				  Standards and Technology (NIST).
2. Calibrate at least two (2) points on each
				  scale to be calibrated. These points should be at approximately one third (1/3)
				  and two thirds (2/3) of full-scale.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.12 - Other Use of Electronically-Produced Radiation To Deliver Therapeutic Radiation Dosage

Current through June 14, 2024
5.12.1
Prohibition on Use
A. A person
				  must not utilize any device which is designed to electrically generate a source
				  of ionizing radiation to deliver therapeutic radiation dosage, and which is not
				  appropriately regulated under any existing category of therapeutic radiation
				  machine, until:
1. The applicant or
				  registrant has, at a minimum, provided the Agency with:
a. A detailed description of the device and
				  its intended application(s);
b.
				  Facility design requirements, including shielding and access control;
c. Documentation of appropriate training for
				  Authorized Physician, qualified medical physicist(s) and other personnel who
				  will be involved in performing quality assurance tasks and/or setting up
				  patients for treatment or delivering treatment;
d. Methodology for measurement of dosages to
				  be administered to patients or human research subjects;
e. Documentation regarding calibration,
				  maintenance, and repair of the device, as well as instruments and equipment
				  necessary for machine quality assurance radiation safety;
f. Radiation safety precautions and
				  instructions; and
g. Other
				  information requested by the Agency in its review of the application;
				  and
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.13 - Emerging and Future Technologies

Current through June 14, 2024
A. Each registrant
				  must develop, implement, and maintain a dedicated quality management program to
				  control the processes used to administer therapeutic radiation with newly
				  acquired, FDA-cleared emerging technologies or previously unused features of a
				  future technology system.
B.
				  Implementation and on-going clinical use of the emerging technology or new
				  features must include:
1. An explicit strategy
				  to ensure quality of processes and patient safety.
2. Approval from facility management and the
				  radiation oncology safety team before the technology arrives and/or new
				  features are used.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 5 - Therapeutic Radiation Machines › Section 216-RICR-40-20-5.14 - Information on Radiation Shielding Required for Plan Reviews

Current through June 14, 2024
5.14.1
All Therapeutic Radiation
				  Machines
A. Basic facility information
				  including:
1. Name, telephone number and
				  Agency registration number of the individual responsible for preparation of the
				  shielding plan;
2. Name and
				  telephone number of the facility supervisor; and
3. The street address, including room number,
				  of the therapeutic radiation machine facility.
4. The plan should also indicate whether this
				  is a new structure or a modification to existing structure(s).
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.1 - Authority

Current through June 14, 2024
A. This Part is promulgated pursuant to the
				  authority conferred under R.I. Gen. Laws §
										23-1.3-5.
B. This Part establishes special requirements
				  for the use of industrial radiation machines not otherwise covered by this
				  Subchapter. The requirements of this Part are in addition to, and not in
				  substitution for, other applicable requirements of this Subchapter.
C. Any notifications, reports or
				  correspondence required by this Part shall be directed to the Agency using
				  contact information specified in §
										1.4   of this
				  Subchapter.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.2 - Exemptions

Current through June 14, 2024
Uses of portable/handheld fluorescence X-ray (open beam)
					 devices that are manufactured without safety devices are exempt from the
					 requirements of §
										6.5(A)   of
					 this Part.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.4 - General Requirements - All Industrial Radiation Machines

Current through June 14, 2024
6.4.1
Radiation Levels
The local components of an industrial radiation machine
					 shall be located and arranged and shall include sufficient shielding or access
					 control such that no radiation levels exist in any area surrounding the local
					 component group which could result in a dose to an individual present in the
					 area in excess of the dose limits given in §1.8.1 of this
					 Subchapter.
6.4.2
Warning Devices
A. The X-ray
				  control shall provide visual indication whenever X-rays are produced.
B. All ancillary warning devices shall be
				  labeled so that their purpose is easily identified and shall have fail-safe
				  characteristics.
C. Posting. Each
				  area or room containing industrial radiation machines shall be conspicuously
				  posted with a sign or signs bearing the radiation symbol and the words "CAUTION
				  - X-RAY EQUIPMENT," or words having a similar intent.
D. Ports. Unused ports on industrial
				  radiation machine source housings shall be secured in the closed position in a
				  manner which will prevent inadvertent opening.
E. Labeling. Each registrant shall ensure
				  that each industrial radiation machine is labeled in a conspicuous manner to
				  caution individuals that radiation is produced when it is energized. This label
				  shall be affixed in a clearly visible location on the face of the control unit.
				  If the industrial radiation machine is not visible from the control unit, the
				  industrial radiation machine shall have a visible indication that it is
				  energized.
F. Radiation Source
				  Housing. Each radiation source housing shall be equipped with an interlock that
				  shuts off the tube if it is removed from the radiation source housing or if the
				  housing is disassembled.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.5 - Additional Requirements - Category A Industrial Radiation Machines

Current through June 14, 2024
A. Safety Device. A safety device shall be
				  provided on all open-beam configurations which prevents the entry of any
				  portion of an individual's body into the primary X-ray beam path or which
				  causes the beam to be shut off upon entry into its path shall be provided on
				  all open-beam configurations.
1. A registrant
				  may apply to the Agency for an exemption from the requirement of a safety
				  device. Such application shall include:
a. A
				  description of the various safety devices that have been evaluated;
b. The reason each of these devices cannot be
				  used; and
c. A description of the
				  alternative methods that will be employed to minimize the possibility of an
				  accidental exposure, including procedures to assure that operators and others
				  in the area will be informed of the absence of safety devices.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.6 - Additional Requirements - Category B Industrial Radiation Machines

Current through June 14, 2024
A. All Category B industrial radiation
				  machines shall be evaluated in accordance with the following requirements:
1. The registrant shall perform an evaluation
				  of the radiation dose limits to determine compliance with §§1.8.1(A)
				  and (B) of this Subchapter at intervals not to exceed twelve (12) months. The
				  registrant shall ensure that radiation emitted five (5) centimeters from the
				  external surface of the cabinet X-ray system does not exceed one half of one
				  (0.5) millirem (five (5.0) µSv) in any one (1) hour;
2. Tests for proper operation of interlocks
				  shall be conducted and recorded at intervals not to exceed twelve (12)
				  months;
3. Records that demonstrate
				  compliance with §
											6.6(A)   of
				  this Part shall be maintained by the registrant for ten (10) years for
				  inspection by the Agency.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.7 - Operating Requirements

Current through June 14, 2024
A. Procedures.
				  Operating and safety procedures shall be written and made available to all
				  industrial radiation machine operators. No individual shall be permitted to
				  operate an industrial radiation machine in any manner other than that specified
				  in the procedures unless such individual has obtained written approval of the
				  radiation safety officer.
B.
				  Bypassing. No individual shall bypass a safety device or interlock unless such
				  individual has obtained the written approval of the radiation safety officer.
				  Such approval shall be for a specified period of time. When a safety device or
				  interlock has been bypassed, a readily discernible sign bearing the words
				  "SAFETY DEVICE NOT WORKING," or words having a similar intent, shall be placed
				  on the radiation source housing.
C.
				  Repair or Modification of Industrial Radiation Machines. Except as specified in
				  §
										6.7(B)   of
				  this Part, no operation involving removal of covers, shielding materials or
				  tube housing or modifications to shutters, collimators, or beam stops shall be
				  performed without ascertaining that the tube is off and will remain off until
				  safe conditions have been restored. The main switch, rather than interlocks,
				  shall be used for routine shutdown in preparation for repairs.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 6 - Radiation Safety Requirements for Industrial Radiation Machines › Section 216-RICR-40-20-6.8 - Personnel Requirements

Current through June 14, 2024
A. Instruction. No
				  individual shall be permitted to operate or maintain an industrial radiation
				  machine unless the individual has received instruction in and demonstrated
				  competence in the following:
1. Identification
				  of radiation hazards associated with the use of the industrial radiation
				  machine;
2. Radiation warning and
				  safety devices incorporated into the industrial radiation machine, or the
				  reasons they have not been installed on certain pieces of equipment and the
				  extra precautions required in such cases;
3. Operating and safety procedures for the
				  industrial radiation machine; and
4. Proper procedures for reporting an actual
				  or suspected exposure in excess of the limits specified in §1.8.1 of this
				  Subchapter.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.1 - Authority

Current through June 14, 2024
A. This Part is promulgated pursuant to the
				  authority conferred under R.I. Gen. Laws §
										23-1.3-5.
B. This Part provides for the licensing of
				  radioactive material. No person shall receive, possess, use, transfer, own or
				  acquire radioactive material except as authorized in a specific or general
				  license issued pursuant to this Part or as otherwise provided in this
				  Part.
C. This Part establishes
				  general licenses for the possession and use of radioactive material and a
				  general license for ownership of radioactive material. The general licenses
				  provided in this Part are subject to the provisions of §§7.4.3, 7.6.2, 7.6.3, 7.6.9 and 7.8.5 of this Part, and Parts 1 and 2 of this
				  Subchapter unless indicated otherwise in the specific provision of the general
				  license.
D. This Part prescribes
				  requirements for the issuance of specific licenses to persons who manufacture
				  or initially transfer items containing radioactive material for sale or
				  distribution to:
1. Persons generally
				  licensed under this Part,  10 C.F.R. Part 31  or equivalent Regulations of
				  another Agreement State (as defined by
				   10 C.F.R. §
												40.4).
2. Persons licensed under Part 9 of this
				  Subchapter.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.2 - Incorporated Material

Current through June 14, 2024
7.2.1
General
				  Provisions for Radioactive Material
A.
				  Except as provided in this Part, the requirements of  10 C.F.R. Part 30  (2021)
				  are incorporated by reference, not including any further editions or amendments
				  thereof and only to the extent that the provisions therein are not inconsistent
				  with this Part.
B. Notwithstanding
				  the provisions of §7.2.1(A) of this Part,
				   10 C.F.R. §§
												30.1, 30.2, 30. 3, 30.4 (paragraph 2 of the
				  definition of "Commencement of Construction" and paragraph 9ii of the
				  definition of "Construction" only), 30.5, 30.6, 30.8, 30.9, 30.12, 30.21(c),
				  30.31, 30.32(e), 30.34(d), (e)(1) and (3), 30.37, 30.39, 30.41(b)(6), 30.52,
				  30.53, 30.55, 30.61, 30.63 and 30.64 are not incorporated by reference.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.3 - Definitions

Current through June 14, 2024
A. In addition to the definitions contained
				  in  10 C.F.R. §§
											30.4, 32.2, 40.4 and §
										70. 4, whenever used in this Part,
				  the following terms shall be construed as follows:
1. "Act" means R.I. Gen. Laws Chapter
				  23-1.3 entitled "Radiation
				  Control."
2. "Agency" means Rhode
				  Island Radiation Control Agency (RCA), Center for Health Facilities Regulation
				  - Radiation Control Program, Rhode Island Department of Health.
3. "NARM" means any naturally occurring or
				  accelerator-produced radioactive material. It does not include byproduct,
				  source, or special nuclear material.
4. "Offshore waters" means that area of land
				  and water, beyond Rhode Island's Submerged Lands Act jurisdiction, on or above
				  the U.S. Outer Continental Shelf.
5. "Radioactive material" means any material
				  (solid, liquid, or gas) which emits radiation spontaneously.
6. "Special nuclear material in quantities
				  not sufficient to form a critical mass" means uranium enriched in the isotope
				  U-235 in quantities not exceeding three hundred fifty (350) grams of contained
				  U-235; uranium-233 in quantities not exceeding two hundred (200) grams;
				  plutonium in quantities not exceeding two hundred (200) grams; or any
				  combination of them in accordance with the following formula: For each kind of
				  special nuclear material, determine the ratio between the quantity of that
				  special nuclear material and the quantity specified above for the same kind of
				  special nuclear material. The sum of such ratios for all of the kinds of
				  special nuclear material in combination shall not exceed "1" (i.e., unity). For
				  example, the following quantities in combination would not exceed the
				  limitation and are within the formula: (175 (grams contained U-235)/350) + (50
				  (grams U-233)/200) + (50 (grams Pu)/200) = 1.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.4 - Exemptions

Current through June 14, 2024
7.4.1
Persons Using Sources of
				  Radiation Under Certain Department of Energy and Nuclear Regulatory Commission
				  Contracts
A. Any prime contractor or
				  subcontractor of the U.S. Department of Energy (DOE) or the U.S. Nuclear
				  Regulatory Commission (NRC) operating within the State of Rhode Island is
				  exempt from the requirements for a license set forth in this Subchapter to the
				  extent that such prime contractor or subcontractor under his contract
				  manufactures, produces, transfers, receives, acquires, owns, possesses, or uses
				  sources of radiation:
1. The performance of
				  work for the DOE at a United States Government- owned or controlled site,
				  including the transportation of sources of radiation to or from such site and
				  the performance of contract services during temporary interruptions of such
				  transportation;
2. Research in, or
				  development, manufacture, storage, testing or transportation of, atomic weapons
				  or components thereof; or
3. The
				  use or operation of nuclear reactors or other nuclear devices in a United
				  States Government-owned vehicle or vessel.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.5 - Licenses

Current through June 14, 2024
A. Licenses for radioactive materials are of
				  two (2) types: general and specific.
1. The
				  Agency issues a specific license to a named person who has filed an application
				  for the license under the provisions of this Subchapter.
2. A general license is provided by
				  regulation, grants authority to a person for certain activities involving
				  radioactive material, and is effective without the filing of an application
				  with the Agency or the issuance of a licensing document to a particular person.
				  However, registration with the Agency may be required by the particular general
				  license.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.7 - General Licenses

Current through June 14, 2024
7.7.1
General
				  License for Certain Detecting, Measuring, Gauging, or Controlling Devices and
				  Certain Devices for Producing Light or an Ionized Atmosphere
For the purpose of this Part, requirements for a general
					 license for certain detecting, measuring, gauging, or controlling devices and
					 certain devices for producing light or an ionized atmosphere are defined by
					  10 C.F.R. §
												31.5.
7.7.2
General License to Install
				  Devices Generally Licensed in §7.7.1
For the purpose of this Part, requirements for a general
					 license to install devices generally licensed in §7.7.1 of this Part are
					 defined by
					  10 C.F.R. §
												31.6.
7.7.3
General License for Luminous
				  Safety Devices for Use in Aircraft
For the purpose of this Part, requirements for a general
					 license for luminous safety devices for use in aircraft are defined by
					  10 C.F.R. §
												31.7.
7.7.4
General License for Calibration
				  or Reference Sources
A. For the
				  purpose of this Part, requirements for a general license for Americium- 241 and
				  Radium-226 in the form of calibration or reference sources are defined by
				   10 C.F.R. §
												31.8.
B. For the purpose of this Part, requirements
				  for a general license for plutonium in the form of calibration or reference
				  sources are defined by
				   10 C.F.R. §
												70.19.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.8 - Serialization of Nationally Tracked Sources, Sealed Source & Device Registry, Records and Reports

Current through June 14, 2024
7.8.1
Records
A. For the purpose of
				  this Part, recordkeeping requirements are defined by
				   10 C.F.R. §§
												30.51, 40.61 and 70.51  [excluding
				   10 C.F.R. §§
												70.51(c), (d) and (e)].
B. Each record required by this
				  Part must be legible throughout the retention period specified by each Agency
				  Regulation. The record may be the original or a reproduced copy or a microform
				  provided that the copy or microform is authenticated by authorized personnel
				  and that the microform is capable of producing a clear copy throughout the
				  required retention period. The record may also be stored in electronic media
				  with the capability for producing legible, accurate, and complete records
				  during the required retention period. Records such as letters, drawings,
				  specifications, must include all pertinent information such as letters, stamps,
				  initials, and signatures. The licensee shall maintain adequate safeguards
				  against tampering with and loss of records.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 7 - Licensing of Radioactive Material › Section 216-RICR-40-20-7.9 - Schedules

Current through June 14, 2024
7.9.1
Exempt Concentrations
For the purpose of this Part, the schedule of exempt
					 concentrations is defined by
					  10 C.F.R. §
												30.70, Schedule A.
7.9.2
Exempt Quantities
For the purpose of this Part, the schedule of exempt
					 quantities is defined by
					  10 C.F.R. §
												30.71, Schedule B.
7.9.3
Quantities of
				  Radioactive Materials Requiring Consideration of the Need for an Emergency Plan
				  for Responding to a Release
For the purpose of this Part, quantities of radioactive
					 materials requiring consideration of the need for an emergency plan for
					 responding to a release are defined by
					  10 C.F.R. §
												30.72.
7.9.4
Schedule C: Quantities of
				  Licensed Material Requiring Labeling
For the purpose of this Part, quantities of licensed
					 material requiring labeling are defined by Appendix B to
					 10 C.F.R. Part
					 30.
7.9.5
Decommissioning Funding
				  Criteria
A. For the purpose of this
				  Part, criteria relating to use of financial tests and parent company guarantees
				  for providing reasonable assurance of funds for decommissioning are defined by
				  Appendix A to    10 C.F.R. Part 30.
B.
				  For the purpose of this Part, criteria relating to use of financial tests and
				  self guarantees for providing reasonable assurance of funds for decommissioning
				  are defined by Appendix C to 10 C.F.R. Part 30.
C. For the purpose of this Part, criteria
				  relating to use of financial tests and self guarantee for providing reasonable
				  assurance of funds for decommissioning by commercial companies that have no
				  outstanding rated bonds are defined by Appendix D to
				  10 C.F.R. Part
				  30.
D. For the purpose of this Part, criteria
				  relating to use of financial tests and self guarantee for providing reasonable
				  assurance of funds for decommissioning by nonprofit colleges, universities, and
				  hospitals are defined by Appendix E to 10 C.F.R. Part 30.
Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 20 - Radiation › Part 8 - Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material › Section 216-RICR-40-20-8.1 - Authority

Current through June 14, 2024
A. This Part is promulgated pursuant to the
				  authority conferred under R.I. Gen. Laws §
										23-1.3-5.
B. This Part has been established to provide
				  the requirements for the physical protection program for any licensee that
				  possesses an aggregated category 1 or category 2 quantity of radioactive
				  material listed in §
										8.8   of this Part. These
				  requirements provide reasonable assurance of the security of category 1 or
				  category 2 quantities of radioactive material by protecting these materials
				  from theft or diversion. Specific requirements for access to material, use of
				  material, transfer of material, and transport of material are included. No
				  provision of this Part authorizes possession of licensed material.
C.
										§§
										8.4  and
				   8.5   of this Part apply to any
				  person who, under the regulations in this Part, possesses or uses at any site,
				  an aggregated category 1 or category 2 quantity of radioactive
				  material.
D.
										§
										8.6   of this Part applies to
				  any person who, under the regulations of this Part:
1. Transports or delivers to a carrier for
				  transport in a single shipment, a category 1 or category 2 quantity of
				  radioactive material; or
2. Imports
				  or exports a category 1 or category 2 quantity of radioactive material; the
				  provisions only apply to the domestic portion of the transport.