reglab/statecodes huggingface dataset:
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.42 - Permanent radiographic installations

Current through June 24, 2024
(1) ENTRY
				  REQUIREMENTS. Each entrance that is used for personnel access to the high
				  radiation area in a permanent radiographic installation shall have either of
				  the following:
(a) An entrance control of the
				  type described in s.
				  DHS
				  157.26(1) (a) 1 that causes the
				  radiation level upon entry into the area to be reduced. Entrance control
				  devices that reduce the radiation level upon entry shall be tested
				  monthly.
(b) Both conspicuous
				  visible and audible warning signals to warn of the presence of radiation. The
				  visible signal shall be actuated by radiation whenever the source is exposed or
				  the machine is energized. The audible signal shall be actuated when an attempt
				  is made to enter the installation while the source is exposed or the machine is
				  energized. The alarm system shall be tested for proper operation with a
				  radiation source each day before the installation is used for radiographic
				  operations. The test shall include a check of both the visible and audible
				  signals.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.43 - Labeling, transportation and storage

Current through June 24, 2024
(1) LABELING
				  REQUIREMENTS. A licensee may not use a source changer or a container to store
				  radioactive material unless the source changer or the storage container has
				  securely attached to it a durable, legible and clearly visible label bearing
				  the standard trefoil radiation caution symbol with conventional colors, which
				  is magenta, purple or black on a yellow background, having a minimum diameter
				  of 25 millimeters and the wording:
CAUTION (or DANGER)
RADIOACTIVE MATERIAL
NOTIFY CIVIL AUTHORITIES
[or "NAME OF COMPANY"]
(2) TRANSPORT.
(a) A licensee may not transport radioactive
				  material unless the material is packaged and the package is labeled, marked and
				  accompanied with appropriate shipping papers under regulations set out in
				  subch. XIII.
(b) A licensee shall
				  lock and physically secure the transport package containing radioactive
				  material in the transporting vehicle to prevent accidental loss, tampering or
				  unauthorized removal.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.44 - Operational radiation safety requirements

Current through June 24, 2024
(1) CONDUCTING
				  INDUSTRIAL RADIOGRAPHIC OPERATIONS.
(a)
				  Whenever radiography is performed at a location other than a permanent
				  radiographic installation, the radiographer shall be accompanied by at least
				  one other certified radiographer or radiographer's assistant. The additional
				  individual shall observe the operations and be capable of providing immediate
				  assistance to prevent unauthorized entry. Radiography may not be performed if
				  only one individual is present.
(b)
				  Except when physically impossible, collimators shall be used in industrial
				  radiographic operations that use radiographic exposure devices that allow the
				  source to be moved out of the device.
(c) A licensee may conduct lay-barge,
				  offshore platform or underwater radiography only if procedures have been
				  approved by the department, the NRC or by another agreement
				  state.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.45 - Recordkeeping requirements

Current through June 24, 2024
(1) RECORDS FOR
				  INDUSTRIAL RADIOGRAPHY. A licensee or registrant shall maintain a copy of the
				  license or registration, documents incorporated by reference and amendments to
				  each of these items until superseded by new documents approved by the
				  department or until the department terminates the license or
				  registration.
(2) RECORDS OF
				  RECEIPT AND TRANSFER OF SOURCES OF RADIATION.
(a) A licensee or registrant shall maintain
				  records showing the receipts and transfers of sealed sources, devices using
				  depleted uranium for shielding and radiation machines and retain each record
				  for 3 years after the record is created.
(b) The records shall include the date, the
				  name of the individual making the record, radionuclide, number of becquerels
				  (curies) or mass and manufacturer, model and serial number of each source of
				  radiation and device, as appropriate.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.46 - Notifications

Current through June 24, 2024
(1) WRITTEN REPORTS. In addition to the
				  reporting requirements specified in and in subch. III, a licensee or registrant
				  shall provide a written report to the department within 30 days of the
				  occurrence of any of the following incidents involving radiographic equipment:
(a) Unintentional disconnection of the source
				  assembly from the control cable.
(b) Inability to retract the source assembly
				  to its fully shielded position and secure it in its retracted
				  position.
(c) Failure of any
				  component which is critical to safe operation of the device to properly perform
				  its intended function.
(d) An
				  indicator on a radiation machine fails to show that radiation is being
				  produced, an exposure switch fails to terminate production of radiation when
				  turned to the off position or a safety interlock fails to terminate x-ray
				  production.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.47 - Reciprocity

Current through June 24, 2024
(1) LICENSES. All reciprocal recognition of
				  licenses by the department shall be granted under subch. II.
(2) CERTIFICATION.
(a) The department shall grant reciprocal
				  recognition of an individual radiographer certification provided that all the
				  following apply:
1. The individual holds a
				  valid certification issued by an independent certifying organization or
				  agreement state that meets the criteria in Appendix A.
2. The requirements and procedures of the
				  certifying entity issuing the certification affords the same or comparable
				  certification standards as those afforded by s.
				  DHS
				  157.44(3) (a).
3. The applicant presents the certification
				  to the department prior to entry into the state.
4. No escalated enforcement action against
				  the individual is pending with the nuclear regulatory commission or in any
				  other state.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter IV - Radiation Safety Requirements for Industrial Radiographic Operations › Section DHS 157.48 - Specific requirements for radiographic personnel performing industrial radiography

Current through June 24, 2024
(1) JOB SITE REQUIREMENTS. At a job site, a
				  licensee or registrant shall supply all the following:
(a) At least one operable, calibrated survey
				  instrument for each exposure device or radiation machine in use.
(b) A current whole body personnel monitor,
				  TLD, film badge or similar approved device for each person performing
				  radiographic operations.
(c) An
				  operable, calibrated pocket dosimeter with a range of zero to 200
				  milliroentgens for each person performing radiographic operations.
(d) An operable, calibrated, alarming
				  ratemeter for each person performing radiographic operations using a
				  radiographic exposure device.
(e)
				  Barrier ropes and signs as required in subch. III.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.51 - Prohibition

Current through June 24, 2024
(1) WELL LOGGING.
(a) A licensee may not perform well logging
				  with a sealed source unless, prior to commencement of the operation, the
				  licensee has a written agreement with the well operator, well owner or land
				  owner that includes all the following provisions:
1. In the event a sealed source is lost in
				  the well, the licensee shall make a reasonable effort at recovery unless, in
				  the licensee's opinion, the recovery effort could result in rupture of the
				  sealed source.
2. If a decision is
				  made to abandon the sealed source in the well, the licensee shall meet the
				  requirements of s. DHS 157.56 (3) and any requirements of the department of
				  natural resources under chs. NR 141, 500 to 544, and 812.
3. If the environment, any equipment, or
				  personnel are contaminated with licensed material, the equipment or personnel
				  shall be decontaminated before release from the site or the site shall be
				  decontaminated before release for unrestricted use.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.52 - Equipment control

Current through June 24, 2024
(1) LIMITS ON LEVELS OF RADIATION. Sources of
				  radiation shall be used, stored and transported in accordance with the
				  transportation requirements of subch. XIII and the dose limitation requirements
				  of subch. III.
(2) STORAGE
				  PRECAUTIONS.
(a) Each source of radiation,
				  except accelerators, shall be provided with a storage or transport container.
				  The container shall be equipped with a lock, or tamper seal for calibration
				  sources, to prevent unauthorized removal of or exposure to the source of
				  radiation.
(b) A source of
				  radiation shall be stored in a manner that minimizes danger from explosion or
				  fire.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.53 - Requirements for personnel safety

Current through June 24, 2024
(1) TRAINING
				  REQUIREMENTS.
(a) A licensee or registrant may
				  not permit an individual to act as a well logging supervisor until the
				  individual has done all of the following:
1.
				  Completed training incorporating the subjects outlined in ch. DHS 157 Appendix
				  J and demonstrated an understanding of the subject matter by successful
				  completion of a written examination.
2. Read and received instruction in the
				  requirements contained in this subchapter and subchs. I, III and X or their
				  equivalent from another state or the NRC, conditions of appropriate license or
				  certificate of registration and the licensee's or registrant's operating and
				  emergency procedures and demonstrated an understanding of the subject matter by
				  successful completion of a written examination.
3. Completed on the job training and
				  demonstrated competence during actual well logging operations to use sources of
				  radiation, related handling tools and radiation survey instruments that will be
				  used on the job.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.54 - Precautionary procedures

Current through June 24, 2024
(1) SECURITY.
				  During each well logging or tracer application, the well logging supervisor or
				  other designated employee shall maintain direct surveillance of the operation
				  to protect against unauthorized or unnecessary entry into a restricted
				  area.
(2) HANDLING TOOLS. A
				  licensee shall provide and require the use of tools that will ensure remote
				  handling of sealed sources other than low-activity calibration
				  sources.
(3) SUBSURFACE TRACER
				  STUDIES.
(a) Protective gloves and other
				  appropriate protective clothing and equipment shall be used by all personnel
				  handling radioactive tracer material. Precautions shall be taken to avoid
				  ingestion or inhalation of radioactive material and to avoid contamination of
				  field stations and temporary job sites.
(b) A licensee may not inject or cause the
				  injection of radioactive material into potable fresh water aquifers without
				  prior written authorization from the department.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.55 - Radiation surveys and records

Current through June 24, 2024
(1) RADIATION
				  SURVEYS.
(a) Radiation surveys or
				  calculations shall be made and recorded for each area where radioactive
				  materials are used and stored.
(b)
				  Radiation surveys shall be made and recorded for the radiation levels in
				  occupied positions and on the exterior of each vehicle used to transport
				  radioactive material. Surveys shall include each source of radiation or
				  combination of sources to be transported in the vehicle.
(c) If the sealed source assembly is removed
				  from the well logging tool before departing the jobsite, the well logging tool
				  detector shall be energized, or a survey meter used, to assure that the well
				  logging tool is free of contamination.
(d) Radiation surveys shall be made and
				  recorded at the jobsite or well-head for each sub-surface tracer study. Surveys
				  shall include measurements of radiation levels before and after the
				  operation.
(e) Records required
				  under pars. (a) to (d) shall include the dates, the identification of
				  individuals making the survey, the identification of survey instruments used
				  and an exact description of the location of the survey. Records of these
				  surveys shall be maintained for inspection by the department for 3 years after
				  completion of the survey.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter V - Radiation Safety Requirements for Well Logging › Section DHS 157.56 - Notification of incidents, abandonment and lost sources

Current through June 24, 2024
(1) PROVISIONS.
				  Notification of incidents, and sources of radiation lost in other than well
				  logging operations, shall be made under appropriate provisions of subch.
				  III.
(2) INITIAL ACTIONS. Whenever
				  a sealed source or device containing radioactive material is lodged in the
				  well-bore or may have ruptured and caused contamination, a licensee shall do
				  all the following:
(a) Monitor at the surface
				  for the presence of radioactive contamination with a radiation survey
				  instrument or well logging tool during recovery operations.
(b) Notify the department immediately by
				  telephone and subsequently, within 30 days, by confirmatory letter if the
				  licensee knows or has reason to believe that a sealed source has been ruptured.
				  The confirmatory letter shall identify the well or other location, describe the
				  magnitude and extent of the escape of radioactive material, assess the
				  consequences of the rupture and explain efforts planned or being taken to
				  mitigate these consequences.
Note:
The department may be contacted at:
					 608-267-4797 during normal business hours of 7:45 am to 4:30 pm, Monday through
					 Friday, except state holidays, and other times at 608-258-0099.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.59 - General requirements

Current through June 24, 2024
(1) MAINTENANCE OF RECORDS. A record required
				  by this subchapter shall be legible throughout the specified retention period.
				  The record may be the original, a reproduced copy or a microform, provided the
				  copy or microform is authenticated by authorized personnel and the microform is
				  capable of producing a clear copy throughout the required retention period. The
				  record may also be stored electronically with the capability for producing
				  legible, accurate, and complete records during the required retention period.
				  Records such as letters, drawings and specifications, shall include all
				  pertinent information such as stamps, initials and signatures. A licensee shall
				  maintain adequate safeguards against tampering with and loss of
				  records.
(2) PROVISIONS FOR
				  RESEARCH INVOLVING HUMAN SUBJECTS. A licensee may conduct research involving
				  human subjects using radioactive material provided all of the following
				  requirements are met:
(a) A licensee shall
				  apply for and receive approval of a specific amendment to its radioactive
				  materials license before conducting the research. A licensee shall obtain
				  informed consent from the human subjects and obtain prior review and approval
				  of the research activities by an "Institutional Review Board" or equivalent
				  under the meaning of these terms as defined and described in the Federal Policy
				  for the Protection of Human Subjects.
Note: The definition and responsibilities of an
					 Institutional Review Board are described on 45 CFR Part 46 which may be
					 downloaded from the following website:
http://www.access.gpo.gov/nara/cfr/waisidx_00/
					 45cfr 46 _00.html
.
(b) The research involving human subjects
				  authorized in par. (a) shall be conducted using radioactive material authorized
				  for medical use in the license.
(c) Nothing in this subsection relieves a
				  licensee from complying with the other requirements in this subchapter or from
				  complying with applicable FDA or other federal requirements governing
				  radioactive drugs or devices.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.61 - Administrative requirements

Current through June 24, 2024
(1) AUTHORITY AND
				  RESPONSIBILITIES FOR THE RADIATION PROTECTION PROGRAM.
(a) In addition to the radiation protection
				  program requirements of s. DHS 157.21, a licensee's management shall approve in
				  writing any of the following:
1. A request
				  for license application, renewal or amendment before submittal to the
				  department.
2. Authorization prior
				  to using licensed materials for any individual to work as an authorized user,
				  authorized nuclear pharmacist or authorized medical physicist.
3. A radiation protection program change that
				  does not require a license amendment and is permitted under sub.
				  (2).
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.62 - Technical requirements

Current through June 24, 2024
(1) POSSESSION, USE AND CALIBRATION OF
				  INSTRUMENTS TO MEASURE THE ACTIVITY OF UNSEALED RADIOACTIVE MATERIALS.
(a) For direct measurements performed under
				  sub. (3), a licensee shall possess and use instrumentation to measure the
				  activity of unsealed radioactive materials prior to administration of unsealed
				  radioactive materials to each patient or human research subject.
(b) A licensee shall calibrate the
				  instrumentation required in par. (a) according to nationally recognized
				  standards or the manufacturer's instructions.
(c) A licensee shall retain a record of each
				  instrument calibration required by this subsection under s. DHS 157.71
				  (6).
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.63 - Unsealed radioactive material - written directive not required

Current through June 24, 2024
(1) USE OF
				  UNSEALED RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION AND EXCRETION STUDIES FOR
				  WHICH A WRITTEN DIRECTIVE IS NOT REQUIRED. A licensee may use for uptake,
				  dilution or excretion studies any unsealed radioactive material, except in
				  quantities that require a written directive under s. DHS 157.61 (4), prepared
				  for medical use that meets any of the following requirements:
Note:
Uptake, dilution and excretion studies
					 determine the amount of radioactive material absorbed by a patient and the
					 patient's ability to excrete the remainder of the radioactive material.
(a) Is obtained from any of the following:
1. A manufacturer or preparer licensed under
				  s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state
				  requirements.
2. A PET radioactive
				  drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other
				  agreement state requirements.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.64 - Unsealed radioactive material - written directive required

Current through June 24, 2024
(1) USE OF UNSEALED
				  RADIOACTIVE MATERIAL FOR WHICH A WRITTEN DIRECTIVE IS REQUIRED. A licensee may
				  use any unsealed radioactive material identified in s. DHS 157.64 (4) (b) 2.
				  g., prepared for medical use, and for which a written directive is required
				  that is any of the following:
(a) Obtained
				  from a manufacturer or preparer licensed under s. DHS 157.13 (4) (i), a PET
				  radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent
				  NRC or other agreement state requirements.
(b) Excluding production of PET
				  radionuclides, is prepared by any of the following:
1. An authorized nuclear
				  pharmacist.
2. A physician who is
				  an authorized user and who meets the requirements specified in sub. (4) or s.
				  DHS 157.63 (5).
3. An individual
				  under the supervision of either an authorized nuclear pharmacist or physician
				  who is an authorized user as specified in s. DHS 157.61
				  (3).
(c) Obtained from an
				  NRC or agreement state licensee for use in research under an investigational
				  new drug application accepted by FDA.
(d) Prepared by the licensee for use under an
				  investigational new drug protocol accepted by FDA.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.65 - Manual brachytherapy

Current through June 24, 2024
(1) USE OF SOURCES FOR MANUAL BRACHYTHERAPY.
				  A licensee shall use only brachytherapy sources for therapeutic medical uses
				  under either of the following criteria:
(a)
				  As approved in the sealed source and device registry for manual brachytherapy
				  medical use. The manual brachytherapy sources may be used for manual
				  brachytherapy uses that are not explicitly listed in the Sealed Source and
				  Device Registry, but must be used in accordance with the radiation safety
				  conditions and limitations described in the SSDR.
(b) In research to deliver therapeutic doses
				  for medical use in accordance with an active investigational device exemption
				  application accepted by the FDA, provided the requirements of s. DHS 157.61 (6)
				  (a) are met.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.66 - Sealed sources for diagnosis

Current through June 24, 2024
(1) USE OF SEALED
				  SOURCES FOR DIAGNOSIS.
(a) A licensee may use
				  sealed sources that are not in medical devices for diagnostic medical uses if
				  all of the following are met:
1. The sealed
				  sources are approved in the sealed source and device registry for diagnostic
				  medicine.
2. If the diagnostic
				  medical uses are not explicitly listed in the sealed source and device
				  registry, the sealed sources are used in accordance with the radiation safety
				  conditions and limitations described in the sealed source and device
				  registry.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.67 - Photon emitting remote afterloader, teletherapy and gamma stereotactic radiosurgery units

Current through June 24, 2024
(1) USE OF A SEALED SOURCE IN A REMOTE
				  AFTERLOADER, TELETHERAPY OR GAMMA STEREOTACTIC RADIOSURGERY UNIT.
(a) A licensee shall use sealed sources in
				  photon emitting remote afterloader units, teletherapy units or gamma
				  stereotactic units for therapeutic medical uses that meet any of the following
				  criteria:
1. Is approved in the sealed source
				  and device registry.
Note:
The sealed source and device
					 registrations may be obtained from the manufacturer or by writing the
					 department at: Department of Health Services, Radiation Protection Section,
					 P.O. Box 2659, Madison WI 53701-2659.
2. In research involving photon-emitting
				  remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
				  units in accordance with an active effective investigational device exemption
				  application accepted by the FDA provided the requirements of s. DHS 157.61 (6)
				  (a) are met.
Note:
The FDA requirements for investigational
					 devices may be found at:
http://www.fda.gov/radiation-emittingproducts/default.htm
.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.68 - Radioactive drugs for medical use

Current through June 24, 2024
(1) PREPARATION. A
				  licensee authorized to manufacture, prepare or transfer for commercial
				  distribution or noncommercial transfer to medical use licensees in a consortium
				  radioactive drugs shall ensure that any individual preparing the drugs is one
				  of the following:
(a) An authorized nuclear
				  pharmacist.
(b) An individual under
				  the supervision of an authorized nuclear pharmacist.
(c) A pharmacist that meets any of the
				  following criteria:
1. The requirements for an
				  authorized nuclear pharmacist as specified in s. DHS 157.61 (9) and
				  (11).
2. Is identified as an
				  authorized nuclear pharmacist on a license issued by the department, an
				  agreement state or the NRC.
3. Is
				  identified as an authorized nuclear pharmacist by a licensee who is authorized
				  by the department, an agreement state or the NRC to designate authorized
				  nuclear pharmacists operating under their license.
4. Functioned as a nuclear pharmacist
				  preparing only radioactive drugs containing accelerator-produced radioactive
				  material, and practiced at a pharmacy at a government agency or federally
				  recognized Indian Tribe before November 30, 2007 or at all other locations of
				  use before August 8, 2009.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.70 - Other medical uses of radioactive material or radiation from radioactive material

Current through June 24, 2024
A licensee may use radioactive material or a radiation
					 source approved for medical use that is not specifically addressed in ss.
					 DHS
					 157.63 to 157.67 if all of the following criteria are
					 met:
(1) APPLICATION. The applicant or
				  licensee has submitted the information required by s.
				  DHS 157.59(2) (b) and
				  (c).
(2) APPROVAL. The applicant or licensee has
				  received written approval from the department in a license and uses the
				  material under this chapter and specific conditions the department considers
				  necessary for the medical use of the material.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.71 - Records

Current through June 24, 2024
(1) RECORDS OF AUTHORITY AND RESPONSIBILITIES
				  FOR RADIATION PROTECTION PROGRAMS.
(a) A
				  licensee shall retain a record of actions taken by the licensee's management
				  under s. DHS 157.61 (1) (a) for 5 years. The record shall include a summary of
				  the actions taken and a signature of licensee management.
(b) A licensee shall retain a current copy of
				  the authorities, duties and responsibilities of the radiation safety officer as
				  required by s. DHS 157.61 (1) (d). The record shall include the signature of
				  the radiation safety officer and licensee management.
(c) For each Associate Radiation Safety
				  Officer appointed under s. DHS 157.61 (1) (b), the licensee shall retain, for 5
				  years after the Associate Radiation Safety Officer is removed from the license,
				  a copy of the written document appointing the Associate Radiation Safety
				  Officer signed by the licensee's management.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VI - Medical Use of Radioactive Material › Section DHS 157.72 - Reports

Current through June 24, 2024
(1) REPORTS OF MEDICAL EVENTS.
(a) A licensee shall report to the department
				  any event, except for events that result from intervention by a patient or
				  human research subject, in which the administration of radioactive material or
				  resulting radiation, except for permanent implant brachytherapy, results in any
				  of the following:
1. A dose that differs from
				  the prescribed dose or dose that would have resulted from the prescribed dosage
				  by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an
				  organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin and to
				  which any of the following apply:
a. The total
				  dose delivered differs from the prescribed dose by 20% or more.
b. The total dosage delivered differs from
				  the prescribed dosage by 20% or more or falls outside the prescribed dosage
				  range.
c. The fractionated dose
				  delivered differs from the prescribed dose, for a single fraction, by 50% or
				  more.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VII - Radiation Safety Requirements for Irradiators › Section DHS 157.73 - Radiation safety requirements

Current through June 24, 2024
(1) PERFORMANCE
				  CRITERIA FOR SEALED SOURCES.
(a) A sealed
				  source installed in an irradiator shall meet all of the following requirements:
1. Be evaluated and receive a certificate of
				  registration under 10 CFR
				  32.210 or the equivalent agreement state
				  regulation.
2. Be doubly
				  encapsulated.
3. Use radioactive
				  material that is as nondispersible and insoluble as practical if the source is
				  used in a wet-source-storage or wet-source-change irradiator.
4. Be encapsulated in a material resistant to
				  general corrosion and to localized corrosion such as 316L stainless steel or
				  other material with equivalent resistance if the sources are for use in
				  irradiator pools.
5. In prototype
				  testing of the sealed source, be leak tested and found leak-free after each of
				  the tests in par. (b).
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.75 - General requirements for all diagnostic x-ray systems

Current through June 24, 2024
(1) Warning label.
				  The control panel containing the main power switch shall bear the following
				  warning statement, 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."
(2) Battery charge indicator. On
				  battery-powered x-ray generators, visual means shall be provided on the control
				  panel to indicate whether the battery is in a state of charge adequate for
				  proper operation.
(3) Leakage
				  radiation from the diagnostic source assembly. The leakage radiation from the
				  diagnostic source assembly measured at a distance of one meter in any direction
				  from the source may not exceed one mGy (115 milliroentgens) in one hour when an
				  x-ray tube is operated at its leakage technique factors. Compliance shall be
				  determined by measurements averaged over an area of 100 square centimeters with
				  no linear dimension greater than 20 centimeters. Leakage technique factors may
				  be any of the following:
(a) For diagnostic
				  source assemblies intended for capacitor energy storage equipment, the
				  maximum-rated peak tube potential and the maximum-rated number of exposures in
				  an hour for operation at the maximum-rated peak tube potential with the
				  quantity of charge per exposure being 10 millicoulombs, which is 10 mAs, or the
				  minimum obtainable from the unit, whichever is larger.
(b) For diagnostic source assemblies intended
				  for field emission equipment rated for pulsed operation, the maximum-rated peak
				  tube potential and the maximum-rated number of x-ray pulses in an hour for
				  operation at the maximum-rated peak tube potential.
(c) For all other diagnostic source
				  assemblies, the maximum-rated peak tube potential and the maximum-rated
				  continuous tube current for the maximum-rated peak tube
				  potential.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.76 - Fluoroscopic equipment

Current through June 24, 2024
Only image-intensified or direct-digital receptor
					 fluoroscopic equipment shall be used for fluoroscopy. Equipment for
					 fluoroscopic imaging or for recording images from the fluoroscopic image
					 receptor, except computed tomography x-ray systems manufactured on or after
					 November 29, 1984, shall meet all the following requirements:
(1) LIMITATION OF USEFUL BEAM.
(a) The fluoroscopic imaging assembly shall
				  be provided with a primary protective barrier which intercepts the entire cross
				  section of the useful beam at any source to image distance. The x-ray tube used
				  for fluoroscopy shall not produce x-rays unless the barrier is in position to
				  intercept the entire useful beam. The air kerma rate due to transmission
				  through the barrier with the attenuation block in the useful beam combined with
				  radiation from the fluoroscopic image receptor shall not exceed 3.34 x 10 -3
				  percent of the entrance air kerma rate, at a distance of 10 cm from any
				  accessible surface of the fluoroscopic imaging assembly beyond the plane of the
				  image receptor.
(b) Compliance
				  shall be determined as follows:
1. The air
				  kerma rate shall be measured as required under sub. (4). The air kerma rate due
				  to transmission through the primary barrier combined with radiation from the
				  fluoroscopic image receptor shall be determined by measurements averaged over
				  an area of 100 square cm with no linear dimension greater than 20 cm.
2. If the source is below the tabletop, the
				  measurement shall be made with the input surface of the fluoroscopic imaging
				  assembly positioned 30 cm above the tabletop. If the source is above the
				  tabletop and the source to image distance is variable, the measurement shall be
				  made with the end of the beam-limiting device or spacer as close to the
				  tabletop as it can be placed, provided that it shall not be closer than 30
				  cm.
3. Movable grids and
				  compression devices shall be removed from the useful beam during the
				  measurement.
4. For all
				  measurements, the attenuation block shall be positioned in the useful beam 10
				  cm from the point of measurement of entrance air kerma rate and between this
				  point and the input surface of the fluoroscopic imaging assembly.
(c) Radiation therapy simulation
				  systems shall be exempt from this requirement provided the systems are intended
				  only for remote control operation and the manufacturer sets forth instructions
				  for assemblers with respect to control location as part of the information
				  required in 21 CFR
				  1020.30(g).
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.78 - Intraoral dental radiographic systems

Current through June 24, 2024
(1) GENERAL. In
				  addition to the provisions of ss.
				  DHS
				  157.74 and 157.75, the requirements in this section
				  apply to x-ray equipment and associated facilities used for dental radiography.
				  Requirements for extraoral dental radiographic systems are contained in s.
				  DHS
				  157.77.
(2) SOURCE-TO-SKIN DISTANCE. X-ray systems
				  designed for use with an intraoral image receptor shall be provided with means
				  to limit source-to-skin distance to not less than either one of the following:
(a) 20 centimeters (8 inches) if operable
				  above 50 kVp. Beam-limiting devices shall be lead lined.
(b) 10 centimeters (4 inches) if operable at
				  50 kVp only. Beam-limiting devices shall be lead lined.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.79 - Veterinary medicine x-ray systems

Current through June 24, 2024
(1) GENERAL. The
				  requirements of this section apply to all animal use x-ray systems used in
				  veterinary practice and are in addition to other provisions in subchs. I and
				  III.
(2) EQUIPMENT.
(a) The tube housing shall be electrically
				  shock proof and of a diagnostic type. The x-ray tube may not be hand-held
				  during exposures.
(b) A device
				  shall be provided to terminate the exposure after a preset time or
				  exposure.
(c) A dead-man type of
				  exposure switch shall be provided with an electrical cord of sufficient length
				  so that the operator or the assistant, may stand out of the useful beam and at
				  least 2 meters (6.5 feet) from the table during all x-ray exposures. A foot
				  operated exposure switch may be used and this switch may be integrated into the
				  table base or the foot switch may be on a 2 meter (6.5 feet) cord.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.80 - Computed tomography x-ray systems

Current through June 24, 2024
(1) EQUIPMENT
				  REQUIREMENTS. A computed tomography (CT) x-ray system shall meet all of the
				  following requirements, as applicable:
(a)
Termination of exposure.
1.
				  Means shall be provided to terminate the x-ray exposure automatically by either
				  de-energizing the x-ray source or shuttering the x-ray beam in the event of
				  equipment failure affecting data collection. The termination shall occur within
				  an interval that limits the total scan time to no more than 110% of its preset
				  value through the use of either a back-up timer or devices which monitor
				  equipment function. A visible signal shall indicate when the x-ray exposure has
				  been terminated. The operator shall be able to terminate the x-ray exposure at
				  any time during a scan, or series of scans under CT x-ray system control, of
				  greater than one-half second duration.
2. For systems that allow high voltage to be
				  applied to the x-ray tube continuously and that control the emission of x-ray
				  with a shutter, the radiation emitted may not exceed 0.88 mGy (100mR) in 1 hour
				  at any point 5 centimeters outside the external surface of the housing of the
				  scanning mechanism when the shutter is closed.
3. Compliance shall be determined by
				  measurements averaged over an area of 100 square centimeters with no linear
				  dimension greater than 20 centimeters.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.82 - General administrative requirements for facilities using therapeutic radiation machines for human use

Current through June 24, 2024
(1) ADMINISTRATIVE
				  CONTROLS. A registrant shall be responsible for directing the operation of the
				  therapeutic radiation machines that have been registered with the department.
				  All persons operating a therapeutic radiation machine shall be instructed in
				  and shall comply with the provisions of the radiation safety requirements of
				  ss.
				  DHS 157.22(1) and (5) to
				  (8) and 157.25(2). A therapeutic radiation
				  machine that does not meet the provisions of this subchapter but is of a type
				  accepted by the US food and drug administration may not be used for irradiation
				  of human patients.
(2) TRAINING FOR
				  RADIATION THERAPY USERS.
(a) A registrant for
				  any therapeutic radiation machine, except dermatology units under 150 kV, shall
				  require the authorized user to be a physician who meets any of the following
				  requirements:
1. Certified or board eligible
				  in one or more of the following:
a. Radiology
				  or therapeutic radiology by the American board of radiology.
b. Radiation oncology by the American
				  osteopathic board of radiology.
c.
				  Radiology, with specialization in radiotherapy, as a British "Fellow of the
				  Faculty of Radiology" or "Fellow of the Royal College of Radiology".
d. Therapeutic radiology by the Canadian
				  royal college of physicians and surgeons.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.83 - Administrative policies and procedures for radiation therapy machines

Current through June 24, 2024
(1) WRITTEN
				  POLICIES. A registrant shall have written policies and procedures to ensure
				  that radiation will be administered as directed by an authorized user. The
				  policies shall meet all of the following specific objectives:
(a) Prior to administration, a written
				  directive is prepared for any external beam radiation therapy dose or
				  electronic brachytherapy dose. A written revision to an existing written
				  directive may be made prior to beginning treatment, or prior to delivery of a
				  fractional dose, provided that the revision is dated and signed by an
				  authorized user. If, because of the patient's condition, a delay to provide a
				  written revision to an existing written directive would jeopardize the
				  patient's health, an oral revision to an existing written directive shall be
				  acceptable provided that the oral revision is documented immediately in the
				  patient's record and a revised written directive is signed by an authorized
				  user within 24 hours of the oral revision.
(b) Prior to the administration of each
				  course of radiation treatments, the patient's identity is verified, by more
				  than one method, as the person named in the written directive.
(c) External beam radiation therapy or
				  electronic brachytherapy final plans of treatment and related calculations are
				  according to the respective written directives.
(d) Each administration is according to the
				  written directive.
(e) Any
				  unintended deviation from the written directive is identified, documented,
				  evaluated and appropriate action is taken.
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.84 - Technical requirements for facilities using therapeutic radiation machines

Current through June 24, 2024
(1)
				  RADIATION PROTECTION SURVEYS.
(a) A
				  registrant shall ensure that radiation protection surveys of all new facilities
				  and existing facilities not previously surveyed are performed with an operable,
				  calibrated survey instrument. The radiation protection survey shall be
				  performed by or under the direction of a medical physicist and shall verify
				  that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the
				  largest clinically available treatment field and with a scattering phantom in
				  the useful beam of radiation, all of the following requirements are met:
1. Radiation levels in restricted areas are
				  not likely to cause personnel exposures in excess of the limits specified in s.
				  DHS 157.22(1)
				  (a).
2. Radiation levels in unrestricted areas do
				  not exceed the limits specified in s.
				  DHS
				  157.23(1) (a) and (b).
Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Subchapter VIII - X-ray Device Requirements › Section DHS 157.85 - Therapeutic radiation machines

Current through June 24, 2024
(1) LEAKAGE
				  RADIATION.
(a) When a therapeutic radiation
				  machine is operated at its maximum dose rate, the leakage air kerma rate may
				  not exceed the value specified at the distance specified for that
				  classification of therapeutic radiation machine.
(b) Leakage radiation from contact therapy
				  systems may not exceed one mGy (103 mR) per hour at 5 centimeters from the
				  surface of the tube housing assembly. Contact therapy tube housing assemblies
				  shall have a removable shield of material, equivalent in attenuation to 0.5
				  millimeters of lead at 100 kV, which may be positioned over the entire useful
				  beam exit port during periods when the beam is not in use.
(c) Leakage radiation from systems operating
				  at 150 kV or less may not exceed one mGy (103 mR) per hour at one meter from
				  the tube housing.
(d) Leakage
				  radiation from systems operating above 150 kV may not exceed 0.1% of the useful
				  beam one meter from the source housing for any of its operating
				  conditions.