Section 4: Ionizing Radiation-Producing Equipment

Contents

4.1 General

New York State Department of Health (NYSDOH) regulates the use of radiation‑producing equipment under the provisions of Title 10, NYS Sanitary Code, Chapter 1, Part 16 (10 NYCRR Part 16). NYSDOH has also adopted the American National Standard Institute N43.2 Radiation Safety for X-ray Diffraction and Fluorescence Analysis Equipment as a guide (these documents are available for review at the Environmental Health and Safety Service Office during normal working hours). Syracuse University is required to register each piece of radiation-producing equipment in active use with the NYSDOH. This includes all analytical x-ray equipment and electron microscopes.

This Section of the Handbook is designed to serve as a guide for ensuring regulatory compliance and the safe operation of radiation-producing equipment. It also contains detailed information on the requirements for becoming an authorized Radiation Equipment Supervisor and a Radiation Equipment Operators.

4.2 Radiation Equipment Supervisor – Application for Use of Radiation-Producing Equipment

Radiation Equipment Supervisors (RESs) are members of the University faculty or staff who are authorized to perform specific procedures involving radiation-producing equipment from the University’s Radiation Safety Committee (RSC).  Prior to commencing work with radiation-producing equipment, an individual must complete and submit an “Application for Use of Radiation Equipment” (Application) to the RSC for review.  The RSC will either grant approval or conditional approval or disapprove of the application based on the information provided, the applicant’s past experience with radiation equipment and the effect the proposed use will have on University property and the safety of the University community. This Section of the Handbook describes the Application process used at the University to evaluate prospective RESs and proposed radiation-producing equipment use.

(i) Completing and Submitting an Application

Prospective RESs may obtain an Application from science department offices or from the Environmental Health and Safety Service Office.  The Application must be completed in full and typed to ensure legibility. The following information must be provided in or as an attachment to the Application:

  • An explanation of the need to use equipment
  • A description of the radiation-producing equipment to be used and a layout drawing of the use area including structures, benches and other work areas,
  • Procedures for proposed operations which involve the use of radiation-producing equipment  sufficiently detailed to evaluate the associated hazards
  • A copy of the applicant’s current Curriculum Vitae
  • A description of the applicant’s past training and experience in using radiation equipment including dates, locations, equipment and process descriptions
  • A list of all individuals who will be working with the equipment under the applicant’s supervision
  • A description of the equipment, including personal protective equipment, that will be available to identify, control and/or minimize the radiation hazard

Detailed instructions for completion of an Application are provided with the Application.  Radiation Safety staff will provide further assistance and answer questions related to the Application upon request.

Once the Application is complete, the applicant must submit it along with any attachments to the RSC via the Radiation Safety Officer (RSO).  The  RSO will complete a radiological safety evaluation consisting of a review of the Application, an interview with the applicant, and a visit to the applicant’s laboratory (as necessary).  Upon completion, the RSO will summarize the evaluation in writing.  The evaluation summary will consist of an item‑by‑item analysis of the Application and the RSO’s recommendation(s).

The Application, attachments and RSO evaluation are then forwarded to each member of the Radiation Safety Committee for comment and action. Questions from members of the RSC will be addressed appropriately by either the RSO or the applicant.  Approval, disapproval or conditional approval will be by majority opinion of the technical members of the Radiation Safety Committee. Records of applications, evaluations, and RSC actions will be kept by EHSS for review.

Following approval by the RSC, the Radiation Equipment Supervisor becomes responsible for all radiation related activities that are performed or required to be performed in accordance with the conditions of approval. Responsibilities include, but are not limited to, relevant equipment purchase, safety surveys, and protocol development and implementation.  The RES is responsible for ensuring that individuals in their laboratory who work with ionizing radiation or who are exposed to ionizing as a result of activities conducted under their  supervision, are properly trained and aware of the related hazards. The RES must also ensure that only approved radiation equipment procedures are performed in the laboratory and that the RSO is notified of any changes in use areas, equipment, individuals or procedures.  A summary of the responsibilities of a Radiation Supervisor are provided in Section 1.3 of this Handbook.

Any additions or modifications to approved procedures or radiation-producing equipment use that could potentially increase or modify the radiation hazard previously evaluated or introduce a new hazard, must be approved by the RSC prior to commencement.  Amendment requests including a revised “Application for Use of Radiation Equipment” should be submitted to the RSC via the RSO.

(ii) Evaluation of an Application

Applications for use of radiation-producing equipment are evaluated based on  the applicant’s past experience and training; the facility and equipment available to the applicant; the safety of the proposed procedures and equipment; the potential for exposure to personnel; the methods to be employed for personnel monitoring; and steps that will be taken to insure that the potential exposures are kept as low as reasonably achievable, etc.  In general, a RES must:

  • Be a permanent or contract member of the University faculty or staff.
  • Be the senior researcher of the project and directly responsible for radiation use in the laboratory.
  • Be the senior occupant of a facility(s) suitable for the proposed work or be authorized to use a suitable facility by the facility’s senior occupant and RSO.
  • Be knowledgeable of the University’s Radiation Protection Program requirements and related regulations.

4.3 Procedure to Become a Radiation Equipment Operator

Syracuse University requires that anyone who wishes to work with radiation-producing equipment have a thorough understanding of regulations and hazards associated with the use of ionizing radiation. This is accomplished through a two stage radiation worker training program.  Stage One of this program must be completed prior to commencing work with ionizing radiation.  Stage Two must be completed in the laboratory under the direct supervision of the RES.  The following lists the steps for completing both stages of the required radiation equipment operator training program:

Stage One

  1. Notify the Radiation Safety Officer (RSO) of your intention to become a radiation equipment operator by completing a “Radiation Worker Sign‑Up” form. This form may be obtained at the Environmental Health and Safety Service Office at 029 Lyman Hall, ext. 4132.
  1. If you have previously worked with ionizing radiation, complete a “Radiation Exposure History Request” form. This signed form will allow the University to request and receive your exposure history from your previous employer.
  1. Schedule a time with the Environmental Health and Safety Service Office, (X-9130), to view videotapes on the radiation hazards associated with x‑ray equipment, and the biological effects of ionizing radiation.
  1. Sign up at the Environmental Health and Safety Service Office and attend the next radiation safety training session (offered as needed). This session covers rules, regulations, and general radiation safety procedures as well as monitoring devices. This session generally lasts approximately three hours and is mandatory for every new radiation-producing equipment operator.
  1. Take an examination which evaluates your understanding of the elements of the University’s Radiation Protection Program, fundamentals of analytical x-rays, radiation terminology, related rules and regulations, risk assessment and biological effects.
  1. Schedule a meeting with the RSO to review your examination results and go over any questions you may have.
  1. Upon the successful completion of these requirements you will be granted conditionally approved radiation equipment operator status and issued a dosimeter. Work with ionizing radiation-producing equipment may then be performed only under direct supervision of the RES.

Stage Two

  1. Prior to operating any radiation-producing equipment, complete a radiation equipment laboratory orientation with your radiation equipment supervisor or an approved radiation equipment operator. Document this training on the “Laboratory Orientation” form and return the completed form to the RSO, room 029 Lyman Hall.
  1. Complete the “Analytical X-ray Procedural Training” with your RES. This training is specific to the equipment that will be used and should be completed in detail. Upon completion of the training return the signed form to the RSO, room 029 Lyman Hall.
  1. Once you have satisfactorily completed the above process, you will be granted approved radiation equipment operator status. This approval is equipment specific. You may only operate the equipment that you have been trained and approved to operate.
  1. If you wish to use another piece of radiation-producing equipment, you must contact the RSO and complete “Equipment and Procedural Training” specific to the new piece of equipment and a “Laboratory Orientation” (as appropriate).

4.4 Operation of Equipment

(i) Equipment Registration

Syracuse University is required to register each piece of radiation-producing equipment in active use with the NYSDOH.  This includes all analytical x-ray equipment and electron microscopes.  The registration is renewed biennially and as changes occur.  It is the responsibility of the equipment’s RES to ensure that Radiation Safety staff is apprised of all purchases of new radiation-producing equipment and changes, modifications or relocation of existing equipment.

(ii) Analytical X-ray Equipment Procedure and Use Log Book

An “Analytical X-ray Equipment Procedure and Use Log” must be readily available at each piece of analytical x-ray equipment.  This manual contains a summary of the requirements of the University’s Radiation-Producing Equipment Program and the equipment’s use log.  Each use of radiation-producing equipment must be entered into the equipment’s use log.  This log must contain the name of the operator, the date, the duration of use (time on and off), and the purpose of the operation.   Detailed standard operating procedures (SOPs)  for the equipment must be available and kept in the Procedure and Use Log Book.  These SOPs must minimally include procedures for all routine operations, sample changes, beam alignments, and emergency shut down.  If any procedures are contained in the equipment’s operation manual, the name and location of this manual must be referenced in the equipment’s Procedure and Use Log Book.

(iii) Inspections

All registered ionizing radiation-producing equipment is inspected biennially by the NYSDOH  for compliance with applicable portions of State regulations and issued guidelines. The Radiation Safety staff will perform inspections on registered equipment at six month intervals or as necessary to ensure the safety of operating personnel (electron microscopes are inspected annually). In addition, any equipment modifications or location changes require a safety survey by Radiation Safety staff prior to the use.  An x-ray tube change on an open beam system also requires a safety survey.

(iv) Personnel

The operation of analytical x-ray equipment is restricted to the designated Radiation Equipment Supervisors (RES) for the unit in question and to approved radiation equipment operators working under the direction of an RES.   RESs receive authorization to use and direct the use of radiation-producing equipment from the RSC (refer to Section 4.2 of the Handbook).  Individuals who wish to become Radiation Equipment Operators should refer to Section 4.3 of the Handbook for specific training requirements.

(v) Posting and Labeling

All laboratories containing radiation-producing equipment must be posted in accordance with Section 6 of this Handbook.  In addition, a “Caution ‑ This Equipment Produces X‑Rays When Energized” label (available from the RSO) must be attached near any switch which energizes an x‑ray tube.

4.5 Rules for the Safe Operation of Ionizing Radiation-Producing Equipment

  1. Only authorized personnel may operate the equipment.
  1. Never operate radiation-producing equipment without specific RES authorization. All individuals operating equipment or working in a controlled area while the equipment is in use must wear their assigned personal radiation monitors.
  1. Set up samples and perform an operational check of the equipment prior to energizing the x‑ray tube. Never change samples with the x‑ray tube energized unless specific authorization to do so is provided in writing from the RSO/RSC.
  1. Operation of the equipment with the safety devices off, in bypass mode, or otherwise compromising the intent of safety interlocks is strictly forbidden unless specifically authorized by the RSC. The exception to this is manual beam alignment procedures performed by the RES.
  1. Prior to beam alignment, check the area for scattered x‑ray and leakage with an appropriate instrument.
  1. The equipment should not be left unattended while energized. If it should become necessary to leave while the equipment is energized, the controlled area must be locked to prevent unauthorized entry.
  1. Radiation equipment must be locked and secured from unauthorized use while not attended by authorized personnel.
  1. A log of equipment use must be maintained containing:
    1. Operator’s name
    2. Date
    3. Times of use (time and duration)
    4. Purpose of operation
  1. Only approved operations may be performed. Major deviations from approved operations must be submitted to the Radiation Safety Committee for approval prior to commencing operation.
  1. Individuals must promptly report to the RSO any condition or unusual occurrence which may lead to or cause unnecessary exposure to ionizing radiation.

4.6 Equipment Modifications or Problems

Radiation-producing equipment, in active use, will be surveyed by the RSO or his designee every six months (annually for electron microscopes).  A survey by Radiation Safety staff must also be completed following any design modification or x‑ray tube changes. Major equipment modifications that may modify the exposure potential and safe guards previously evaluated must be reviewed and approved by the Radiation Safety Officer and/or Radiation Safety Committee prior to commencing  the modification(s).

Any apparent damage or malfunctions in the equipment must be reported to the RES immediately. Repairs should be completed as soon as possible and provisions should be made immediately to eliminate hazards. Radiation leakage surveys must be performed after non‑routine operations such as repair and alignment. These surveys can be performed by Radiation Safety staff.  All repairs involving the tube or tube housing or other apparatus which could affect personnel exposure must be reported to the RSO for the purpose of scheduling a radiation survey, prior to equipment operations.

4.7 Analytical Radiation-Producing Equipment Laboratory Requirements

(i) General Requirements for Analytical X-ray Laboratories

The following are general requirements for analytical x-ray equipment laboratories (adapted from ANSI 43.2-1977):

  1. Detailed standard operating procedures (SOPs) for the equipment must be available and kept in the Procedure and Use Log Book. These SOPs must minimally include procedures for all routine operations, sample changes and beam alignments.  If any procedures are contained in the equipment’s operation manual, the name and location of this manual must be referenced in the equipment’s Procedure and Use Log Book.
  1. Emergency shut-off procedures must be written and readily available. These shutoff procedures must either be visibly posted by the equipment or placed in the equipment’s Procedure and Use Log book.
  1. All operations involving the removal of covers, shielding materials or tube housings, or involving modifications to shutters, collimators or beam stops must be performed with the tube off. The main switch, rather than safety interlocks, must be used for routine shut down in preparation for repairs. Following reassembly, the x‑ray system must be checked by the Radiation Equipment Supervisor to assure proper operation.
  1. Radiation leakage surveys must be performed by Radiation Safety staff following non‑routine operations (i.e. repairs, alignment, tube changes)
  1. A warning light or device of fail‑safe design labeled “X-ray On” is required near any switch which energizes the x‑ray tube. Fail‑safe means a failure of the indicator will cause the equipment to fail in a mode such that personnel are safe from exposure to radiation. For example, if a light indicating “X-ray On” fails, the production of x‑rays shall be prevented; if a shutter status indicator fails, the shutter shall close.
  1. A “Caution ‑ This Equipment Produces X‑Rays When Energized” label (available from the RSO) shall be attached near any switch which energizes an x‑ray tube.
  1. A visible fail‑safe light or indicator is required near the radiation source housing to indicate when the x‑ray tube is energized.

(ii) Specific Requirements for Enclosed Beam X-ray Systems

An enclosed beam x-ray system is a system in which all possible x‑ray paths are fully enclosed.  The following are requirements specific to enclosed beam x-ray systems (adapted from ANSI N43.2-1977):

  1. Access ports to the sample chamber must be provided with interlocks of fail-safe design that prevent x‑ray generation or entry of the x‑ray beam into the chamber when any port is open.
  1. The inherent shielding of the chamber walls shall be sufficient to ensure that the dose in any unrestricted area does not exceed 2 mrem in any one hour and that the total effective dose equivalent to any non-occupationally exposed individual does not exceed 100 mrem in a year.
  1. The radiation source, sample, detector, and analyzing crystal (if used) must be enclosed in a chamber or coupled chambers that cannot be entered by any part of the body during normal operation.

(iii) Specific Requirements for Open Beam X-ray Systems

An open beam x-ray system is a system in which one or more x‑ray paths are not fully enclosed. The following are requirements specific to open beam x-ray systems (adapted from ANSI N43.2-1977):

  1. Each port of the radiation source housing must have a beam shutter that can be opened only when accessory apparatus or a collimator is coupled to the port.
  1. A guard or interlock must be provided which prevents exposure of any part of the body to the primary beam.
  1. Radiation levels external to the x‑ray tube housing with all shutters closed shall not exceed 2.5 mrem per hour as measured at 5 centimeters from the surface of the housing within which an x‑ray tube is operating at full rated power and at maximum rated accelerating potential.
  1. Shutters at unused ports should be secured to prevent casual opening.  All shutters must be provided with a “shutter open” indicator of fail-safe design.
  1. Radiation exposure levels in the vicinity of controls and adjustments of the x‑ray accessory apparatus used during normal operation shall not exceed 37.5 mrem per hour to the hands or 2.5 mrem per hour to the whole body, gonads, blood forming organs, or lens of the eye.
  1. A system barrier must be provided which is sufficient to ensure that the dose from the source in any unrestricted area does not exceed 2 mrem in any one hour and that the total effective dose equivalent to any non-occupationally exposed individual does not exceed 100 mrem in a year.

(iv) Specific Requirements for Electron Microscopes

Electron microscopes generate unwanted x‑rays through interactions of charged particles accelerated under high voltages. Users must be aware that radiation at the electron gun, camera, ports, high voltage power supply unit, and other accessible locations can exist.  The following are requirements specific to electron microscopes:

  1. RES is responsible for developing, posting and maintaining current, operating procedures including alignment techniques for each electron microscope. These procedures should be posted at each microscope location.
  1. The manufacturer’s operating instructions must be available and followed whenever the unit is disassembled or adjusted.
  1. All movable shielding must be in place prior to the operation of the unit.
  1. Radiation leakage surveys should be performed after non‑routine operations such as repair and alignment. These surveys can be performed by Radiation Safety staff upon request.
  1. A “Caution ‑ This Equipment Produces X‑Rays When Energized” label (available from the RSO) must be attached near any switch which energizes the microscope.

(v) Miscellaneous and Special Types of Radiation-Producing Equipment

Other types of radiation‑producing equipment not covered in this Handbook will be governed by special inspections or surveys by the RSO. Operating procedures including alignment techniques must be posted at each machine location. It is the responsibility of the supervisor to develop, post, and keep these procedures current.

4.8 Radiation Exposure/Dose Limits For Radiation-Producing Equipment

The following limits have been established to ensure that radiation equipment operators and members of the general public do not exceed radiation exposure limits established by NYSDOH in 10 NYCRR Part 16 or the recommendations of ANSI N43.2-1977:

  1. The equipment must be shielded to ensure that the dose in any unrestricted area does not exceed 2 mrem in any one hour and that the total effective dose equivalent to any non-occupationally exposed individual does not exceed 100 mrem in a year.
  2. Normal operation procedures shall be such that a qualified operator following instructions will not receive in any one hour a dose equivalent in excess of 37.5 mrem to the hands and forearms or 2.5 mrem to the whole body, gonads, blood forming organs or lens of the eye.
  3. Manual alignment procedures should be such that a qualified operator aware of the radiation hazards will not receive in any one hour a dose equivalent in excess of 37.5 mrem to the hands and forearms or 2.5 mrem to the whole body, gonads, blood forming organs or lens of the eye while following these instructions. If either of these dose rates is likely to be exceeded, a definite warning shall be included in the alignment instructions. Alignment procedures must include provisions for the use of protective equipment (lead gloves, lead aprons and leaded eye protection).
  4. The dose due to unwanted radiation from components such as high voltage rectifiers must not cause the dose in any unrestricted area to exceed 2 mrem in any one hour and must not result in a total effective dose equivalent  to any non-occupationally exposed individual in excess of the 100 mrem in a year.

4.9 Diagnostic X-ray Equipment

The use and operation of diagnostic x-ray equipment is regulated in New York State by the New York State Department of Health under the provisions of Title 10 of the State Sanitary Code, Chapter 1, Part 16, “Ionizing Radiation”, as authorized by Public Health Law 225.  The use of ionizing radiation, including diagnostic x-ray equipment, at Syracuse University (SU) is governed by the University’s Radiation Safety Committee.  In addition, a sub-committee of the SU Radiation Safety Committee has been established  to oversee the Radiation Safety/Quality Assurance Program for the diagnostic x-ray equipment at the SU Student Health Center. NYSDOH defines a small x-ray facility as a facility performing less than 2500 diagnostic radiographic examinations per year.  SU Health Center’s diagnostic x-ray facility meets this definition.

(i) Medical X-ray Quality Assurance Manual

The University has developed a “Medical X-ray Quality Assurance Manual” in accordance with the requirements of Part 16 of the NYS Sanitary Code and NYSDOH’s “Guide for Radiation Safety/Quality Assurance Programs”.  The manual is intended to serve as a reference for authorized users and persons responsible for quality assurance functions.  The manual contains quality assurance procedures, acceptable operating parameters and time frames in addition to radiation safety/quality assurance policies specific to SU.   The frequency for the performance of quality assurance  tests established in this manual are in accordance with the NYSDOH’s requirements for small diagnostic x-ray facilities.  For some QC testing procedures, increased frequencies have been established by SU to ensure diagnostic image quality.  Copies of this manual are available from the Environmental Health and Safety Service Office and at the Student Health Center’s X-ray Department.  It is the responsibility of the SU Student Health Center’s radiology personnel to ensure that the documents and procedures provided in this manual are current and complete.

(ii) Quality Assurance Testing Responsibilities

A Medical Quality Assurance Sub-Committee of the RSC has been appointed to oversee the Radiation Safety/Quality Assurance program at SU’s Student Health Service.  It is the responsibility of this sub-committee to provide direction to the program, assure that proper documentation and testing is maintained, review the program’s effectiveness and determine any changes which should be made.  This sub-committee meets on a frequency adequate to meet their responsibilities, with a minimum of one meeting annually.

It is the responsibility of the SU Health Center’s radiological technicians to notify the proper individuals when QC testing results are found to be inconsistent with established operating parameters. This notification shall occur within 48 hours of discovery of the inconsistency or problem.  The Syracuse University Health Center’s Senior Physician shall be notified immediately of all problems that could potentially effect diagnostic image quality.  Syracuse University’s Radiation Safety Officer shall be notified immediately of all problems relating to radiation safety and/or patient exposure.  These individuals shall also be informed of any corrective action that is taken and the results of the post-corrective action testing.

(iii) Quality Assurance Testing Frequency

The Syracuse University RSC in accordance with NYSDOH requirements has established the following QA Procedure frequencies for the University’s large (>2500 films/year) x-ray facility: 

Daily

  • Equipment function: dial malfunction, mechanical safety, electrical safety
  • Processor Stability: speed, contrast, base/fog, solution temperature
  • Processor Control Chart

Eight Weeks

  • Preventive maintenance on processor.

Quarterly

  • X-ray field/image receptor alignment
  • Positive beam limitation sizing
  • Light field/x-ray field alignment 

Semi-Annually

  • Interlocks and Exposure switch
  • Protective equipment
  • Cassette maintenance
  • SafeLight and Darkroom fog check
  • kVp accuracy
  • MA linearity
  • Radiographic timer reproducibility and accuracy
  • Viewbox luminance 

Annually

  • Film/screen contact
  • Repeat/reject analysis
  • Sensitometer Calibration
  • Densitometer Calibration
  • Half Value Layer
  • SID (source image distance)

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