Boston University/ Boston Medical Center
Analytical X-Ray
Safety Manual
[BU/ BMC ANALYTICAL X-RAY SAFETY MANUAL] Rev. 3 : 2013
BOSTON UNIVERSITY ANALYTICAL X-RAY EQUIPMENT SAFETY PROGRAM
Page
Table of Contents
1.0
Purpose
5
2.0
Scope and Applications
5
3.0
Organization of X-ray Safety Program
3.1 Permitting and Registration
3.2 Training and Instruction
3.3 Enforcement Actions
3.4 Deficiency Correction
Analytical X-ray Equipment:
4.1 X-ray Permit Holder’s Responsibilities
4.2 X-ray Supervisor’s Responsibilities
4.3 Operators' Responsibilities
4.4 Minors
General Equipment and Safety Requirements
5.1 Safety Devices
5.2 Warning Devices
5.3 Ports
5.4 Labeling
5.5 Shutters
5.6 Warning Lights
5.7 Radiation Source Housing
5.8 Generator Cabinet
5.9 Separate Room
5.10 Permanent Shields
5.11 Set Up Procedures
5.12 Test Safety Devices
5.13 Viewing Devices and Alignment
5.14 X-ray Use Log
Radiation Survey
5
7
7
8
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10
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14
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Personal Monitoring and Control of X-ray Exposure
7.1 Proper Use of Dosimetry Devices
15
15
4.0
5.0
6.0
7.0
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Table of Contents
Page
Appendix A: Definitions
17
Appendix B: Application for a Permit to Possess and Use Equipment that Emits
Ionizing Radiation (XR-1)
Appendix C: X-ray User Certification Form (XR-2)
21
Appendix D: Template SOP (XR-3)
28
Appendix E: X-ray Laboratory Inspection Checklist (XR-4)
38
Appendix F: X-ray Equipment Inventory (XR-5)
41
26
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1.0
Purpose
Analytical X-ray equipment is used for X-ray diffraction analysis, fluorescence analysis,
or direct X-ray transmission analysis of materials. These analytical X-ray systems are
comprised of components that utilize X-rays to determine elemental composition, or to
examine the microstructure of materials. These analytical X-ray devices are used for nonmedical purposes.
The primary objective of this program is to keep occupational exposures to radiation As
Low As Reasonably Achievable (ALARA) while utilizing these types of equipment. This
safety program establishes Boston University and Boston Medical Center procedures for
the safe operation of analytical X-ray equipment and the associated potential radiation
hazards.
2.0
Scope and Application
Analytical X-ray equipment has become a major tool in research and quality control
programs. Despite the advances in operating techniques and equipment design, the most
common hazards are due to operators' errors and equipment malfunctions. The potential
exposures to the primary beam are of a major concern when evaluating potential radiation
exposures. Exposures to the primary beam in a typical analytical X-ray unit may be as
great as 100,000 R/min.
This program applies to all departments, supervisors, employees, students, visiting
scientists, and any personnel from other organizations who work with or near analytical
X-ray equipment at Boston University. Operational procedures will be established for
each X-ray unit to maintain radiation exposures As Low As Reasonably Achievable
(ALARA) with due considerations as to the feasibility and nature of the research being
conducted.
3.0
Organization of X-ray Safety Program
Radiation Safety Committee:
The Boston University (BU) and Boston Medical Center (BMC) Radiation Safety
Committee is responsible for the establishment and continuing review of the Radiation
Safety Program at Boston University and Boston Medical Center (BU/BMC). The
Committee is also responsible for the BU and BMC compliance with the radiation safety
regulations promulgated by the State, Federal, and local agencies for ionizing radiationproducing equipment. Such equipment must be registered with the BU/BMC Division of
Medical Physics and Radiation Safety (DMPRS). Boston University has a separate Laser
Safety Committee and Program which deals with the use of laser equipment.
Chief Medical Physicist:
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The Chief Medical Physicist oversees the implementation of the analytical X-ray
equipment program including surveys, procedures and incident review.
Radiation Safety Officer:
The Radiation Safety Officer oversees the radiological safety of the analytical X-ray
equipment.
Boston University Division of Medical Physics and Radiation Safety
The Boston University Division of Medical Physics and Radiation Safety (DMPRS)
provides services to assist departments, supervisors, students and technicians in
maintaining a comprehensive analytical X-ray equipment safety program including:
1.
Training and instruction in the safety procedures and practices required for all
persons who work with or near analytical X-ray equipment.
2.
Managing the RIMS website that allows X-ray Permit Holders to review
information specific to their labs such as Authorized User status, training status,
and lab profile information at http://www.bu.edu/rims
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3.1
3.
Maintaining a current listing of analytical X-ray equipment and its authorized
users.
4.
Evaluating each installation as to the control of radiation exposures including
recommendations for placement of radiation warning signs and/or warning
devices.
5.
Performing routine annual radiation safety inspections of analytical X-ray
equipment.
6.
Review and approval of modifications to X-ray apparatus that affects radiation
protection including X-ray tube housing, cameras, shielding, and safety
interlocks.
7.
Providing personal monitoring badges and area monitors.
8.
Investigating any unusual radiation exposures to personnel and taking remedial
action, if necessary.
9.
Assisting in achieving compliance with all applicable federal, state, and local
rules and regulations.
10.
Registering X-ray units with the Massachusetts Department of Public Health as
per section 105 CMR 120.000.
Permitting and Registration of users of Analytical X-ray equipment with the
Division of Medical Physics and Radiation Safety
All analytical X-ray equipment must be registered with DMPRS using X-ray Equipment
Inventory Form XR-5.
The supervisor of the analytical X-ray equipment must apply for a Permit to Possess and
Use Equipment that Emits Ionizing Radiation using Form XR-1.
Permits are issued by Radiation Safety Committee upon recommendation by Radiation
Generating Devices Subcommittee.
Permits are revived annually by DMPRS.
No person shall begin using analytical X-ray equipment without first completing the
required DMPRS training and SOP specific training which is to be documented on the
X-ray User Certification Form, XR-2.
3.2
Training and Instruction
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Individuals requiring X-ray Safety training may register for training on-line via RIMS at
http://www.bu.edu/rims/
a.
Permit Holders, Lab Staff, and Students
All permit holders, laboratory staff, and students working with or frequenting a
lab using analytical X-ray equipment must complete the Basic Analytical X-ray
Training on RIMS. The permit holder must provide to staff and students any
additional training specific to the instrument and its standard operating
procedures.
b.
Auxiliary Workers
All custodians, trades and non-technical workers who will work in or frequent an
X-ray restricted area must attend the Radiation Safety Awareness program
presented by DMPRS.
c.
Visitors
A visitor is defined as someone who enters the lab on an infrequent basis solely
for the purposes of observation. A visitor may not operate the Analytical X-ray
Equipment
d.
Exceptions
The Radiation Safety Officer (RSO) or Chief Medical Physicist may exercise
discretion in modifying the training requirements for each training category as
appropriate.
3.3
Enforcement Actions
The Radiation Safety Committee can suspend or revoke an Analytical X-ray Permit
which is not in compliance with BU/BMC policies and regulations. When an Analytical
X-ray Permit is suspended or revoked, authorized users of that equipment may not utilize
the unit and the equipment may be locked out at the discretion of the RSO.
A suspended authorization will not be reinstated until the Committee is assured that
reasonable measures have been instituted to prevent recurrence of the deficiencies.
A revoked permit will require new permit application
3.4
Deficiency Correction
Laboratories using analytical X-ray equipment are inspected by DMPRS annually.
Additional inspections may be conducted at the discretion of the Radiation Safety
Officer or Chief Medical Physicist, for example, as a component of an X-ray incident
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investigation.
The results of the inspection will be documented with copies sent to the Permit Holder.
Inspection findings will be reported to the Radiation Generating Device subcommittee
for further recommendation
4.0
Analytical X-ray Equipment
The inventory of the analytical X-ray equipment is available in DMPRS
4.1
Permit Holder's Responsibilities
Each analytical X-ray equipment Permit Holder is responsible for:
1.
Providing the Boston University DMPRS with a complete XR-1 form
(Application for Permit to Possess and Use Equipment that Emits Ionizing
Radiation at BU). See Appendix B. DMPRS will review each proposed
installation and corresponding operating procedures. A permit must be obtained
from the Radiation Safety Committee before the X-ray equipment is operated.
2.
All operations carried out with the equipment.
3.
Ensuring that all the personnel under their supervision are registered with and
receive initial training from the DMPRS in analytical X-ray equipment safety.
4.
Compliance with the specific recommendations made by the DMPRS, and also
the general equipment and safety requirements listed in Section 7.0.
5.
Ensuring that only authorized users will enter the areas that are restricted due to
the use of the analytical X-ray units.
6.
Providing specific hands-on training to the authorized user(s) for each analytical
X-ray unit, in accordance with the approved Standard Operating Procedures
(SOP). A template SOP may be found in Appendix D, Form XR-3. Completed
SOPs for each piece of X-ray equipment will be maintained in the X-ray Manual
and updated annually. An up-to-date list of Authorized Users shall be posted on
the lab’s permit.
7.
Ensuring that the project has a properly operating survey instrument that has been
calibrated within the last twelve months.
8.
Informing DMPRS of acquisitions, transfers, servicing or decommissioning of Xray equipment. The X-ray inventory shall be amended as needed to reflect such
changes. (Appendix F, Form XR-5).
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9.
10.
Notifying the Radiation Safety Officer (RSO) and Chief Medical Physicist of the
Boston University Division of Medical Physics and Radiation Safety when:
a)
it is necessary to alter safety devices, such as bypassing interlocks. The
exception would be generic bypassing for test purposes that has been
authorized by DMPRS.
b)
it is known or suspected that a radiation exposure of personnel may have
occurred.
c)
an existing unit is moved or beam path is altered.
d)
there are changes in operating parameters such as kV and mA beyond that
which were approved by DMPRS.
e)
there are changes in the approved shielding.
f)
there is any major service performed on the X-ray unit by lab personnel.
g)
an outside service technician is contracted. Such technician must be
registered with the MDPH and approved by the RSO or Chief Medical
Physicist.
h)
planning to procure new analytical X-ray equipment or to dispose, sell or
gift unwanted equipment. Procurement or removal of such equipment
requires the advance authorization of the BU RSO.
Emergency Procedures
Written emergency procedures shall be established for each X-ray analytical unit
by the Permit Holder and shall be posted in a conspicuous location near each Xray unit. These should include the telephone number(s) of the Permit Holder, the
BU Division of Medical Physics and Radiation Safety, the BU Campus Police
Department, and instructions to follow in the event of a known or suspected
accident involving radiation exposure
4.2
X-ray Supervisor’s Responsibility
1.
Assuming the responsibilities of the X-ray Permit Holder in the absence of that
individual.
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4.3
Operators’ Responsibility
Each authorized user of the analytical X-ray equipment is responsible for:
4.4
1.
Completing the analytical X-ray safety training provided by the BU DMPRS prior
to operating the analytical X-ray equipment.
2.
Receiving specific hands-on training with each analytical X-ray
instrument provided by the X-ray supervisor in accordance with the
written SOP.
3.
Wearing the assigned personal monitoring dosimeter (s) (see Section 7.0)
4.
Documentation of items 1, 2 and 3 on the X-ray User Authorization Form,
XR-2 (see Appendix C) that is maintained in the X-ray Safety Manual in
the laboratory.
Minors
Minors are not allowed to operate analytical X-ray equipment. The Permit Holder
shall be responsible for ensuring that the presence of any minor in the laboratory
is in full compliance with the Boston University Personnel Policy Manual (see
http://www.bu.edu/hr/files/documents/employee-handbook.pdf, page 8).
5.0
General Equipment and Safety Requirements
As defined in 105 CMR 120.603.
5.1
SAFETY DEVICE
A device 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. Exception to this
requirement may be granted through the Department of Public Health with the
prior approval of the BU RSO and Chief Medical Physicist.
5.2
WARNING DEVICES
Open beam configurations shall be provided with a readily discernible indication
of:
a.) X-ray tube "on-off" status located near the radiation source housing if the
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primary beam is controlled in this manner; and/or
b.) Shutter "open-closed" status located near each port on the radiation source
housing if the primary beam is controlled in this manner.
Warning devices shall be labeled so that their purpose is easily identifiable. On
equipment installed after February 9, 1996, warning devices shall have fail-safe
characteristics.
5.3
PORTS
Unused ports on radiation source housings shall be secured in the closed position
in a manner that will prevent casual opening.
5.4
LABELING
All analytical X-ray equipment shall be labeled with readily discernible sign(s)
bearing the radiation symbol and the words:
a.) "CAUTION-HIGH INTENSITY X-RAY BEAM" on X-ray source
housing; and
b.) CAUTION RADIATION-THIS EQUIPMENT PRODUCES
RADIATION WHEN ENERGIZED" near any switch that energizes
an X-ray tube if the radiation source is an X-ray tube; or
c.) CAUTION-RADIOACTIVE MATERIAL" on the source housing if
the radiation source is a radionuclide.
5.5
SHUTTERS
On open beam configurations installed after February 9, 1996, each port on the
radiation source housing shall be equipped with a shutter that cannot be opened
unless a collimator or a coupling has been connected to the port.
5.6
WARNING LIGHTS
An easily visible warning light labeled with the words "X-RAY ON" shall be
located:
a.) near any switch that energizes an X-ray tube and shall be illuminated only
when the tube is energized; or
b.) In the case of a radioactive source, near any switch that opens a housing
shutter and shall be illuminated only when the shutter is open.
On equipment installed after February 9, 1996, warning lights shall have fail-safe
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characteristics.
5.7
RADIATION SOURCE HOUSING
Each radiation source housing shall be subject to the following requirements:
a.) Each X-ray tube 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.
b.) Each radioactive source housing or port cover or each X-ray tube housing
shall be so constructed that, with all shutters closed, the radiation measured at
a distance of 5 centimeters from its surface is not capable of producing a dose
in excess of 2.5 millirems in one hour. For systems utilizing X-ray tubes, this
limit shall be met at any specified tube rating.
5.8
GENERATOR CABINET
Each X-ray generator shall be supplied with a protective cabinet, which limits
leakage radiation measured at a distance of 5 centimeters from its surface such
that it is not capable of producing a dose in excess of 0.25 millirem in one hour.
5.9
SEPARATE ROOM
The analytical X-ray equipment must be placed in a separate room from other
work areas whenever practical.
5.10
PERMANENT SHIELDS
Properly installed permanent shields should be used in preference to temporary
shielding. When temporary shielding is necessary, it must be securely fastened.
5.11
SET-UP PROCEDURES
Set-up procedures will be carried out with the X-ray beam off or with shutters
closed as much as possible. If the latter, a survey shall be performed before the
starting set-up.
5.12
TEST SAFETY DEVICES
All safety devices such as interlocks, shutters, warning lights, etc. will be tested
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upon each use to ensure proper operation.
5.13
VIEWING DEVICES AND ALIGNMENT
Particular attention should be given to viewing devices to ensure that lenses and
other transparent components attenuate the radiation beam to minimal levels when
alignment involves working near the primary beam. The beam current should be
reduced when a fluorescent alignment tool is used; dimming the room light will
permit a significant reduction in beam current. The fluorescent alignment tool
should be long enough to permit the analytical X-ray equipment user's hand to be
kept a safe distance from the beam.
The Division of Medical Physics and Radiation Safety can be consulted for more
detailed advice.
5.14
X-RAY USE LOG
A use log for each X-ray unit is required for all open beam analytical X-ray units.
It is recommended but not required for other analytical x-ray units. The use log
should document the authorized user, date, and duration of each use of the
equipment. Completed logs should be available for review by DMPRS.
6.0
Radiation Surveys
Analytical X-ray equipment USERS are required to make and keep records of the
following surveys with a GM survey meter:
1.
Upon equipment installation and within every 12 months thereafter;
2.
Following any reconfiguration of the system;
3.
Following maintenance requiring disassembly or removal of a local
component;
4.
During maintenance and alignment requiring the presence of a primary Xray beam when a local component has been disassembled or removed;
5.
Any time a visual inspection of local components reveals an abnormal
condition; and
6.
Whenever personnel monitoring devices show a significant increase over
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the previous monitoring period or the readings are approaching the limits
specified in 105 CMR 120.211.
DMPRS will make surveys according to the following guidelines:
7.0
1.
Upon the installation of the X-ray equipment and at least once a year
thereafter.
2.
Upon any change in the initial arrangement, number, or type of local
components in the system.
3.
Upon any maintenance requiring the disassembly or removal of a local
component in the system.
Personnel Monitoring and Control of X-ray Exposure
The DMPRS periodically checks and surveys Analytical X-ray devices to
ascertain that safety procedures are followed. In addition, personnel who are
required to be badged per applicable state regulations (i.e. 105 CMR 120) will be
monitored. Dosimeters will be provided to all X-ray personnel working with open
beam analytical X-ray equipment to ensure that exposures are maintained
ALARA. Employees not working with open beams may request to be monitored
on a voluntary basis.
Radiation exposure limits are provided in the Massachusetts state regulations 105
CMR 120.211.
Any X-ray worker who is pregnant may voluntarily declare her pregnancy and the
estimated date of conception in writing to the BU/BMC Division of Medical
Physics and Radiation Safety. Thereafter, her occupational exposure shall be
limited to 500 millirem for the nine-month gestational period. Declaration of
pregnancy forms are available at:
http://www.bu.edu/ehs/plans/management-plans/rpo/forms.
At the RSO's discretion, an investigation may be performed at any exposure level.
7.1
PROPER USE OF DOSIMETRY DEVICES
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The analytical X-ray equipment users who were assigned dosimeters will wear
whole body badges and/or finger rings as assigned by the DMPRS. The
monitoring device should be worn such that the body part nearest the primary
beam is monitored. Monitoring badges worn on the chest or abdomen may
provide an indication as to the amount of stray radiation to the whole body.
Operations involving the use of analytical X-ray equipment will be planned so
that the exposures are in compliance with the occupational limits shown above.
OTHER REQUIREMENTS:
1.
Do not take dosimetry badges or rings home with you.
2.
Do not leave badges / rings in a high background area.
3.
Dosimetry issued by BU/BMC DMPRS can only be used at Boston University
and Boston Medical Center.
4.
Please contact DMPRS if you lose your badge / ring.
5.
Do not wear another person’s badge / ring, or allow someone else to take
your dosimetry device.
.
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APPENDIX A
DEFINITIONS
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APPENDIX A
DEFINITIONS
ANALYTICAL X-RAY EQUIPMENT: Any device, which uses X-rays for the purpose of
examining the microstructure of materials. This includes all types of X-ray diffraction and
spectrographic equipment.
ANALYTICAL X-RAY SYSTEM: A group of components which x rays to determine the
elemental composition or to examine the microstructure of materials.
ANODE: A positive electrode; in an X-ray tube, it is the target for the accelerated electrons.
CATHODE: A negative electrode; it is the filament at which free electrons are produced by
thermionic emission.
DOSE, ABSORBED (RAD): The amount of energy deposited in medium by a beam of
ionizing radiation. The special unit of absorbed dose is the RAD, which is equal to 100 ergs/gm
or 0.01 joule/kilogram.
DOSE EQUIVALENT (REM): A quantity that expresses the irradiation incurred by exposed
persons on a common scale for all radiations. It is defined numerically as the product of the
absorbed dose in rads multiplied by the quality factor and the REM. (For radiation protection
purposes in this safety program, the dose equivalent in rems may be considered numerically
equivalent to the absorbed dose in rads and exposure in roentgens.)
EXPOSURE (ROENTGEN): A measure of the ionization produced in air by x or gamma
radiation. This special unit of exposure is the roentgen, which is equal to 2.58 E-4 coulomb of
charge collected per kilogram of air exposed.
FAIL-SAFE DESIGN: One in which all failures of indicator or safety components that can
reasonably be anticipated cause the equipment to fail in a mode such that personnel are safe from
exposure to radiation. For example: (a) If a light indicating “X RAY ON” fails, the production
of X-rays shall be prevented, and (b) if a shutter status indicator fails, the shutter shall close.
HALF VALUE LAYER (HVL): The thickness of any material that is required to reduce the
intensity of a given beam by one half.
INSTALLATION ENCLOSURE: That portion of an X-ray installation, which clearly defines
the transition from a non-controlled area to a controlled area, and provides such shielding as may
be required to limit the dose rate in non-controlled areas during normal operation.
INTERLOCK: A device for precluding access to an area in which radiation is present by
automatically reducing the exposure rate upon entry by personnel or parts of their body.
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kVp (KILOVOLTAGE PEAK): The maximum potential difference applied between the
anode and cathode by a pulsating voltage generator.
LEAKAGE RADIATION: All radiation coming from within the X-ray tube housing except
the primary radiation beam.
LOCAL COMPONENT: Part of an analytical X-ray system that includes areas that are struck
by x rays such as radiation source housing, port and shutter assemblies, collimator, sample
holders, cameras, goniometers, detectors and shielding, but do not include power supplies,
transformers, amplifiers, readout devices, and control panels.
mAs (MILLIAMPERE SECONDS): A combination unit, which is the product of the tube
current (expressed in mA) and the exposure time (expressed in seconds). The total output of an
X-ray tube is directly proportional to the mAs (or either of its components).
MAXIMUM PERMISSIBLE DOSE EQUIVALENT: The maximum dose equivalent that a
person or specified parts thereof shall be allowed to receive in a stated period of time.
NORMAL OPERATION: Operation under conditions suitable for collecting data
recommended by a manufacturer of the X-ray system. Recommended shielding and barriers
shall be in place.
OPEN-BEAM CONFIGURATION: An analytical X-ray system in which an individual could
accidentally place some part of their body in the primary beam path during normal operation.
PERMIT HOLDER (X-RAY): The BU faculty member issued an internal permit for use of
analytical X-ray equipment by the Radiation Safety Committee.
PRIMARY BEAM: Radiation which passes through an aperture of the source housing by a
direct path from either the X-ray tube or a radioactive source located in the radiation source
housing, which is either unscattered or undeflected.
RADIATION AREA: Any area accessible to personnel in which there exists radiation at such
levels that a major portion of the body (whole body, head and trunk, active blood-forming
organs, gonads, or eye lenses) could receive in any one hour a dose equivalent in excess of 5
mrem, or in 5 consecutive days a dose equivalent in excess of 100 mrem.
SCATTERED RADIATION: Radiation that, during passage through matter, has been deviated
in direction.
STRAY RADIATION: The sum of leakage and scattered radiation.
SYSTEM BARRIER: That portion of an X-ray installation, which clearly defines the transition
from a controlled area to a radiation area and provides such shielding as may be required to limit
the dose rate in the controlled areas during normal operations.
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THERMIONIC EMMISSION: The process by which free electrons are produced at the
cathode of an X-ray tube when the filament is electrically heated such that the thermal energy
imparted to the electrons is sufficient to overcome the forces binding them to the filament.
TUBE HOUSING-APPARATUS COMPLEX: Those parts of an analytical X-ray device in
which X-rays are produced and utilized. This includes the X-ray tube housing, shutter or port
assemblies, collimator, cameras, goniometers, and electronic radiation detectors. This is not
intended to include such components as transformers, control panels, or temporary shielding.
X-RAY GENERATOR: That portion of an X-ray system, which provides the accelerating
voltage and current for the X-ray tube.
X-RAY DIFFRACTION EQUIPMENT: An analytical X-ray device in which an X-ray beam
(usually monochromatic) is made to strike a specimen, causing a portion of the beam to be
diffracted. Measurements of certain parameters of the diffracted beam may be used to provide
qualitative and/or quantitative information about the specimen.
X-RAY FLUORESCENCE EQUIPMENT: An analytical X-ray device in which a
polychromatic X-ray beam is made to strike a specimen, producing X-ray fluorescence, which is
characteristic of the specimen. A portion of the fluorescent radiation is directed into an
analyzing crystal where it is diffracted. The wavelength of interest may then be monitored by a
properly positioned detector to produce qualitative and/or quantitative analysis of the specimen.
X-RAY RESTRICTED AREA: A specified area in which exposure of personnel to radiation
or radioactive material is controlled and which is under the supervision of a person who has
knowledge of the appropriate radiation protection practices, including pertinent regulations.
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APPENDIX B
Boston University/
Boston Medical Center
Form XR-1
Application for a Permit to Possess and Use Equipment
that Emits Ionizing Radiation
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Medical Physics and
Radiation Safety
72 East Concord St.
Boston, Massachusetts
02119-2511
Tel: 617.638.7052
Fax: 617.638.7509
APPLICATION FOR
ANALYTICAL X-RAY USE PERMIT
(Non-Human Use)
New
Renewal
Amendment
Please complete each section of this form and attach additional sheets as necessary. Return the
completed application to the Division of Medical Physics and Radiation Safety at the address
shown above. The RSO will review your application and notify you of preapproval or if further
information is needed. The final approval of your application will be issued by the RadiationGenerating Devices subcommittee.
Applications will require a copy of a current:
a) CV,
b) X-ray related trainings and certificates,
c) SOPs,
d) Completed user certification,
e) X-ray unit inventory, and
f) Laboratory layout map
SECTION A. PROPOSED PERMIT HOLDER
Permit Holder Name:
Home Phone:
Office Phone:
Lab phone:
X-ray Supervisor Name:
Email:
Home Phone:
Office Phone:
Lab phone:
Email:
TRAINING AND EXPERIENCE
Permit Holder
X-ray supervisor
Highest Degree Obtained
And Specialty
Institution
Training
Where Trained (most recent)
Date
Hours of
Training
Please describe your training and experience with x-ray units you are planning on
using.
PROPOSED X-RAY USER(S) authorized to perform beam alignment (if applicable)
Note: List the specific X-ray unit serial number(s) for which the individual has been trained and
authorized.
User (Last, First)
X-Ray System (SNs)
Training Date
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Radiation Protection
Office
80 East Concord St.
Boston, Massachusetts
02119-2511
Tel: 617.638.7052
Fax: 617.638.7509
SECTION B. PROPOSED UNIT(S)
Instructions: All Analytical X-ray units are required to be registered with the Radiation Safety
Officer.
X-RAY
MANUFACTU
RER
X-RAY
MODEL
SERIAL
NUMBER
BU
PROPERTY ID
EHS REF
NUMBER
X-RAY TYPE
(diffraction,
spectrographic,
mammography)
POWER /
ENERGY
OUTPUT
APPLICATION
INSTALLATION
DATE
OWNERSHIP
(BU, other)
AGE OF
SYSTEM
STATUS
(Active /
Inactive)
Page | 24
Radiation Protection
Office
80 East Concord St.
Boston, Massachusetts
02119-2511
Tel: 617.638.7052
Fax: 617.638.7509
SECTION C. SOP(S)
Please attach a copy of proposed SOPs for each unit (form XR-3).
SECTION D. X-RAY USERS
Please attach an X-ray User Authorization form for each X-ray user (form XR-2).
I agree to fully comply with the safety requirements outlined by the Massachusetts Department
of Public Health (105 CMR 120.600) and the Boston University/BMC Analytical X-ray Safety
Manual. I will operate all analytical X-ray equipment in a safe manner, and I will only operate
the equipment for which I have been permitted by the Radiation Safety Committee.
Permit Holder Signature:
Date:
RSO:
Date:
Page | 25
APPENDIX C
Boston University/
Boston Medical Center
XR-2
X-ray User Certification Form
Analytical X-Ray User Certification Form
X-Ray Permit Holder: ___________________________________________________
Lab location and room: _____________________________ Lab telephone number: __________________
Instructions for Completing the X-Ray User Certification Form:
1. Read the responsibilities and certification items listed below.
2. Ensure all conditions of certification have been met.
3. Ensure each person listed provides a signature upon completion of conditions
Your responsibilities as an X-Ray Analytical Equipment user are:
1. You must complete an initial Analytical X-Ray Safety training on line via RIMS.
2. You must familiarize yourself with the location and content of your X-Ray Analytical Equipment permit.
3.
You must use X-Ray Analytical Equipment at designated locations approved in the permit.
4.
Your work must be performed in the manner specified in the SOP (standard operating procedures). There
shall be no changes in the approved procedures without the prior approval of the RSO.
5.
You are only allowed to use the X-Ray Analytical Equipment system(s) listed on your permit that you have
been trained on.
6.
You must notify the RSO/CMP of new purchases of any analytical X-Ray systems and register these
systems with the RSO/CMP. Routine operation of analytical X-Ray systems may not begin until the RSO
has been notified and has conducted a thorough survey and given approval for operation.
7.
You must notify the RSO/CMP of any analytical X-Ray system transfer or disposal.
8.
You must perform any maintenance or repair to your X-Ray Analytical Equipment system unless proper
documentation is presented to the RSO.
9.
If you will be aligning an open beam system, you must possess and wear dosimeters provided to you by the
DMPRS.
10. You must read, understand, and follow all safety requirements specific to use of your X-Ray systems.
11. You must know how to respond, report, and who to contact in case of an emergency involving an X-Ray
system.
I certify that:
 I have read, understood and agree to above stated laser user responsibilities.
 I have completed the on-line Analytical X-Ray Safety Training.
 I have been provided training specific to the laboratory and its X-Ray units by the PI.
 I have read and understood the information specific to laser safety requirements and the laboratory SOP.
 I will follow all laboratory safety procedures at all times.
 I will report any accident, potential exposure or safety concerns to my supervisor immediately and the
RSO.
Signature: __________________________________
Print name: _________________________________
Date: ____________________
BU ID: ___________________
If you need additional information, please contact the Department of Medical Physics and
Radiation Safety at 617- 638-7052.
Note: Violations of health and safety requirements are considered as serious infractions that may result in the
suspension and/or termination of the protocol or an individual’s privileges to work with X-Ray systems.
Page | 27
APPENDIX D
Boston University/
Boston Medical Center
Form XR-3
Template SOP
Page |
28
XR-3
Boston University/Boston Medical Center
Division of Medical Physics and Radiation Safety
SOP for
Title
Location
Contact
X-ray Permit Holder:
X-ray Supervisor:
Office Phone #
Emergency Phone #
Revision History
Revision
A
Description of Changes
Effective Date
Author
Initial Release:
Approvals
Name and Title
Signature
Date
Page |
29
A. EQUIPMENT INFORMATION
1. X-ray specifications
Type: (diffraction, etc.)
Manufacturer:
Manufacturer Information:
Manuf. Date:
Model:
Serial #:
BU Property #:
Status:
Installation date:
Max. Power:
Model:
Serial #:
Calib. Date:
Probes:
Model:
Serial #:
Calib. Date:
2. Survey meter specifications
Manufacturer:
3. Dosimetry
 X-ray users shall wear the whole body dosimetry and / or finger rings as
assigned by DMPRS
 Do not remove badges from the lab or leave badges in a high exposure area.
Page |
30
B. GENERAL SAFETY REQUIREMENTS
1. Exposure Risk
Do not expose any part of the body to the primary radiation beam. The greatest potential
for acute exposure occurs during the manipulation of the sample to be irradiated.
Exposure rates of up to 10,000 R/sec can occur at the housing ports of certain X-ray
units... Signs of exposure include erythema (reddening) of the skin in less than 0.3
seconds. Serious and permanent injury may occur if exposure lasts more than 0.1
seconds. Scattered radiation can also produce high exposure rates (100s of mr/hr).
Immediately report any suspected exposures to the X-ray Permit Holder (xxx-xxxx), the
DMPRS (638-7052), and the Research Occupational Health Program
(Call the Research Occupational Health Program (ROHP) at 617-414-7647. Boston
Medical Center Emergency Department on the Medical Campus 617-414-4075 or go to
the nearest hospital emergency room )
2. Access Controls
Describe access controls, including use of interlocks. It is the responsibility of the user to
maintain and enforce access control.
 Access to X-ray lab via card/key entry system.
 X-ray housing depresses interlocks. Removing screws will defeat interlocks. Do
not override interlocks.
 Interlocks may be defeated for alignment purposes only with permit holder’s
approval.
3. Warning Signs & Lights
 “CAUTION: X-RAY RADIATION. AUTHORIZED PERSONNEL ONLY”
signs are posted above the X-ray Unit and on doors leading to any restricted
area.
 “CAUTION X-RAYS—THIS EQUIPMENT PRODUCES X-RAYS WHEN
ENERGIZED” signage is posted near any switch that energizes the X-ray tube.
 “CAUTION: HIGH INTENSITY X-RAY BEAM” signage is affixed to the X-ray
source housing.
 WARNING LIGHTS: Each X-ray unit has a fail-safe warning light to indicate
when the X-ray tube is energized.
Page |
31
4. Authorized Users:
X-ray Users: Authorized users include only those personnel listed in the X-ray Safety Manual / X-ray
User Authorization Records. X-ray Users must have:
(a) completed the Initial X-ray Safety Training provided by Boston University's Office of
Environmental Health and Safety,
(b) enrolled in the applicable dosimetry program at BU, and
(c) had specific, documented training on this X-ray's SOP.
Users are responsible for reviewing and complying with all applicable rules, regulations and
University procedures as explained in the BU X-ray Safety Manual and other BU X-ray Safety
Program documents. An “X-ray User Authorization Form” for each authorized user shall be
documented in the X-ray manual using form XR-2.
5. Alignment procedures:
All X-ray users need to keep in mind that the majority of X-ray accidents occur while aligning the
X-ray beam. All possible steps will be taken to prevent any such accidents. Alignment procedures
are performed in accordance to the manufacturer’s instructions.





Notify supervisor prior to commencing with alignment procedures.
Notify lab personnel of initiation of alignment procedure.
Ensure that there are no unauthorized occupants in the area.
Complete “Safe Operating Procedures” as itemized in part C.1.
Operator will not leave the area until the X-ray housing is replaced and the interlocks are
operational.
6. Actions:
Prior to operating the X-ray unit, verify that the following actions have been implemented. Notify the
permit holder prior to operating the X-ray equipment if there are any “NO” responses.
ACTION
YES NO
ACTION
YES NO
Are safety devices operating
Are all signs and labels in place as
properly? (interlocks, beam
noted in B.3?
cut-offs)
Are the X-ray on/off light(s)
Is a survey meter available &
functioning?
calibrated?
Are unused ports on the
Is a current written SOP available?
radiation source closed?
Is the lab secure?
Is a written Use log available &
in use?
Are all necessary interlocks operating properly?
Page |
32
C. SAFE X-RAY OPERATING PROCEDURES
1. Prior to operation of the ___________ X-ray System, each of the following safe operating steps shall
be implemented. Post section C.1. of the X-ray SOP, “Safe X-ray Operating Procedures” in close
proximity to the
X-ray Unit. This list of safe operating procedures shall be maintained in clear view of the operator.
POWER ON SEQUENCE

Record the date and start time on the X-ray Use log, form XSP-3.

Perform a radiation survey if required (see instructions on Use log).











POWER OFF SEQUENCE
(Non-Emergency)








Enter stop time and date on the X-ray Use Log, form XSP-3.
(Emergency)

Hit the emergency power off button for this unit or the entire lab (See floor plan reference #
XXXX).
33
Page |
2. Floor plan
Attach a diagram of X-ray use area. (A simple block diagram will do. Block diagram should also
be posted in a prominent location, either on the lab door or inside the laboratory.)
3. Photograph of X-ray unit:
Page | 35
4. Beam Configuration:
Yes
No
N/A
Does this device have a configuration such that any portion of a person’s
body can enter the primary X-ray path?
Is there a functioning safety device that will shut off the beam upon entry
to the path?
If there is no such safety device, has an exemption been issued by the
MDPH?
Is there a readily discernable indication of X-ray “on / off”?
Is the “on / off” indicator located near each port on the radiation source
housing?
Is there a shutter “open / closed” status indicator located near each port on
the radiation source housing?
For open beam devices installed after February 1995, does each port have
a shutter that cannot be opened unless a collimator or coupling has been
connected to the port?
5. Non-beam hazards, if any:
List and describe how they have been addressed (electrical, trip & fall, etc.)
Hazard
Response Action
6. Hazardous material handling:
List hazardous materials involved, such as chemical or biological, including the quantity, handling and
labeling requirements.
Hazardous Material
Quantity
Handling and Labeling Requirements
Page | 36
7. Hazardous Waste:
Identification of hazardous waste generated by the activity (if any) and its disposal.
Waste Identification
Disposal Requirements
8. Emergency Procedures:
Authorized X-ray users will be familiar with the building’s emergency evacuation plan, location of
emergency equipment, and emergency procedures for fires or other emergencies. Emergency shut off
procedures for lasers consist of shutting off electrical power to the X-ray system. Note locations of main
electrical shut off switches to the X-ray.
Power off X-ray via:
 On/Off switch on X-ray control panel
 Emergency power off (EPO) button on wall. (Reference specific EPO that shuts down this
equipment from floor plan.) Follow specific instructions for each piece of equipment.
 Circuit breaker box
 Follow BU Safety/ Emergency Instructions on flip chart if there is a need to contact Police, Fire or
Ambulance Emergency Response personnel. (BUPD 353-2121)
9. Maintenance:
Only OEHS authorized, licensed and certified outside service personnel will maintain the equipment. A
current copy of the MDPH registration information for all outside contractors must be on file at OEHS prior
to any service. All relief devices, safety interlocks, alarms and other hazard prevention devices will be
maintained, calibrated, and tested for functionality on a regular basis in accordance with standard industrial
practices and recommendations of the manufacturers.
Service Agreement with:
Date of last maintenance inspection:
Page | 37
APPENDIX E
Boston University/
Boston Medical Center
XR-4
Analytical X-ray Restricted Laboratory Inspection
Checklist
XR-4
Boston University/Boston Medical Center
Division of Medical Physics and Radiation Safety
X-ray Radiation Restricted Laboratory Inspection Checklist
Building Address:
Permit Holder:
Inspected By:
Survey Meter Model:
Room(s):
Serial #:
Date:
Calib. Date:
NOTE: S = Satisfactory; U = Unsatisfactory; NA = Not Applicable.
S
U
NA
Item
GENERAL X-RAY RADIATION SAFETY
1. Security: Doors are closed & locked when
unoccupied; closed when person is physically
in that specific room.
2. Personnel respond to requests for
bioassays from DMPRS.
3. Personnel are working with X-ray sources
in accordance with ALARA.
4. Radiation survey of representative areas
result in dose rates < 0.03 mr/hr.
5. X-ray sources stored properly, labeled,
locked if necessary.
6. All personnel are registered with DMPRS
and training is current.
7. Applicable dosimetry worn when X-ray
equipment is in use, and stored on dosimetry
rack.
RECORDS
8. Radiation surveys are performed as
required and records are filed with the X-ray
Safety Manual.
9. Physical inventory of equipment is
current.
10. Records available for transfer of X-ray
equipment to / from other institutions.
11. X-ray Safety Manual has completed User
Authorization Form for each user.
12. A current written SOP is posted.
13. Use logs are up to date and posted.
14. A current permit, including an accurate
list of Authorized Users, is posted.
15. Service technicians are registered with
MDPH and approved by RSO.
Comments
Page 2
X-ray Radiation Restricted Laboratory Inspection Checklist
S
U
NA
Item
FACILITIES & EQUIPMENT
16. Egress unobstructed.
17. Appropriate shielding in use.
18. Safety equipment unobstructed.
19. Exits are identifiable.
20. EPO is present and functioning.
21. X-ray generator has protective cabinet
that limits leakage radiation as specified.
22. Fire extinguishers are inspected annually
& tagged.
23. Survey meters: proper type, adequate
number and calibrated annually.
POSTINGS, SIGNS, LABELS & WARNINGS
24. X-ray Safety Manual available.
25. “Caution: X-ray Radiation. Authorized
Personnel Only.” sign posted on door.
26. “Caution X-rays. This equipment
produces X-rays when Energized.” Posted
near “ON” switch.
27. MDPH registration is posted and
current.
28. “Caution- High intensity X-ray beam”
affixed to source housing.
29. Fail safe warning light(s) indicate when
the X-ray tube is energized present &
functioning.
30. MRCP Form 120.750-1 “Notice to
Employees” posted.
POSTINGS, SIGNS, LABELS & WARNINGS
36. Emergency contact flip chart posted.
37. Copy of BU X-ray Permit available.
38. Shutter “OPEN / CLOSED” status
indicator near each X-ray port.
40. All areas used for X-ray equipment are
clearly marked.
Comments
APPENDIX F
Boston University/
Boston Medical Center
XR-5
X-ray Equipment Inventory Form
XR-5
Boston University/Boston Medical Center
Division of Medical Physics and Radiation Safety
X-RAY EQUIPMENT INVENTORY
Last Update:
X-ray Permit Holder:
Office Phone:
Department:
Lab Phone:
Home Phone:
Alternate Contact:
Office Phone:
X-RAY
MANUFACTURER
X-RAY MODEL
Bldg. Address:
Email:
Email:
Lab Phone:
SERIAL NUMBER
EHS REF
NUMBER
Room #s:
Home Phone:
BU PROPERTY ID
X-RAY TYPE
(diffraction, spectrographic,
mammography)
POWER / ENERGY
OUTPUT
APPLICATION
INSTALLATION
DATE
AGE OF SYSTEM
OWNERSHIP
(BU, other)
STATUS
(Active / Inactive)
XR-5
Boston University/Boston Medical Center
Division of Medical Physics and Radiation Safety
X-RAY EQUIPMENT INVENTORY
Page 2
X-RAY
MANUFACTURER
X-RAY MODEL
SERIAL NUMBER
EHS REF NUMBER
BU PROPERTY ID
X-RAY TYPE
(diffraction, spectrographic,
mammography)
POWER / ENERGY
OUTPUT
APPLICATION
INSTALLATION
DATE
AGE OF SYSTEM
OWNERSHIP
(BU, other)
STATUS
(Active / Inactive)