Current through all regulations passed and filed through March 18, 2024
As used in this rule, "therapy equipment" means photon therapy
systems and electron therapy systems operating at or above one megavolt (MV).
In addition to the rules in Chapters 3701:1-38 and 3701:1-67 of the
Administrative Code, handlers of therapy equipment shall comply with the
following:
(A) Upon installation of
therapy equipment, acceptance testing shall be performed to verify that the
equipment complies with all manufacturer specifications. In the event that
manufacturer specifications are unavailable for reference, all therapy
equipment shall be tested to ensure compliance with the standards of this rule.
Any modification of equipment that occurs pursuant to initial acceptance
testing shall entail appropriate retesting in order to re-determine compliance
with applicable manufacturer standards or standards of this rule.
(B) Leakage radiation outside the maximum
useful beam in photon and electron modes shall not exceed the manufacturer
specifications, or in the absence of the manufacturer specifications:
(1) The absorbed dose due to leakage
radiation, excluding neutrons, at any point outside the maximum sized useful
beam, but within a circular plane of radius two meters which is perpendicular
to and centered on the central axis of the useful beam at the nominal treatment
distance, such as patient plane, shall not exceed a maximum of 0.2 per cent and
an average of 0.1 per cent of the absorbed dose on the central axis of the beam
at the nominal treatment distance. Measurements shall be averaged over an area
not exceeding one hundred square centimeters at a minimum of sixteen points
uniformly distributed in the plane;
(2) Except for the area defined in paragraph
(B)(1) of this rule, the absorbed dose due to leakage radiation, excluding
neutrons, at one meter from the electron path between the electron source and
the target or electron window shall not exceed 0.5 per cent of the absorbed
dose on the central axis of the beam at the nominal treatment distance.
Measurements shall be averaged over an area not exceeding one hundred square
centimeters;
(3) For equipment
manufactured after
July 21, 2014, the neutron absorbed
dose outside the useful beam shall be in compliance with "International
Electrotechnical Commission Document 60601-2-1:2009/AMD1:2014 (IEC 60601-2-1:2009/AMD1:2014)," (IEC) documents which, may be
purchased from the "IEC National Committee of United States of America, ANSI,
25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212)
642-4900,
http://www.iec.ch/. Evidence
of a product conformity assessment (CA) showing the parameter referenced in
this rule is in compliance with IEC 60601-2-1:2009/AMD1:2014
shall be considered adequate to meet the requirements of this rule;
and
(4) For each piece of therapy
equipment, the handler shall determine, or obtain from the manufacturer, the
leakage radiation existing at the positions specified in paragraphs (B)(1) and
(B)(2) of this rule for the specified operating conditions. Records on leakage
radiation measurements shall be maintained at the installation for inspection
by the department.
(C)
Leakage radiation through beam limiting devices shall not exceed the
manufacturer specifications, or in the absence of the manufacturer
specifications, shall meet the following:
(1)
Using photon radiation, all adjustable or interchangeable beam limiting devices
shall attenuate the useful beam such that at the nominal treatment distance,
the maximum absorbed dose anywhere in the area shielded by the beam limiting
device(s) shall not exceed two per cent of the maximum absorbed dose on the
central axis of the useful beam measured in a one hundred square centimeter
radiation field, or maximum available field size if less than one hundred
square centimeters;
(2) Using
electron radiation, all adjustable or interchangeable electron applicators
shall attenuate the radiation, including but not limited to photon radiation
generated by electrons incident on the beam limiting device and electron
applicator and other parts of the radiation head, such that the absorbed dose
in a plane perpendicular to the central axis of the useful beam at the nominal
treatment distance shall not exceed:
(a) A
maximum of two per cent and average of 0.5 per cent of the absorbed dose on the
central axis of the useful beam at the nominal treatment distance. This limit
shall apply beyond a line seven centimeters outside the periphery of the useful
beam; and
(b) A maximum of ten per
cent of the absorbed dose on the central axis of the useful beam at the nominal
treatment distance. This limit shall apply beyond a line two centimeters
outside the periphery of the useful beam; and
(3) Measurements of leakage radiation for:
(a) Photon radiation shall have measurements
through the beam limiting devices made with the beam limiting devices closed
and any residual aperture blocked by at least two tenth value layers of
suitable absorbing material. In the case of overlapping beam limiting devices,
the leakage radiation through each set shall be measured independently at the
depth of maximum dose. Measurements shall be made using a radiation detector of
area not exceeding ten square centimeters; and
(b) Electron radiation shall have
measurements through the electron applicators made with the electron beam
directed into the air and using a radiation detector of area up to but not
exceeding one square centimeter suitably protected against radiation which has
been scattered from material beyond the radiation detector. Measurements shall
be made using one centimeter of water equivalent build up material.
(D) Filters and wedges
shall comply with the following:
(1) Each
wedge that is removable from the system shall be clearly marked with an
identification number. For removable wedges, the nominal wedge angle shall
appear on the wedge or wedge tray, if it is permanently mounted to the tray. If
the wedge or wedge tray is significantly damaged, the wedge transmission factor
shall be redetermined;
(2) If the
absorbed dose rate information required by paragraph (I) of this rule relates
exclusively to operation with a field flattening filter or beam scattering foil
in place, such foil or filter shall be removable only by authorized service
personnel; and
(3) For equipment
manufactured after
June 01, 2013, which utilizes
wedges, interchangeable field flattening filters, or interchangeable beam
scattering foils:
(a) Irradiation shall not be
possible until a selection of a wedge or a positive selection to use "no wedge"
has been made via the treatment control system, either manually or
automatically;
(b) An interlock
system shall be provided to prevent irradiation if the filter selected is not
in the correct position;
(c) A
display shall be provided by the treatment control system showing the wedges,
interchangeable field flattening filter(s), or interchangeable beam scattering
foil(s) in use; and
(d) An
interlock shall be provided to prevent irradiation if any filter or beam
scattering foil selection operation carried out in the treatment room does not
agree with the filter or beam scattering foil selection operation carried out
via the treatment control system.
(E) For equipment manufactured after
July 21, 2014, x-ray stray radiation in the
useful electron beam, absorbed dose at the surface during x-ray irradiation and
stray neutron radiation in the useful x-ray beam shall be in compliance with
"International Electrotechnical Commission (IEC) Document 60601-2-1:2009/AMD1:2014," (IEC) documents which, may be
purchased from the "IEC National Committee of United States of America, ANSI,
25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212)
642-4900, http://www.iec.ch/. Evidence
of a product CA showing the parameters referenced in this rule are in
compliance with IEC 60601-2-1:2009/AMD1:2014 shall be
considered adequate to meet the requirements of this rule.
(F) All therapy equipment subject to the
requirements of this rule shall be provided with redundant beam monitoring
systems. The
detectors for these systems shall be fixed in the
useful beam during treatment to indicate the dose rate.
(1)
Each redundant beam monitoring
system shall be provided with
an independently powered integrating
dose
meter. Alternatively, dose meters with shared
components may be used if the production of radiation is terminated upon
failure of any common components.
(2) The detector and the system into which
that detector is incorporated shall meet the following requirements:
(a) Each detector shall form part of a beam
monitoring system from whose readings the absorbed dose at a reference point
can be calculated;
(b) Each beam
monitoring system shall be capable of independently monitoring, interrupting,
and terminating irradiation;
(c)
For equipment manufactured after
June 01, 2013, the design
of the beam monitoring systems shall ensure that the:
(i) Malfunctioning of one system shall not
affect the correct functioning of the other system(s); and
(ii) Failure of either system shall terminate
irradiation or prevent the initiation of radiation; and
(d) Each beam monitoring system shall have a
legible treatment control system display. For therapy equipment manufactured
after February 15, 2001, each display shall:
(i) Maintain a reading until intentionally
reset;
(ii) Have only one scale and
no electrical or mechanical scale multiplying factors;
(iii) Utilize a design such that increasing
dose is displayed by increasing numbers; and
(iv) In the event of power failure, the beam
monitoring information required in paragraph (F)(2)(d)(iii) of this rule,
displayed by the control system at the time of failure shall be retrievable in
at least one system for a twenty minute period of time.
(G) The following
requirements shall be met for beam symmetry:
(1) A bent-beam linear accelerator with beam
flattening filter(s) subject to the requirements of this rule shall be provided
with auxiliary device(s) to monitor beam symmetry;
(2) The device(s) referenced in paragraph
(G)(1) of this rule, shall be able to detect field asymmetry greater than ten
per cent; and
(3) The device(s)
referenced in paragraph (G)(1) of this rule, shall be configured to terminate
irradiation if the specifications in paragraph (G)(2) of this rule,
cannot be maintained.
(H) The following requirements shall be met
for the selection and display of monitor units:
(1) Irradiation shall not be possible until a
new selection of a number of monitor units has been made via the treatment
control system;
(2) The
pre-selected number of monitor units shall be displayed by the treatment
control system until reset manually for the next irradiation;
(3) After termination of irradiation, it
shall be necessary to reset the dosimeter display before subsequent treatment
can be initiated; and
(4) For
therapy equipment manufactured after
June 01, 2013, it
shall be necessary for the operator to reset the pre-selected monitor units
after each termination of an irradiation and before a new irradiation can be
initiated.
(I) For
therapy equipment manufactured after
June 01, 2013, a
system shall be provided from whose readings the air kerma rate or absorbed
dose rate at a reference point can be calculated. The radiation detectors
specified in paragraph (F) of this rule may form part of this system. In
addition:
(1) The monitor unit rate shall be
displayed by the treatment control system;
(2) If the therapy equipment can deliver
under any conditions an air kerma rate or absorbed dose rate at the nominal
treatment distance more than twice the maximum value specified by the
manufacturer, a device shall be provided which terminates irradiation when the
air kerma rate or absorbed dose rate exceeds a value twice the specified
maximum. The dose rate at which the irradiation will be terminated shall be a
record maintained by the handler;
(3) If the therapy equipment can deliver
under any fault condition(s) an air kerma rate or absorbed dose rate at the
nominal treatment distance more than ten times the maximum value specified by
the manufacturer, a device shall be provided to prevent the air kerma rate or
absorbed dose rate anywhere in the radiation field from exceeding twice the
specified maximum value and to terminate irradiation if the excess absorbed
dose at the nominal treatment distance exceeds four gray (four hundred rad);
and
(4) For each piece of therapy
equipment, the handler shall determine, or obtain from the manufacturer, the
maximum value(s) specified in paragraphs (I)(2) and (I)(3) of this rule, for
the specified operating conditions. Records of these maximum value(s) shall be
maintained at the installation for inspection by the department.
(J)
During
stationary beam radiation therapy, termination of irradiation by the beam
monitoring systems
shall meet the following requirements:
(1)
The primary system shall terminate irradiation
when the pre-selected number of monitor units set via
the control system has been detected by the system;
(2)
The secondary system
shall be capable of terminating irradiation when not more than fifteen per cent
or forty monitor units above the pre-selected number of monitor units set via
the control system has been detected by the system; and
(3) For equipment manufactured after February
15, 2001, a treatment control system indicator shall show which monitoring
system has terminated irradiation.
(K) It shall be possible to terminate
irradiation and equipment movement or go from an interruption condition to
termination condition at any time from the operator's position at the treatment
control panel.
(L) If the therapy
equipment has an interrupt mode, it shall be possible to interrupt irradiation
and equipment movements at any time from the treatment control panel. Following
an interruption, it shall be possible to restart irradiation by operator action
without any reselection of operating conditions. If any change is made of a
pre-selected value during an interruption, irradiation and equipment movements
shall be automatically terminated.
(M) A suitable irradiation control system
shall be provided to terminate the irradiation after a pre-set time interval
and shall meet the following requirements:
(1)
A timer shall be provided which has a treatment control system display. The
timer shall have a pre-set time selector and an elapsed time
indicator;
(2) The timer shall be a
cumulative timer that activates with an indication of "BEAM-ON" and retains its
reading after irradiation is interrupted or terminated. After irradiation is
terminated and before irradiation can be reinitiated, it shall be necessary to
reset the elapsed time indicator; and
(3) The timer shall terminate irradiation
when a pre-selected time has elapsed, if the dose monitoring systems have not
previously terminated irradiation.
(N) Therapy equipment capable of both x-ray
therapy and electron therapy shall meet the following additional requirements:
(1) Irradiation shall not be possible until a
selection of radiation type (x-rays or electrons) has been made via the
treatment control system;
(2) The
radiation type selected shall be displayed by the treatment control system
before and during irradiation;
(3)
An interlock system shall be provided to ensure that the therapy equipment can
principally emit only the radiation type that has been selected;
(4) An interlock system shall be provided to
prevent irradiation with x-rays, except to obtain an image, when electron
applicators are fitted;
(5) An
interlock system shall be provided to prevent irradiation with electrons when
accessories specific for x-ray therapy are fitted; and
(6) An interlock system shall be provided to
prevent irradiation if any selected operations carried out in the treatment
room do not agree with the operations selected via the treatment control
system.
(O) Therapy
equipment capable of generating radiation beams of different energies shall
meet the following requirements:
(1)
Irradiation shall not be possible until a selection of energy has been made via
the treatment control system;
(2)
The nominal energy value selected shall be displayed by the treatment control
system until reset manually for the next irradiation. After termination of
irradiation, it shall be necessary to reset the nominal energy value selected
before subsequent treatment can be initiated; and
(3) Irradiation shall not be possible until
the appropriate flattening filter or scattering foil for the selected energy is
in its proper location.
(4) For
therapy equipment manufactured after
July 21, 2014, the
selection of energy shall be in compliance with "International Electrotechnical
Commission (IEC) Document 60601-2-1:2009/AMD1:2014," (IEC) document which, may be
purchased from the "IEC National Committee of United States of America, ANSI,
25 West 43rd Street, 4th Floor, New York, New York, 10036," telephone (212)
642-4900,
http://www.iec.ch/. Evidence
of a product CA showing the parameter referenced in this rule is in compliance
with IEC
60601-2-1:2009/AMD1:2014 shall be considered
adequate to meet the requirements of this rule.
(P) Therapy equipment capable of both
stationary beam radiation therapy and moving beam radiation therapy shall meet
the following requirements:
(1) Irradiation
shall not be possible until a selection of stationary beam radiation therapy or
moving beam radiation therapy has been made via the treatment control
system;
(2) The mode of operation
shall be displayed by the treatment control system;
(3) An interlock system shall be provided to
ensure that the therapy equipment can operate only in the mode that has been
selected;
(4) An interlock system
shall be provided to prevent irradiation if any selected parameter in the
treatment room does not agree with the parameter displayed by the treatment
control system;
(5) Moving beam
radiation therapy shall be controlled to obtain the selected relationships
between incremental monitor units and incremental movement. For therapy
equipment manufactured after
June 01, 2013:
(a) An interlock system shall be provided to
terminate irradiation if the number of monitor units delivered in any ten
degrees of rotation or one centimeter of linear motion differs by more than
twenty per cent from the selected value;
(b) Where angle terminates the irradiation in
moving beam radiation therapy, the monitor units delivered shall differ by less
than five per cent from the monitor unit value selected;
(c) An interlock shall be provided to prevent
motion of more than five degrees or one centimeter beyond the selected limits
during moving beam radiation therapy;
(d) An interlock shall be provided to require
that a selection of direction be made via the treatment control system in all
units which are capable of both clockwise and counter-clockwise moving beam
radiation therapy; and
(e) Moving
beam radiation therapy shall be controlled with both primary position sensors
and secondary position sensors to obtain the selected relationships between
incremental monitor units and incremental movement;
(6) Where the beam monitor system terminates
the irradiation in moving beam radiation therapy, the termination of
irradiation shall be as required by paragraph (J) of this rule; and
(7) For equipment manufactured after the
effective date of this rule, an interlock system shall be provided to terminate
irradiation if movement:
(a) Occurs during
stationary beam radiation therapy; or
(b) Does not start or stops during moving
beam radiation therapy unless such stoppage is a pre-planned
function.
(Q)
The control panel shall have a warning label which cautions individuals that
radiation is produced when the therapy equipment is energized.
Effective: 3/1/2016
Five Year Review
(FYR) Dates: 11/10/2015 and
11/15/2020
Promulgated
Under: 119.03
Statutory
Authority: 3748.04
Rule
Amplifies: 3748.01,
3748.02,
3748.04,
3748.05,
3748.06,
3748.07,
3748.12,
3748.121,
3748.13,
3748.14,
3748.15,
3748.17,
3748.18,
3748.19,
3748.20,
3748.22,
3748.99
Prior
Effective Dates: 2/15/2001, 9/1/05, 1/14/11,
6/1/13