Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-67 - External Beam Radiation Therapy Equipment › Section 3701:1-67-06 - Standards for therapy equipment operating at or above one megavolt (MV)

Current through all regulations passed and filed through July 1, 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.