Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 120.000 - The Control of Radiation › GENERAL INFORMATION › Section 120.502 - Definitions

Current through Register 1525, July 5, 2024
As used in
				  105 CMR
				  120.500, the following definitions
				  apply:
Address of Use
means the building or
				  buildings that are identified on the license and where radioactive material may
				  be produced, prepared, received, used, or stored.
Area of Use
means a portion of a
				  physical structure that has been set aside for the purpose of producing,
				  preparing, receiving, using, or storing radioactive material.
Associate Radiation Safety Officer
means an individual who:
(1) Meets the requirements in
				  105 CMR
				  120.524 and
				  105 CMR
				  120.529; and
(2) Is currently identified as an Associate Radiation Safety
				  Officer for the types of use of byproduct material for which the individual has
				  been assigned duties and tasks by the Radiation Safety Officer on:
(a) A specific medical use license issued by the Agency,
				  Nuclear Regulatory Commission or an Agreement State; or
(b) A medical use permit issued by a Nuclear Regulatory
				  Commission master material licensee.
Authorized Medical Physicist
means
				  an individual who:
(1) Meets the requirements in
				  105 CMR
				  120.525(A)  and
				  120.529;
				  or
(2) Is identified as a medical physicist or teletherapy
				  physicist on:
(a) A specific medical use license or equivalent permit
				  issued by the Agency, Nuclear Regulatory Commission or Agreement State;
(b) A permit issued by the Agency, Nuclear Regulatory
				  Commission or Agreement State medical use license of broad scope that is
				  authorized to permit the use of radioactive material;
(c) A medical use permit issued by a NRC master material
				  licensee; or
(d) A permit issued by a NRC master material license broad
				  scope medical use permittee.
Authorized Nuclear Pharmacist
means
				  a pharmacist as defined in 105 CMR 120 005 who:
(1) Meets the requirements in
				  105 CMR
				  120.526(A)  and
				  120.529;
				  or
(2) Is identified as an authorized nuclear pharmacist
				  on:
(a) A specific license issued by NRC or Agreement State that
				  authorizes medical use or the practice of nuclear pharmacy;
(b) A permit issued by a NRC master material licensee that
				  authorizes medical use or the practice of nuclear pharmacy;
(c) A permit issued by a NRC or Agreement State broad scope
				  medical use licensee that authorizes medical use or the practice of nuclear
				  pharmacy; or
(d) A permit issued by a NRC master material license broad
				  scope medical use permittee that authorizes medical use or the practice of
				  nuclear pharmacy; or
(3) Is identified as an authorized nuclear pharmacist by a
				  commercial nuclear pharmacy that has been authorized to identify authorized
				  nuclear pharmacists; or
(4) Is designated as an authorized nuclear pharmacist in
				  accordance with
				  105
				  CMR 120.128(J)(2)(d).
Authorized User
means a physician,
				  dentist, or podiatrist who:
(1) Meets the requirements in
				  105 CMR
				  120.529 and
				  120.546(A),
				  120.551(A),
				  120.556(A),
				  120.557(A),
				  120.558(A),
				  120.566(A),
				  120.569(A),
				  or
				  120.587(A);
				  or
(2) Identified as an authorized user on:
(a) A NRC or Agreement State license that authorizes the
				  medical use of byproduct material;
(b) A permit issued by a NRC master material licensee that is
				  authorized to permit the medical use of byproduct material;
(c) A permit issued by a NRC or Agreement State specific
				  licensee of broad scope that is authorized to permit the medical use of
				  byproduct material; or
(d) A permit issued by a NRC master material license broad
				  scope permittee that is authorized to permit the medical use of byproduct
				  material.
Brachytherapy
means a method of
				  radiation therapy in which sources are utilized to deliver a radiation dose at
				  a distance of up to a few centimeters, by surface, intracavitary, intraluminal
				  or interstitial application.
Brachytherapy Source
means a
				  radioactive source or a manufacturer-assembled source train or a combination of
				  these sources that is designed to deliver a therapeutic dose within a distance
				  of a few centimeters.
Client's Address
means the address
				  of use or a temporary jobsite for the purpose of providing mobile medical
				  service in accordance with
				  105 CMR
				  120.541.
Dedicated Check Source
means a
				  radioactive source that is used to assure the constant operation of a radiation
				  detection or measurement device over several months or years. This source may
				  also be used for other purposes.
Dentist
means an individual licensed
				  by the Commonwealth to practice dentistry.
Diagnostic Clinical Procedures
				  Manual
means a collection of written procedures that describes
				  each method (and other instructions and precautions) by which the licensee
				  performs diagnostic clinical procedures; where each diagnostic clinical
				  procedure has been approved by the authorized user and includes the
				  radiopharmaceutical, dosage, and route of administration.
High Dose-rate Remote Afterloader
				  (HDR)
means a device that remotely delivers a dose rate in excess
				  of 12 gray (1200 rads) per hour at the treatment site.
Low Dose-rate Remote Afterloader
				  (LDR)
means a device that remotely delivers a dose rate of less
				  than or equal to two gray (200 rads) per hour at the treatment site.
Management
means the chief executive
				  officer or other individual having the authority to manage, direct, or
				  administer the licensee's activities, or those persons' delegate or
				  delegates.
Manual Brachytherapy
means a type of
				  therapy in which brachytherapy sources are manually applied or inserted.
Medical Institution
means an
				  organization in which several medical disciplines are practiced.
Medical Use
means the intentional
				  internal or external administration of radioactive material, or the radiation
				  from radioactive material to patients or human research subjects under the
				  supervision of an authorized user.
Medium Dose-rate Remote Afterloader
				  (MDR)
means a device that remotely delivers a dose rate of greater
				  than two gray (200 rads), but less than, or equal to, 12 gray (1200 rads) per
				  hour at the treatment site.
Mobile Medical Service
means the
				  transportation of radioactive material and its medical use at the client's
				  address.
Ophthalmic Physicist
means an
				  individual who:
(1) Meets the requirements in 105 CMR 120.564A(A)(2) and
				  105 CMR
				  120.529; and
(2) Is identified as an ophthalmic physicist on a:
(a) Specific medical use license issued by the Agency,
				  Nuclear Regulatory Commission or an Agreement State;
(b) Permit issued by the Agency, Nuclear Regulatory
				  Commission or Agreement State broad scope medical use licensee;
(c) Medical use permit issued by a Nuclear Regulatory
				  Commission master material licensee; or
(d) Permit issued by a Nuclear Regulatory Commission master
				  material licensee broad scope medical use permittee.
Output
means the
Exposure
rate, dose rate, or a quantity related in a
				  known manner to these rates from a brachytherapy source or a teletherapy,
				  remote afterloader, or gamma stereotactic radiosurgery unit for a specified set
				  of exposure conditions.
Patient Intervention
means actions
				  by the patient or human research subject, whether intentional or unintentional,
				  such as dislodging or removing treatment devices or prematurely terminating the
				  administration.
Preceptor
means an individual who
				  provides, directs, or verifies the training and experience required for an
				  individual to become an authorized user, an authorized medical physicist, an
				  authorized nuclear pharmacist, a Radiation Safety Officer, or an Associate
				  Radiation Safety Officer.
Prescribed Dosage
means the quantity
				  of a radiopharmaceutical activity as documented:
(1) In a written directive as specified in
				  105 CMR
				  120.521; or
(2) In accordance with the directions of the authorized user
				  for procedures performed pursuant to
				  105
				  CMR 120.544,
				  120.547
				  and
				  120.552.
Prescribed Dose
means:
(1) For gamma stereotactic radiosurgery, the total dose as
				  documented in the written directive; or
(2) For teletherapy, the total dose and dose per fraction as
				  documented in the written directive; or
(3) For manual brachytherapy, either the total source
				  strength and exposure time, or the total dose, as documented in the written
				  directive; or
(4) For remote brachytherapy afterloaders, the total dose and
				  dose per fraction as documented in the written directive.
Pulsed Dose-rate Remote Afterloader
				  (PDR)
means a special type of remote afterloading device that uses
				  a single source capable of delivering dose rates in the "high dose-rate" range,
				  but:
(1) Is approximately one-tenth of the activity of typical
				  high dose-rate remote afterloader sources; and
(2) Is used to simulate the radiobiology of a low dose rate
				  treatment by inserting the source for a given fraction of each hour.
Radiation Safety Officer
means an
				  individual who:
(1) Meets the requirements in
				  105 CMR
				  120.524(A) or (C)(1)  and
				  120.529;
				  or
(2) Is identified as a Radiation Safety Officer on:
(a) A specific medical use license issued by NRC or Agreement
				  State; or
(b) A medical use permit issued by NRC master material
				  license.
Sealed Source
means any radioactive
				  material that is encased in a capsule designed to prevent leakage or escape of
				  the radioactive material.
Sealed Source and Device Registry
means the national registry that contains all the registration certificates,
				  generated by both Nuclear Regulatory Commission and the Agreement States, that
				  summarize the radiation safety information for the sealed sources and devices
				  and describe the licensing and use conditions approved for the product.
Stereotactic Radiosurgery
means the
				  use of external radiation in conjunction with a stereotactic guidance device to
				  precisely deliver a dose to a tissue volume.
Structured Educational Program
means
				  an educational program designed to impart particular knowledge and practical
				  education through interrelated studies and supervised training.
Teletherapy
as used in
				  105 CMR
				  120.500, means a method of radiation therapy
				  in which collimated gamma rays are delivered at a distance from the patient or
				  human research subject.
Temporary Jobsite
means a location
				  where mobile medical services are conducted other than those location(s) of use
				  authorized on the license.
Therapeutic Dosage
means a dosage of
				  unsealed radioactive material that is intended to deliver a radiation dose to a
				  patient or human research subject for palliative or curative treatment.
Therapeutic Dose
means a radiation
				  dose delivered from a sealed source containing radioactive material to a
				  patient or human research subject for palliative or curative treatment.
Treatment Site
means the anatomical
				  description of the tissue intended to receive a radiation dose, as described in
				  a written directive.
Type of Use
means use of radioactive
				  material as specified under
				  105
				  CMR 120.544,
				  120.547,
				  120.552,
				  120.559,
				  120.569,
				  120.570
				  or
				  120.589.
Unit Dosage
means a dosage
				  that:
(1) Is obtained or prepared in accordance with
				  105
				  CMR 120.544,
				  120.547,
				  120.552;
				  and
(2) Is to be administered as a single dosage to a patient or
				  human research subject without any further manipulation of the dosage after it
				  is initially prepared.
Visiting Authorized User
means an
				  authorized user who is not identified on the license of the licensee being
				  visited.
Written Directive
means an
				  authorized user's written order for the administration of radioactive material
				  or radiation from radioactive material to a specific patient or human research
				  subject, as specified in
				  105 CMR
				  120.521.