Current through 2024-52, December 25, 2024
Section 144-220-E-D-24 - Radiation safety requirements for the use of radiation machinesA. Locking of radiation machines. The control panel of each radiation machine shall be equipped with a locking device that will prevent the unauthorized use of an x-ray system or the accidental production of radiation. The radiation machine shall be kept locked and the key removed at all times except when under the direct visual surveillance of a radiographer.B. Permanent storage precautions for the use of radiation machines. Radiation machines shall be secured, while in storage to prevent tampering or removal by unauthorized individuals.C. Requirements for radiation machines used in industrial radiographic operations. (1) Equipment used in industrial radiographic operations involving radiation machines manufactured after October 1, 1987, shall be certified at the time of manufacture to meet the criteria set forth by ANSI N537-1976, except accelerators used in industrial radiography.(2) The registrant's name and city or town where the main business office is located shall be prominently displayed with a durable, legible, clearly visible label(s) on both sides of all vehicles used to transport radiation machines for temporary job site use.D. Operating and internal audit requirements for the use of radiation machines. (1) Each registrant shall conduct an internal audit program to ensure that the requirements of this Part, the conditions of the certificate of registration, and the registrant's operating and emergency procedures are followed by radiographic personnel.(2) Each radiographer's and radiographer assistant's performance during an actual radiographic operation shall be audited and documented at intervals not to exceed six months.(3) If a radiographer or a radiographer assistant has not participated in a radiographic operation during the six months since the last audit, the radiographer or the radiographer assistant shall demonstrate knowledge of the training requirements of this Part by an oral or written and practical examination administered by the registrant before the individual can next participate in a radiographic operation.(4) The Agency may consider alternatives in those situations where the individual serves as both radiographer and RSO.(5) In those operations where a single individual serves as both radiographer and RSO and performs all radiography operations, an audit program is not required.(6) No individual, other than a radiographer or a radiographer assistant, who is under the personal supervision of a radiographer, shall manipulate controls or operate radiation machines used in industrial radiographic operations. Only one radiographer is required to operate radiation machines during industrial radiography.(7) Radiographic operations shall not be conducted at storage sites unless specifically authorized by the certificate of registration.(8) Records of audits specified in this subsection shall be made and maintained in accordance with Subpart E.(9) Records of the annual refresher training required by E.16 shall be made and maintained in accordance with Subpart E.E. Radiation surveys for the use of radiation machines.(1) No industrial radiographic operation shall be conducted unless at least one calibrated and operable radiation survey instrument, as described in E.8, is used for each radiation machine energized.(2) A physical radiation survey shall be made after each radiographic exposure using radiation machines to determine that the machine is off.(3) All potential radiation areas where industrial radiographic operations are to be performed shall be posted in accordance with E.22, based on estimated dose rates, before industrial radiographic operations begin. An area survey shall be performed during the first radiographic exposure to confirm that E.22 requirements have been met and that unrestricted areas do not have radiation levels in excess of the limits specified in Part D.(4) Records of the surveys required by E.24 shall be made and maintained in accordance with Subpart E.F. Requirements for radiation machines in enclosed radiography. (1) Systems for enclosed radiography, including shielded-room radiography and cabinet x-ray systems not otherwise exempted, shall comply with all applicable requirements of this section.(2) Systems for enclosed radiography designed to allow admittance of individuals and systems not otherwise exempted shall be evaluated at intervals not to exceed one year to ensure compliance with the applicable requirements of this Part and Part H as applicable.(3) Certified and certifiable cabinet x-ray systems, including those designed to allow admittance of individuals, are exempt from the requirements of this section except that: (a) No registrant shall permit any individual to operate a cabinet x-ray system until the individual has received a copy of and instruction in the operating procedures for the unit.(b) Tests for proper operation of interlocks must be conducted and recorded at intervals not to exceed 12 months.(c) The registrant shall perform an evaluation to determine compliance with Parts E and H (as applicable) and 21 CFR 1020.40 at intervals not to exceed one year.(4) Certified cabinet x-ray systems shall be maintained in compliance with 21 CFR 1020.40 and no modification shall be made to the system unless prior Agency approval has been granted.(5) Records required by this subsection shall be made and maintained in accordance with Subpart E.G. Registration requirements for industrial radiographic operations.(1) Radiation machines used in industrial radiographic operations shall be registered in accordance with Parts F and/or H, as applicable.(2) In addition to the registration requirements in Parts F and/or H, an application for a certificate of registration shall include the following information: (a) A schedule or description of the program for training radiographic personnel that specifies: (ii) Annual refresher training;(iii) On-the-job training;(iv) Procedures for administering the oral and written examination to determine the knowledge, understanding, and ability of radiographic personnel to comply with the requirements of this Part, the conditions of the certificate of registration, and the registrant's operating and emergency procedures; and(v) Procedures for administering the practical examination to demonstrate competence in the use of sources of radiation, and radiation survey instruments that may be employed in industrial radiographic assignments.(b) Written operating and emergency procedures, including all items listed in E.17;(c) A description of the internal audit program to ensure that radiographic personnel follow the requirements of this Part, the conditions of the certificate of registration, and the registrant's operating and emergency procedures at intervals not to exceed six months;(d) A list of permanent radiographic installations, descriptions of permanent storage use sites, and the location(s) where all records required by this Part will be maintained. Radiographic equipment shall not be stored or used at a permanent site unless such site is specifically authorized by the certificate of registration. A storage site is permanent if radiation machines are stored at that location and if one or more of the following applies:(i) The registrant establishes telephone service that is used for contracting or providing industrial radiographic services for the registrant;(ii) Industrial radiographic services are advertised for or from the site;(iii) Radiation machines stored at that location are used for industrial radiographic operations conducted at other sites; or(iv) Any registrant conducting radiographic operations or storing radiation machines at any location not listed on the certificate of registration for a period in excess of 90 days in a calendar year shall notify the Agency prior to exceeding the 90 days.(v) A description of the organization of the industrial radiographic program, including delegations of authority and responsibility for operation of the radiation safety program; and(vi) Procedures for verifying and documenting the certification status of radiographers and for ensuring that the certification of individuals acting as radiographers remains valid.(3) A certificate of registration will be issued if the requirements of this subsection and all applicable sections of Parts F and/or H are met.10-144 C.M.R. ch. 220, § E-D-24