Performance Requirements for Industrial Radiography Equipment

(A) Conformance with ANSI Standards. Equipment used in industrial radiographic operations shall meet the following minimum criteria: (1) Each radiographic exposure device, source assembly, sealed source, and associated equipment shall meet the criteria set forth by ANSI N432-1980: Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography, (published as NBS Handbook 136, issued January 1981). This publication may be purchased from the American National Standards Institute, Inc., 25 West 43rd Street, New York, New York 10036; Telephone: (212) 642–4900. (2) Radiation machines manufactured after January 10, 1992 used in industrial radiographic operations shall be certified at the time of manufacture to meet the criteria set forth by ANSI N537- 1976, except accelerators used in industrial radiography. (3) All radiographic exposure devices and associated equipment in use after January 10, 1996, must comply with the requirements of 105 CMR 120.315. (4) In lieu of 105 CMR 120.315(A)(1), equipment used in industrial radiographic operations need not comply with § 8.9.2(c) of the Endurance Test in ANSI N432-1980, if the prototype equipment has been tested using a torque value representative of the torque that an individual using the radiography equipment can realistically exert on the lever or crankshaft of the drive mechanism. (5) Engineering analysis may be submitted by a licensee to demonstrate the applicability of previously performed testing on similar individual radiography equipment components. Upon review, the agency may find this an acceptable alternative to actual testing of the component in accordance with 105 CMR 120.315(A)(1). (6) In addition to the requirements specified in 105 CMR 120.315(A)(1), the following requirements apply to radiographic exposure devices, source changers, source assemblies, sealed sources and associated equipment. (a) The licensee shall ensure that each radiographic exposure device has attached to it a durable, legible, clearly visible label bearing the: 1. Chemical symbol and mass number of the radionuclide in the device; 2. Activity and the date on which this activity was last measured; 3. Model or product code and serial number of the sealed source; 4. Name of the manufacturer of the sealed source; and, 5. Licensee's name, address, and telephone number. (b) Radiographic exposure devices intended for use as Type B packages must meet the applicable transportation requirements of 10 CFR part 71. (c) Opening, repair or modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless approved by the Agency, the U.S. Nuclear Regulatory Commission (NRC) or Agreement State. (7) Modification of any exposure devices and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, controls or guide tubes would not compromise the design safety features of the system. (B) Labeling Storage, and Transportation (1) The licensee may not use a radiographic exposure device source changer or a container to store radioactive material unless the radiographic exposure device source changer or the storage container has securely attached to it a durable, legible, and clearly visible label bearing the standard trefoil radiation caution symbol conventional colors, i.e., magenta, purple or black on a yellow background, having a minimum diameter of 25 mm, and the wording: "CAUTION. RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)" or "DANGER. RADIOACTIVE MATERIAL. NOTIFY CIVIL AUTHORITIES (OR NAME OF COMPANY)." (2) The licensee may not transport radioactive material unless the material is packaged, and the package is labeled, marked, and accompanied with appropriate shipping papers in accordance with 105 CMR 120.770 (3) Radiographic exposure devices, source changers, storage containers, and radiation machines, must be physically secured to prevent tampering or removal by unauthorized personnel. The licensee shall store radioactive material in a manner that will minimize danger from explosion or fire. (4) The licensee shall lock and physically secure the transport package containing radioactive material in the transporting vehicle to prevent accidental loss, tampering, or unauthorized removal. (5) The licensee’s or registrant’s name and city or town where the main business office is located shall be prominently displayed with a durable, clearly visible label(s) on both sides of all vehicles used to transport radioactive material or radiation machines for temporary job site use. (C) Performance Requirements. In addition to the requirements specified in 105 CMR 120.315(A) and (B), the following requirements apply to radiographic exposure devices, source assemblies, and associated equipment that allow the source to be moved out of the device for routine operations or to source changers: (1) The coupling between the source assembly and the control cable must be designed in such a manner that the source assembly will not become disconnected if cranked outside the guide tube. The coupling must be such that it cannot be unintentionally disconnected under normal and reasonably foreseeable abnormal conditions. (2) The device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device. (3) The outlet fittings, lock box, and drive cable fittings on each radiographic exposure device must be equipped with safety plugs or covers which must be installed during storage and transportation to protect the source assembly from water, mud, sand or other foreign matter. (4) Each sealed source or source assembly must have attached to it or engraved on it, a durable, legible, visible label with the words: "DANGER -- RADIOACTIVE." The label must not interfere with the safe operation of the exposure device or associated equipment. (5) The guide tube must be able to withstand a crushing test that closely approximates the crushing forces that are likely to be encountered during use, and be able to withstand a kinking resistance test that closely approximates the kinking forces that are likely to be encountered during use. (6) Guide tubes must be used when moving the source out of the device. (7) An exposure head, endcap, or similar device designed to prevent the source assembly from passing out of the end of the guide tube shall be attached to the outermost end of the guide tube during radiographic operations. (8) The guide tube exposure head connection must be able to withstand the tensile test for control units specified in ANSI N432-1980. (9) Source changers must provide a system for ensuring that the source will not be accidentally withdrawn from the changer when connecting or disconnecting the drive cable to or from a source assembly. (D) Leak Testing and Replacement of Sealed Sources. (1) The replacement of any sealed source fastened to or contained in a radiographic exposure device and leak testing of any sealed source must be performed by persons authorized to do so by the Agency, the Nuclear Regulatory Commission, or another Agreement State. (2) The opening, repair, or modification of any sealed source must be performed by persons specifically authorized to do so by the Agency, the Nuclear Regulatory Commission, or another Agreement State. (3) Each licensee who uses a sealed source shall have the source tested for leakage at intervals not to exceed six months. The leak testing of the source must be performed using a method approved by the Agency, the Nuclear Regulatory Commission, or by another Agreement State. The wipe sample should be taken from the nearest accessible point to the sealed source where contamination might accumulate. The wipe sample must be analyzed for radioactive contamination. The analysis must be capable of detecting the presence of 185 becquerels (0.005 mCi) of radioactive material on the test sample and must be performed by a person specifically authorized by the Agency, the Nuclear Regulatory Commission, or another Agreement State to perform the analysis. The license shall maintain the records of the leak tests for inspection by the Agency for five years after it is made. (4) Unless a sealed source is accompanied by a certificate from the transferor that shows that it has been leak tested within six months before the transfer, it may not be used by the licensee until tested for leakage. Sealed sources that are in storage and not in use do not require leak testing, but must be tested before use or transfer to another person if the interval of storage exceeds six months. (5) Any test conducted pursuant to 105 CMR 120.315(D)(1) and (2) which reveals the presence of 185 Bq (0.005 microcuries) or more of removable radioactive material shall be considered evidence that the sealed source is leaking. The licensee shall immediately withdraw the equipment involved from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with regulations of the Agency. Within five days after obtaining results of the test, the licensee shall file a report with the Agency describing the equipment involved, the test results, and the corrective action taken. (6) Each exposure device using DU shielding and an "S" tube configuration shall be tested for DU contamination at intervals not to exceed 12 months. The analysis must be capable of detecting the presence of 185 Bq (0.005 microcuries) of radioactive material on the test sample and must be performed by a person specifically authorized by the Commission or an Agreement State to perform the analysis. Should such testing reveal the presence of DU contamination, the exposure device must be removed from use until an evaluation of the wear of the S-tube has been made. Should the evaluation reveal that the S-tube is worn through, the device may not be used again. DU shielded devices do not have to be tested for DU contamination while in storage and not in use. Before using or transferring such a device, however, the device must be tested for DU contamination, if the interval of storage exceeds 12 months. Each licensee shall maintain records of leak testing of sealed sources and devices containing DU. The licensee shall retain each record for agency inspection for five years from the date of the leak test. (7) An applicant or licensee who desires to conduct its own tests for leakage or contamination shall establish procedures to be followed when testing sealed sources for leakage or contamination and shall submit a description of such procedures to the Agency for approval. The description shall include the: (a) Instrumentation to be used; (b) Method of performing the tests; and (c) Pertinent experience of the individual(s) who will perform the test.