Citations within the context of their regulations
Review the enforcement history for every citation given out with the Radiation Emitting Devices sector.
21 CFR 1040.10(i) - (i) Modification of a certified product. The modification of a laser product, previously certifi...
21 CFR 1040.10(e)(1) - (1) Tests for certification. Tests on which certification under § 1010.2 is based shall account ...
21 CFR 1040.10(e)(2) - (2) Test conditions. Except as provided in § 1010.13, tests for compliance with each of the appl...
21 CFR 1040.10(h)(1)(i) - (i) Adequate instructions for assembly, operation, and maintenance, including clear warnings conc...
21 CFR 1040.10(h)(1)(ii) - (ii) A statement of the magnitude, in appropriate units, of the pulse durations(s), maximum radia...
21 CFR 1040.10(h)(1)(iii) - (iii) Legible reproductions (color optional) of all labels and hazard warnings required by paragr...
21 CFR 1040.10(h)(1)(iv) - (iv) A listing of all controls, adjustments, and procedures for operation and maintenance, includ...
21 CFR 1040.10(h)(1)(vi) - (vi) In the case of laser products classified with a 7 millimeter diameter aperture stop as provi...
21 CFR 1040.10(h)(2)(i) - (i) In all catalogs, specification sheets, and descriptive brochures pertaining to each laser pro...
21 CFR 1040.10(h)(2)(ii) - (ii) To servicing dealers and distributors and to others upon request at a cost not to exceed the...
21 CFR 1040.10(f)(1) - (1) Protective housing. Each laser product shall have a protective housing that prevents human a...
21 CFR 1040.10(f)(3) - (3) Remote interlock connector. Each laser system classified as a Class IIIb or IV laser product...
21 CFR 1040.10(f)(4) - (4) Key control. Each laser system classified as a Class IIIb or IV laser product shall incorpor...
21 CFR 1040.10(f)(2)(i) - (i) Each laser product, regardless of its class, shall be provided with at least one safety inter...
21 CFR 1040.10(f)(2)(iii)(a) - (a) Human access to a level of laser radiation in excess of the accessible emission limits of Cla...
21 CFR 1040.10(f)(2)(iii)(b) - (b) Laser radiation in excess of the accessible emission limits of Class II to be emitted directl...
21 CFR 1040.10(f)(5)(i) - (i) Each laser system classified as a Class II or IIIa laser product shall incorporate an emissio...
21 CFR 1040.10(f)(5)(ii) - (ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emissi...
21 CFR 1040.10(f)(5)(iii) - (iii) For laser systems manufactured on or before August 20, 1986, if the laser and laser energy ...
21 CFR 1040.10(f)(6)(i) - (i) Each laser system classified as a Class II, III, or IV laser product shall be provided with o...
21 CFR 1040.10(g)(10) - (10) Label specifications. Labels required by this section and § 1040.11 shall be permanently af...
21 CFR 1040.10(g)(3) - (3) Class IV designation and warning. Each Class IV laser product shall have affixed a label bea...
21 CFR 1040.10(g)(4) - (4) Radiation output information on warning logotype. Each Class II, III, and IV laser product s...
21 CFR 1040.10(g)(9) - (9) Positioning of labels. All labels affixed to a laser product shall be positioned so as to ma...
21 CFR 1040.10(g)(1)(ii) - (ii) Each Class II laser product shall have affixed a label bearing the warning logotype A (figur...
21 CFR 1040.10(g)(2)(i) - (i) Each Class IIIa laser product with an irradiance less than or equal to 2.5 × 10−3 W cm2− shal...
21 CFR 1040.10(g)(2)(iii) - (iii) Each Class IIIb laser product shall have affixed a label bearing the warning logotype B (fi...
21 CFR 1040.10(g)(5)(i) - (i) “AVOID EXPOSURE—Laser radiation is emitted from this aperture,” if the radiation emitted thro...
21 CFR 1040.10(g)(5)(ii) - (ii) “AVOID EXPOSURE—Hazardous electromagnetic radiation is emitted from this aperture,” if the r...
21 CFR 1040.10(g)(6)(iv) - (iv) “DANGER—Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM.” for Class IIIb accessible...
21 CFR 1040.10(g)(6)(v) - (v) “DANGER—Laser radiation when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATIO...
21 CFR 1040.10(g)(7)(i) - (i) “CAUTION—Laser radiation when open and interlock defeated. DO NOT STARE INTO BEAM.” for Class...
21 CFR 1040.10(g)(7)(v) - (v) “DANGER—Laser radiation when open and interlock defeated. AVOID EYE OR SKIN EXPOSURE TO DIREC...
21 CFR 1040.20(f) - (f) Test for determination of compliance. Tests on which certification pursuant to § 1010.2 is b...
21 CFR 1040.20(e)(1)(i) - (i) A reproduction of the label(s) required in paragraph (d)(1) of this section prominently displ...
21 CFR 1040.20(e)(1)(v) - (v) Instructions for obtaining repairs and recommended replacement components and accessories whi...
21 CFR 1040.20(d)(1)(i) - (i) A warning statement with the words “DANGER—Ultraviolet radiation. Follow instructions. Avoid ...
21 CFR 1040.20(d)(2)(iii) - (iii) The words “Use ONLY in fixture equipped with a timer.”
21 CFR 1040.20(d)(3)(v) - (v) A label may contain statements or illustrations in addition to those required by this paragra...
21 CFR 1040.20(c)(2)(iii) - (iii) No timer interval may have an error greater than 10 percent of the maximum timer interval o...
21 CFR 1040.20(c)(2)(iv) - (iv) The timer may not automatically reset and cause radiation emission to resume for a period gr...
21 CFR 1040.11(c) - (c) Demonstration laser products. Each demonstration laser product shall comply with all of the ...
21 CFR 1040.11(b) - (b) Surveying, leveling, and alignment laser products. Each surveying, leveling. or alignment la...
21 CFR 1040.11(a)(1) - (1) Incorporate in each Class III or IV medical laser product a means for the measurement of the ...
21 CFR 1040.11(a)(2) - (2) Supply with each Class III or IV medical laser product instructions specifying a procedure an...
21 CFR 1040.11(a)(3) - (3) Affix to each medical laser product, in close proximity to each aperture through which is emi...
21 CFR 1002.10(a) - (a) Identify which listed product is being reported.
21 CFR 1002.10(j) - (j) Report for each model all warning signs, labels, and instructions for installation, operation...
21 CFR 1002.10(d) - (d) Describe the function, operational characteristics affecting radiation emissions, and intende...
21 CFR 1002.10 - Product reports.
21 CFR 1002.13 - Annual reports.
21 CFR 1002.12 - Abbreviated reports.
21 CFR 1002.11 - Supplemental reports.
21 CFR 1002.20(a) - (a) Manufacturers of electronic products shall, where reasonable grounds for suspecting that such...
21 CFR 1002.31(a) - (a) Every manufacturer required to maintain records pursuant to this part, including records rece...
21 CFR 1002.30(b)(2) - (2) Records received from dealers or distributors pursuant to § 1002.41.
21 CFR 1002.30(a)(1) - (1) Description of the quality control procedures with respect to electronic product radiation sa...
21 CFR 1002.30(a)(2) - (2) Records of the results of tests for electronic product radiation safety, including the contro...
21 CFR 1002.30(a)(4) - (4) Copies of all written communications between the manufacturer and dealers, distributors, and ...
21 CFR 1002.41(a)(1) - (1) The dealer or distributor elects to hold and preserve such information and to immediately fur...
21 CFR 1002.40(a) - (a) Dealers and distributors of electronic products for which there are performance standards and...
21 CFR 1003.10(b) - (b) Except as authorized by § 1003.30, furnish notification with reasonable promptness to the fol...
21 CFR 1003.10(a) - (a) Immediately notify the Secretary in accordance with § 1003.20, and
21 CFR 1003.20 - Notification by the manufacturer to the Secretary.
21 CFR 1003.21(a) - (a) The notification to the persons specified in § 1003.10(b) shall be in writing and, in additio...
21 CFR 1004.1 - Manufacturer's obligation to repair, replace, or refund cost of electronic products.
21 CFR 1005.3 - Importation of noncomplying goods prohibited.
21 CFR 1005.25(a) - (a) Every manufacturer of electronic products, prior to offering such product for importation int...
21 CFR 1010.3(a) - (a) Every manufacturer of an electronic product to which a standard under this subchapter is appl...
21 CFR 1010.3(a)(1) - (1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “I...
21 CFR 1010.3(a)(2) - (2) The place and month and year of manufacture:
21 CFR 1010.3(a)(2)(ii) - (ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviatio...
21 CFR 1010.4(d) - (d) Certification of equipment covered by variance. The manufacturer of any product for which a ...
21 CFR 1010.2(b) - (b) The certification shall be in the form of a label or tag permanently affixed to or inscribed ...
21 CFR 1010.2(c) - (c) Such certification shall be based upon a test, in accordance with the standard, of the indivi...
21 CFR 1010.2(a) - (a) Every manufacturer of an electronic product for which an applicable standard is in effect und...
21 CFR 1020.30(g) - (g) Information to be provided to assemblers. Manufacturers of components listed in paragraph (a...
21 CFR 1020.30(c) - (c) Manufacturers' responsibility. Manufacturers of products subject to §§ 1020.30 through 1020....
21 CFR 1020.30(j) - (j) Warning label. The control panel containing the main power switch shall bear the warning sta...
21 CFR 1020.30(k) - (k) Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagno...
21 CFR 1020.30(n) - (n) Aluminum equivalent of material between patient and image receptor. Except when used in a CT...
21 CFR 1020.30(e) - (e) Identification of x-ray components. In addition to the identification requirements specified...
21 CFR 1020.30(d) - (d) Assemblers' responsibility
21 CFR 1020.30(d)(1) - (1) Reports of assembly. All assemblers who install certified components shall file a report of ...
21 CFR 1020.30(h)(1)(ii) - (ii) A schedule of the maintenance necessary to keep the equipment in compliance with this sectio...
21 CFR 1020.30(h)(2)(i) - (i) Statements of the leakage technique factors for all combinations of tube housing assemblies a...
21 CFR 1020.30(h)(2)(ii) - (ii) Cooling curves for the anode and tube housing; and
21 CFR 1020.30(h)(3)(i) - (i) A statement of the rated line voltage and the range of line-voltage regulation for operation ...
21 CFR 1020.30(h)(3)(ii) - (ii) A statement of the maximum line current of the x-ray system based on the maximum input volta...
21 CFR 1020.30(h)(3)(v) - (v) Generator rating and duty cycle;
21 CFR 1020.30(h)(3)(vi) - (vi) A statement of the maximum deviation from the preindication given by labeled technique facto...
21 CFR 1020.30(h)(3)(viii) - (viii) A statement describing the measurement criteria for all technique factors used in paragrap...
21 CFR 1020.30(h)(4)(i) - (i) Leakage technique factors for all combinations of tube housing assemblies and beam-limiting d...
21 CFR 1020.30(m)(1) - (1) Half-value layer (HVL). The HVL of the useful beam for a given x-ray tube potential shall no...
21 CFR 1020.31(c)(1) - (1) Equipment having independent selection of x-ray tube current (mA). The average ratios of air...
21 CFR 1020.33(f)(1) - (1) Visual indication. The CT conditions of operation to be used during a scan or a scan sequenc...
21 CFR 1020.33(c)(3) - (3) Imaging performance information. The following performance data shall be provided for the CT...
21 CFR 1020.33(c)(2)(ii) - (ii) The CTDI in the center location of the dosimetry phantom for each selectable CT condition of...
21 CFR 1020.33(c)(2)(i)(c) - (c) Along lines parallel to the axis of rotation and 1.0 centimeter interior to the surface of th...
21 CFR 1020.40(c)(5) - (5) Ground fault. A ground fault shall not result in the generation of x-rays.
21 CFR 1020.40(c)(4)(i) - (i) Each door of a cabinet x-ray system shall have a minimum of two safety interlocks. One, but n...
21 CFR 1020.40(c)(6)(iii) - (iii) Two independent means which indicate when and only when x-rays are being generated, unless ...
21 CFR 1030.10(c)(2)(i) - (i) Microwave ovens shall have a minimum of two operative safety interlocks. At least one operati...
21 CFR 1030.10(c)(2)(v) - (v) One (the primary) required safety interlock shall prevent microwave radiation emission in exc...
21 CFR 1030.10(c)(2)(vi) - (vi) A means of monitoring one or both of the required safety interlocks shall be provided which ...
21 CFR 1030.10(c)(3)(i) - (i) Compliance with the power density limit in paragraph (c)(1) of this section shall be determin...
21 CFR 1030.10(c)(3)(iii) - (iii) Measurements shall be made with the microwave oven operating at its maximum output and cont...
21 CFR 1030.10(c)(3)(iv) - (iv) Measurements shall be made with the door fully closed as well as with the door fixed in any ...