D.C. Mun. Regs. tit. 22, r. 22-B10808

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10808 - PRODUCT REPORTS

10808.1

Every manufacturer of a product or component requiring a product report as set forth in Table 1 of § 10804 shall submit a product report to the Department, prior to the introduction of such product into commerce. The report shall be distinctly marked "Radiation Safety Product Report of (name of manufacturer)" and shall:

(a) Identify which listed product is being reported;

(b) Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling to enable the Director to determine the place of manufacture;

(c) Include information on all components and accessories provided in, on, or with the listed product that may affect the quantity, quality, or direction of the radiation emissions;

(d) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product;

(e) State the standard or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a District standard, if applicable;

(f) For each model, describe the physical or electrical characteristics, such as shielding or electronic circuitry, incorporated into the product in order to meet the standards or specifications reported pursuant to Paragraph (e);

(g) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures;

(h) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing of each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary;

(i) Provide sufficient results of the testing, measuring, and quality control procedures described in accordance with Paragraphs (g) and (h) to enable the Department to determine the effectiveness of those test methods and procedures;

(j) Report for each model all warning signs, labels, and instructions for installation, operation, and use that relate to electronic product radiation safety; and

(k) Provide, upon request, such other information as the Department may reasonably require to enable it to determine whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Department to carry out the purposes of the Act.

D.C. Mun. Regs. tit. 22, r. 22-B10808

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.