Section 22-B10816. RECORDS TO BE MAINTAINED BY MANUFACTURERS

 

10816.1Manufacturers of products listed under Table 1 of § 10804 shall establish and maintain the following records with respect to such products:

 

(a) Description of the quality control procedures with respect to electronic product radiation safety;

 

(b) Records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures;

 

(c)For those products displaying aging effects which may increase electronic product radiation emission, records of the results of tests for durability and stability of the product, and the basis for selecting these tests;

 

(d) Copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product; and

 

(e)Data on production and sales volume levels if available.

 

10816.2In addition to the records required by § 10816.1, manufacturers of products listed in § 10816.3 shall establish and maintain the following records with respect to such products:

 

(a) A record of the manufacturer's distribution of products in a form which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers; and

 

(b)Records received from dealers or distributors pursuant to § 10813.

 

10816.3Manufacturers shall maintain reports for the following radiation-emitting products:

(a)Ultrasonic products;

 

(b)Microwave heating equipment;

 

(c)High voltage vacuum switches;

 

(d)Rectifier tubes;

 

(e)Shunt regulator tubes;

 

(f)Cathode ray tubes intended to be operated at voltages greater than five thousand volts (5000 V) but less than fifteen thousand volts (15,000 V);

 

(g)Ultraviolet lamps and products containing such lamps intended for irradiation of any part of the human body by light of wavelength in air less than three hundred twenty nanometers (320 nm) to perform a diagnostic or therapeutic function;

 

(h)Television receivers that meet the District standard, provided the voltage of the cathode ray tube cannot exceed fifteen thousand volts (15,000 V);

 

(i)High voltage vacuum switches, rectifier tubes, shunt regulator tubes, and cathode ray tubes intended to be operated at voltages of fifteen thousand (15,000) or greater;

 

(j)Products in addition to television receivers that are subject to radiation standards; and

 

(k)Diagnostic x-ray, cabinet x-ray, microwave ovens, laser products, and sunlamp.

 

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.

source

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