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21 CFR Part 1030 — Performance Standards for Microwave and Radio Frequency Emitting Products

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united states, us regulation, us federal regulation, code of federal regulations, cfr, federal regulation, 21, 1030, part 1030, 21 cfr 1030, 21 cfr part 1030, food, and, drugs, food and drug administration, department of health and human services, radiological health

PART 1030—PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss, 371, 381. § 1030.10 Microwave ovens. (a) Applicability. (b) Definitions Microwave oven (2) Cavity (3) Door (4) Safety interlock (5) Service adjustments or service procedures (6) Stirrer (7) External surface (8) Equivalent plane-wave power density (c) Requirements Power density limit. (2) Safety interlocks. (ii) Failure of any single mechanical or electrical component of the microwave oven shall not cause all safety interlocks to be inoperative. (iii) Service adjustments or service procedures on the microwave oven shall not cause the safety interlocks to become inoperative or the microwave radiation emission to exceed the power density limits of this section as a result of such service adjustments or procedures. (iv) Microwave radiation emission in excess of the limits specified in paragraph (c)(1) of this section shall not be caused by insertion of an insulated wire through any opening in the external surfaces of a fully assembled oven into the cavity, waveguide, or other microwave-energy-containing spaces while the door is closed, provided the wire, when inserted, could consist of two straight segments forming an obtuse angle of not less than 170 degrees. (v) One (the primary) required safety interlock shall prevent microwave radiation emission in excess of the requirement of paragraph (c)(1) of this section; the other (secondary) required safety interlock shall prevent microwave radiation emission in excess of 5 milliwatts per square centimeter at any point 5 centimeters or more from the external surface of the oven. The two required safety interlocks shall be designated as primary or secondary in the service instructions for the oven. (vi) A means of monitoring one or both of the required safety interlocks shall be provided which shall cause the oven to become inoperable and remain so until repaired if the required safety interlock(s) should fail to perform required functions as specified in this section. Interlock failures shall not disrupt the monitoring function. (3) Measurement and test conditions. (ii) Microwave ovens shall be in compliance with the power density limits if the maximum reading obtained at the location of greatest microwave radiation emission, taking into account all measurement errors and uncertainties, does not exceed the limit specified in paragraph (c)(1) of this section, when the emission is measured through at least one stirrer cycle. As provided in § 1010.13 of this chapter, a manufacturer may request alternative test procedures if, as a result of the stirrer characteristics of a microwave oven, such oven is not susceptible to testing by the procedures described in this paragraph. (iii) Measurements shall be made with the microwave oven operating at its maximum output and containing a load of 275 ±15 milliliters of tap water initially at 20 ±5 °centigrade placed within the cavity at the center of the load-carrying surface provided by the manufacturer. The water container shall be a low form 600-milliliter beaker having an inside diameter of approximately 8.5 centimeters and made of an electrically nonconductive material such as glass or plastic. (iv) Measurements shall be made with the door fully closed as well as with the door fixed in any other position which allows the oven to operate. (4) User instructions. (i) Occupy a separate section and are an integral part of the regularly supplied users' manual and cookbook, if supplied separately, and are located so as to elicit the attention of the reader. (ii) Are as legible and durable as other instructions with the title emphasized to elicit the attention of the reader by such means as bold-faced type, contrasting color, a heavy-lined border, or by similar means. (iii) Contain the following wording: Precautions To Avoid Possible Exposure To Excessive Microwave Energy ( a ( b ( c 1 2 3 ( d (iv) Include additional radiation safety precautions or instructions which may be necessary for particular oven designs or models, as determined by the Director, Center for Devices and Radiological Health or the manufacturer. (5) Service instructions. (i) Occupy a separate section and are an integral part of the regularly supplied service manual and are located so as to elicit the attention of the reader. (ii) Are as legible and durable as other instructions with the title emphasized so as to elicit the attention of the reader by such means as bold-faced type, contrasting color, a heavy-lined border, or by similar means. (iii) Contain the following wording: Precautions To Be Observed Before And During Servicing To Avoid Possible Exposure To Excessive Microwave Energy ( a ( b 1 2 3 4 5 ( c ( d ( e (iv) Include additional radiation safety precautions or instructions which may be necessary for particular oven designs or models, as determined by the Director, Center for Devices and Radiological Health or the manufacturer. (6) Warning labels. (i) A label, permanently attached to or inscribed on the oven, which shall be legible and readily viewable during normal oven use, and which shall have the title emphasized and be so located as to elicit the attention of the user. The label shall bear the following warning statement: Precautions For Safe Use To Avoid Possible Exposure To Excessive Microwave Energy DO NOT Attempt to Operate This Oven With: ( a ( b ( c (ii) A label, permanently attached to or inscribed on the external surface of the oven, which shall be legible and readily viewable during servicing, and which shall have the word “CAUTION” emphasized and be so located as to elicit the attention of service personnel. The label shall bear the following warning statement: Caution: (iii) The labels provided in accordance with paragraphs (c)(6)(i) and (ii) of this section shall bear only the statements specified in that paragraph, except for additional radiation safety warnings or instructions which may be necessary for particular oven designs or models, as determined by the Director, Center for Devices and Radiological Health or the manufacturer. (iv) Upon application by a manufacturer, the Director, Center for Devices and radiological Health, Food and Drug Administration, may grant an exemption from one or more of the statements (radiation safety warnings) specified in paragraph (c)(6)(i) of this section. Such exemption shall be based upon a determination by the Director that the microwave oven model for which the exemption is sought should continue to comply with paragraphs (c)(1) through (3) of this section under the adverse condition of use addressed by such precautionary statement(s). An application shall be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Copies of the written portion of the application, including supporting data and information, and the Director's action on the application will be maintained by the Dockets Management Branch for public review. The application shall include: ( a ( b ( c ( d [38 FR 28640, Oct. 15, 1973, as amended at 40 FR 14752, Apr. 4, 1975; 40 FR 52007, Nov. 7, 1975; 46 FR 8461, Jan. 27, 1981; 48 FR 57482, Dec. 30, 1983; 50 FR 13566, Apr. 5, 1985; 53 FR 11254, Apr. 6, 1988; 59 FR 14365, Mar. 28, 1994; 88 FR 3654, Jan. 20, 202]

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