Reprinted from http://www.lessemf.com/mw-stnds.html#FDA
US Food and Drug Administration, HHS § 1030.10
PART 1030—PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO
FREQUENCY EMITTING PRODUCTS
AUTHORITY: Secs. 501, 502, 510, 515–520, 701, 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360,
360e–360j, 371, 381); secs. 354–360F of the Public
Health Service Act (42 U.S.C. 263b–263n).
§ 1030.10 Microwave ovens.
(a) Applicability. The provisions of this standard are applicable
to microwave ovens manufactured after October 6, 1971.
(b) Definitions
(1) Microwave oven means a device designed to heat, cook, or dry
food through the application of electromagnetic energy at frequencies
assigned by the Federal Communications Commission in the normal
ISM heating bands ranging from 890 megahertz to 6,000 megahertz.
As defined in this standard, ''microwave ovens'' are limited to
those manufactured for use in homes, restaurants, food vending,
or service establishments, on interstate carriers, and in similar
facilities.
(2) Cavity means that portion of the microwave oven in which food
may be heated, cooked, or dried.
(3) Door means the movable barrier which prevents access to the
cavity during operation and whose function is to prevent emission
of microwave energy from the passage or opening which provides
access to the cavity.
(4) Safety interlock means a device or system of devices which
is intended to prevent generation of microwave energy when access
to the cavity is possible.
(5) Service adjustments or service procedures means those servicing
methods prescribed by the manufacturer for a specific product
model. (6) Stirrer means that feature of a microwave oven which
is intended to provide uniform heating of the load by constantly
changing the standing wave pattern within the cavity or moving
the load.
(7) External surface means the outside surface of the cabinet
or enclosure provided by the manufacturer as part of the microwave
oven, including doors, door handles, latches, and control knobs.
(8) Equivalent plane-wave power density means the square of the
root-mean-square (rms) electric field strength divided by the
impedance of free space (377 ohms).
(c) Requirements—
(1) Power density limit. The equivalent plane-wave power
density existing in the proximity of the external oven surface
shall not exceed 1 milliwatt per square centimeter at any point
5 centimeters or more from the external surface of the oven, measured
prior to acquisition by a purchaser, and, thereafter, 5 milliwatts
per square centimeter at any such point.
(2) Safety interlocks.
(i) Microwave ovens shall have a minimum of two operative safety
interlocks. At least one operative safety interlock on a fully
assembled microwave oven shall not be operable by any part of
the human body, or any object with a straight insertable length
of 10 centimeters. Such interlock must also be concealed, unless
its actuation is prevented when access to the interlock is possible.
Any visible actuator or device to prevent actuation of this safety
interlock must not be removable without disassembly of the oven
or its door. A magnetically operated interlock is considered to
be concealed, or its actuation is considered to be prevented,
only if a test magnet held in place on the oven by gravity or
its own attraction cannot operate the safety interlock. The test
magnet shall be capable of lifting vertically at zero air gap
at least 4.5 kilograms, and at 1 centimeter air gap at least 450
grams when the face of the magnet, which is toward the interlock
when the magnet is in the test position, is pulling against one
of the large faces of a mild steel armature having dimensions
of 80 millimeters by 50 millimeters by 8 millimeters.
(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. (i) Compliance with the power
density limit in paragraph (c)(1) of this section shall be determined
by measurement of the equivalent plane-wave power density made
with an instrument which reaches 90 percent of its steady-state
reading within 3 seconds, when the system is subjected to a step-function
input signal. Tests for compliance shall account for all measurement
errors and uncertainties to ensure that the equivalent plane-wave
power density does not exceed the limit prescribed by paragraph
(c)(1) of this section.
(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. Manufacturers of microwave ovens to which
this section is applicable shall provide, or cause to be provided,
with each oven, radiation safety instructions which:
(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) Do not attempt to operate this oven with the door open since
open-door operation can result in harmful exposure to microwave
energy. It is important not to defeat or tamper with the safety
interlocks.
(b) Do not place any object between the oven front face and the
door or allow soil or cleaner residue to accumulate on sealing
surfaces.
(c) Do not operate the oven if it is damaged. It is particularly
important that the oven door close properly and that there is
no damage to the: (1) Door (bent), (2) hinges and latches (broken
or loosened), (3) door seals and sealing surfaces.
(d) The oven should not be adjusted or repaired by anyone except
properly qualified service personnel.
(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. Manufacturers of microwave ovens to
which this section is applicable shall provide or cause to be
provided to servicing dealers and distributors and to others upon
request, for each oven model, adequate instructions for service
adjustments and service procedures, and, in addition, radiation
safety instructions which:
(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) Do not operate or allow the oven to be operated with the door
open.
(b) Make the following safety checks on all ovens to be serviced
before activating the magnetron or other microwave source, and
make repairs as necessary:
(1) Interlock operation, (2) proper door closing, (3) seal and
sealing surfaces (arcing, wear, and other damage), (4) damage
to or loosening of hinges and latches, (5) evidence of dropping
or abuse.
(c) Before turning on microwave power for any service test or
inspection within the microwave generating compartments, check
the magnetron, wave guide or transmission line, and cavity for
proper alignment, integrity, and connections.
(d) Any defective or misadjusted components in the interlock,
monitor, door seal, and microwave generation and transmission
systems shall be repaired, replaced, or adjusted by procedures
described in this manual before the oven is released to the owner.
(e) A Microwave leakage check to verify compliance with the Federal
performance standard should be performed on each oven prior to
release to the owner.
(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. Except as provided in paragraph (c)(6)(iv)
of this section, microwave ovens shall have the following 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) Object Caught in Door. (b) Door
That Does Not Close Properly. (c) Damaged Door, Hinge, Latch,
or Sealing Surface.
(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:
This Device is to be Serviced Only by Properly Qualified Service
Personnel. Consult the Service Manual for Proper Service Procedures
to Assure Continued Compliance with the Federal Performance Standard
for Microwave Ovens and for Precautions to be Taken to Avoid Possible
Exposure to Excessive Microwave Energy.
(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 556 21 CFR Ch. I (4–1–97 Edition)
§ 1040.10 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), (2), and (3) of this section under
the adverse condition of use addressed by such precautionary statement(s).
An original and two copies of applications shall be submitted
to the Dockets Management Branch (HFA–305), Food and Drug
Administration, rm. 1–23, 12420 Parklawn Dr., Rockville,
MD 20857. 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 Branch for public review.
The application shall include: (a) The specific microwave oven
model(s) for which the exemption is sought. (b) The specific radiation
safety warning(s) from which exemption is sought. (c) Data and
information which clearly establish that one or more of the radiation
safety warnings in paragraph (c)(6)(i) of this section is not
necessary for the specified microwave oven model(s). (d) Such
other information and a sample of the applicable product if required
by regulation or by the Director, Center for Devices and Radiological
Health, to evaluate and act on the application. [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] |