INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT

[Title 47 CFR 18]
[Code of Federal Regulations (annual edition) - October 1, 2004 Edition]
[Title 47 - TELECOMMUNICATION]
[Chapter I - FEDERAL COMMUNICATIONS COMMISSION]
[Subchapter A - GENERAL]
[Part 18 - INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT]
[From the U.S. Government Printing Office]

47TELECOMMUNICATION12004-10-012004-10-01falseINDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT18PART 18TELECOMMUNICATIONFEDERAL COMMUNICATIONS COMMISSIONGENERAL
PART 18_INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT--Table of Contents

Subpart A_General Information

Sec.
18.101 Basis and purpose.
18.107 Definitions.
18.109 General technical requirements.
18.111 General operating conditions.
18.113 Inspection by Commission representatives.
18.115 Elimination and investigation of harmful interference.
18.117 Report of interference investigation.
18.121 Exemptions.
18.123 Transition provisions for compliance with the rules.

Subpart B_Applications and Authorizations

18.201 Scope.
18.203 Equipment authorization.
18.207 Technical report.
18.209 Identification of authorized equipment.
18.211 Multiple listing of equipment.
18.212 Compliance information.
18.213 Information to the user.

Subpart C_Technical Standards

18.301 Operating frequencies.
18.303 Prohibited frequency bands.
18.305 Field strength limits.
18.307 Conduction limits.
18.309 Frequency range of measurements.
18.311 Methods of measurements.

Authority: 47 U.S.C. 4, 301, 302, 303, 304, 307.

Source: 50 FR 36067, Sept. 5, 1985, unless otherwise noted.

Subpart A_General Information

Sec. 18.101 Basis and purpose.

The rules in this part, in accordance with the applicable treaties
and agreements to which the United States is a party, are promulgated
pursuant to section 302 of the Communications Act of 1934, as amended,
vesting the Federal Communications Commission with authority to regulate
industrial, scientific, and medical equipment (ISM) that emits
electromagnetic energy on frequencies within the radio frequency
spectrum in order to prevent harmful interference to authorized radio
communication services. This part sets forth the conditions under which
the equipment in question may be operated.

Sec. 18.107 Definitions.

(a) Radio frequency (RF) energy. Electromagnetic energy at any
frequency in the radio spectrum from 9 kHz to 3 THz (3,000 GHz).
(b) Harmful interference. Interference which endangers the
functioning of a radionavigation service or of other safety services or
seriously degrades, obstructs or repeatedly interrupts a
radiocommunication service operating in accordance with this chapter.
(c) Industrial, scientific, and medical (ISM) equipment. Equipment
or appliances designed to generate and use locally RF energy for
industrial, scientific, medical, domestic or similar purposes, excluding
applications in the field of telecommunication. Typical ISM applications
are the production of physical, biological, or chemical effects such as
heating, ionization of gases, mechanical vibrations, hair removal and
acceleration of charged particles.
(d) Industrial heating equipment. A category of ISM equipment used
for or in connection with industrial heating operations utilized in a
manufacturing or production process.
(e) Medical diathermy equipment. A category of ISM equipment used
for therapeutic purposes, not including surgical diathermy apparatus
designed for intermittent operation with low power.
(f) Ultrasonic equipment. A category of ISM equipment in which the
RF energy is used to excite or drive an electromechanical transducer for
the production of sonic or ultrasonic mechanical energy for industrial,
scientific, medical or other noncommunication purposes.
(g) Consumer ISM equipment. A category of ISM equipment used or
intended to be used by the general public in a residential environment,
notwithstanding use in other areas. Examples are domestic microwave
ovens, jewelry

[[Page 858]]

cleaners for home use, ultrasonic humidifiers.
(h) ISM frequency. A frequency assigned by this part for the use of
ISM equipment. A specified tolerance is associated with each ISM
frequency. See Sec. 18.301.
(i) Marketing. As used in this part, marketing shall include sale or
lease, offer for sale or lease, advertising for sale or lease, the
import or shipment or other distribution for the purpose of sale or
lease or offer for sale or lease. See subpart I of part 2 of this
chapter.
(j) Magnetic resonance equipment. A category of ISM equipment in
which RF energy is used to create images and data representing spatially
resolved density of transient atomic resources within an object.

Note: In the foregoing, sale (or lease) shall mean sale (or lease)
to the user or a vendor who in turn sells (or leases) to the user. Sale
shall not be construed to apply to devices sold to a second party for
manufacture or fabrication into a device which is subsequently sold (or
leased) to the user.

[50 FR 36067, Sept. 5, 1985, as amended at 59 FR 39472, Aug. 3, 1994]

Sec. 18.109 General technical requirements.

ISM equipment shall be designed and constructed in accordance with
good engineering practice with sufficient shielding and filtering to
provide adequate suppression of emissions on frequencies outside the
frequency bands specified in Sec. 18.301.

Sec. 18.111 General operating conditions.

(a) Persons operating ISM equipment shall not be deemed to have any
vested or recognizable right to the continued use of any given
frequency, by virtue of any prior equipment authorization and/or
compliance with the applicable rules.
(b) Subject to the exceptions in paragraphs (c) and (d) of this
section and irrespective of whether the equipment otherwise complies
with the rules in this part, the operator of ISM equipment that causes
harmful interference to any authorized radio service shall promptly take
whatever steps may be necessary to eliminate the interference.
(c) The provisions of paragraph (b) of this section shall not apply
in the case of interference to an authorized radio station or a
radiocommunication device operating in an ISM frequency band.
(d) The provisions of paragraph (b) of this section shall not apply
in the case of interference to a receiver arising from direct
intermediate frequency pickup by the receiver of the fundamental
frequency emissions of ISM equipment operating in an ISM frequency band
and otherwise complying with the requirements of this part.

Sec. 18.113 Inspection by Commission representatives.

Upon request by a representative of the Commission the manufacturer,
owner, or operator of any ISM equipment shall make the equipment
available for inspection and promptly furnish the Commission with such
information as may be required to indicate that the equipment complies
with this part.

Sec. 18.115 Elimination and investigation of harmful interference.

(a) The operator of ISM equipment that causes harmful interference
to radio services shall promptly take appropriate measures to correct
the problem.
(b) If the operator of ISM equipment is notified by the Commission's
Engineer in Charge (EIC) that operation of such equipment is endangering
the functioning of a radionavigation or safety service, the operator
shall immediately cease operating the equipment. Operation may be
resumed on a temporary basis only for the purpose of eliminating the
harmful interference. Operation may be resumed on a regular basis only
after the harmful interference has been eliminated and approval from the
EIC obtained.
(c) When notified by the EIC that a particular installation is
causing harmful interference, the operator or manufacturer shall arrange
for an engineer skilled in techniques of interference measurement and
control to make an investigation to ensure that the harmful interference
has been eliminated. The EIC may require the engineer making the
investigation to

[[Page 859]]

furnish proof of his or her qualifications.

Sec. 18.117 Report of interference investigation.

(a) An interim report on investigations and corrective measures
taken pursuant to Sec. 18.115 of this part shall be filed with the EIC
of the local FCC office within 30 days of notification of harmful
interference. The final report shall be filed with the EIC within 60
days of notification.
(b) The date for filing the final report may be extended by the
Engineer in Charge when additional time is required to put into effect
the corrective measures or to complete the investigation. The request
for extension of time shall be accompanied by a progress report showing
what has been accomplished to date.

Sec. 18.121 Exemptions.

Non-consumer ultrasonic equipment, and non-consumer magnetic
resonance equipment, that is used for medical diagnostic and monitoring
applications is subject only to the provisions of Sec. Sec. 18.105,
18.109 through 18.119, 18.301 and 18.303 of this part.

[59 FR 39472, Aug. 3, 1994; 60 FR 47302, Sept. 12, 1995]

Sec. 18.123 Transition provisions for compliance with the rules.

Consumer ISM devices, induction cooking ranges and ultrasonic
equipment that are authorized under the certification, verification or
declaration of conformity procedures on or after July 12, 2004 shall
comply with the conducted limits specified in Sec. 18.307. All such
devices that are manufactured or imported on or after July 11, 2005
shall comply with the conducted limits specified in Sec. 18.307.
Equipment authorized, imported or manufactured prior to these dates
shall comply with the conducted limits specified in Sec. 18.307 or with
the conducted limits that were in effect immediately prior to September
9, 2002.

[67 FR 45671, July 10, 2002]

Subpart B_Applications and Authorizations

Sec. 18.201 Scope.

This subpart contains the procedures and requirements for
authorization to market or operate ISM equipment under this part.

Sec. 18.203 Equipment authorization.

(a) Consumer ISM equipment, unless otherwise specified, must be
authorized under either the Declaration of Conformity or certification
procedure prior to use or marketing. An application for certification
shall be filed with the Commission on an FCC Form 731, pursuant to the
relevant sections in part 2, subpart J of this chapter and shall also be
accompanied by:
(1) A description of measurement facilities pursuant to Sec. 2.948,
or reference to such information already on file with the Commission.
(2) A technical report pursuant to Sec. Sec. 18.207 and 18.311.
(b) Consumer ultrasonic equipment generating less than 500 watts and
operating below 90 kHz, and non-consumer ISM equipment shall be subject
to verification, in accordance with the relevant sections of part 2,
subpart J of this chapter.
(c) Grants of equipment authorization issued, as well as on-site
certifications performed, before March 1, 1986, remain in effect and no
further action is required.

[50 FR 36067, Sept. 5, 1985, as amended at 63 FR 36603 July 7, 1998]

Sec. 18.207 Technical report.

When required by the Commission a technical report shall include at
least the following information:
(a) A description of the measurement facilities in accordance with
Sec. 2.948. If such a description is already on file with the
Commission, it may be included by reference.
(b) A copy of the installation and operating instructions furnished
to the user. A draft copy of such instructions may be submitted with the
application, provided a copy of the actual document to be furnished to
the user is submitted as soon as it is available, but no later

[[Page 860]]

than 60 days after the grant of the application.
(c) The full name and mailing address of the manufacturer of the
device and/or applicant filing for the equipment authorization.
(d) The FCC Identifier, trade name(s), and/or model number(s) under
which the equipment is or will be marketed.
(e) A statement of the rated technical parameters that includes:
(1) A block and schematic diagram of the circuitry.
(2) Nominal operating frequency.
(3) Maximum RF energy generated.
(4) Electrical power requirements of equipment.
(5) Any other pertinent operating characteristics.
(f) A report of measurements, including a list of the measuring
equipment used, and a statement of the date when the measuring equipment
was last calibrated and when the measurements were made. The frequency
range that was investigated in obtaining the report of measurements
shall be indicated. See also Sec. Sec. 18.309 and 18.311.

[50 FR 36067, Sept. 5, 1985, as amended at 63 FR 36603, July 7, 1998]

Sec. 18.209 Identification of authorized equipment.

(a) Each device for which a grant of equipment authorization is
issued under this part shall be identified pursuant to the applicable
provisions of subpart J of part 2 of this chapter. Changes in the
identification of authorized equipment may be made pursuant to Sec.
2.933 of part 2 of this chapter. FCC Identifiers as described in
Sec. Sec. 2.925 and 2.926 of this chapter shall not be used on
equipment subject to verification or Declaration of Conformity.
(b) Devices authorized under the Declaration of Conformity procedure
shall be labelled with the logo shown below. The label shall not be a
stick-on, paper label. It shall be permanently affixed to the product
and shall be readily visible to the purchaser at the time of purchase,
as described in Sec. 2.925(d) of this chapter. Permanently affixed
means that the label is etched, engraved, stamped, silkscreened,
indelibly printed, or otherwise permanently marked on a permanently
attached part of the equipment or on a nameplate of metal, plastic, or
other material fastened to the equipment by welding, riveting, or a
permanent adhesive. The label must be designed to last the expected
lifetime of the equipment in the environment in which the equipment may
be operated and must not be readily detachable. The logo follows:
[GRAPHIC] [TIFF OMITTED] TR07JY98.027

[63 FR 36603, July 7, 1998]

Sec. 18.211 Multiple listing of equipment.

(a) When the same or essentially the same equipment will be marketed
under more than one FCC Identifier, equipment authorization must be
requested on an FCC Form 731 for each FCC Identifier.
(b) If equipment authorization for additional FCC Identifiers is
requested in the initial application, a statement shall be included
describing how these additional devices differ from the basic device
which was measured and stating that the report of measurements submitted
for the basic device applies also to the additional devices.
(c) If equipment authorization for additional FCC Identifiers is
requested after a grant has been issued by the FCC for the basic device,
the application may, in lieu of the report of measurements, be
accompanied by a statement including:
(1) FCC Identifier of device for which measurements are on file with
the FCC.
(2) Date when equipment authorization was granted for the device(s)
listed under paragraph (c)(1) of this section and the file number of
such grant.
(3) Description of the difference between the device listed under
paragraph (c)(1) of this section and the additional device(s).
(4) A statement that the report of measurements filed for the device
listed under paragraph (c)(1) of this section applies also to the
additional device(s).
(5) Photographs pursuant to Sec. 2.1033(c).

[[Page 861]]

Sec. 18.212 Compliance information.

(a) Equipment authorized under the Declaration of Conformity
procedure shall include the following compliance information in lieu of
the information required by Sec. 2.1077.
(1) Identification of the product, e.g., name and model number.
(2) A statement similar to the following:

This device complies with Part 18 of the FCC Rules.

(3) The name and address of the responsible party as defined in
Sec. 2.909 of the rules. This party must be located within the United
States.
(b) The compliance information may be placed in the instruction
manual, on a separate sheet, or on the packaging. There is no specific
format for this information.

[63 FR 36603, July 7, 1998]

Sec. 18.213 Information to the user.

Information on the following matters shall be provided to the user
in the instruction manual or on the packaging if an instruction manual
is not provided for any type of ISM equipment:
(a) The interference potential of the device or system
(b) Maintenance of the system
(c) Simple measures that can be taken by the user to correct
interference.
(d) Manufacturers of RF lighting devices must provide an advisory
statement, either on the product packaging or with other user
documentation, similar to the following: This product may cause
interference to radio equipment and should not be installed near
maritime safety communications equipment or other critical navigation or
communication equipment operating between 0.45-30 MHz. Variations of
this language are permitted provided all the points of the statement are
addressed and may be presented in any legible font or text style.

[50 FR 36069, Sept. 5, 1985, as amended at 51 FR 17970, May 16, 1986; 64
FR 37419, July 12, 1999]

Subpart C_Technical Standards

Sec. 18.301 Operating frequencies.

ISM equipment may be operated on any frequency above 9 kHz except as
indicated in Sec. 18.303. The following frequency bands, in accordance
with Sec. 2.106 of the rules, are allocated for use by ISM equipment:

------------------------------------------------------------------------
ISM frequency Tolerance
------------------------------------------------------------------------
6.78 MHz.................................. 15.0
kHz
13.56 MHz................................. 7.0
kHz
27.12 MHz................................. 163.0
kHz
40.68 MHz................................. 20.0
kHz
915 MHz................................... 13.0
MHz
2,450 MHz................................. 50.0
MHz
5,800 MHz................................. 75.0
MHz
24,125 MHz................................ 125.0
MHz
61.25 GHz................................. 250.0
MHz
122.50 GHz................................ 500.0
MHz
245.00 GHz................................ 1.0
GHz
------------------------------------------------------------------------

Note: The use of the 6.78 MHz 15 kHz frequency
band is subject to the conditions of footnote 524 of the Table of
Allocations. See Sec. 2.106.

Sec. 18.303 Prohibited frequency bands.

Operation of ISM equipment within the following safety, search and
rescue frequency bands is prohibited: 490-510 kHz, 2170-2194 kHz, 8354-
8374 kHz, 121.4-121.6 MHz, 156.7-156.9 MHz, and 242.8-243.2 MHz.

Sec. 18.305 Field strength limits.

(a) ISM equipment operating on a frequency specified in Sec. 18.301
is permitted unlimited radiated energy in the band specified for that
frequency.
(b) The field strength levels of emissions which lie outside the
bands specified in Sec. 18.301, unless otherwise indicated, shall not
exceed the following:

----------------------------------------------------------------------------------------------------------------
RF Power generated by Field strength limit Distance
Equipment Operating frequency equipment (watts) (uV/m) (meters)
----------------------------------------------------------------------------------------------------------------
Any type unless otherwise Any ISM frequency.... Below 500............ 25.................. 300
specified (miscellaneous). 500 or more.......... 25xSQRT(power/500).. \1\300
Any non-ISM frequency Below 500............ 15.................. 300
500 or more.......... 15xSQRT(power/500).. \1\300
Industrial heaters and RF On or below 5,725 MHz Any.................. 10.................. 1,600
stabilized arc welders. Above 5,725 MHz...... Any.................. (\2\)............... (\2\)
Medical diathermy................. Any ISM frequency.... Any.................. 25.................. 300
Any non-ISM frequency Any.................. 15.................. 300

[[Page 862]]

Ultrasonic........................ Below 490 kHz........ Below 500............ 2,400/F(kHz)........ 300
500 or more.......... 2,400/F(kHz)x \3\300
SQRT(power/500).
490 to 1,600 kHz..... Any.................. 24,000/F(kHz)....... 30
Above 1,600 kHz...... Any.................. 15.................. 30
Induction cooking ranges.......... Below 90 kHz......... Any.................. 1,500............... \4\30
On or above 90 kHz... Any.................. 300................. \4\30
----------------------------------------------------------------------------------------------------------------
\1\ Field strength may not exceed 10 [mu]V/m at 1600 meters. Consumer equipment operating below 1000 MHz is not
permitted the increase in field strength otherwise permitted here for power over 500 watts.
\2\ Reduced to the greatest extent possible.
\3\ Field strength may not exceed 10 [mu]V/m at 1600 meters. Consumer equipment is not permitted the increase in
field strength otherwise permitted here for over 500 watts.
\4\ Induction cooking ranges manufactured prior to February 1, 1980, shall be subject to the field strength
limits for miscellaneous ISM equipment.

------------------------------------------------------------------------
Field strength limit at 30 meters
Frequency (MHz) ([mu]V/m)
------------------------------------------------------------------------
Non-consumer equipment:
30-88........................... 30
88-216.......................... 50
216-1000........................ 70
Consumer equipment:
30-88........................... 10
88-216.......................... 15
216-1000........................ 20
------------------------------------------------------------------------

Notes

1. The tighter limit shall apply at the boundary between two
frequency ranges.
2. Testing for compliance with these limits may be made at closer
distances, provided a sufficient number of measurements are taken to
plot the radiation pattern, to determine the major lobes of radiation,
and to determine the expected field strength level at 30, 300, or 1600
meters. Alternatively, if measurements are made at only one closer fixed
distance, then the permissible field strength limits shall be adjusted
using 1/d as an attenuation factor.

[50 FR 36070, Sept. 5, 1985, as amended at 51 FR 17970, May 16, 1986; 52
FR 43197, Nov. 10, 1987]

Sec. 18.307 Conduction limits.

For the following equipment, when designed to be connected to the
public utility (AC) power line the radio frequency voltage that is
conducted back onto the AC power line on any frequency or frequencies
shall not exceed the limits in the following tables. Compliance with the
provisions of this paragraph shall be based on the measurement of the
radio frequency voltage between each power line and ground at the power
terminal using a 50 [mu]H/50 ohms line impedance stabilization network
(LISN).
(a) All Induction cooking ranges and ultrasonic equipment:

------------------------------------------------------------------------
Conducted limit (dB[mu]V)
Frequency of emission (MHz) ----------------------------------------
Quasi-peak Average
------------------------------------------------------------------------
0.009-0.05..................... 110................ --
0.05-0.15...................... 90-80 *............ --
0.15-0.5....................... 66 to 56 *......... 56 to 46 *
0.5-5.......................... 56................. 46
5-30........................... 60................. 50
------------------------------------------------------------------------
* Decreases with the logarithm of the frequency.

(b) All other part 18 consumer devices:

------------------------------------------------------------------------
Conducted limit (dB[mu]V)
Frequency of emission (MHz) ----------------------------------------
Quasi-peak Average
------------------------------------------------------------------------
0.15-0.5....................... 66 to 56 *......... 56 to 46 *
0.5-5.......................... 56................. 46
5-30........................... 60................. 50
------------------------------------------------------------------------
* Decreases with the logarithm of the frequency.

------------------------------------------------------------------------
Maximum RF line
voltage measured
Frequency (MHz) with a 50 uH/50
ohm LISN (uV)
------------------------------------------------------------------------
Non-consumer equipment:
0.45 to 1.6........................................ 1,000
1.6 to 30.......................................... 3,000
Consumer equipment:
0.45 to 2.51....................................... 250
2.51 to 3.0........................................ 3,000
3.0 to 30.......................................... 250
------------------------------------------------------------------------

(d) If testing with a quasi-peak detector demonstrates that the
equipment complies with the average limits specified in the appropriate
table in this section, additional testing to demonstrate compliance
using an average detector is not required.

[[Page 863]]

(e) These conduction limits shall apply only outside of the
frequency bands specified in Sec. 18.301.
(f) For ultrasonic equipment, compliance with the conducted limits
shall preclude the need to show compliance with the field strength
limits below 30 MHz unless requested by the Commission.
(g) The tighter limits shall apply at the boundary between two
frequency ranges.

[50 FR 36067, Sept. 5, 1985, as amended at 52 FR 43198, Nov. 10, 1987;
64 FR 37419, July 12, 1999; 67 FR 45671, July 10, 2002]

Sec. 18.309 Frequency range of measurements.

(a) For field strength measurements:

----------------------------------------------------------------------------------------------------------------
Range of frequency measurements
Frequency band in which device operates ------------------------------------------------------------------------
(MHz) Lowest frequency Highest frequency
----------------------------------------------------------------------------------------------------------------
Below 1.705............................ Lowest frequency generated in the 30 MHz.
device, but not lower than 9 kHz.
1.705 to 30............................ Lowest frequency generated in the 400 MHz.
device, but not lower than 9 kHz.
30 to 500.............................. Lowest frequency generated in the Tenth harmonic or 1,000 MHz,
device or 25 MHz, whichever is whichever is higher.
lower.
500 to 1,000........................... Lowest frequency generated in the Tenth harmonic.
device or 100 MHz, whichever is
lower.
Above 1,000............................ ......do........................... Tenth harmonic or highest
detectable emission.
----------------------------------------------------------------------------------------------------------------

(b) For conducted powerline measurements, the frequency range over
which the limits are specified will be scanned.

[50 FR 36070, Sept. 5, 1985, as amended at 51 FR 17971, May 16 1986]

Sec. 18.311 Methods of measurements.

The measurement techniques which will be used by the FCC to
determine compliance with the technical requirements of this part are
set out in FCC Measurement Procedure MP-5, ``Methods of Measurements of
Radio Noise Emissions from ISM equipment''. Although the procedures in
MP-5 are not mandated, manufacturers are encouraged to follow the same
techniques which will be used by the FCC.