Paul Lovell asked
>>I understand that Part 18 applies to ISM products but what is its current
status (ie active or waived)? Is it just EMC or does it cover other
things?
Please excuse my ignorance, I'm new to the medical field, but I'm told
there
are no FCC emissions requirements for medical devices, something which
surprised me given how much effort goes into complying with Part 15 in the
IT field. <<
There are various FCC restrictions on all radio frequency sources. Part 1
has limits for exposure of humans to RF, Part 2 forbids causing harmful
interference to licensed services and Part 15 has limits on how much may be
emitted by unlicensed devices even in the absence of interference. Part 18
is specific to ISM equipment:
[
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.
]
At specific ISM frequencies the radiated limits are nonexistent, it being
recognized that no licensed radio service will use those frequencies (but
see Part 1):
[
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: ...
]
Do note that complying with a limit does NOT relieve one from the
obligation to mitigate harmful interference.
Part 18 may be viewed at
http://www.access.gpo.gov/nara/cfr/waisidx_00/47cfr18_00.html
Part 1 includes limits for human exposure to RF.
[
Sec. 1.1310 Radiofrequency radiation exposure limits.
The criteria listed in table 1 shall be used to evaluate the
environmental impact of human exposure to radiofrequency (RF) radiation
as specified in Sec. 1.1307(b), except in the case of portable devices
which shall be evaluated according to the provisions of Sec. 2.1093 of
this chapter. Further information on evaluating compliance with these
limits can be found in the FCC's OST/OET Bulletin Number 65,
``Evaluating Compliance with FCC-Specified Guidelines for Human Exposure
to Radiofrequency Radiation.''
]
http://www.access.gpo.gov/nara/cfr/waisidx_00/47cfr1_00.html
FCC Bulletin OET-65 discusses human RF exposure limits:
[
..all transmitting facilities and devices regulated by this Commission that
are the subject of an FCC decision or action (e.g., grant of an application
or response to a petition or inquiry) are expected to comply with the
appropriate RF radiation exposure guidelines, or, if not, to file an
Environmental Assessment (EA) for review under our NEPA procedures, if such
is required. ...
]
http://www.fcc.gov/Bureaus/Engineering_Technology/Documents/bulletins/oet65
/oet65.pdf
I hope this is of some help.
Cortland Richmond
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