Current through Register Vol. 30, No. 38, September 20, 2024
A. A registrant shall ensure that each laser
product has a protective housing that prevents access to laser and collateral
radiation if it exceeds the exposure limits for Class 1 lasers in R9-7-1426. If
a laser's accessible emission levels must exceed the limits for Class 1 lasers,
the registrant shall use a laser from the lowest class that will enable the
registrant to perform the intended function.
B. To prevent access to radiation above the
applicable MPE, a registrant shall ensure that each laser has a safety
interlock, which prevents operation of the laser if a person has removed any
portion of the protective housing that can be removed or displaced without the
use of tools during normal operation or maintenance. The registrant shall
ensure that:
1. Service, testing, or
maintenance of a laser does not render the interlocks inoperative or increase
radiation outside the protective housing to levels that exceed the applicable
MPE, unless a controlled area is established as specified in
R9-7-1433;
2. For pulsed lasers,
interlocks are designed to prevent the laser from firing;
3. For Class 3b and 4 continuous wave (cw)
lasers, interlocks turn off the power supply or interrupt the beam.
4. An interlock does not allow automatic
accessibility to radiation emission above the applicable MPE when the interlock
is closed; and
5. Multiple safety
interlocks or a means to preclude removal or displacement of the interlocked
portion of the protective housing is provided if failure of a single interlock
could result in:
a. Human access to levels of
laser radiation that exceed the radiant power accessible emission limit for
Class 3a laser radiation, or
b.
Laser radiation that exceeds the accessible emission limit for Class 2, emitted
directly through the opening created by removal or displacement of a portion of
the protective housing.
C. A registrant shall ensure that a laser
with viewing ports, viewing optics, or display screens, included as an integral
part of the enclosed laser or laser system has:
1. A suitable means to attenuate laser and
collateral radiation transmitted through the optical system to less than the
accessible emission limit for collateral radiation required by
21 CFR
1040.10, April 1, 2004, which is incorporated
by reference, published by the Office of Federal Register National Archives and
Records Administration, Washington, D.C. 20408, and on file with the
Department. This incorporation by reference contains no future editions or
amendments; and
2. Specific written
administrative procedures developed by the LSO, and use controls, such as
interlocks or filters, if there is increased hazard to the eye or skin
associated with the use of optical systems such as lenses, telescopes, or
microscopes.
D. A
registrant shall ensure that each Class 3 or 4 laser product provides a visual
or audible indication before the emission of accessible laser radiation that
exceeds the limits for Class 1, as follows:
1. For Class 3, except for laser products
that allow access to less than 5 milliwatts peak visible laser radiation, and
Class 4 lasers, the indication occurs before the emission of the radiation and
allows enough time for action to avoid exposure;
2. Any visual indicator is clearly visible
through protective eyewear designed specifically for the wavelength of the
emitted laser radiation;
3. If the
laser and laser energy source are housed separately and can be operated at a
separation distance of greater than 2 meters, both the laser and laser energy
source incorporate visual or audible indicators; and
4. Any visual indicators are positioned so
that viewing does not require human access to laser radiation that exceeds the
applicable MPE.
E. In
addition to the information signs, symbols, and labels prescribed in R9-7-1427,
R9-7-1428, and R9-7-1429, each registrant shall provide, near the signs,
symbols, and labels within the laser facility, operating procedure restrictions
and any other safety information required to ensure compliance with this
Article and minimize exposure to laser and collateral radiation.
