SIGMA LASER STENT AND TUBE CUTTER
990-401
B-5
Comparison of Classifications
The following charts have been created to illustrate the various similarities and differences between the
classification criteria of the different laser standards.
Class
IEC 60825 (Amend. 2)
U.S. FDA/CDRH
ANSI-Z136.1 (2000)
Class 1 Any laser or laser system containing a laser that cannot emit laser radiation at levels that are
known to cause eye or skin injury during normal operation. This does not apply to service
periods requiring access to Class 1 enclosures containing higher class lasers.
Class 1M Not known to cause eye or
skin damage unless collecting
optics are used.
N/A
N/A
Class 2a N/A
Visible lasers that are not intended
for viewing and cannot produce any
known eye or skin injury during
operation based on a maximum
exposure time of 1000 seconds.
N/A
Class 2 Visible lasers considered incapable of emitting laser radiation at levels that are known to
cause skin or eye injury within the time period of the human eye aversion response (0.25
seconds).
Class 2M Not known to cause eye or
skin damage within the
aversion response time unless
collecting optics are used.
N/A
N/A
Class 3a N/A
Lasers similar to Class 2 with the
exception that collecting optics
cannot be used to directly view the
beam
Visible Only
Lasers similar to Class 2
with the exception that
collecting optics cannot
be used to directly view
the beam
Class 3R Replaces Class 3a and has
different limits. Up to 5 times
the Class 2 limit for visible
and 5 times the Class 1 limits
for some invisible.
N/A
N/A
Class 3b Medium powered lasers (visible or invisible regions) that present a potential eye hazard for
intrabeam (direct) or specular (mirror-like) conditions. Class 3b lasers do not present a diffuse
(scatter) hazard or significant skin hazard except for higher powered 3b lasers operating at
certain wavelength regions.
Class 4 High powered lasers (visible or invisible) considered to present potential acute hazard to the
eye and skin for both direct (intrabeam) and scatter (diffused) conditions. Also have potential
