You are on page 1of 4

,-.

u
.

Lawrence Livermore National Laboratory

November 18,1992

Jerome E. Dennis, Chief


LightProducts Branch .-
Division of Standards Enforcement C3

Office of Compliance and Surveillance


Center for Device and Radiological Health
HFZ-312
1390 Piccard Drive
Rockville, MD 20750

REFERENCE: Notice of Consideration of Possible Amendments to the Federal


Performance Standard for Laser Products, J.E. Dennis, FDA, 9/23/92

Mr. Dennis:

Thank you for giving the Laboratory the opportunity to comment on possible
amendments to the Federal Performance Standard for Laser Products. The Laboratory
has comments on the following two proposals:

Proposal #3
FDA is proposing to lower the maximum emission duration to be considered,
for Class 1 lasers that are not intended to be viewed, to 100 seconds. Classification of
lasers for which viewing is intended as Class 1 would still require consideration of
exposure durations of 10Q seconds. For this latter group, a less restrictive criterion is
found in the ANSI Z136.1 standard, i.e., “maximum exposure duration resulting from
the inherent design or intended use”.

Where laser products are intended for viewing, it would normally be relatively
easy to define a maximum likely (or even unlikely) exposure duration, and that
duration would normally be less than 101 seconds. For this reason, and for
consistency between standards, adoption of something similar to the ANSI approach
would be recommended.
~..i,,f~
Proposal #7
FDA is considering changes to the tables in 21 CFR 1040.10(d) for{ e purpqse. -e-\
-’@’
of making the resulting classifications agree more nearly with the t I ~ and A~I o
classifications. It is stated that the present structure of the tables will be maintained if :
possible because manufacturers are accustomed to it and because it is si $&r than the.- Q
$
corresponding ANSI and IEC tables. 0+
6/ @’
{ . . ‘~[~
. . g~$$+
. . )

~~d.doqy

recwd m U% !~! 3OlCKL 23A% I ~ @


An Equal Oppor!uniiy Employer ● Universly of California ● P. O. Box 808 Livermore, CA 94551-9900 ● Telephone (5 10) 422-1100● Twx 910-386-8339 UCLLL L VMR
,: d. M n
Possible Amendments 2 November 18, 1992

Certainly the ANSI calculations are more complex, but if simplification results
-
in some systems being considered more hazardous than they wo;ld be under the
ANSI or IEC methods, the more complex should be used. The extra engineering cost
of making the more complex calculation applies just once to each laser product, while
the cost of the required mitigating features for a system that unnecessarily falls into a
higher classification applies to each unit sold.

Other proposed amendments in this document seem to be reasonable and


acceptable changes. If you have any questions, please contact Scott Hildum, the
Laboratory’s Laser Safety Officer at (510) 422-5263.

~YY3&
Dennis K. Fisher
Associate Director
Plant Operations
JSHDK13kdd

cc: HS 92-134
George Campbell
David Counts
Bill Silver
Scott Hildum
Date file
-. . *
.n=
-
xxx x x xxx Xxxxxxxx Axxxxxxxx xx xx xxx xx xxx Xxxxxxxxx
xxx xxx xxx Xxxxxxxx y;xxxxxx xxx xxx xxx xxx xxx Xxxxxxxxx
xxx Xxxx xxx x x x xxx Xxxx Xxxx xxx Xxxx xxx xxx
xxx Xxxxx xxx xxx xxx xxx Xxxxx Xxxxx xxx Xxxxx xxx xxx
xxx Xxxxxxxxx x x x xxx XXX XXXXXXXXXXX XXX XXXXXXXXX XXX 1218
xxx xxx Xxxxx xxx xxx xxx x x x x x x x x x x x x x x x Xxxxx x x x X x x x
xxx xxx Xxxx xxx xxx xxx xxx x xxx xxx xxx Xxxx xxx N2G
xxx xxx xxx Xxxxxxxx Xxxxxxxxx xxx xxx xxx xxx xxx Xxxxxxxxx
xxx xxx xx Xxxxxxxx Xxxxxxxxx xxx xxx xxx xxx xx Xxxxxxxxx
FROM I DATE
LAWRENCE LIVERMORE N A T I O N A L L A B O R A TO R Y ( L A L z ) 11/18/92
I
SUBJ
COMMENTING ON POSSIBLE AMENDMENTS TO FEDERAL PERFORMANCE STANDARD
OF LASER PRODUCTS.

CFJ$L FILE RECD


232314 PNTS LALZ/Ll 12/01/92

INCOMING ROUTE SHEET, OFFICE OF COMPLIANCE, DEVICES AND RADIOLOGICAL HEALTH

ROUTE TO UNIT INITIALS DATE COMMENTS:

JERRY DENNIS LPB

JOY LAZAROFF LPB

NOTE : UNLESS OTHERWISE MARKED THE ATTACHED IS AN ACTION COPY AND NEED NOT
BE RETURNED TO FILE. 1!$ FILE POINT CHANGES ARE NECESSARY NOTE THEM
ON THIS SHEET, THEN RETURN IT OR A PHOTOCOPY TO THE DMS FfLE STAFF.

Xxxxxx Xxxxxx Xxxxxx Xxxxxx xxx


Xxxxxxxx Xxxxxxxx Xxxxxxxx Xxxxxxxx XI* Xxxx
xxx xxx xxx xxx xxx xxx xxx xxx Xxxx Xxxxx
xxx xxx xxx xxx xxx Xxxxxx
xxx Xxxxx xxx Xxxxx xxx xxx xxx
xxx Xxxxx xxx Xxxxx xxx xxx xxx
Xxxx xxx Xxxx xxx xxx Xxxxxxxxxx
Xxxx xxx xxx Xxxx xxx xxx xxx XXXXX*)UKIXX
Xxxxxxxxxx X;**W;*X Xxxxxxxxxx x~:m:;;x xxx
Xxxxxxxxxx Xxxxxxxxxx xxx xxx
~wcx
scann~~
From:
UNIVERSITY OF CALIFORNIA
~ LAWRENCE LIVE RMORE NATIONAL LABORATORY
P.o. BOX 808
LIVE RMORE, CALIFORNIA, 94551

To: Jerome E. Dennis, Chief


Light Products Branch
Division of Standards Enforcement
Offic of Compliance and Surveillance
Center for Device and Radiological Health
HFZ-312
1390 Piccard Drive
Rockville, MD 20750