[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1040.11]

[Page 674-675]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1040_PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS--
Table of Contents
 
Sec. 1040.11  Specific purpose laser products.

    (a) Medical laser products. Each medical laser product shall comply 
with all of the applicable requirements of Sec. 1040.10 for laser 
products of its class. In addition, the manufacturer shall:
    (1) Incorporate in each Class III or IV medical laser product a 
means for the measurement of the level of that laser radiation intended 
for irradiation of the human body. Such means may have an error in 
measurement of no more than 20 percent when calibrated in accordance 
with paragraph (a)(2) of this section. Indication of the measurement 
shall be in International System Units. The requirements of this 
paragraph do not apply to any laser radiation that is all of the 
following:
    (i) Of a level less than the accessible limits of Class IIIa; and
    (ii) Used for relative positioning of the human body; and
    (iii) Not used for irradiation of the human eye for ophthalmic 
purposes.
    (2) Supply with each Class III or IV medical laser product 
instructions specifying a procedure and schedule for calibration of the 
measurement system required by paragraph (a)(1) of this section.
    (3) Affix to each medical laser product, in close proximity to each 
aperture through which is emitted accessible laser radiation in excess 
of the accessible emission limits of Class I, a label bearing the 
wording: ``Laser aperture.''

[[Page 675]]

    (b) Surveying, leveling, and alignment laser products. Each 
surveying, leveling. or alignment laser product shall comply with all of 
the applicable requirements of Sec. 1040.10 for a Class I, IIa, II or 
IIIa laser product and shall not permit human access to laser radiation 
in excess of the accessible emission limits of Class IIIa.
    (c) Demonstration laser products. Each demonstration laser product 
shall comply with all of the applicable requirements of Sec. 1040.10 
for a Class I, IIa, II, or IIIa laser product and shall not permit human 
access to laser radiation in excess of the accessible emission limits of 
Class I and, if applicable, Class IIa, Class II, or Class IIIa.

[50 FR 33702, Aug. 20, 1985]