21 CFR 1040.11 - Specific purpose laser products.

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§ 1040.11 Specific purpose laser products.

(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 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.”

(b) Surveying, leveling, and alignment laser products. Each surveying, leveling. or alignment laser product shall comply with all of the applicable requirements of § 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 § 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]

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