FDA Amendment 21 CFR Part 1040 Effective Sept. 1986

Electronic products, HID lamps, Incorporation by reference, Lasers, Medical devices, Radiation protection, Standards, Sunlamps. Therefore, under the Public Health Service Act, as amended by the Radiation Control for Health and Safety Act of 1968. Part 1040 is amended to read as follows:

PART 1040—PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

1. The authority citation for Part 1040 continues to read as follows:

2. By revising 1040.20. to read as follows:

§1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

(a) Applicability.

(1) The provisions of this section, as amended, are applicable as specified herein to the following products manufactured on or after Sept. 8, 1986.

(i) Any sunlamp product.

(ii) Any ultraviolet lamp intended for use in any sunlamp product.

(2) Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980, but before Sept. 8, 1986, are subject to the provisions of this section as published in the FEDERAL REGISTER of Nov. 9, 1979 (44 FR 65357).

(b) Definitions. As used in this section the following definitions apply:

(1) "Exposure position" means any position, distance,
orientation, or location relative to the radiating surfaces of the sunlamp product at which the user is intended to be exposed to ultraviolet radiation from the product, as recommended by the manufacturer.

(2) "Intended" means the same as "intended uses" in 801.4.

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