International progress in standards and regulation for light based home use devices

The recent development of light-based laser and intense light devices for consumer use with or without physician direction has raised new challenges in safety standards and regulatory requirements for these appliances.Home-use laser products have emission levels from “embedded” lasers that would ordinarily result in their having laser hazard classifications of 3B or 4, but because of design features and interlocks, cannot emit radiation which is hazardous to the eye when the product is in contact with the skin. When not in contact with the skin, emission is normally disabled anyway. With no outside emission, safety control measures in current horizontal standards do not make much sense. The International Electrotechnical Commission (IEC) has therefore defined a new laser Class 1C in its draft revisions to IEC standard 60825-1. Since laser appliances of laser Class 1C are diverse products, safety requirements may be too general if contained in the horizontal laser safety standard. Therefore, the general IEC 60825-1 only allows laser Class 1C to be attributed by a manufacturer to it’s product when a vertical safety standard exists which contains specific safety requirements which cover eye and skin hazards posed by the respective product (such as appliances for hair removal and skin rejuvenation).Whilst no equivalent ocular hazard generally arises with home-use intense light sources (ILS), higher Risk Group “embedded” ILS sources which pose a risk for the skin could conceivably be employed in home-use devices for certain applications (e.g. acne therapy).If this new laser classification is approved, the vertical standards will specify the appropriate design, engineering, reliability, test methods, labelling and instructional controls required for safe consumer use. This paper gives an overview of the recent state of development of a vertical standard which includes lasers categorized laser Class 1C, in the IEC 60335 series.