This International Standard specifies requirements and test methods for polymerization lamps in the wavelength range 385 nm to 515 nm intended for chairside use for the polymerization of plastic-based dental materials. This International Standard applies to rechargeable battery-operated quartz-tungsten-halogen lamps and fluorescent diode (LED) lamps. Curing lamps can have a built-in power supply (rechargeable battery) or be connected to the external power supply (mains). Lasers or plasma arc devices are not described in this International Standard. This International Standard does not apply to curing lamps used in the dental laboratory for the fabrication of indirect restorations, veneers, prostheses or other oral dental applications. This International Standard takes precedence over IEC 60601-1 when specified in the relevant sections of this International Standard.
EN ISO 10650:2015 Referenced Document
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-57:2011 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 62471:2006 Photobiological safety of lamps and lamp systems
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements