UNE EN ISO 9680:2021 pdf download – Odontología. Lámparas dentales (ISO 9680:2021) (Ratificada por la Asociación Española de Normalización en enero de 2022.)
3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO 4073, IEC 60598-1, IEC 60601-1, CIE S 017 and the following apply. ISO and IEC maintain terminology databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https:// www .iso .org/ obp — IEC Electropedia: available at https:// www .electropedia .org/ 3.1 operating light device designed for use by an operator for illuminating the oral cavity, which either distributes, filters or transforms the light, or does any combination of these, transmitted from one or more light sources and which includes all parts necessary for supporting, fixing and protecting the light sources, and circuit auxiliaries together with the means of connecting them to the supply 3.2 light-activated restorative material dental material intended for oral use that incorporates a monomer system, the polymerization of which is activated by light 4? Classification 4.1 According to type of protection against electric shock Operating lights are classified in accordance with IEC 60601-1 as follows: a) Class I equipment; or b) Class II equipment. 4.2 According to mode of operation Operating lights are classified in accordance with IEC 60601-1 for continuous operation.
5 Requirements and recommendations 5.1 General requirements Operating lights shall be designed, constructed and manufactured so that, when properly transported, stored, installed, used and maintained according to the instructions, they cause no danger which can reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in single-fault condition. Operating lights shall be capable of being adjusted so as to permit illumination of the oral cavity in all patient operating positions. If the equipment passes all the tests described in this document, it shall be considered that these requirements are fulfilled.