UNE EN ISO 9680-2021 pdf free download – Dentistry — Operating lights.
This document specifies requirements and test methods for operating lights used in the dentaloffice and intended for illuminating the oral cavity of patients. It also contains specifications on theinstructions for use, marking and packaging-
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources,for example,from dental handpieces and dentalheadlamps and also operating lights which are specifically designed for use in oral surgery.
Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document.For dated references, only the edition cited applies.Forundated references, the latest edition of the referenced document(including any amendments) applies.ISO 1942,Dentistry – Vocabulary
ISO4073, Dentistry —Information system on the location of dental equipment in the working area of theoral health care provider
ISO 9687, Dentistry — Graphical symbols for dental equipment
ISO 11664-1,Colorimetry – Part 1: CIE standard colorimetric observers
ISO 14971, Medical devices —Application of risk management to medical devices
ISO 15223-1,Medical devices — Symbols to be used with information to be supplied by the manufacturer— Part i: General requirements
ISO/IEC 17025,General requirements for the competence of testing and calibration laboratories
ISO 17664-1,Processing of health care products —Information to be provided by the medical devicemanufacturer for the processing of medical devices —Part 1:Critical and semi-critical medical devicesISO 17664-2,Processing of health care products — Information to be provided by the medical devicemanufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO/CIE 19476, Characterization of the performance of illuminance meters and luminance meters
ISO 21530, Dentistry — Materials used for dental equipment surfaces — Determination of resistance tochemical disinfectants
IEC 60598-1,Luminaires – Part 1: General requirements and tests
IEC.60601-1:2005+AMD1:2012+AMD2:2020,Medical electrical equipment —Part 1: General requirementsfor basic safety and essential performance
IEC. 62366-1,Medical devices — Part 1:Application of usability engineering to medical devicesIEC 62471:2006,Photobiological safety of lamps and lamp systems
IEC/TR 62471-2:2009，Photobiological safety of lamps and lamp systems — Part 2: Guidance onmanufacturing requirements relating to non-laser optical radiation safety
5.2 Optical requirements
5.2.1 Adjustable level of iluminance
The level of iluminance shall be adjustable between a minimum level and maximum level specified by the manufacturer. The maximum level of iluminance shall be at least 15 000 lx at a distance of 700 mm
from the operating light.
The adjustment of iluminance may be either continuous or in discrete levels.
Test in accordance with Z.2 and 7.3.2.
The requirements of 5.2.1 do not apply to any operating mode(s) intended only for use while handling light-activated restorative materials.
5.2.2
Illumination pattern
5.2.2.1 llumination areas and iluminance levels
The ilumination pattern shall be measured to determine the maximum iluminance, E v.max, and the following iso-lluminance lines in accordance with Z3.2: 0,90 x E v,max, 0,75x E v,max 0,50 x E y,max,
0,10 x E v.max and 1 200 lx.
The inner area of ilumination, area A, is defined as the area bounded by the is-illuminance line corresponding to 75 % of the maximum iluminance. The outer border of area A shall be on or outside of an ellipse with a horizontal axis of 50 mm and a vertical axis of 25 mm, in which the horizontal axis and
vertical axis of the ellipse are aligned with the major axis and minor axis of the ilumination pattern,respectively (see Eigure 1)- The iluminance shall not be less than 75 % of E v.max throughout the llipse.
Test in accordance with Z3.2.
The outer area of ilumination, area B, is defined as the area bounded by the is-illuminance line corresponding to 50 % of the maximum iluminance. The outer border of area B shall be on or outside of an ellipse with a horizontal axis of 80 mm and a vertical axis of 40 mm and with the same axes as the
smaller llipse assoclated with area A (see Figure 2]. Test in accordance with Z.3.2.UNE EN ISO 9680 pdf download