BS EN ISO 9680:2021 pdf free download – Dentistry一Operating lights.
52.6 Shadow
The hard shadow of a disc with 20 mm diameter at a distance of 50 mm shall have no dimension greater than 12mm.
Test in accordance with 7.3.7.
5.2.7 Colour fidelity
For general illumination of the oral cavity, the operating light shall have a general colour fidelity index, b R , of at least 85.
NOTE The importance of accurately assessing colour in dental diagnosis and treatment while using an b operating light supports specifying R as the measure for colour fidelity in this document even though CIE 224
indicates that R is not intended as a universal replacement for the general colour rendering index, R a at this time. The decision to specify R fin this document was made in consultation with CIE.
Test in accordance with 7.3.8.
The requirements of 5.2.7 do not apply to any operating modes intended only for use while handling light-activated restorative materials.
5.2.8 Actinic UV hazard exposure for the skin and eye
The risk group classification of the operating light for actinic ultraviolet hazard (E ) shall be Risk Group 1 or lower, as specified in IEC 62471:2006,6.1 , tested under the conditions specified in 7.39. Unless the operating light is classified as an exempt group for actinic ultraviolet hazard, the permissible exposure duration, t max, per IEC 62471:2006, 4.3.1 shall be calculated in accordance with 7.3.9.
Compliance with this requirement shall be verified either by documentation (e.g. test report by the light source manufacturer) which verifies that all of the light sources used in the operating light do not emit in the applicable wavelength range (200 nm to 400 nm), or by testing in accordance with 7.3.9.
5.2.9 Near-UV hazard exposure for the eye
The risk group classification of the operating light for near-UV hazard (E twA) shall be Risk Group 1 or lower, as specified in IEC 6247 1:2006, 6.1 , when tested under the conditions specified in 7i10.
Unless the operating light is classified as exempt group for near-IJV hazard, the permissible exposure duration, tmax, per IEC 6247 1:2006, 4.3.2 shall be calculated in accordance with 7.3.10.
Compliance with this requirement shall be verified either by documentation (e.g. test report by the light source manufacturer) which verifies that all of the light sources used in the operating light do not emit in the applicable wavelength range (315 nm to 400 nm), or by testing in accordance with 7.3.10.
5.2.10 Retinal blue light hazard exposure
The risk group classification br retinal blue light hazard (L B) per IEC 62471:2006, 6.1 shall he Risk Group 1 or lower when tested under the conditions specified in 7.3.11.
Unless the operating light is classified as exempt group for retinal blue light hazard, the permissible exposure duration, t max, per IEC 62471:2006, 4.3.3 shall be calculated in accordance with 7L31 1,.
Test in accordance with 7.3.11.
5.2.11 Single fault condition for photobiological safety
Analysis under single fault condition shall be applied to the requirements for actinic UV exposure for skin and eye (see 528), near-UV exposure for the eye (see 52.9) and retinal blue light hazard exposure (see 52.10). The operating light shall be considered single fault safe (IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.7) if the risk group classification of the operating light does not exceed Risk Group 2 given in IEC 62471:2006, 6.1 under single fault condition.
NOTE A single fault condition, such as a short circuit or an open circuit of any component other than a component with high-integrity characteristics or a software failure, can lead to a higher LED driving current, increased light emission and a higher photobiological risk group classification.