T/CI 041-2023 Active

Scope: This document specifies the terms and definitions, technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of LED medical endoscopic cold light sources (hereinafter referred to as LED cold light sources). This document applies to LED cold light sources used as functional supply devices in endoscopic examinations and surgeries. Main technical content: 4. Technical requirements - The text markings on the appearance panel should be clear and complete. - The outer surface should be smooth and uniform in color, without corrosion spots, scratches, stains, sharp edges, burrs, or other defects. - Spectral performance 4.2.1 Color rendering index: Except for special spectral applications, LED cold light sources suitable for optical observation should have good color rendering, with a color rendering index not less than 91. 4.2.2 Correlated color temperature: Except for special spectral applications, LED cold light sources suitable for optical observation should have a correlated color temperature within the range of 4000 K to 6500 K. 4.2.3 Radiant flux ratio of red, green, and blue light for LED cold light sources used in imaging systems, the corresponding spectral response of the imaging system should be provided. Taking the green light radiant flux φeg in the wavelength range of 515 nm to 545 nm as the reference, the nominal value of the red light radiant flux φer and φeg ratio in the wavelength range of 630 nm to 660 nm should be 0.85, with a tolerance of ±10%; and the blue light radiant flux φeb and φeg ratio in the wavelength range of 435 nm to 465 nm should be 1.25, with a tolerance of ±10%. If the light source is claimed not to meet the requirements of the above response segments, the corresponding response segment distribution and matching ratio should be provided. 4.2.4 Spectral characteristics for special spectral applications: For LED cold light sources used for special spectral application