YY/T 0932-2014Medical luminaires - Medical head-mounted luminaires (English PDF)

4.1 Optical requirements

4.1.1 Illuminance The manufacturer shall specify the illumination at the specified distance from the light outlet, with a tolerance of ±20%.

4.1.2 Spot diameter The manufacturer shall specify the spot diameter at the specified distance from the light outlet, with a tolerance of ±10%.

4.1.3 Color rendering index The color rendering index of emitted light shall be >= 85.

4.1.4 Color temperature The color temperature of emitted light shall be between 3 000 K ~ 6 700 K.

4.2 Headband adjustment range (if applicable) The adjustment range of headband shall be no less than 520 mm ~ 640 mm.

4.3 Brightness adjustment function The light output shall be adjustable from at least 10% of the maximum value to the maximum value, and an indication of the relative light intensity ratio or intensity change direction corresponding to the maximum light intensity shall be given.

4.4 Material biocompatibility Application site materials in direct contact with the operator's skin, such as headbands, shall be proven to be biocompatible in one of the following ways:

a) According to the biological evaluation principles of GB/T 16886.1-2011, the following requirements shall be met: -- No cytotoxicity; -- No delayed-type hypersensitivity. Emphasize the light of the light source to the maximum position; respectively measure the spot diameter in horizontal direction and vertical direction at the distance specified by the manufacturer, and calculate the average value.

5.1.4 Color rendering index

5.1.4.1 Equipment For the spectral radiation measurement system, the spectral measurement range is not less than 380 nm ~ 780 nm, the wavelength resolution is not more than 2 nm, and the relative spectral radiance difference is not more than 1%.

5.1.4.2 Steps The wavelength step of the spectral radiation system is selected at 5 nm. Measure the relative spectral power distribution S(lambda) of the light source when the light intensity setting of the light source is adjusted to the maximum value.

5.1.4.3 Calculation It shall be carried out according to the provisions of GB/T 5702-2003 and GB/T 7922- 2008.

5.1.5 Correlated color temperature According to the relative spectral power distribution S (lambda) of the light source measured in 5.1.3.2, calculate the color coordinates u and v according to GB/T 5702-2003, and then find the corresponding correlated color temperature according to the blackbody radiation trajectory in the uv chromaticity coordinate diagram.

5.2 Headband adjustment range Check with a general measuring tool.

5.3 Brightness adjustment function Proceed according to the method of 5.1.2.

5.4 Biocompatibility of materials

5.4.1 General The following materials can be finished parts or test pieces processed by the same method. The shape and size of test materials shall be prepared and treated according to the test requirements.