CSA - CAN/CSA-C22.2 NO. 60601-2-41:11 AMD 1
Medical electrical equipment — Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
| Organization: | CSA |
| Publication Date: | 1 January 2015 |
| Status: | inactive |
| Page Count: | 15 |
| ICS Code (Other medical equipment): | 11.040.99 |
| ICS Code (Diagnostic equipment): | 11.040.55 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
Surgical luminaires are intended to produce a high illumination in the visible range (400 nm - 780 nm). They are not intended to produce invisible and potentially harmful UV radiation. However, in order not to lose too much of the visible blue light output, the cut-off filtering for UV may allow some output in the longest wavelength range of the UVA close to the visible blue boundary of 400 nm.
If measured with a radiometer that produces a flat wavelength response, a maximum unweighted UV irradiance of 10 W/m2 in the range from 300 nm - 400 nm therefore is allowed.
Other IEC standards exist that also state maximum UV irradiance values. An example is IEC 60601-2-50 that allows for a maximum effective UV irradiance of 0,1 mW/m2. This value is 5 orders of magnitude lower than the 10 W/m2 listed in IEC 60601-2-41. The difference lies in the term effective irradiance. An effective UV irradiance or UV dose value indicates that a spectral weighting function (like, e.g. the ICNIRP combined action spectrum for skin and eyes) has been applied to the actual irradiance as measured by a radiometer with a flat spectral response.
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