Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...]

#1
Hi folks, I've been trying to classify the medical device that I am working on in one of the risks groups presented by the IEC 60601-2-57. Such medical device emits blue light with peak power in the 405 nm range, having around 16% of its energy in the region below 400 nm.

Then, the first very important table of this same standard is the Table 201.101, which describes the limits according to the wavelength and the radiance/irradiance limits.
Well, in this table the Actinic UV range completely contains the Near UV range, presenting much lower limits. Therefore, I conclude that there is no need for making any calculations regarding the Near UV group.

Am I right or am I missing something important here?

Thank you in advance.
 
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