IEC 60601-2-57 item 201.12.4.2 - Indication of parameters relevant to safety

E

Eduardo Nico

Hello All,

I´m working on a IPL project that was launched before the effectiveness of standard 60601-2-57.

The only item I´m facing some difficulty to comply is the 201.12.4.2 - Indication of parameters relevant to safety because the 2nd paragraph:

The LS EQUIPMENT OUTPUT emitted at the treatment area shall be checked each time the LS EQUIPMENT is switched on....


Our intention is to have an internal verification of the light energy but this 2nd paragraph says "at the treatment area".
I´ve seen few companies declaring compliance with this standard and tests reports are not accessible. Most IPL products do not have an external power meter to comply to this item at the treatment area.

My question is: Is it a consense that measuring the energy of light in an indirect way (internal to handpiece) is acceptable?
 
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