Medical laser equipment IEC60601-2-22

Hi everyone,

Our medical device, a therapeutic ultrasound machine, embeds a laser motion detector which stops the treatment if the patient moves (US emission is stopped).

For reasons I won't discuss here, this laser is classified as 3B per the IEC60825-1:2014.

Is this laser considered a "surgical, cosmetic, therapeutic or diagnostic laser equipment" and therefore falls under the scope of the IEC60601-2-22 ?

Thank you very much for your help with that.

 

The purpose of your laser is not "surgical, cosmetic, therapeutic or diagnostic" so it is not included in the scope.

However, I would be inclined to understand what safety and essential performance measures are included in -2-22. It may be that these measures would be a good risk reduction option. And if, as an example, there is a requirement to limit power you could use that limit and point to -2-22 as being the source. Use it as a "design input" that reflects the state-of-the-art.

 

Thanks for your answer. I wanted to raise the question because our testing laboratory is challenging us saying that our device is "driven" by the laser (since it can stop the US emission), and then can be considered as a therapeutic device itself.

Concerning the safety measures described in the standard, we comply with those dealing with labeling. The rest of them are very disproportionate with respect to our use of the laser.. not being compelled to apply them would be appreciated

 

As long as IEC 608025-1 is applied there is no reason to refer to IEC 60601-2-22. For the most part, 601-2-22 has a lot of cross references to 825-1 anyway, the special (unique) requirements in the standard would be related to the application of laser power to the patient, which obviously does not apply here.

In some cases, when there is no particular standard, it is appropriate to use a particular standard for a similar device. But this is not one of those cases. Rather, this is one of the cases where people use the title without thinking (i.e. the word "laser" appears in the title, hence it should be used for any device with a laser.).

Anyway, the new text/note in Ed 3.1 for Clause 10.4 makes it pretty clear. IEC 60825-1 for general purpose lasers, and if it is Class 3B/4 and for use on patients, then use also IEC 60601-2-22.