Laser Safety Consulting

SEL has been evaluating laser safety products to IEC 60825-1 since the early 1990s, where, over that time, we have often submitted to Notified Bodies (most often German ones) for their approval marks. In reading the standard today, there are still some gray areas that have to be determined that would be difficult to do, without such a history -- experience in the courtroom so to speak where precedence is established. Single fault considerations in particular need to be suitably vetted with said expertise where "every reasonably conceivable single fault needs to be considered". 

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SEL can conduct testing in its lab, and sometimes, due to the nature of the laser (scanning or pulsed types) we do so at our clients' facilities with their equipment and ability to introduce the necessary faults most easily.

 

Typically we prepare the IEC 60825-1 test report which includes the clause-by-clause, line-by-line reckoning of the compliance details, and then use that as the basis of our CDRH/FDA product submittal report, which SEL has been making on behalf of its clients, with its clients, for decades. We can support making annual reports as well, which are required every year by laser manufacturers, to account for what was shipped and possible incidents in the field.

 

We work to make sure the product's labels, manuals, sales literature, which are to be submitted to the CDRH/FDA, are compliant; and support the efforts in production required to comply with its requirements and ultimately put only safe products out onto the marketplace.