Hi,
Although laser notice 56 mentions :
"For the manufactures that conform to the clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 that FDA identifies as comparable with 21 CFR 1040.10 and 1040.11, FDA does not intend to enforce the applicable requirements in 21 CFR 1040.10 and 1040.11."
The FDA recognised standard only mentions the edition 2 of IEC 60825-1
Any idea , what should I mention on my Declaration of conformity. We have tested to edition 3.
Thanks & Regards,
|  | Rashmi Pillay Regulatory Affairs Manager Ellex – Lumibird Medical group 3-4 Second Ave, Mawson Lakes SA 5095
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