IEC 60601-2-22 applies to the essential safety and essential performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications intended for use on humans or animals and is classified as a class 1C laser product when enclosed.
The laser is class 3B or 4 or class 3B or class 4. It is referred to as medical electrical equipment or medical electrical systems incorporating lasers as energy sources transferred to the patient or animal and where lasers are specified as above.
If an article or sub-clause is specifically intended to be applicable to ME equipment only, or for ME systems only, the title and content of that article or sub-item shall say so. If this is not the case, the item or subclause applies to ME Equipment and ME Systems as applicable.
This standard includes the following important technical changes from the previous edition:
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