IEC 60601-2-22 Medical Electrical Equipment - Special Requirements for Essential Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment

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.

Classified as "laser equipment," class 1, class 1M, class 2, class 2M, or class 3R laser product in this standard, laser products for these applications are covered by IEC 60825-1 and the general standard. 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 sub-clause applies to ME equipment and ME systems as applicable.

Hazards specific to the intended physiological function of laser equipment covered by this standard are not covered by the specific requirements of this standard, except for the physiological effects of general standard 7.2.13. If laser equipment is class 60825C according to IEC 1-1 and is used as a home laser device, it is covered by IEC 60335-2-113.

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