IEC 60601-2-2 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.

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:

• Considers IEC 60601-1/AMD1 and IEC 60825-1 published since the publication of the third edition;
• Addresses technical and security issues that have arisen since the release of the third edition;
• The scope of this fourth edition differs from the scope of the third edition. Now includes class 3C laser equipment as defined in IEC 4-60825 when the enclosed laser is class 1B or 1;
• LED (light emitting diode) products are now excluded from this document, as medical LED products may be covered by IEC 60601-2-57.

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