IEC EN 60601-2-22 Medical Electrical Equipment, Part 2-22: Standard Test for Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment

Medical Device Tests

IEC EN 60601-2-22 Medical Electrical Equipment, Part 2-22: Standard Test for Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment

EUROLAB laboratory provides testing and compliance services within the scope of IEC EN 60601-2-22 standard. IEC EN 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.

IEC EN 60601-2-22 Medical Electrical Equipment, Part 2-22: Standard Test for Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment

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.

Laser equipment in this standard is classified as a class 1, class 1M, class 2, class 2M or class 3R laser product, and 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 an ME system only, the title and content of that article or sub-item will 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.

EUROLAB assists manufacturers with IEC EN 60601-2-22 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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