IEC 60601-2-22 Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment Testing
Medical electrical equipment – Part 2-22: basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-22 Scope:
IEC 60601 2 22 and EN 60601 2 22 testing applies to the basic safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a class 3B or class 4 laser product as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as laser equipment.
Throughout IEC 60601-2-22, light emitting diodes (LED) are included whenever the word “laser” is used.
NOTE 1 Refer to Definition 3.49 in IEC 60825-1.
NOTE 2 Laser products for these applications classified as a class 1, 1M, 2, 2M or class 3R laser product, are covered by IEC 60825-1 and IEC 60601-1.
Hazards inherent in the intended physiological function of medical electronic equipment or medical equipment systems within the scope of this standard are not covered by specific requirements in IEC 60601-2-22 except in 7.2.13 and 8.4.1 of the General Standard.
EN 60601-2-22 testing can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability.
Keystone Compliance assists manufacturers with IEC 60601-2-22 and EN 60601-2-22 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-22 test lab needs.