Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
|Publication Date:||1 November 2019|
|ICS Code (Therapy equipment):||11.040.60|
|ICS Code (Radiographic equipment):||11.040.50|
|ICS Code (Optoelectronics. Laser equipment):||31.260|
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER is of CLASS 3B or 4, or CLASS 3B, or CLASS 4.
MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS which incorporate lasers as sources of energy being transferred to the PATIENT or animal and where the lasers are specified as above, are referred to as "laser equipment" in this document.
NOTE 1 LASER PRODUCTS for these applications classified as a Class 1, Class 1M, CLASS 2, Class 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1:2014 and by the general standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies to ME EQUIPMENT and to ME SYSTEMS, as relevant.
Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard.
NOTE 2 See also 4.2, RISK MANAGEMENT process, of the general standard.
NOTE 3 If the laser equipment is CLASS 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016.