CSA C22.2 No. 60601-2-22:23
Scope
Replacement:
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
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.040.50;
11.040.60;
31.260
Statut:
Norme
Date de Publication:
2023-02-28
Numéro Standard:
CSA C22.2 No. 60601-2-22:23