WG 4 - TC 76/WG 4

IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).

IEC 60825:2022, which is a Technical Report, serves as a guide to the employer, the responsible person, the laser safety officer, the laser user and other persons involved, on the safe use of lasers and laser equipment classified as laser class 1C, 3B or 4 in interventional applications of laser beams on humans, excluding use of consumer products. This document explains the control measures recommended for the safety of the laser user, patients, clients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.

IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-22:2019 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. 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. 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. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition;
b) it addresses technical and safety issues which have arisen since publication of the third edition;
c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4;
d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.

IEC TR 62471-3:2015(E) which is a technical report, provides guidelines for the safe use of intense pulsed light (IPL) source equipment in professional premises. It describes possible adverse incidents that may occur in respect of the use of IPL devices and recommends measures to avoid them. IEC TR 62471-3:2015 sets out the control measures recommended for the safety of recipients of IPL treatment, staff, service, maintenance personnel and others. Engineering controls which form part of the IPL equipment or the installation are also briefly described to provide an understanding of the general principles of protection.

IEC 60601-2-57:2011 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photo-biological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment. IEC 60601-2-57:2011 does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy. Light source equipment may consist of a single or multiple sources of optical radiation, with or without power supply, or may be incorporated into a complex system that includes optical, electricalor mechanical systems or sources of other radiation.

This part of IEC 60825 serves as a guide to the employer, the responsible organisation, the laser safety officer, the laser operator and other persons involved, on the safe use of lasers and laser equipment classified as class 3B or class 4. It covers all applications of laser beams on humans in, but not limited to, health-care facilities, cosmetic and hair removal centres and dental practices, including applications in vehicles and domestic premises. This technical report explains the control measures recommended for the safety of patients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection. The subject areas covered in this guide include - beam delivery systems; - biological effects of laser radiation; - reporting of accidents and dangerous situations; - checklists. The object of this report is to enhance the protection of persons from laser radiation and other associated hazards by providing guidance on how to establish safety procedures, precautions and user control measures.