ISS EIT.EVL - Optical radiation safety and laser equipment

Amendment of EN 60825-1 in relation to European regulation (LVD2)

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.

This part of EN 60825 provides requirements and specific guidance for the manufacture and safe use of laser products and systems used for point-to-point or point-to-multipoint free space optical data transmission. This standard only addresses the open beam portion of the system. If portions of the equipment or system incorporate optical fibre that extends from the confinements of the enclosure(s), the manufacturing and safety requirements under EN 60825-1 apply to those portions only. This standard does not apply to systems designed for purposes of transmitting optical power for applications such as material processing or medical treatment. This standard also does not apply to the use of systems in explosive atmospheres. The objective of this part of EN 60825 is to: - provide information to protect people from potentially hazardous optical radiation produced by free space optical communication systems (FSOCS) by specifying engineering controls and requirements, administrative controls and work practices according to the degree of the hazard; - specify requirements for manufacturing, installation, service and operating organisations in order to establish procedures and provide written information so that proper precautions can be adopted.

2019-09-26: not to be offered for LVD citation, DOW extension

This part of IEC 62471 provides requirements regarding photobiological safety of the optical
radiation emitted by image projectors. This part of IEC 62471 does not deal with other
hazards such as electrical, mechanical or fire hazards.
This part of IEC 62471 provides requirements regarding:
• optical radiation safety assessment of image projectors;
• projector risk groups;
• testing conditions and measurement conditions;
• manufacturer’s requirements including user information.
The scope of this part of IEC 62471 is photobiological safety of image projectors including the
emissions from laser-illuminated projectors that fulfill the requirements as specified in
IEC 60825-1:2014, 4.4 and for which visible light emission has been excluded from
classification in IEC 60825-1.
This part of IEC 62471 does not address safety requirements for laser display products where
collimated laser beams — generally scanned — are employed. It does address those laserilluminated
projectors that employ a laser source to illuminate, for example, a micro-electromechanical
system (MEMS) without scanned beams or crystal-based display projector system.
NOTE Image projectors containing lasers are subject to those provisions of IEC 60825-1 applicable to the
embedded laser. See IEC 60825-1:2014, 4.4 for which visible light emission has been excluded from the laser
product classification.
This part of IEC 62471 includes projectors for only visible image projection and does not
include ultraviolet (UV) projectors, infrared (IR) projectors, general lighting service (GLS)
lamps (GLS; defined in IEC 62471) or projector lamp systems used for general lighting, which
are treated in separate International Standards.

EN IEC 60825-1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. Although lasers exist which emit at wavelengths less than 180 nm (within the vacuum ultraviolet), these are not included in the scope of the standard since the laser beam normally has to be enclosed in an evacuated enclosure, and, therefore, the potential optical radiation hazards are inherently minimal. A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Typically, laser products are used for demonstration of physical and optical phenomena, materials processing, data reading and storage, transmission and display of information, etc. Such systems have found use in industry, business, entertainment, research, education, medicine and consumer products. Laser products that are sold to other manufacturers for use as components of any system for subsequent sale are not subject to IEC 60825-1, since the final product will itself be subject to this standard. Laser products that are sold by or for manufacturers of end products for use as repair parts for the end products are also not subject to IEC 60825-1. However, if the laser system within the laser product is operable when removed from the end product, the requirements of this Part 1 apply to the removable laser system.

Amandma A2:2011 je dodatek k standardu SIST EN 60825-4:2008.
This part of IEC 60825 specifies the requirements for laser guards, permanent and temporary (for example for service), that enclose the process zone of a laser processing machine, and specifications for proprietary laser guards. This standard applies to all component parts of a guard including clear (visibly transmitting) screens and viewing windows, panels, laser curtains and walls. Requirements for beam path components, beam stops and those other parts of a protective housing of a laser product which do not enclose the process zone are contained in IEC 60825-1. In addition this part of IEC 60825 indicates: a) how to assess and specify the protective properties of a laser guard; and b) how to select a laser guard.

This International Standard 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 photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).
This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.
NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope.
LS 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, electrical or mechanical systems or sources of other radiation.
NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive.

This part 2 of IEC 60825 provides requirements and specific guidance for the safe operation and maintenance of optical fibre communication systems (OFCS). In these systems optical power may be accessible outside the confinements of transmitting equipment or at great distance from the optical source. This standard requires the assessment of hazard levels at accessible locations as a replacement for classification according to IEC 60825-1. It applies to the complete installed end-to-end OFCS, including its components and subassemblies that generate or amplify optical radiation. Individual components and subassemblies that are sold only to OEM vendors for incorporation into a complete installed end-to-end OFCS need not be assessed to this standard, since the final OFCS should itself be assessed according to this standard. The objective of this Part 2 of IEC 60825 is: to protect people from optical radiation resulting from OFCS; - provide requirements for manufacturers, installation organizations, service organizations and operating organizations in order to establish procedures and supply information so that proper precautions can be adopted; - ensure adequate warnings are provided to individuals regarding the potential hazards associated with OFCS through the use of signs, labels and instructions.

This project will define which classes of laser products are considered acceptable to be made available on the Common Market in Europe as consumer products