CLC/TC 76 - Optical radiation safety and laser equipment

This Standard provides the optical radiation safety requirements for ultraviolet lamp products, including UV LED products. This standard provides requirements for: - optical radiation safety assessment and ultraviolet-product risk groups; - user information for safety measures; - appropriate labelling of ultraviolet lamp products This standard addresses those lamps and lamp products where the ultraviolet emission serves the primary purpose of the product and where more than half of the optical radiation emitted between 180 nm - 3 000 nm is in the spectral region 180 nm - 400 nm. If more than half of the optical radiation emitted between 180 nm - 3 000 nm is outside of the spectral region 180 nm - 400 nm, then the base standard IEC 62471-1 should be used. This standard covers medical diagnostic devices/products that emit primarily UV radiation. Because photobiological effects from UV radiation are based on the total accumulated exposure (dose) received, this standard relies on the concept of ‘Time-weighted Average’ exposures where the assessment distance for determining the RG is chosen based on realistic exposure distances and exposure durations. In other words, it is not expected that people will be exposed at very close distances, e.g. 20 - 30 cm, for extended periods of time. This standard is needed to provide assessment distances and specific guidance that are application-specific and realistic rather than the more general values in IEC 62471 where the specific application is unknown and time-weighted average exposures are not application-specific. This Standard does not provide requirements for: - lamps which primarily emit visible and/or infrared radiant energy - lamp products used for general lighting or infrared illumination or heating, which are treated in separate standards. - fluorescent ultraviolet lamps for tanning (covered by IEC 60335-2-27 and IEC 61228). - medical treatment devices/products (see IEC 60601-2-57), but covers UV medical diagnostic products.

CCMC origin

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.

This document specifies the requirements for laser products intended for consumers. The scope of this document does not include products intended for professional use (non-consumer laser products) and restrictions as specified in this standard do not apply to non-consumer laser products. For non-consumer laser products, compliance with EN 60825 1 is sufficient to achieve the necessary level of safety. Electric Toys containing lasers, which are covered by EN 62115, are excluded from the scope of this document. Class 1C consumer laser products are not in the scope of this document. For example, cosmetic and beauty care Class 1C laser products are covered by FprEN 60335 2 113.

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

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.

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

IEC 62471-5:2015(E) provides a risk group classification system for image projectors, and measurement conditions for optical radiation emitted by image projectors. It includes manufacturing requirements that may be required as a result of an image projector system being assigned to a particular risk group. Therefore, this part of IEC 62471 provides safety requirements for lamp systems that are intended to produce projected visible optical radiation, such as theatre projectors, data projectors and home-use projectors. The assigned risk group of a projector product also may be used by projector manufacturers to assist with any risk assessments, e.g. for occupational exposure in workplaces. National requirements may exist for the assessment of products or occupational exposure.

IEC 60825-1:2014 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. 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. The objectives of this part of IEC 60825 are: - to introduce a system of classification of lasers and laser products emitting radiation in the wavelength range 180 nm to 1 mm according to their degree of optical radiation hazard in order to aid hazard evaluation and to aid the determination of user control measures; - to establish requirements for the manufacturer to supply information so that proper precautions can be adopted; - to ensure, through labels and instructions, adequate warning to individuals of hazards associated with accessible radiation from laser products; and - to reduce the possibility of injury by minimizing unnecessary accessible radiation and to give improved control of the laser radiation hazards through protective features. This edition includes the following significant technical changes with respect to the previous edition: - a new class, Class 1C, was introduced; - the measurement condition 2 ("eye loupe" condition) was removed; - a classification of the emission of laser products below a certain radiance level that are intended to be used as replacement for conventional light sources can, as an option, be based on the IEC 62471 series; - and the accessible emission limits (AELs) for Class 1, 1M, 2, 2M and 3R of pulsed sources, particularly of pulsed extended sources, were updated to reflect the latest revision of the ICNIRP guidelines on exposure limits (accepted for publication in Health Physics Journal 2013, see also www.icnirp.org).

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 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 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.

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.

Gives guidance for evaluating the photobiological safety of lamps and lamp systems including luminaires. Specifically it specifies the exposure limits, reference measurement technique and classification scheme for the evaluation and control of photobiological hazards from all electrically powered incoherent broadband sources of optical radiation, including LEDs but excluding lasers, in the wavelength range from 200 nm through 3000 nm. This standard was prepared as Standard CIE S 009:2002 by the International Commission on Illumination.

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 EN 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 EN 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 Technical Report contains the national wordings of laser warning labels to be read in conjunction with EN 60825-1:1994.

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.

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. Applies to all component parts of a guard including clear (visibly transmitting) screens and viewing windows, panels, laser curtains and walls.

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).

This document is applicable to products that emit laser radiation for the purpose of free space optical data transmission. This document does not apply to laser products designed for the purposes of transmitting optical power for applications such as material processing or medical treatment. This document also does not apply to the use of laser products in explosive atmospheres (see IEC 60079-0). Light-emitting diodes employed by free space optical communication systems, used for the purpose of free space optical data transmission, do not fall into the scope of this document. NOTE If the laser product incorporates an optical fibre that extends from the confinements of the enclosure, the requirements in IEC 60825-2 applies.

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 this International Standard, light emitting diodes (LED) are included whenever the word 'laser' is used. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition of IEC 60601-2-22, published in 1995. This edition constitutes a technical revision. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.

IEC 60825-1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. 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. However, if the laser system within the laser product is operable when removed from the equipment, the requirements of this Part 1 apply to the removable unit. Any laser product is exempt from all further requirements of this Part 1 if classification by the manufacturer of that product according to Clauses 3, 8 and 9 shows that the emission level does not exceed the AEL (accessible emission limit) of Class 1 under all conditions of operation, maintenance, service and failure. In addition to the hazards resulting from laser radiation, laser equipment may also give rise to other hazards such as fire and electric shock. This Part 1 describes the minimum requirements. Compliance with this Part 1 may not be sufficient to achieve the required level of product safety. Laser products must conform to the applicable performance and testing requirements of the applicable product safety standards. Where a laser system forms a part of equipment which is subject to another IEC product safety standard (e.g. for medical equipment (IEC 60601-2-22), IT equipment (IEC 60950), audio and video equipment (IEC 60065), equipment for use in hazardous atmospheres (IEC 60079), or electric toys (IEC 62115)), this Part 1 will apply in accordance with the provisions of IEC Guide 1042) for hazards resulting from laser radiation. If no product safety standard is applicable, then IEC 61010-1 applies. In previous editions, LEDs were included in the scope of IEC 60825-1, and they may be still included in other parts of the IEC 60825 series. However, with the development of lamp safety standards, optical radiation safety of LEDs in general can be more appropriately addressed by lamp safety standards. The removal of LEDs from the scope of this Part 1 does not preclude other standards from including LEDs whenever they refer to lasers. CIE S009 may be applied to determine the risk group class of an LED or product incorporating one or more LEDs. The MPE (maximum permissible exposure) values of this Part 1 were developed for laser radiation and do not apply to collateral radiation. However, if a concern exists that accessible collateral radiation might be hazardous, the laser MPE values may be applied to conservatively evaluate this potential hazard. The MPE values are not applicable to intentional human exposure to laser radiation for the purpose of medical or cosmetic/aesthetic treatment. The objectives of this part of IEC 60825 are the following: to introduce a system of classification of lasers and laser products according to their degree of optical radiation hazard in order to aid hazard evaluation and to aid the determination of user control measures; to establish requirements for the manufacturer to supply information so that proper precautions can be adopted; to ensure, through labels and instructions, adequate warning to individuals of hazards associated with accessible radiation from laser products; to reduce the possibility of injury by minimizing unnecessary accessible radiation and to give improved control of the laser radiation hazards through protective features.

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.

Superseded by EN 60825-4:2006

EN following parallel vote * Superseded by EN 60825-4:2006

This Guide has been prepared in order to provide information and guidance to employers and employees in organisations in which lasers are used. It is supplementary to the safety requirements specified in the EN 60825 series of standards on laser safety. The Guide outlines procedures for the management of laser hazards and defines levels of competence for those who work with laser equipment or who have responsibility for laser safety.

EN following parallel vote * Corrigendum to EN issued April 2004

Supersedes A11:1997

Provides requirements and specific guidance for the safe use of optical fibre and/or control communication systems where optical power may be accessible at great distance from the optical source. The objective of this part 2 of EN 60825 is to: - protect people from optical radiation resulting from optical fibre communication systems. This requires the introduction of engineering requirements and work practices according to the degree of hazard; - lay down requirements for manufacturers and operating organizations in order to establish procedures and supply information so that proper precautions can be adopted; - ensure adequate warning to individuals of the hazards associated with optical fibre communication systems through signs, labels and instructions; - reduce the possibility of injury by minimizing unnecessary accessible radiation, give improved control of the optical radiation through protective features and provide safe usage of products by specifying user control measures.

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. Applies to all component parts of a guard including clear (visibly transmitting) screens and viewing windows, panels, laser curtains and walls.

Corrigendum to EN/A11 issued July 1997 * Superseded by A1:2002

Deals with the safety of laser products. Covers laser radiation in the wavelength range 180 nm to 1 mm, indicates safe working levels of laser radiation and introduces a system of classification of lasers and laser products according to their degree of hazard. Has the status of a group safety publication in accordance with IEC Guide 104.

Applies to laser equipment for medical applications, classified as a class 3B or class 4 laser product according to the classification in EN 60825-1.

Provides requirements and specific guidance for the safe use of optical fibre and/or control communication systems where optical power may be accessible at great distance from the optical source. Does not apply to optical fibre systems primarily designed to transmit optical power for applications such as material processing or medical treatment.

This standard lays down definitions and minimum requirements, as well as suitable test procedures, for the characteristics and manufacturing standards for detectors, instruments and equipment for the measurement of power and energy of laser radiation.