BS EN 60825-1:2014+A11:2021 - Page 2

Safety of laser products. Equipment classification and requirements | Status: Current

1 Scope and object 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 laserbeam 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.

NOTE 1 Operable equipment does not require a tool to prepare for operation.

Any laser product is exempt from all further requirements of this Part 1 if classification by the manufacturer of that product according to Clauses 4 and 5 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. Such a laser product may be referred to as an exempt laser product.

NOTE 2 The above exemption is to ensure that inherently safe laser products are exempt from Clauses 6,7,8 and 9.

In addition to the adverse effects potentially resulting from exposure to laser radiation, some laser equipment may also have other associated hazards, such as electricity, chemicals and high or low temperatures. Laser radiation may cause temporary visual impairment, such as dazzle and glare. Such effects depend on the task and ambient lighting level and are beyond the scope of this Part 1. The classification and other requirements of this standard are intended to address only the laser radiation hazards to the eyes and skin. Other hazards are not included within its scope. This Part 1 describes requirements that are considered sufficient to achieve the required level of product safety for general laser products with respect to hazards to the eye and skin posed by laser radiation, provided that consumer laser products comply with EN 506891 (see 9.5 in this amendment EN 60825 1:2014/A11:2021). Also, as required in 5.3 b) of EN 60825‑1, that laser products classified as Class 1C comply with the respective applicable part of either the EN 60601 series or the EN 60335 series that contains requirements for the safe exposure of the skin (note that the exposure of the skin is not necessarily limited to the MPE values of the skin), if applicable, as well as specific requirements for the performance and testing of the safeguard that prevents hazardous emission towards the eye. Depending on the type of the product, laser products such as for example medical lasers, machines or toys can be required to conform to the applicable performance and testing requirements of their relevant product safety standards.

NOTE 3 See 3.92 for “general laser product”.

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 series), audio and video equipment (IEC 60065), audio-video and IT equipment (IEC 62368‑1), electrical equipment for measurement, control, and laboratory use (IEC 61010‑1), 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. For ophthalmic instruments, to ensure patient safety, ISO 15004‑2 should be consulted and the principles of the limits provided there should be applied for laser radiation (see also Annex C and D). In previous editions, light-emitting diodes (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. IEC 62471 may be applied to determine the risk group of an LED or product incorporating one or more LEDs. Some other (vertical) standards may require the application of the measurement, classification, engineering specifications and labelling requirements of this standard (IEC 60825‑1) to LED products. Laser products with accessible radiance below the criteria specified in 4.4, designed to function as conventional light sources, and which satisfy the requirements specified in 4.4 may alternatively be evaluated under the IEC 62471 series of standards, "Photobiological safety of lamps and lamp systems". Such a product remains within the scope of this part of IEC 60825, except that the above-described optical radiation emission need not be considered for classification. The MPE (maximum permissible exposure) values provided in Annex A 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 laserMPE values may be applied to conservatively evaluate this potential hazard, or the exposure limit values in IEC 62471 should be consulted. The MPE values in Annex A are not applicable to intentional human exposure to laser radiation for the purpose of medical or cosmetic/aesthetic treatment.

NOTE 4 Informative Annexes A to G have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes are not regarded as definitive or exhaustive.

The objectives of this part of IEC 60825 are the following:

• • 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;
• • to reduce the possibility of injury by minimizing unnecessary accessible radiation and to give improved control of the laser radiation hazards through protective features.