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Laser Classification

Scientists have used research and knowledge about the dangers of sunlight and regular artificial light sources to set safe exposure limits for various laser radiations. These are often called Maximum Permissible Exposures (MPE’s) by laser safety experts. Based on extensive experience gained from countless hours of laser use, lasers are categorized into four risk classes, ensuring standardized safety measures. Erchonia Corporation prioritizes laser safety, and all our products adhere to the highest standards. Our lasers fall under the IEC Class 2 classification due to their low power, visibility, and nonionizing properties.

What is a Laser?

A laser, which stands for Light Amplification by Stimulated Emission of Radiation, produces energy in the optical part of the electromagnetic spectrum. This energy is intensified through stimulated emission, not to be confused with harmful radiation. Laser light color is identified by its wavelength, typically measured in nanometers, with one billion nanometers in a meter. Laser light covers nonionizing wavelengths from ultraviolet (100 – 400nm) through visible (400 – 700nm) to infrared (700nm – 1mm) regions.

Laser Hazards & Beam Hazards

Laser beams are highly focused and can raise the temperature of objects they touch, potentially altering or damaging them. In addition to thermal effects, lasers can also cause harm through photochemical effects, especially in the ultraviolet or blue spectrum. Human eyes are particularly vulnerable to lasers, especially in the retinal hazard region (around 400 nm to 1400 nm), where laser beams can focus on the retina. This can result in significant damage, with collimated laser rays concentrated by a factor of 100,000 times on the retina, making proper laser safety crucial.

Safety Standards

Laser safety standards, such as the ANSI Z136 series, are vital in various fields and serve as the foundation for laser safety. These standards are not only referenced by OSHA and many U.S. states but also provide essential guidance on classifying lasers, safety calculations, hazard control, and recommendations for Laser Safety Officers. Manufacturers of laser products must comply with FDA regulations, certifying their products meet specific safety standards, with each laser bearing a label indicating its hazard classification since August 1976.


The Laser Safety Officer

ANSI Z136.1 mandates that facilities using Class 3b or Class 4 lasers must appoint a Laser Safety Officer (LSO) responsible for ensuring laser safety during operations, maintenance, and servicing. This LSO must have the authority to oversee laser hazard control, evaluate laser risks, and implement necessary safety measures.

The LSO’s role can be full or part-time, coming from safety-related departments like occupational health and safety or engineering. Regardless of the department, they require proper training to establish and manage laser safety programs. LSO duties encompass hazard evaluation, setting up hazard zones, ensuring compliance, approving procedures, equipment, and installations, providing safety training, and managing personal protective equipment recommendations and approvals, among other administrative tasks.

Controlling Laser Hazards

Lasers can be used safely by having proper facilities, equipment, and trained personnel. The ANSI Z136 laser safety standards outline two control categories: Engineering Controls (e.g., protective housings, interlocks) and Administrative/Procedural Controls (e.g., procedures, protective gear).

Engineering Controls are reliable but may be costly, reducing reliance on human compliance. Administrative/Procedural Controls enhance safety through education, training, and safety procedures during laser operation, maintenance, and servicing.

For those working with Class 3 lasers, safety training is important, and working in marked controlled areas is recommended. Class 4 lasers typically require eye protection, facility interlocks, and extra safeguards. The ANSI Z136.1 laser safety standard outlines control measures for each laser classification and is crucial for laser safety programs. For more information, contact the Laser Institute of America at 407-380-1553.

In accordance with the Food and Drug Administration’s guidelines under Title 21, Volume 8, 800-1299 (21CFR1040), laser devices are classified as follows:

Class I Laser Product

These lasers do not allow access during operation to levels of laser radiation exceeding the limits in Table I.

Class IIa Laser Product

They permit access to visible laser radiation above Table I limits but not beyond Table II-A limits.

Class II Laser Product

These lasers allow access to visible laser radiation beyond Table II-A but not exceeding Table II limits.

Class IIIa Laser Product

Access is granted to visible laser radiation beyond Table II but not exceeding Table III-A limits.

Class IIIb Laser Product

These lasers permit access to laser radiation above Table III-A but not beyond Table III-B limits.

Class III Laser Product

Encompasses both Class IIIa and Class IIIb laser products.

Class IV Laser Product

Allows access to laser radiation exceeding Table III-B limits during operation.

Additional FDA Definitions:

Emission Duration: The time during which human access to laser or collateral radiation could occur during laser product operation, maintenance, or service, expressed in seconds.

Human Access: The ability to intercept laser or collateral radiation with any part of the human body. For Class IIIb or IV laser products, it includes access to laser radiation reflected by any single introduced flat surface from inside the product through an opening in its protective housing.

Laser: Any device capable of producing or amplifying electromagnetic radiation primarily through controlled stimulated emission, with wavelengths above 250 nm but less than or equal to 13,000 nm, or after August 20, 1986, wavelengths equal to or greater than 180 nm but less than or equal to 1.0*10^6 nm.