Laser Testing to BS EN 60825-1

Europe

As part of the CE marking process, all laser and LED products sold in Europe must be certified to EN 60825-1. The same requirements apply to LED products as they do to laser products.

Additional standards may apply such as:

• EN 60825-2 for fibre optic laser communication products
• EN 60825-12 for open beam laser communication products
• Low Voltage Directive
• Transmission Equipment
• Machinery Directive
• General Product Safety
• Medical Devices Directive
• Radio & Telecommunication Directive

Manufacturers can self-certify their equipment to EN 60825-1, but the standard is highly complex and difficult to interpret, and in many cases, an expert is required to obtain the correct laser Class for the product. In any case, many manufacturers prefer to have independent verification of their classification requirements compliance.

Product conformity is achieved in Europe by requiring manufacturers to certify to the relevant standards for their product. The manufacturer is responsible for identifying relevant standards, designing the product accordingly, and making a declaration of conformity in the user instructions. The various national enforcement bodies are then responsible for detecting non-compliances and intervening where necessary. The standards are set by expert committees and are constantly reviewed and improved. This system places a great deal of responsibility and trust in the manufacturers, but it also allows standards to be kept up to date with changing technology, knowledge, and current practice.

USA

For laser products, the situation in the United States is somewhat different. Product safety in the United States is governed by federal regulations enforced by the Food and Drug Administration (FDA), and in the case of laser products by the FDA’s Center for Devices and Radiological Health (CDRH). The Federal Regulations are written into law, and manufacturers are required by law to follow them. They must also register the products with the FDA before selling or importing them into the country.

The regulation that governs laser products is known as 21 CFR 1040.10. This regulation was enacted into law in the 1970s and has remained unchanged ever since. As a result, it is now very out of date. Nonetheless, it remains in effect, and until recently, all laser products sold in the United States had to comply with this regulation.

The CDRH issued ‘Laser Notice 50’ in 2001, indicating that the FDA will now accept IEC classification and labeling. Manufacturers selling their products in the United States can now choose between IEC 60825-1 classification and labeling or 21 CFR 1040.10. In both cases, the products must be FDA-registered. LED products are not subject to 21 CFR 1040.10 (or any other Federal Regulation) and do not require registration.

Despite the fact that the CDRH laser regulations are Federal Law, registration is a’self declare’ process, similar to EU regulations. However, CDRH does occasionally review submissions and, if they do not meet Federal Regulations, may prohibit the use of the offending products or require that all equipment in place be changed to comply. It is also worth noting that the FDA never ‘approves’ equipment, though on rare occasions they may indicate that they have reviewed the submission and have no further questions about it.

International

IEC 60825-1, IEC 60825-2, and IEC 60825-12 are currently identical to the corresponding EN standards (though EU standards agencies reserve the right to deviate from them for safety reasons). These standards apply to Japan, Australia, Canada, and pretty much every other country that hasn’t already been covered.

Because IEC 60825-1 is also applicable in Europe (under the EN designation) and the United States (with the exception of a few clauses), it has become the global laser safety standard.

EN and IEC 60825-1 and -12 require classification to be performed at the highest emitted power under reasonably foreseeable single fault failure conditions (‘reasonably foreseeable failure conditions’ is used by EN / IEC 60825-2). This is most noticeable in electronic drive circuits for diode lasers, where a component failure, such as a short circuited transistor, may increase the output power of the laser and cause the product to emit above the AEL of the desired Class. In this case, unless the electronics are redesigned to eliminate the problem, the product must be classified at a higher level. Many manufacturers previously overlooked this requirement and succeeded in complying because the diodes were generally low power and would frequently be destroyed very quickly when subjected to a higher drive current than that intended by the circuit design. However, as the power and cost of laser diodes have decreased, most manufacturers are using higher power diodes operating at a small percentage of their maximum output to increase reliability. As a result, if a component fails, increasing the drive current of the laser diode, many of these devices will happily run at twenty times the intended product output. This may present not only a classification problem, but also a serious safety issue in some cases.

TO BS EN 60825-1

• Product Classification
• Any embedded lasers’ class (if applicable)
• Wavelengths that are available during normal operation
• Typical powers available during normal operation
• Is the laser capable of firing continuously or repeatedly while pulsing?
• Laser source datasheets
• Interlock datasheets and logic diagram (if applicable)
• One operational unit, as close to the final version as possible
• Brief description of product, its function, and number of laser sources
• Unit set-up / operating instructions
• Circuit diagrams relating to laser power (if below Class 4)
• If these cannot be supplied, then 1 spare laser module
• Details of pulse structure
• Any additional equipment necessary to operate unit
• Copies of all required laser safety labels
• Copy of product user manual

TO BS EN 60601-2-22

• Same requirements as testing for BS EN 60825-1
• Power density, energy density, and closest point of access