Dramatic laser safety classification changes affect U.S. and international manufacturers

United States and international laser product standards define the safety 'class' of laser products. Laser classes generally indicate the laser's hazard level during normal operation. Recently, some of these standards, such as the International Electrotechnical Commission (IEC; Geneva, Switzerland) Edition 3, 2014, have changed in a manner that will shift the future class designation of many laser products. This change will in turn bring significant benefits to some laser manufacturers, while simultaneously causing problems for other manufacturers, customers, and laser users across hundreds of industries and applications.

Many markets for laser products are strictly limited to lasers of certain classes, either legally or in a practical manner. For example, United States regulations limit laser projection systems and alignment lasers to the FDA's Center for Devices and Radiological Health (CDRH; Silver Spring, MD) classification IIIa (equivalently characterized as class 3R by the IEC), and new legislation in the European Union unnecessarily limits consumers to only class 1 and class 2 laser products. In other cases, the use of a Class 3B product vs. a class 3R product means the addition of a formally trained Laser Safety Officer (LSO) to the organization, as well as the application of safety training, safety equipment, formal operating procedures, and much more.

The international laser product standard IEC 60825-1 was just updated in late 2014, after many years without changes. Due to a better understanding in the last decade of the physics and biology of the actual ocular hazards presented by lasers, the 60825-1 2014 standard was dramatically revamped. These changes relax some laser class limits, allowing many laser products to lower their class and open broad new markets previously barred to their higher class.

However, some class limits have been tightened (decreases in allowable limits)—especially for pulsed infrared (IR) laser products—which will cause some laser products to jump from class 1 to class 3R or 3B, posing significant problems for many products, markets, and users.

Laser manufacturers have a relatively short time to reclassify laser products before they are legally responsible to certify with the updated laser product classes. The European Union, Japan, and other regions have already adopted Edition 3, while the U.S. is preparing for this change shortly. These changes in class will require the redesign of some products where engineered safety components (called 'performance features') must legally be added to laser products that increase in class, while other manufacturers will be able to reduce manufacturing costs by removing expensive safety features from products that will drop in class.

These critical classification issues and related data regarding the dramatically changing U.S. and international regulatory landscape will impact a large number of laser products and manufacturers globally. Unfortunately, to date many laser manufacturers are not aware of these now-formalized changes. Many other big-picture changes are dictated by this major rework of the laser product standards. Changes to laser standards do not affect the class of existing products, only those products manufactured after the effective date of the new standard. The IEC 60825-1 edition 3, 2014 standard is available at www.iec.ch.

Casey Stack is the president of Laser Compliance, commissioner of the International Board of Laser Safety, vice chair of Z136.10, and contributing author to IEC 60825.1; e-mail: [email protected].