Laser Safety Labels: Navigating the Shift from Notice 50 to Notice 56

Laser Safety in Focus: Transitioning from Notice 50 to Notice 56
The laser landscape is evolving, and with it, the regulatory framework governing product safety from the U.S. Food & Drug Administration (FDA). By the end of this year (December 31, 2024), the FDA intends to withdraw Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50). This change is because newer International Electrotechnical Commission (IEC) standards have been issued; stakeholders will need to transition to Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56). Keep reading to better understand some of the key elements and takeaways to be aware of.

Embracing Enhanced Safety with Updated IEC Standards
Laser Notice No. 56 aligns with the latest iterations of IEC standards, specifically IEC 60825-1:2014 and IEC 60601-2-22:2011 (with amendment 1). These updated standards are more stringent, reflecting advancements in laser technology and prioritizing enhanced safety for everyone.

Navigating the Compliance Landscape
While Laser Notice No. 50 offered manufacturers a choice between the FDA's 21 CFR standards and the older IEC versions, Notice 56 prioritizes compliance with the updated IEC standards. However, the FDA acknowledges overlap in specific areas, facilitating a smoother transition. This overlap is acknowledged for laser products not considered medical devices, and they will be required to have a certification label stating either of the following statements:

• “Complies with FDA performance standards for laser products except for conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.”
• “Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3, as described in Laser Notice No. 56, dated May 8, 2019.”

Your product should not fall under any of the medical device classification categories as defined by the FDA, available here.

Key Changes to Be Aware Of
Important areas to be aware of in the new notice include:

• Stricter Labeling Requirements: Laser warnings and hazard information must be clearer and more conspicuous. This includes legibility even in low light conditions, as well as information including laser class, wavelength, maximum output power, and beam divergence.
• Redefined Laser Class Boundaries: The classification of lasers based on their potential for harm has been modified, requiring some reclassification for lasers previously in Class 3a or 3b which may now be classified as Class 4 or Class 3R due to stricter power limits or changes in beam divergence. (It’s important to remember that under IEC 60825, Class 3a lasers have been replaced by Class 3R, with up to 5 times the Class 2 limit for visible and 5 times the Class 1 limits for some invisible.)
• Enhanced Safety Features for Medical Laser Equipment: More stringent protocols and features are mandated for medical laser devices, including interlock systems and additional visual warnings.

The FDA also addressed their future intentions to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with the IEC’s, although for now they are not enforcing compliance as long as IEC 60825-1 and IEC 60601-2-22 are met.

A Signal Word Overview for Laser Labels
All lasers must have matching signal words on their labels that identify the severity of the hazard based on the type of laser class:

• CAUTION for Class 2 and Class 3R lasers (Note commercial lasers may use DANGER for Class 3R, which is acceptable.)
• WARNING for Class 3B and for most Class 4 lasers (Note commercial lasers may use DANGER for Class 3B and Class 4, which is acceptable.)
• DANGER for Class 4 lasers that have very high power, pulse energy or irradiance (for example, >100 W average power, >1 J pulse energy, or >1016 W/cm2 )

Manufacturers: Leading the Charge in Compliance:
The main responsibility for these changes is on manufacturers to ensure their laser products meet the new IEC standards before the deadline. This extends to incorporating compliant laser safety labels that accurately reflect the product's classification and potential hazards during the production process. For those with laser products in their facilities or those that manufacture equipment with lasers, it may be time to reassess your hazards and risks, and make sure that your warnings and instructions are up-to-date and in compliance.

Your Reliable Partner in Laser Safety
The updated standards prioritize user safety, encouraging a more cautious and informed approach to working with lasers. Here at Clarion Safety, we’re committed to providing top-tier laser safety labels that adhere to the latest regulations and best practices. Our comprehensive range of labels offers clear communication of laser hazards, helps fulfill compliance requirements, and features durable materials for use across a wide range of environments.