CDRH laser information labels
This page is under construction. For now, refer to 21 CFR 1040.10(g), Labeling requirements, for the FDA/CDRH regulations.
Danger
“Danger” and the red color is used for a hazardous situation that will result in death or serious injury if a person is not careful, or if control measures fail.
For labels on lasers sold in the U.S., “Danger” is used on:
In 2014, the ANSI Z136.1 standard was changed to require “Danger” only for Class 4 lasers that have exposed beams of 1 kilowatt (1000 watts) or more.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
For labels on lasers sold in the U.S., “Danger” is used on:
- Class IIIa (3R) lasers with an irradiance above 2.5 mW/cm²
- Class IIIb (3B) lasers
- Class IV (4) lasers.
In 2014, the ANSI Z136.1 standard was changed to require “Danger” only for Class 4 lasers that have exposed beams of 1 kilowatt (1000 watts) or more.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
Warning
“Warning” and the orange color is used for a hazardous situation that could result in death or serious injury if a person is not careful, or if control measures fail.
For labels on lasers sold in the U.S., “Warning” is not currently used.
In 2014, the ANSI Z136.1 standard was changed to require “Warning” to be used for Class 3B and 4 lasers where the output exceeds the Maximum Permissible Exposure (MPE), except for Class 4 lasers of 1 kW or above that use the “Danger” signal word instead.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
For labels on lasers sold in the U.S., “Warning” is not currently used.
In 2014, the ANSI Z136.1 standard was changed to require “Warning” to be used for Class 3B and 4 lasers where the output exceeds the Maximum Permissible Exposure (MPE), except for Class 4 lasers of 1 kW or above that use the “Danger” signal word instead.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
Caution
“Caution” and the yellow color is used for a hazardous situation that could result in minor or moderate injury if a person is not careful, or if control measures fail.
For labels on lasers sold in the U.S., “Caution” is used on:
The ANSI Z136.1:2014 standard uses “Caution” for Class 2, 2M and 3R lasers.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
For labels on lasers sold in the U.S., “Caution” is used on:
- Class II (2) lasers
- Class IIa (2M) lasers
- Class IIIa (3R) lasers with an irradiance of 2.5 mW/cm² or less
The ANSI Z136.1:2014 standard uses “Caution” for Class 2, 2M and 3R lasers.
As of mid-2017, FDA has not changed their regulations to match or allow the ANSI Z136.1:2014 standard.
Disclaimer
SAFETY NOTICE: This website is intended for the educational, instructional and informational purposes of the user and is not to be considered a substitute for a knowledgeable and trained Laser Safety Officer (LSO) with the duties and responsibilities as defined in the ANSI Z136 standard published by the American National Standard Institute.
While the labels herein may be sufficient for relatively simple and common laser types, for more complex situations, consult an expert in laser regulatory compliance.
While the labels herein may be sufficient for relatively simple and common laser types, for more complex situations, consult an expert in laser regulatory compliance.
