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Laser Compliance > Laser Labeling Requirements


Laser Labeling Requirements



Meet CDRH & IEC Standards for Laser Labels


Laser labeling is a vital aspect of laser product compliance. Understanding the different laser labeling requirements can not only save laser product manufacturers valuable time and resources but help avoid expensive fines and penalties in the future as well.


The two main standards of laser labeling include CDRH laser label standards and IEC laser label standards, with CDRH applying to US markets and IEC applying to international markets, as they tend to be accepted as the worldwide standard.


CDRH Laser Label Standards


The Center for Devices and Radiological Health (CDRH) of the FDA sets the United States standards for laser labeling. Title 21, Subchapter J, Parts 1010.2, 1010.3 and 1040.10 governs the US standard of laser product labeling. To learn more about 21 CFR laser compliance beyond labeling, contact Laser Compliance now.

To start meeting CDRH laser label standards, you will determine the following:


  1. The laser’s classification
  2. Is it visible, invisible, or both?
  3. Will additional labels be required of the product?:
    1. On a non-interlocked protective housing?
    2. Or on a defeat-ably interlocked protective housing?

The maximum laser radiation output, pulse duration and emitted wavelengths might be needed. Separate labeling is sometimes required near the aperture.


IEC Laser Label Standards


The International Electrotechnical Commission (IEC) standard 60825-1 identifies the content and style of laser safety labeling internationally.


IEC requirements share similarities to those listed above for CDRH safety labels.


However, IEC regulations permit a standard style and an alternate label. Traditional labels often combine text with a symbol. Newer labels utilize symbol-based communication.


A New Label Trend


Symbol-based labeling is being adopted that incorporates best practices for all industries globally. This circumvents language barriers and uses color-coded severity level panels to indicate the level of risk.


We have answers – and solutions!


Are you developing a laser product and need input on labeling?


Are you needing to save time and money in the decision-making, design, and implementation of your labeling?


We can help. Contact us or email us at sales@lasercompliance.com. You may also call +1 (623) 455-8565 and speak with a laser compliance consultant. We look forward to answering your questions and getting your labeling for your laser product under way.




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