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Label Schemes for Laser Products |
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There are three label schemes that manufacturers can apply to their laser products. Click one one of the buttons below to launch the applicable presentation. |
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CDRH 21 CFR 1010 and 1040 |
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For countries that recognize U.S. FLPPS.
This should be considered if the
laser product is only sold in the U.S. |
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IEC 60825 – 1 |
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For countries that only recognize IEC.
For example Europe recognizes this format. |
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CDRH + Laser Notice # 50 – Recommended Scheme for Global Market |
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Recommended for selling to an international market. With the exception of language translation requirements this method should meet the key requirements for all countries that have national standards. For example selling both into Europe and the U.S. this option should be used. |
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Note: Laser products used for Optical Fiber Communications Systems, Free Air-Space Communications Telecommunications, and Class 3B and Class 4 laser systems may have additional IEC 60825-1 label requirements. |
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