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Required Documentation for all End Products
The documentation should contain a diagram showing the location of the laser aperture and warning statement as shown in the
example in
Figure
6-3.
Figure 6-3. Example of Diagram Showing Class 2 Laser Labeling
Required Labeling for Class 1 End Products
The following guidance is provided for end product labelling for products containing Class 1 scan engines:
1 - Certification Statement from FDA/IEC Label Set, 2005
The following text must appear on the end product:
• "Complies with 21CFR1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001. "
• "EN60825-1:1994+ A1:2002 +A2:2001"
• "IEC60825-1:1993+A1:1997+A2:2001"
Required location:
For most end products, this text should be located on the exterior of the product, or inside
the battery compartment, software module compartment or other user accessible area.
Access to these areas must not require special tools. Refer to the current applicable laser
safety standards for the end product for specific requirements for the end product.
Font:
Use a sans serif type font such as Arial or equivalent. The height must be at least 0.032 in.
minimum.
Color:
No color requirement. Contrast must be high enough to render this text legible.
2 - Identification
The name and address of the manufacturer must appear on the product.
Regulatory Requirements 6-3
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