Safety of Children's Toy Laser Products
This guidance addresses children's toy laser products, defined as products primarily used as toys manufactured, designed, intended, or promoted for novelty or visual entertainment use by children under 14 years of age. It excludes laser products used in professional or academic settings.
Recommended Actions
- Ensure laser emissions do not exceed FDA Class I or IEC Class 1 limits
- Implement appropriate labeling including IEC Class 1 designation
- Obtain necessary product certification for entire toy or removable laser components
- Review product marketing, sales channels, and features to determine if product qualifies as children’s toy
- Incorporate appropriate safety features, warnings, and instructions
- Ensure compliance with both FDA and CPSC regulations
- Consider potential misuse scenarios by children in product design
- Document compliance with Federal Performance Standards for Laser Products
Key Considerations
Human Factors
- Products should consider that children may use lasers in unsafe or uncontrolled manner
- Retinal injuries may go unnoticed and unreported
- Products should consider supervision by adults who may not recognize dangers
Labelling
- IEC Class 1 designation labeling is recommended
- Promotion, advertising, labeling, packaging, and product graphics should be considered in determining if product is a children’s toy
Safety
- Must comply with Federal Performance Standards for Laser Products
- Emission levels should not exceed FDA Class I or IEC Class 1 limits
- Entire toy needs certification unless laser-emitting parts are removable
- Should incorporate safety features, warnings, and instructions for safe use
Other considerations
- Location of product sales (e.g., toy stores) helps determine if product is a children’s toy
- Purpose and features of product indicate intended use by children
- Products are subject to both FDA and CPSC regulations
Relevant Guidances
- Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 Standards
- Laser Illuminated Projectors (LIPs) - Classification, Safety Requirements and Labeling
- Laser Products - Performance Standards and Safety Requirements
Related references and norms
- IEC 60825-1:2007: Safety of laser products
- 21 CFR 1040.10 and 1040.11: Federal Performance Standards for Laser Products
Original guidance
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