Certified Healthcare Safety Professional (CHSP) Practice Exam

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What FDA regulation pertains to laser performance?

  1. 21 CFR 1000

  2. 21 CFR 1040

  3. 21 CFR 1050

  4. 21 CFR 1060

The correct answer is: 21 CFR 1040

The regulation that pertains to laser performance is found in 21 CFR 1040. This established standard outlines the performance standards for laser products, including safety requirements, classifications of lasers, and testing methods to ensure that they do not pose hazards to users or the public. The regulations are part of the FDA's mission to protect public health by ensuring that laser products are safe and effective for their intended purposes. 21 CFR 1040 specifically addresses various aspects of laser safety, such as labeling requirements, safety features, and compliance testing protocols. These measures are essential in minimizing risks associated with laser exposure, such as skin burns, eye damage, and other potential hazards resulting from improper use or malfunction. Understanding this regulation is crucial for professionals working in environments that utilize laser technology, as adherence ensures safety standards are met and helps in mitigating risks associated with laser applications.