Laser Safety
Regulations and Processes

ABCO has two full-time Laser Safety Officers (LSOs) on staff to ensure every ABCO solution is in compliance with federal regulations guaranteeing the ultimate safety. FDA product registration is required by federal law. The LSO will document compliance with safety measures taken to convert a Class 4 Laser into a Class 1 Laser System.

ABCO Automation incorporates laser technologies in a wide range of design build projects. Examples of previous ABCO laser projects include branding tools with laser etching, wire marking for product identification, laser welding precision nuclear components, perforating packaging films, date coding medical products for traceability. Incorporating lasers into a system will ensure a consistent high-quality result.

WE UNDERSTAND LASER SAFETY AND REGULATIONS

Laser markers start out life as a Class 4 Laser – defined as an eye and skin hazard for both direct and scattered exposure. Our turnkey systems are designed to convert a hazardous Class 4 Laser into a completely safe Class 1 Laser System.

During the product design phase, our engineering team will incorporate Nominal Hazard Zone information in the laser product design, following FDA-CDRH requirements for laser products. For Build to Print projects, we require the client to provide a copy of their FDA product report and accession number. All client-provided FDA product reports will be reviewed by our LSO (Laser Safety Officer). The LSO will also review and approve all laser systems prior to shipping the completed project.

FDA product registration is required by federal law. Our LSO will document compliance with safety measures taken to convert a Class 4 Laser into a Class 1 Laser System. Proper documentation includes the LSO Risk Assessment Review, photo documentation, FDA Product Registration Report, and the FDA Annual Product Shipment Report.

We understand laser safety and regulations.
ABCO has two full-time Laser Safety Officers on staff.
EXAMPLES OF LASER PROJECTS
  • Branding tools with laser etching
  • Wire marking for product identification
  • Laser welding precision nuclear components
  • Perforating packaging films
  • Date coding medical products for traceability
LASER SAFETY
  • Complete Nominal Hazard Zone calculation
  • Define laser beam control measures
  • Determine safety labeling requirements
  • Prepare supporting information for the FDA product registration report
  • Prepare and file FDA product registration
  • Prepare and file annual FDA report
  • Order and maintain laser label inventory
  • Incorporate Nominal Hazard Zone information in the laser product design

Laser Classifications

Class 1

  • A Class 1 laser is safe under all conditions of normal use.
  • Maximum permissible exposure (MPE) cannot be exceeded when viewing a laser with the naked eye.
  • Inherently safe; no possibility of eye damage.
  • Enclosure/guarding preventing user access to the laser beam during normal operation.

Class 2

  • Considered safe because the blink reflex (glare aversion response to bright lights) will limit the exposure to no more than 0.25 seconds.
  • Limited to 1 mW continuous wave, or more if the emission time is less than 0.25 seconds or if the light is not spatially coherent.
  • Intentional suppression of the blink reflex could lead to eye injury.
  • Some laser pointers and measuring instruments are class 2.

Class 3

  • Dangerous in combination with optical instruments which change the beam diameter or power density, though even without optical instrument enhancement direct contact with the eye for over two minutes may cause serious damage to the retina.
  • Output power does not exceed 5 mW.
  • Beam power density may not exceed 2.5 mW/cm2 if the device is not labeled with a “caution” warning label; otherwise, a “danger” warning label is required.
  • Many laser sights for firearms and laser pointers commonly used for presentations are in this category.

Class 4

  • Class 4 lasers have output powers of more than 500 mW in the beam and may cause severe, permanent damage to eye or skin without being magnified by optics of eye or instrumentation.
  • Diffuse reflections of the laser beam can be hazardous to skin or eye within the Nominal Hazard Zone.
  • Many industrial, scientific, military and medical lasers are in this category.
  • Many handheld lasers (laser pointers) at this output level are in this category.

Laser Safety Requirements

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Maximum Permissible Exposure (MPE)

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Laser Safety Guarding

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