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. FDA product registration is required by federal law. The LSO documents the compliance of safety measures taken to convert a Class 4 Laser into a Class 1 Laser System.
ABCO incorporates laser technologies in a wide range of design build projects, including branding tools with laser etching, wire marking for product identification, laser welding of precision nuclear components, perforating packaging films, date coding on medical products for traceability.
WE UNDERSTAND LASER SAFETY AND REGULATIONS
Laser markers start out as a Class 4 Laser which is defined as an eye and skin hazard for both direct and scattered exposure. We design turnkey systems to convert a hazardous Class 4 Laser into a completely safe Class 1 Laser System.
During the product design phase, our engineering team incorporates 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 are reviewed by our LSO (Laser Safety Officer). The LSO also reviews and approves all laser systems prior to shipping the completed project. We provide all the proper documentation, including the LSO Risk Assessment Review, photo documentation, FDA Product Registration Report, and the FDA Annual Product Shipment Report.
Experts at Laser Safety
ABCO has two full-time Laser Safety Officers on staff.
We ensure measures are taken to convert a Class 4 Laser into a Class 1 Laser System.
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
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
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.
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.
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 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.