Products emitting laser radiation can represent a potential hazard to the human eyes and skin. Therefore, manufacturers of laser products need to develop products with safety in mind to avoid potential injuries. The product development and evaluation from a laser safety aspect can be based on the international laser safety standard IEC 60825-1:2014. This product safety standard provides a classification scheme, related evaluation methods and limits, and requirements for the product's construction, labeling, and user manual. However, although this is an international standard, compliance with the standard does not automatically mean that manufacturers will meet all requirements of all countries and regions. Some countries base their national laser product safety requirements on earlier versions of IEC 60825-1, others have their own regulations, and some regions use deviating standards.
This paper presents an overview of regional and national similarities and differences in laser product safety and then focuses on a comparison between the international requirements defined by IEC 60825-1:2014 and the United States regulations based on the United States Code of Federal Regulations (CFR), Title 21, Chapter I, Subchapter J, Part 1040 (hereby simplified to be called ‘21CFR 1040’ for the remainder of this paper).