Washington, DC - The Food and Drug Administration (FDA) is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standards for laser products and medical laser products. The FDA also wants to reduce the economic burden on affected manufacturers, to improve the effectiveness of FDA's regulation of laser products, and to better protect and promote the public health.
For further information go to www.federalregister.gov or "Laser Products Proposed Amendment to Performance Standard." Electronic or written comments on the proposed rule must be submitted by September 23, 2013.
"The proposed changes will update the requirements for manufacturers of lasers from international regulations set in 1985," said Peter Baker, LIA executive director. "The current action will allow manufacturers to use the 2007 version of the IEC 60825-1 (2nd edition) and other related standards for determination of hazard class for lasers sold in the US. This will be beneficial for any US manufacturer and distributors of lasers in the US."
"This has minimal impact on the need for the ANSI Z136 standards, as the IEC 60825-1 standard codifies requirements for manufacturers of lasers (e.g. engineering controls on laser devices, separation into a laser hazard class) while the ANSI Z136 series of standards is for users of lasers," Baker added. "The ANSI standard has a thorough outline of user control measures, training, and bioeffects of lasers necessary for establishment of a laser safety program in any organization."
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