US Government to Harmonize Laser Standards

Robert C. Pini

Laser manufacturers should be aware that the US Food and Drug Administration has proposed changing regulations on laser performance standards. The amendments would bring standards set by the Center for Devices and Radiological Health in line with the International Electrotechnical Commission standards for laser and medical laser products.

Companies should read and comment on the proposed changes, said Jim Smith of Rockwell Laser Industries, a firm of laser safety consultants in Cincinnati. He described the changes as, "for the most part," a relaxation of the current restrictions. Specifically, Class IIIa lasers would be downclassed. And the classification of a laser's operational time limit would be based on a shorter duration.

In the past, the time-limit classification was based on all-day occupational exposure. Yet the experience of the last decade has shown that shorter classification times are warranted.

"We're trying to become more realistic," said Jerome Dennis, a consumer safety officer at the center. "We're looking at exposure limits." He said the changes also reflect the reality that class limits have not been changed since the 1970s. While the magnitude of class limits hasn't changed, the way they are measured has.

Chief among the proposed changes:

The current Class IIa, its definition and its table of accessible emission limit would be eliminated.
Arabic numerals would be used for the class designations.
The accessible emission limit for Class I devices would be reduced for exposure to repeated pulsed light, which is more hazardous than either single-pulse or continuous-wave light.
Requirements for an emission indicator and beam attenuator would be eliminated for systems in Class II, IIIa and also IIIb when visible output is 5 mW or less.
Scanning safeguards would be required to react only to changes caused by failures and not to intentional changes.
The rules would exclude light-emitting diodes because they cannot be focused to as intense a retinal image as lasers.

Written comments on the proposal must be submitted by June 22, 1999, with an effective date to be set one year after the final rule is published in the Federal Register.

The proposed amendments are located at www.fda.gov/ohrms/dockets/98fr/032499d.txt and at www.fda.gov/ohrms/dockets/98fr/032499c.pdf.