The Differences between U.S. and E.U. Laser Standards

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI August 1998 Column

HELP DESK

Karl J. Hejlik, writer and editor for the Laser Institute of America, a professional society that fosters laser applications and safety, describes the differences between U.S. and European standards for medical laser products.

What is the status of the FDA laser radiation standard for medical devices, especially low-power, laser-based diagnostic sensors, compared to the standard in the European Union?

Since the first European standard for laser products (IEC-825) was published in 1984, there have been significant differences between it and the U.S. standard published by FDA's Center for Devices and Radiological Health (CDRH). Over the years, these differences have caused confusion and noncompliance and have increased costs for many manufacturers who ship products to both the United States and Europe.

Both standards have been revised in the past and are now being simultaneously reworked, so harmonizing them is analogous to shooting a moving target from a moving vehicle. Nevertheless, it's been tried. In the most recent effort (Spring 1996), CDRH informally distributed proposed changes to its standard to laser manufacturers and various other interested parties for their input. However, the center could not predict when a formal proposal or revised standard would be completed.

Although a complete examination of these suggested revisions is not possible here, a couple of issues are worth noting.

One change that would affect manufacturers is CDRH's adoption of the International Electrotechnical Commission (IEC) definition for laser classes, including the historically troublesome Class 3A. Although it is hoped there would be only a small number of products affected, there are products in the United States currently defined as Class 3A that would become 3B. This would mean stricter control measures for those devices, as laid out by the American National Standards Institute's Z136.1, "For Safe Use of Lasers."

Another issue is extending the CDRH standard to include light-emitting diodes (LEDs). Although the standard does not require LED sources that are inherently Class 1 to be tested, market pressure is often put on the manufacturer to carry out third-party testing, according to CDRH.

The IEC standard already includes LEDs but exempts inherently Class 1 LED products. For consistency, IEC has extended this exemption to inherently Class 1 laser products. Many experts think that if FDA allows this exemption, underclassified products could be placed on the market, since it is unclear how unlabeled and untested products could be accepted as inherently Class 1.

Industry response to CDRH's proposal to include LEDs in its laser standard was generally negative, so it is unknown whether the two standards can be harmonized on this point.

Other changes proposed by CDRH deal with sampling intervals, repetitive pulses, radiance and irradiance measurements, emission indicators, and beam attenuators.

Medical laser products are defined as those intended for irradiation of the human body for surgery, therapy, or diagnosis. Under both U.S. and European standards, Class 3B and 4 medical laser products must incorporate a means for measuring the level of irradiation to the human body. In the current effort to harmonize the standards, there is an emphasis on accuracy and stability of performance. CDRH proposes that outputs be within ±20% of the preset or selected value. An alarm indicating unacceptable deviance and an emergency stop control would be required on all medical laser devices.

Many devices used in the medical field for diagnosis and other purposes would not be considered medical laser products under the standards and thus would not be subject to any additional regulation—for example, diagnostic devices that only come into contact with cells or tissue samples.

The issues surrounding the U.S. and European standards for laser products are very complex. Questions about laser standards or other laser-related application or safety concerns can be directed to the Laser Institute of America at 1-800-34-LASER or 407/380-1553.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

Copyright ©1998 Medical Device & Diagnostic Industry