CDRH and International Laser Product Safety

Moe Lamothe

FDA's Center for Devices and Radiological Health, in accepting requirements of a new IEC standard, has lifted a burden from equipment manufacturers.

Illustration by TAISHA PAYTON

All laser products—that is, equipment incorporating lasers as components—must be classified according to their output levels. Of particular interest to the information technology industry are lasers used for telecommunications, for internal equipment signaling, and in such devices as laser pointers.

In the United States, compliance with the regulations for lasers and laser products issued by the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) is mandatory. The current CDRH regulations pertaining to laser emissions are found in 21 CFR 1040.10 and 1040.11.¹ These regulations, however, have been modified in a peculiar fashion to allow laser products conforming to the requirements of a new European standard to be accepted into U.S. commerce before planned amendments to the U.S. standards are issued.

This article outlines the laser safety requirements of the latest revision of the European standard IEC 60825-1, which CDRH is already acknowledging.

Harmonization of Compliance Requirements

Until recently, companies manufacturing laser products for sale in Europe and North America had to conduct separate power-output tests for each market. The variant limits and test methods often resulted in different classifications for the same product. But the January 2001 publication and adoption of Amendment 2 of the IEC standard 60825-1 (IEC 60825-1/Am. 2) introduced a common set of requirements that are now accepted by both European and U.S. regulatory bodies.² Canadian regulations in this matter are less clear.

For equipment intended to be sold in the United States, Laser Notice No. 50 was issued in July 2001. This notice advises that CDRH now accepts classification to the newly amended version of IEC 60825-1 as an alternative to meeting the requirements currently published by the center.³ The result of this is effectively one set of requirements applicable in both Europe and the United States. Most manufacturers have been classifying their products to accord with the requirements of both continents, so this action by CDRH lightens the regulatory burden. The text of the laser notice is reproduced in the sidebar on pages 184–185. Among the essential requirements of the document are additional filing and follow-up requirements specifically pertinent to CDRH.

There are no filing requirements in Europe, but most of the relevant safety standards require compliance as part of the approval process. (IEC 60825-1 is referenced in such standards as IEC 60950 and IEC 61010-1.)

In Canada, the applicable current regulations appear in Part VII (Laser Scanners) of the Canadian Radiation Emitting Devices Act.⁴ Canadian electrical safety standards such as CSA C-22.2 No. 60950 have been harmonized with the U.S. standards. The Canadian variation of the international electrical safety standard cites the regulatory legislation named, but it does not reference any particular standard. Compliance with CDRH requirements, however, is common practice.

Amendment 2 of IEC 60825-1

IEC 60825-1/Am. 2 has significantly changed the previously existing laser safety requirements that dated back to the IEC base standard of 1993. The revision adds three new laser classes (1M, 2M, and 3R) and deletes one (Class 3A). It increases accessible emission limits (AELs) for classes 1, 1M, and 3R, and introduces new maximum permissible exposure (MPE) values and new measuring conditions.

Allowable limits and ranges for the existing classes have also been modified. The new Class 1 has dual limits (for retinal photochemical and thermal hazards) for the wavelength range of 400–600 nm. The thermal hazard limit for point-time sources in the visible spectrum between 400 and 700 nm was increased from 0.221 to 0.39 mW.

A consolidated edition of IEC/EN 60825-1/Am. 2 is available as IEC 60825-1, Edition 1.2 2001-08. It consists of the 1993 base standard along with the first and second amendments of 1997 and 2001. All standards and related documents can be purchased from the Web site of the International Electrotechnical Commission.⁵ Interested persons can either select the PDF format for immediate download or request that printed copies be mailed. These standards are also available from the American National Standards Institute.⁶

November 1, 2001, was the official CENELEC publication date for EN 60825-1/Am. 2 with Special National Conditions. Use of EN 60825-1/Am. 2 will be mandatory on January 1, 2004, and thereafter, and also on that date, the current European laser safety standard, EN 60825-1:1994/Am. 1, will be withdrawn.

CDRH Laser Notice No. 50—"Laser Products—Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; Final Guidance for Industry and FDA"

Purpose

This guidance describes the conditions under which laser product manufacturers may introduce into U.S. commerce laser products that comply with the IEC standards 60825-1, as amended, and 60601-2-22. This guidance also describes additional requirements of the CDRH standard and alternate certification statements to be used with such
products.

Issue

The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) intends to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC 60825-1 and 60601-2-22 standards. Although CDRH began its amendment process in anticipation of the amendment of IEC 60825-1, it is not yet ready to publish an amendment. CDRH has acknowledged the advantages of one set of criteria and requirements worldwide. Amendment 2 to IEC 60825-1 was published in January 2001. As a result, manufacturers distributing products in both the United States and countries that require conformance with, or that recognize, IEC 60825-1 will have to evaluate the conformance of their products with this standard. This often requires them to change the hazard classification of their products. These manufacturers are requesting relief from CDRH so that they will have to comply with only one laser product radiation safety standard.

Background

Laser products for introduction into commerce in or imported into the United States must comply with 21 CFR 1040.10 and 1040.11 as applicable, be certified and identified in accordance with 21 CFR 1010.2 and 1010.3, and be reported in accordance with 21 CFR 1002.10. CDRH has issued notices to laser product manufacturers and importers stating nonobjection to lack of emission indicators or beam attenuators on Class II and Class IIIa systems, and hazard warning labels as specified in IEC 60825-1. These notices reduced the regulatory burden on both the industry and the agency.

CDRH will not object to conformance with many sections of IEC 60825-1, as amended, and IEC 60601-2-22 as alternatives to comparable sections of 21 CFR 1040.10 and 1040.11. CDRH plans to amend federal regulations for laser products to reflect those sections of the IEC standards. CDRH is also listing sections of its standard that contain requirements to which manufacturers must conform. This action is appropriate because of the numerous requests for relief, the amendment of IEC 60825-1, and the center's intent to harmonize its requirements with many of those of the IEC standards.

The Least-Burdensome Approach

We believe we should consider the least-burdensome approach in all areas of regulated products. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least-burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.

Guidance

Effective immediately, and until the effective date(s) of any amendments of the federal regulations affecting laser products, CDRH will not object to conformance with the comparable sections of IEC 60825-1, as amended by Amendment 2 of January 2001, in lieu of conformance with the following sections of 21 CFR 1040:

1040.10(b)—Definitions.
1040.10(c)(1)—Classification.
1040.10(d)—Accessible emission limits.
1040.10(e)—Tests for determination of compliance.
1040.10(f)(1)—Protective housing.
1040.10(f)(2)—Safety interlocks.
1040.10(f)(3)—Remote interlock connector.
1040.10(f)(4)—Key control.
1040.10(f)(5)—Laser radiation emission indicator.
1040.10(f)(6)—Beam attenuator.
1040.10(f)(7)—Location of controls.
1040.10(f)(8)—Viewing optics.
1040.10(f)(9)—Scanning safeguard.
1040.10(g)—Labeling requirements.
1040.10(h)(1)—User information.
1040.11(a)—Medical laser products.

CDRH intends to harmonize the requirements of these [foregoing] sections with those of the IEC standards. However, laser products must conform to the following sections of the CDRH standards:

1010.2—Certification.
1010.3—Identification.
1010.4—Variances.
1040.10(a)—Applicability.
1040.10(c)(2)—Removable laser systems.
1040.10(f)(10)—Manual reset mechanism.
1040.10(h)(2)—Purchasing and servicing information.
1040.10(i)—Modification of a certified product.
1040.11(b)—Surveying, leveling, and alignment of laser products.
1040.11(c)—Demonstration laser products.

CDRH intends to retain these requirements even if they differ from the IEC. They are either beyond the scope of the IEC standard, are sufficiently different, or are not normative and included as recommendations in the User's Guide section of the IEC standard.

In using this guidance, manufacturers should [1] use the following modified statement of compliance on the certification label: "Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notice No. 50, dated (Insert date of this guidance)" or "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated (Insert date of this guidance);" and [2] submit product reports or supplemental reports to describe changes to products in accordance with this guidance.

The effectiveness of this guidance will end on the effective date(s) of any amendments to the federal regulations applicable to laser products under Chapter 1, Subchapter J, of Title 21 of the Code of Federal Regulations.

Effects on IEC/EN 60825-2

If a product contains a laser and is part of a system, its manufacturer may also need to consider the requirements of IEC/EN 60825-2 for Europe (Optical Fibre Communication Systems). The requirements in the current edition of that standard are based on IEC 60825-1/Am. 1 allowable levels. Because Amendment 2 to 60825-1 both deleted and added laser classes, IEC has published an information sheet to clarify how IEC 60825-2 should be interpreted in the context of the new general laser safety requirements. References in the Part 2 standard are to be changed as follows:

"Hazard Level 2" should be replaced with "Hazard Level 2 or Hazard Level 2M, as appropriate."
"Hazard Level 3A" should be replaced with "Hazard Level 1M or Hazard Level 3R, as
In Annex B, 3B Hazard Level, in the Controlled Location column, "Hazard Level kx3A" should be replaced with "Hazard Level 1M or Hazard Level 2M."
All remaining references to Hazard Level kx3A should be deleted.
All classification and hazard-level evaluations shall be made in accordance with IEC 60825-1/Am. 2.
In Table 1 of page 11, clause 4.4.2, the limiting aperture values for IEC 60825-1/Am. 2 shall be substituted.
On page 14, all informative annexes should be deleted, and old Annex B should be replaced by a new Annex A, which is reproduced as Table I of this article.

Conclusion

IEC 60825-1/Am. 2 introduces significant revisions of the laser safety requirements for equipment. With CDRH now accepting evaluations to IEC 60825-1/Am. 2 in lieu of evaluations to the published CDRH requirements, it is time for all affected manufacturers to be using the new requirements in the design of new products and the performance of laser safety testing.

References

1. Code of Federal Regulations, 21 CFR 1040.10 and 1040.11; downloadable from the Internet at http://www.fda.gov/cdrh/radhlth/cfr/21cfr1040.10.pdf.

2. IEC 60825-1 (2001-08), "Safety of Laser Products—Part 1: Equipment Classification, Requirements, and User's Guide," consolidated ed. 1.2 (Geneva: International Electrotechnical Commission, 2001).

3. Center for Devices and Radiological Health, U.S. Food and Drug Administration, "Laser Products—Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22; Final Guidance for Industry and FDA," Laser Notice No. 50 (Rockville, MD: FDA/CDRH Office of Compliance, July 26, 2001); downloadable from the Internet at http://www.fda.gov/cdrh/comp/guidance/1346.pdf.

4. Canada, R.S. 1985, c. R-1, Radiation-Emitting Devices Regulations (REDR), C.R.C. c. 1370; downloadable from the Internet at http://lois.justice.gc.ca/en/R-1/C.R.C.-c.1370/157802.html#rid-157814.

5. International Electrotechnical Commission on-line store at http://www.iec.ch/webstore.

6. American National Standards Institute on-line store at http://webstore.ansi.org/ansidocstore.

7. IEC 60825-2 (2000-05), "Safety of Laser Products—Part 2: Safety of Optical Fibre Communication Systems," ed. 2.0 (Geneva: International Electrotechnical Commission, 2000).

Moe Lamothe, PE, is the president of M. A. Lamothe & Associates Inc. (Georgetown, ON, Canada), which has assisted companies with the testing and approval of electrical products since 1979.

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