UL has full service laser laboratories in the United States and Japan enabling UL to ensure that laser products meet United States FDA (CDRH) and IEC 60825 laser safety requirements. This process allows manufacturers to confirm and document compliance with the laser product safety requirements as they market their laser products around the world.
The UL advantage
UL has experience in the CDRH 21CFR and IEC 60825 requirements and can assist manufacturers with these laser evaluations. UL can measure the radiation levels, classify the measured radiation, determine the applicable requirements, work with the manufacturer to resolve any nonconformities, and generate the appropriate documentation (CDRH 21CFR and/or IEC 60825) to support compliance.
Note that the declaration of CDRH 21CFR compliance must come directly from the manufacturer. UL can generate a ready-to-file CDRH Report for the manufacturer. The manufacturer can then submit this Report to the CDRH to declare compliance and initiate the generation of the CDRH Accession Letter.
UL can tailor the laser evaluations according to the manufacturer's needs. UL's laser evaluation services are designed to provide laser product manufacturers with only the level of service they require. For example, a manufacturer may only want the laser radiation measurement data provided by a third party rather than a full evaluation. UL can provide this service. In addition, the laser evaluation services can be part of a UL Listing/Recognition/CB Certification safety evaluation or a separate evaluation only for CDRH 21CFR and/or IEC 60825.
Laser safety compliance in the United States
The Center for Devices and Radiological Health (CDRH) regulates laser products imported into or manufactured in the United States. The CDRH is a branch of the U.S. Government under the Food and Drug Administration (FDA). Manufacturers of laser products (anyone that manufactures, assembles, or imports a laser product) must ensure that their products do not emit hazardous and unnecessary laser radiation. To ensure the product complies with the CDRH laser regulations, laser product manufacturers use the requirements of the CDRH 21 Code of Federal Regulations (21 CFR).
Once compliance has been determined and the appropriate CDRH documentation is completed, the manufacturer submits the documentation to the CDRH. Upon receipt of this documentation, the CDRH sends an Accession Letter to the manufacturer that notifies them the report has been received and is on file. The Accession Letter can be used by the manufacturer to show that the laser product is on file with the CDRH. The CDRH does not approve the report but may contact the manufacturer if they have questions on the submittal.
In addition, compliance to CDRH 21CFR may be required to support a UL Listing/Recognition certification safety evaluation performed by UL.
Laser safety compliance outside of the United States
In order to market a laser product outside of the United States, a laser product manufacturer should be able to provide technical documentation showing compliance to the applicable laser requirements: the IEC 60825 series of standards. This series includes IEC 60825-1 for all laser products and IEC 60825-2 (additional requirements for Optical Fiber Communication Systems).
In addition, compliance with IEC 60825 may be required to support a UL Listing/Recognition and/or CB certification safety evaluation performed by UL.
Differences between the CDRH 21CFR and IEC 60825
The differences between the CDRH 21CFR and IEC 60825 requirements include test methods, classification, labeling, construction features and information requirements. However, the CDRH has attempted to harmonize somewhat with the IEC 60825 by way of CDRH Laser Notice No. 50. Laser Notice 50 indicates that the CDRH will not object to the use of portions of IEC 60825 in lieu of the equivalent CDRH 21CFR requirements. However, the CDRH does maintain some deviations to IEC 60825, and the manufacturer is still required to submit an appropriate Report to the CDRH.
How laser products are evaluated to CDRH 21CFR and/or IEC 60825
An evaluation to the CDRH 21CFR and/or IEC 60825 typically consists of:
- Measuring laser radiation levels
- Classification of the measured radiation
- Determination of the applicable labeling/construction/information requirements
- Ensuring the product is in compliance with those requirements
- Generation of the appropriate documentation to support compliance
The classification schemes in the CDRH 21CFR and IEC 60825 are divided into laser class levels. In CDRH 21CFR, Class I is the least hazardous and Class IV is the most hazardous (with intermediate levels of IIa, II, IIIa, and IIIb). In IEC 60825, Class 1 is the least hazardous and Class 4 is the most hazardous (with intermediate levels of 1M, 2, 2M, 3R, and 3B). The classification of a laser product is typically determined by comparing the measured radiation levels to accessible emission limits calculated from equations in the CDRH 21CFR and/or IEC 60825. The resulting classification then determines the magnitude of the construction, labeling and information requirements that are applicable to the laser product.