April 23, 2020
Optical radiation technologies are an important part of many different product types, from vehicles’ advanced driver-assistance systems (ADASs) to laboratory products to cutting-edge virtual and augmented reality systems.
However, laser and LED radiation presents a potential hazard to the skin and eyes. Several safety standards, including the FDA/CDRH 21CFR Part 1040 (laser), IEC 60825-1 (laser), and IEC 62471 (LED) provide a means to assess the potential radiation hazard, determine a classification scheme to help inform one of the potential hazards, and provide safeguards such as labeling, user manual statements, and construction features to help mitigate the potential hazard. Compliance with these requirements and regulations may be required for introducing the product into U.S. commerce or for better access to the global market.
Consumers, retailers, and original equipment manufacturers (OEMs) need to trust these lasers and LEDs are as safe to the skin and eyes as possible. That’s where UL comes in – we have many years of experience in evaluating products to the laser and LED radiation product safety standards, and we are an active participant on the main technical committees involved with creating and maintaining these standards. We have global optical radiation laboratories that are qualified to perform these optical radiation evaluations for issuing IEC CB Test Reports and CB Certificates.
We offer testing and certification to laser/LED radiation product safety standards and provide optical radiation services for many industries, including but not limited to:
- Technology and electronics
- Industrial products
- Healthcare and life sciences
- Automotive and mobility
- Energy and power technologies
Our services, experts and global network of laboratories can provide assistance that is tailor-made for your optical radiation safety needs, ranging from:
- A letter report simply containing the Laser Class or LED Risk Group of a product, or even a prototype – in case you simply want to better understand the potential radiation hazard of your product.
- Advisory services that provide information on the laser or LED radiation testing methods and requirements, or just to answer questions you may have on these requirements.
- Assistance with preparing the necessary FDA/CDRH documentation required to be on file with the FDA prior to introducing your laser product into U.S. commerce.
- UL Verification Mark to support a marketing type claim you wish to make about the laser or LED, such as low optical emissions, performance related, etc.
- A full certification to an IEC laser or LED radiation product safety standard with a certificate. Our experts will listen to your needs and explain the best service level offering to meet them. Results are provided in an appropriate format, helping you increase turnaround times and access to global markets.
- Risk mitigation: By working with UL, we will be able to help you minimize optical radiation hazards by identifying issues early on.
- Competitive advantage: Working with UL shows your commitment to safety, and a recognizable UL name enhances trust in your product.
We test optical radiation devices to the following requirement and regulations:
- IEC 60825-1 (outside the United States)
- FDA/CDRH 21 CFR 1040 (inside the U.S.)
- FDA/CDRH Laser Notice 50 or 56 (to allow the user of some portions of IEC 60825-1 for FDA/CDRH compliance)
- IEC 62471
- RP-27 series of standards
Contact us to learn more about our optical radiation services or visit our service page.