Laser Equipment Classification – U.S. FDA and IEC: The Foundation to Entry into the Global Marketplace
About the Webinar:
In the U.S., FDA regulations require that any laser-based product (medical devices, ITE equipment, tools, audio/video, etc.) marketed in the U.S. must comply with the Code of Federal Regulations Title 21, and this includes Part 1040, Sec. 1040.10 , “Laser products.” Outside of the U.S., the requirements to be met are IEC 60825-1, “Safety of laser products.” Not only is such U.S. compliance the law, but doing so significantly decreases the risk of harm to laser product users, maintenance, and service personnel.
The foundation for both the U.S. laser regulations and the IEC laser standards is the classification of the laser hazard. Once the Class of the laser product is known, then labeling and marking, instructions for user, maintenance and service, and construction features can be additionally verified or evaluated for compliance to the standard.
This webinar will cover the fundamental classification schemes of U.S. 21CFR and IEC60825-1 including:
Level of hazards (acute and chronic)
Marking and labeling
User, maintenance, service instructions
Some differences between U.S. and IEC regulations and standards regarding classification
Who Will Benefit:
Manufacturers of laser based end-use products or laser components wishing to market their products in, or outside of the U.S.
Mr. Boden is an Executive Technical Consultant and Director of Training & Safety for Laser for ‘Laser Product Safety, LLC’ located near Research Triangle Park, NC. He holds an MS in Biomedical Engineering from Northwestern University. He has 32 years of experience in R&D, Project Management of complex engineering projects, and is recognized as a U.S. and global laser and photo-biological optical radiation safety expert regarding FDA CDRH, OSHA, IEC, ANSI, and UL Safety Standard compliance, regulation, testing, training, and laser facilities safety assessment.
Mr. Boden presently serves on the U.S. Technical Advisory Group to IEC Technical Committee 76 – Optical Radiation Safety and Laser Equipment, and is active on many other U.S. and global technical committees on laser and photo-biological safety including ANSI Safety Standards Committee Z136.1, “Safe Use of Lasers,” and ANSI Subcommittee SSC-8, “Safe Use of Lasers in R&D and Testing,” as applied to laser facilities and university research labs. Mr. Boden was the catalyst for the formation of the IEC Committee of Testing Laboratories Working Group 6 for Photo-biological Safety. He has assessed laser testing laboratories around the globe, and has directed the building of laser testing laboratories in the U.S., Japan, and Europe. His expertise is acknowledged by many awards and publications.