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US: Underwriters Labs offers third-party testing for laser pointer sellers
Underwriters Laboratories announced on October 17 2013 that it will offer third-party testing of laser pointers for manufacturers and retailers. UL said this came in response to increasing laser pointer incidents and mislabeling. In February 2013, the National Institute of Standards and Technology reported that most laser pointers they tested were not in compliance with U.S. laser regulations.
These regulations, 21 CFR 1040.10 and 1040.11, require laser product manufacturers only to self-certify to the Food and Drug Administration that their products meet safety standards. Once the FDA’s Center for Devices and Radiological Health reviews and acknowledges the certification, the laser product can be marketed in the United States.
UL is providing a third-party, independent check on the manufacturer’s claims. This can be provided to retailers such as Amazon.com which in August 2013 began requiring third-party verification of lasers sold on its website. UL can also assist with preparation of a manufacturer’s FDA report.
These regulations, 21 CFR 1040.10 and 1040.11, require laser product manufacturers only to self-certify to the Food and Drug Administration that their products meet safety standards. Once the FDA’s Center for Devices and Radiological Health reviews and acknowledges the certification, the laser product can be marketed in the United States.
UL is providing a third-party, independent check on the manufacturer’s claims. This can be provided to retailers such as Amazon.com which in August 2013 began requiring third-party verification of lasers sold on its website. UL can also assist with preparation of a manufacturer’s FDA report.
From an Underwriters Laboratories press release which is reprinted below. UL has additional details about its laser testing service here on its website.
Third Party Laser Pointer Safety Testing is Essential for Consumer Safety
UL assists laser pointer retailers and manufacturers in testing compliance to U.S. FDA CDRH requirements
NORTHBROOK, Ill., Oct. 17, 2013 /PRNewswire/ -- UL (Underwriters Laboratories), a world leader in advancing safety science, announces the launch of its new laser safety testing offering for laser pointer retailers and manufacturers.
The increasingly widespread applications of laser pointers and the growing number of incidents in connection with these devices being misused have aroused concerns about laser pointer safety. Recent testing performed by the National Institute of Standards and Technology (NIST), which revealed that many laser pointers were not in compliance with U.S. federal safety regulations, points to the need for third party confirmation of a laser pointer manufacturer's self-certification to the FDA requirements.
"Laser powers over 5mW can be hazardous, causing potential issues such as temporary visual problems or eye injuries. Therefore, the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) mandates a laser power limit of 5mW for visible hand-held laser pointers (equivalent to CDRH Class IIIa or IEC Class 3R). Laser pointers over 5mW cannot be legally sold or marketed in, or imported into the United States," said Winn Henderson, subject matter expert for Optical Radiation, UL.
Currently, to meet U.S. federal safety regulations, laser product manufacturers are only required to submit a self-certified CDRH report and obtain an acknowledgment letter from the CDRH for marketing, selling, or importing the product into the United States.
"Despite not requiring third party checks by law, some retailers are requesting that laser pointer manufacturers provide a third party laser safety report in order to sell their laser pointers and to better protect the safety of consumers. Therefore many manufacturers are approaching UL for laser testing, classification, and CDRH report services in pursuit of meeting these retailer requirements," said Henderson.
UL's laboratories in the United States, Japan and Korea can test all types of laser products to both CDRH and IEC laser safety requirements, resulting in a complete CDRH Report ready to file with the FDA or an IEC 60825-1 CB Test Report with CB Certificate. In addition, UL can create a specialized Laser Pointer Safety Evaluation short-form report to document the results of the laser pointer third party check. For more information, visit www.ul.com/lasers.
About UL
UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, testing, inspection, advisory and education services, visit http://www.UL.com.
Third Party Laser Pointer Safety Testing is Essential for Consumer Safety
UL assists laser pointer retailers and manufacturers in testing compliance to U.S. FDA CDRH requirements
NORTHBROOK, Ill., Oct. 17, 2013 /PRNewswire/ -- UL (Underwriters Laboratories), a world leader in advancing safety science, announces the launch of its new laser safety testing offering for laser pointer retailers and manufacturers.
The increasingly widespread applications of laser pointers and the growing number of incidents in connection with these devices being misused have aroused concerns about laser pointer safety. Recent testing performed by the National Institute of Standards and Technology (NIST), which revealed that many laser pointers were not in compliance with U.S. federal safety regulations, points to the need for third party confirmation of a laser pointer manufacturer's self-certification to the FDA requirements.
"Laser powers over 5mW can be hazardous, causing potential issues such as temporary visual problems or eye injuries. Therefore, the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) mandates a laser power limit of 5mW for visible hand-held laser pointers (equivalent to CDRH Class IIIa or IEC Class 3R). Laser pointers over 5mW cannot be legally sold or marketed in, or imported into the United States," said Winn Henderson, subject matter expert for Optical Radiation, UL.
Currently, to meet U.S. federal safety regulations, laser product manufacturers are only required to submit a self-certified CDRH report and obtain an acknowledgment letter from the CDRH for marketing, selling, or importing the product into the United States.
"Despite not requiring third party checks by law, some retailers are requesting that laser pointer manufacturers provide a third party laser safety report in order to sell their laser pointers and to better protect the safety of consumers. Therefore many manufacturers are approaching UL for laser testing, classification, and CDRH report services in pursuit of meeting these retailer requirements," said Henderson.
UL's laboratories in the United States, Japan and Korea can test all types of laser products to both CDRH and IEC laser safety requirements, resulting in a complete CDRH Report ready to file with the FDA or an IEC 60825-1 CB Test Report with CB Certificate. In addition, UL can create a specialized Laser Pointer Safety Evaluation short-form report to document the results of the laser pointer third party check. For more information, visit www.ul.com/lasers.
About UL
UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, testing, inspection, advisory and education services, visit http://www.UL.com.