The L Mark
Laser Safety Training
CE Assistance Services
Laser Product Safety, LLC is a TUV SUD America Inc. Authorized Partner CARAT Laboratory http://www.tuvam.com. Laser Safety testing includes all product types and categories, i.e. Fiber Optic Telecom Equipment, Information Technology Equipment, Military Equipment, NVGs, Audio/Video Equipment, Medical and Dental Equipment, Laboratory and Measurement Equipment, LED Arrays, Portable Tools, Laser Levels, Iris scanners, Barcode scanners, Imaging, Projection, Laser Rangefinders, LRFs, Ophthalmic Equipment, Photographic Equipment, Industrial Systems, Beam Dumps, Laser Curtains, Alignment devices, Surveillance Equipment, Time of Flight, Solid State Lighting, Toys, etc. Also included are products intended for use with, or protection from lasers or LEDs. We also offer a Class 1 Field
Evaluation program for eligible, already installed, industrial laser systems, i.e. laser markers for packaging, engravers, cutters, etc. as well as laser safety training courses and workshops.
Laser Product Safety, LLC is also a NEMKO Partner Testing Laboratory http://www.nemko.com and we specialize in laser safety testing and
LED safety testing and classifying laser, LED, UV and IR products and components to global laser/LED safety regulations. LPS offers International approvals for over 150 countries via the Nemko Direct program. We also offer customized laser safety training courses and workshops. Laser Product Safety, LLC is also an agent representing customers to Underwriters Laboratories Inc.
Laser Product Safety, LLC is a CARAT Certified Laboratory of TUV SUD America operating in conformance with ISO/IEC/EN 17025, General Requirements for the Competence of Testing and Calibration Laboratories.. Whether your LED or laser device is Class 1, Class 1M, Class 2, Class 2M, Class 3R, Class 3B or Class 4, we can perform laser safety testing and radiation measurements required for classification determination on your laser/LED product and prepare your US FDA CDRH reports, and/or your IEC 60825 reports. Either ship a sample of your product to our laboratory, or, we can come to your facility with our equipment and perform the necessary LED or laser safety testing at your location. If your company uses LEDs or lasers, we can train and/or assist your Laser Safety Officer in developing and implementing your company laser safety program and laser safety testing. We also offer laser safety training courses and workshops.
The European Medical Device Directive 93/42/EEC, the Machinery Directive 2006/42/EC, the Personal Protective Equipment (PPE) Directive 89/686/EEC, the CE Mark Directive 93/68/EEC, the Toy Directive 2009/48/EC 88/378/EEC and most notably, the Low Voltage Directive 2006/95/EC 73/23/EEC (LVD) requires that products be marked with the "CE" Mark to indicate compliance with all applicable IEC safety standards before they can be legally introduced into the EU marketplace. (Note: EN standards are the IEC standards adopted by the countries of the European community and each country may add various national deviations particular to their country. EN stands for "European Norm".) If you manufacture a product or a component that incorporates a laser or LED (depending on the LED application), then IEC 60825, the standard for safety of laser products, is the IEC safety standard your product would be required to be in compliance with, to address laser and LED radiation hazard concerns. IEC 62471 Ed. 1 and CIE S 009/E:2002, the standard for Photobiological Safety for Lamps and Lamp Systems would apply to LEDs, UV and IR Lamps, Lamp Systems, etc. http://www.iec.ch
If you manufacture a product or a component that incorporates a laser, US Federal Law requires testing and classification of your product to US FDA 21CFR. Before you can legally introduce your product into US commerce, a Product Report detailing compliance with 21CFR requirements is required be filed with the US FDA CDRH to obtain an Accession number issued to your product. Products employing LEDs fall into the scope of ANSI/IESNA RP-27.1-96, Photobiological Safety for Lamps & Lamp Systems - General Requirements. Many laser product manufacturers only file a Product Report and overlook the additional reports required to be filed with the US FDA CDRH as applicable to production. Failure to prepare and file all required CDRH report may result in fines when audited, i.e. Supplemental report, Annual report, Abbreviated report, Radiation Quality Control report, Radiation Test Result report, Dealer and Distribution report, Incident report, Defect report, Variance report, etc. http://www.fda.gov
In Canada, the national laser product safety regulations is the Radiation Emitting Devices Act, Chapter R-1:2001, (RED) issued by Department of Justice Canada, "An Act respecting the sale and importation of certain radiation emitting devices." RED refers to both 21CFR and IEC 60825 as the prescribed regulations for the purpose of radiation protection to persons. Depending on the particular Canadian province and the local Canadian authority having jurisdiction, either 21CFR or IEC 60825 compliance is required for laser products introduced in Canadian commerce. http://canada.justice.gc.ca
The International marketplace outside of the US, Canada and Europe require compliance with IEC 60825 and AS/NZS 2211 for laser and LED products. http://www.iec.ch
Laser Product Safety LLC serves the International community. Product samples are shipped to Laser Product Safety LLC for testing and evaluation from all over the world. You can find us serving in every corner of the globe. Laser Product Safety LLC has an experienced and qualified staff that can provide laser safety training and/or assist you with all the required LED and laser safety testing, reports and certifications to enable you to introduce your laser/LED product in the worldwide marketplace.
Laser Product Safety LLC's latest publications !
This Feature article was published in the International Laser Safety Conference Program & Proceedings, 2015, Paper P107, Pages 295-299. Merging the Scientific Method Into the Project Plan
Merging the Scientific Method into the Project Plan.pdf
This Feature article was published in Medical Design briefs, September 2014, Volume 4, Number 9, Pages 16-20.
Safety, Compliance, and Regulation: The Gateway for Laser-Based Products into the Marketplace
Laser Product Safety LLC Provides Expert Opinion and/or Testimony as Expert Witness - Laser Accident/Injury:
- MICHELLE FRASCONE, Plaintiff, vs. UNIVERSITY OF SCRANTON, Defendant. In the United States Court of Common Pleas Of Lackawanna County Civil Division, Commonwealth of Pennslyvania. Case No. 14-CV-4587. Laser eye injury case invloving a high-power Class IV laser beam in a university research laboratory in which student's eye was severely injured. Expert for plaintiff.
- TELEBRANDS CORP., Plaintiff, vs. 1BYONE PRODUCTS INC., Defendant. In The United States District Court For The District Of Delaware. Case No. 1:17-CV-00997-UNA. Case invloving laser based lighting for decorative holiday lighting. Expert for plaintiff.
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