The L Mark
Laser Safety Training
CE Assistance Services
Product Safety, LLC is dedicated to helping our
customers classify their LASER and LED/LEP products
for the Global & Domestic Market Since 2003."
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
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.
Product Safety, LLC is also a NEMKO Partner Testing Laboratory
http://www.nemko.com and we specialize in laser safety
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
program. We also offer customized laser safety training
courses and workshops. Laser Product Safety, LLC
is also an agent representing customers to Underwriters
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.
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.
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.
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.
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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