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Testing/Report Services 1. CDRH
Product Report - (Required report for all laser products and components introduced in US commerce) This service includes radiation testing and classification. A complete, ready to be filed, product report for the CDRH to obtain an Accession number is provided to you in the required format. Also included is a detailed technical listing of all applicable markings, interlocks, construction features, user manual statements, etc. required by 21CFR to be incorporated on your product. 2. CDRH Testing only - This service includes radiation testing to 21CFR when all you need is test data. 3. CDRH Supplemental Report - This service provides you a complete, ready to be filed, supplemental report in the required format for the CDRH, and includes all 21CFR required information and details for new models introduced into US commerce. 4. CDRH Annual Report - This service provides you a complete, ready to be filed, annual report due to the CDRH annually on September 1, in the required format and includes all 21CFR required information and details for your production volume. 5. CDRH
Variance Report - This service provides you a complete variance request in the required format, ready for submission to the CDRH, and includes all 21CFR required information and details for a variance request. 6. CDRH Defect Report - This service provides you a complete defect report ready for submission to the CDRH in the required format, and includes all 21CFR required information and details for a defect report. 7. CDRH Exemption Report - This service provides you a complete exemption report ready for submission to the CDRH in the required format, and includes all 21CFR required information and details for a exemption report. 8. CDRH Radiation Report - This service provides you a complete radiation report ready for submission to the CDRH in the required format, and includes all 21CFR required information and details for a radiation report. 9. IEC 60825-1 Report - (Required report for all laser and LED (depending on the LED application) products introduced in Europe and International commerce) This service includes radiation testing and classification. A complete report on the official IEC 60825-1 TRF for compliance with the European LVD 72/23/EEC to support your CE Mark is provided to you. Also included is a detailed technical listing of all applicable markings, interlocks, construction features, user manual statements etc. required to be incorporated on your product. 10. IEC 60825-1 Amendment Report - This service includes radiation testing and preparation of an IEC 60825-1 Amendment to your existing IEC 60825-1 Report. Also included is a detailed technical listing of all applicable markings, interlocks, construction features, user manual statements etc. required to be incorporated on your product. 11. IEC 60825-1 Testing only - This service includes radiation testing to IEC 60825-1 when all you need is test data. 12. IEC
60825-1/-2 Report - (Required report for all Fiber Optic Telecom Equipment introduced in Europe and International commerce) This service includes radiation testing and classification. A complete report on the official IEC 60825-1/-2 TRF for compliance with the European LVD 72/23/EEC to support your CE Mark is provided to you. Also included is a detailed technical listing of all applicable markings, 13. IEC 60825-1/-12 Report - (Required report for all Free Space Optical Communication Systems introduced in Europe and International commerce) This service includes radiation testing and classification. A complete report on the official IEC 60825-1/-12 TRF for compliance with the European LVD 72/23/EEC to support your CE Mark is provided to you. Also included is a detailed technical listing of all applicable markings, interlocks, construction features, user manual statements etc. required to be incorporated on your product. 14. IEC 60825-1/601-2-22 Report - (Required report for all Medical Equipment introduced in Europe and International commerce) This service includes radiation testing and classification. A complete report on the official IEC 60825-1/601-2-22 TRF for compliance with the European LVD 72/23/EEC to support your CE Mark is provided to you. Also included is a detailed technical listing of all applicable markings, interlocks, construction features, user manual statements etc. required to be incorporated on your product. 15. IEC 62471 Ed. 1 / CIE S 009/E:2002 / IEC 60601-2-57 Report - (Required for LEDs, UV and IR Lamps) This service includes testing and evaluation. A complete technical report is provided. 16. Facility Assessment to ANSI Z136.1 - (Required for US facilities compliance with OSHA i.e. Hospitals, Medical Clinics, Dentist Offices, Lasik Eye Surgery Clinics, Industrial Businesses, etc..) This service includes an assessment of your facility to ANSI Z136.1, the standard for safe use of lasers. Includes a list of all applicable protective safeguards, signs, interlocks, administrative measures, etc. required to be incorporated in your facility. 17. ANSI/IESNA
RP-27.1-96 Report - (Report for all LED devices, UV Lamps, etc. products and 18. Safety Eyewear Optical Density determination service - This service includes radiation testing to determine the appropriate optical density of laser safety eyewear for you to recommend for use with your product as required by 21CFR and IEC 60825. 19. Laser
Safety Eyewear Testing - This service includes testing and evaluation to determine compliance with EN 207, EN 208 and ANSI Z87 performance requirements for laser safety eyewear. A complete technical report is provided. 21. Class
1 Field Inspection Program - All
installed laser equipment is eligible for LPS's Field Evaluation Service. The most common field-evaluated products are production line industrial laser equipment employing Class 3B or 4 lasers, where the laser processing area is housed in an overall enclosure. We provide onsite testing and evaluation to determine Class 1 certification eligibility of your installed laser equipment. Additional Testing Services: 1. Product Safety Testing - UL testing, CE Mark testing, CB Report and Certificate testing, EMC, FCC, EN5022 testing. Click on our "CE Assistance Services" page for more details. 2. LOCA Testing - Unique testing capabilities include two Nuclear, Loss of Coolant Accident, LOCA environment simulator test chambers and an in-house thermogravimetric analyzer. Our LOCA test chambers create environmental conditions identified in NUREG-0588 and Appendix A of IEEE 323-74. 3. Shock and Vibration Testing - Modal analysis testing, structural dynamics testing, MIL-STD-810F standard testing, machinery vibration testing, shipping shock and vibration testing, and railroad impact testing. Please
note the MIL-STD-810 series of standards, issued by the US Army's Developmental Test Command, will likely be updated in May 2008 with the release of revision G, while a draft version should be available in late 2007. The current MIL-STD-810F revision has been in effect since January 1, 2000, when it superseded revision E from July 14, 1989. The 810 series test methods have been approved for use by all departments and agencies of the Department of Defense (DoD). The MIL-STD-810 series of tests covers a broad range of environmental conditions such as: low pressure for altitude testing, exposure to high and low temperatures plus temperature shock (both operating and in storage), rain (including wind blown and freezing rain), humidity, fungus, salt fog for rust testing, sand and dust exposure, explosive atmosphere, leakage, acceleration, shock and transport shock (triangle/sine/square wave shocks), gunfire vibration, and random vibration. This standard applies real-world wear and tear to components, subsystems, and complete systems in a laboratory setting that accelerates the testing process while it readies the DUT for final field testing. 4. Environmental Conditioning Testing - Thermal Analysis TGA/DSC, thermal aging testing, accelerated aging (thermal/wear), temperature testing, humidity testing, NFPA pyrotechnic testing chambers, salt fog testing, caustic solution testing and UL testing. 5. Seismic Testing - Seismic qualification of all types of equipment such as seismic analysis of ventilation system ductwork and ductwork accessories. Telcordia NEBS testing, Finite element modeling and analysis. Through seismic and dynamic analysis, testing or a combination of both, our qualification programs meet the IEEE, ANSI, AISC, and UBC codes and standards, as well as applicable ASME codes. 6. Structural
Testing - Static load testing, proof load testing, ultimate strength testing, stress strain measurements, and mechanical failure analysis and testing. Static proof and ultimate load testing for many different highly non-linear systems, Stress strain measurements for non-conventional bolting systems, Specialty pressure vessel systems testing, Anchorage systems testing, Fatigue testing of various types of cycling equipment, Failure analysis of mechanical systems such as fans and blowers, and Power transmission and building structural failure testing due to rotating equipment located inside the building. 8. Hydraulic System Testing - Hydraulic system failure analysis, hydraulic system failure FIT rate and MTBF testing, hydraulic system testing, and hydraulic system reliability testing.
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