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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 12-177
Standard
UL  122-2007 (R2011)
Standard for Photographic Equipment - Ed. 5.0
Scope/Abstract
1.1 These requirements cover electrically-operated, cord-connected photographic equipment rated 300 V or less, and permanently connected photographic equipment rated 600 volts or less, intended for household or commercial use on interior wiring systems in accordance with the National Electrical Code, NFPA 70. These requirements also cover battery-powered photographic equipment involving a risk of fire or electric shock.

1.2 These requirements cover motion picture projectors, including those intended for use in motion picture theaters; still picture projectors; equipment intended for use in taking photographs; accessories intended for use with or installation upon picture projectors or intended to be employed in viewing, editing or handling films, slides, pictures, drawings, or similar stationary graphic material; cameras; chemical replenishers; contact printers; enlargers; exposure meters; film copiers, film cutters, film dryers; film editors; household film viewers; film and paper processors; film rewinders, film strip projectors; film strip projector-phonograph combinations; film strip projector-tape player combinations; motor-operated projector screens; silent and sound motion picture projectors; print dryers; print processors; printing easels; opaque projectors; overhead projectors; photoflash equipment; photographic timers; photometers, flash cameras; slide projectors; silver recovery units; slide projector-phonograph combinations; slide projector-tape player combinations; slide sorters; slide viewers; stripping and line-up tables; video printers; and similar equipment.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 892
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Ilko Ilev
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2489
  ilko.ilev@fda.hhs.gov
Standards Development Organization
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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