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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 064 Date of Entry 05/26/2025 
FR Recognition Number 12-375
Standard
ANSI UL  122-2019
Standard for Safety Photographic Equipment - Ed. 5.0 [Including revisions through October 15, 2019]
Scope/Abstract
1.1 These requirements cover electrically-operated, cord-connected photographic equipment rated 300V 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.

1.3 These requirements do not cover commercial film viewers and dark room safelights, which are evaluated under the requirements for fixtures and portable lamps; projector tables, which are evaluated under the requirements for utility tables; microfilm and micrographic equipment, which are evaluated under the requirements for office appliances and business equipment; or portable photographic lamps and floodlights, which are evaluated under the requirements for stage and studio lighting fixtures.

1.4 Electric photographic equipment intended for use in a hazardous location as defined in the National Electrical Code is evaluated on the basis of its compliance with the requirements in this standard, and other appropriate examination and tests to determine whether it is acceptable for the purpose.

1.5 A product that contains features, characteristics, components, materials, or systems new or different from those covered by the requirements in this standard, and that involves a risk of fire or of electric shock or injury to persons shall be evaluated using appropriate additional component and end-product requirements to maintain the level of safety as originally anticipated by the intent of this standard. A product whose features, characteristics, components, materials, or systems conflict with specific requirements or provisions of this standard does not comply with this standard. Revision of requirements shall be proposed and adopted in conformance with the methods employed for development, revision, and implementation of this standard.
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.
Transition Period
FDA recognition of UL 122-2007 (R2011) [Rec# 12-177] will be superseded by recognition of UL 122-2019 [Rec# 12-375]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-177] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-177] will not be accepted.
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 Organizations
ANSI American National Standards Institute https://www.ansi.org/
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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