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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 014 Date of Entry 03/31/2006 
FR Recognition Number 12-137
ISO  4090 Third eidition 2001-08-15
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
This International Standard specifies the nominal s, aim dimensions with tolerances, weights, and certain tests for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of sheets, such as laser films and video.

This International Standard also includes information regarding the appropriate marking of these products, and special attention is given to cassettes/screens/films used for mammography.

This International Standard does not include films in roll format (see informative annex A).
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)*
Regulation Number Device Name Device Class Product Code
§892.1840 Film, Radiographic Class 1 IWZ
§892.1840 Media, Reusable Image Class 1 LQA
§892.1850 Cassette, Radiographic Film Class 2 IXA
§892.1860 Changer, Radiographic Film/Cassette Class 2 KPX
§892.1900 Controller, Temperature, Radiographic Class 2 EGT
§892.1900 Dryer, Film, Radiographic Class 2 EGW
§892.1900 Processor, Radiographic-Film, Automatic, Dental Class 2 EGY
§892.1900 Processor, Radiographic-Film, Automatic Class 2 IXW
§892.1900 Processor, Cine Film Class 2 IXX
§892.1910 Grid, Radiographic Class 1 IXJ
§892.1960 Screen, Intensifying, Radiographic Class 1 EAM
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.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.