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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 12-138
ISO  5799 Second edition 1991-08-01
Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
This International Standard specifies methods for determining the ISO Speed and ISO average gradient of the film/process combinations used in medical and dental radiography other than mammography. Sensitometric procedures are descry bed for films exposed directly to X-rays. The purpose of this International Standard is to provide a method for the measurement of ISO Speed and ISO average gradient so that the characteristics of the fiIm/process System tan be obtained reproducibly and tan also be compared with those of other Systems.
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
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.