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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 12-136
Standard
ISO  9236-1 Second edition 2004-02-01
Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
Scope/Abstract
This part of ISO 9236 specifies methods for the determination of the sensitometric curve shape, average gradient and speed of a single sample of a screen/film/filmholder/processing system for medical radiography. It is not applicable to special radiographic applications such as mammography, dental radiography and direct-exposing medical radiographic systems (see for example ISO 5799 [3]).
The filmholder can be any means that ensures close screen/film contact and prevents the film from being exposed to ambient light. In particular, the filmholder can be a light-tight vacuum bag, as often used in the laboratory, or a radiographic cassette as used in medical radiography.
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)
Radiology
*These are provided as examples and others may be applicable.
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