ISO 4090 Third eidition 2001-08-15

Standard Organization:

ISO 4090 Third eidition 2001-08-15
Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications

Recognition Date2006-03-31
Recognition List014
Recognition Number12-137
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Radiology
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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).

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.1960 Screen, Intensifying, Radiographic Class 1 EAM
§892.1910 Grid, Radiographic Class 1 IXJ
§892.1900 Controller, Temperature, Radiographic Class 2 EGT
§892.1900 Dryer, Film, Radiographic Class 2 EGW
§892.1900 Processor, Cine Film Class 2 IXX
§892.1900 Processor, Radiographic-Film, Automatic Class 2 IXW
§892.1900 Processor, Radiographic-Film, Automatic, Dental Class 2 EGY
§892.1860 Changer, Radiographic Film/Cassette Class 2 KPX
§892.1850 Cassette, Radiographic Film Class 2 IXA
§892.1840 Film, Radiographic Class 1 IWZ
§892.1840 Media, Reusable Image Class 1 LQA

FDA Guidance:

There is no relevant guidance developed at this time.

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