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U.S. Department of Health and Human Services

Radiation-Emitting Products

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What does "designated by the film manufacturer as appropriate for mammography" mean, and how does the facility establish that they meet this requirement?

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This simply means that the film manufacturer has established that the properties of the film are appropriate for mammography and markets it for such purposes, not that the film must be sold only for mammography. One mechanism to establish compliance would be to have documentation from the manufacturer, such as advertising material or specific literature, that clearly identifies the film and its intended use.

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