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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 019 Date of Entry 12/19/2007 
FR Recognition Number 12-176
IEC  61223-3-2 Second eidtion 2007-07
Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
This part of IEC 61223 applies to the effectiveness of mammographic X-RAY EQUIPMENT, with respect to image quality and dose, in combination with aspects of EQUIPMENT safety.

This standard applies to mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.

The tests described in this standard require the quality and performance of the X-RAY IMAGE RECEPTORS to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-RAY EQUIPMENT. This includes RADIOGRAPHIC FILMS, INTENSIFYING SCREENS, RADIOGRAPHIC CASSETTES, storage phosphor plates and ASSOCIATED EQUIPMENT such as film processors or storage phosphor plate readers, IMAGE DISPLAY DEVICES and HARD COPY CAMERAS.

For testing RADIOGRAPHIC CASSETTES and INTENSIFYING SCREENS, this standard makes reference to ISO 4090. Sensitivity and contrast for the screen-film image receptors are considered to be stated according to ISO 9236-3.
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
§892.1715 21 CFR 900.12 (b), 90 Full Field Digital, System, X-Ray, Mammographic Class 2 MUE
Relevant FDA Guidance and/or Supportive Publications*
Premarket Applications for Digital Mammography System, Policy Guidance Documents under MQSA

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Stephen Glick
 Jabari Calliste
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.