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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 12-270
Standard
IEC 61223-3-5 First edition 2004-08
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
Scope/Abstract
This standard - defines the essential parameters which describe the performance of the CT scanners with regard to image quality, patient dose and positioning; - defines the methods of testing the essential parameters; - evaluates compliance with the tolerances of the parameters specified by the accompanying documents. These methods rely mainly on non-invasive measurements, using appropriate test equipment, performed during the installation or after it has been completed. Signed statements covering steps in the installation procedure may be used as part of the acceptance test report. This part of IEC 61223 is intended to assist in performing the acceptance tests on a CT scanner. The aim is to verify compliance of the installation with specifications affecting the image quality, patient dose and positioning.
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.
Transition Period
FDA recognition of IEC 61223-3-5 First edition 2004-08[Including: Technical Corrigendum 1 (2006)] [Rec# 12-270] will be superseded by recognition of IEC 61223-3-5 Edition 2.0 2019-09 [Rec# 12-328]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-270] until December25, 2022. After this transition period, declarations of conformity to [Rec # 12-270] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
FDA Technical Contacts
 Laurel Burk
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5933
  laurel.burk@fda.hhs.gov
 Lu Jiang
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  240-402-5779
  Lu.Jiang@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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