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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 026 Date of Entry 03/14/2011 
FR Recognition Number 12-226
IEC  61223-2-6 Second Edition 2006-11
Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
This part of IEC 61223 provides assistance in performing CONSTANCY TESTS on a CT SCANNER.

It applies to those components of CT SCANNERS which influence the image quality, PATIENT dose and positioning.

This standard

- defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, PATIENT dose and positioning; the list of parameters to be tested can be found in section 4.5;

- defines the methods of testing the essential parameters;

- provides criteria to be applied in the evaluation of data for compliance with the tolerances of the parameters specified by the ACCOMPANYING DOCUMENTS and with respect to BASELINE VALUES.

These methods rely on non-invasive measurements, using appropriate test equipment, performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA or to enable the early recognition of changes in the properties of components of the EQUIPMENT.

The aim is to verify compliance with specifications affecting the image quality, PATIENT dose and PATIENT positioning.

It is not intended to consider:

- aspects of mechanical and electrical safety nor

- aspects of mechanical, electrical and software performance, unless they are essential for performing the CONSTANCY TESTS and directly affect 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.
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
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography. Document issued on October 20, 2006.

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 Contact
 Stanley H. Stern
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.