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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 063 Date of Entry 12/23/2024 
FR Recognition Number 12-364
Standard
IEC  61223-3-8 Edition 1.0 2024-03
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
Scope/Abstract
This part of IEC 61223 applies to evaluation of the imaging performance and related QUALITY CONTROL parameters of X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022.
NOTE Cone-beam CT is a MODE OF OPERATION in INTERVENTIONAL X-RAY EQUIPMENT. This document discusses such MODE OF OPERATION in the informative Annex F.

This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display.

This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS, which are part of the QUALITY ASSURANCE PROGRAM in medical imaging departments and are intended to be performed by or under the responsibility of the RESPONSIBLE ORGANIZATION. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the MANUFACTURER'S installation instructions.

IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the RESPONSIBLE ORGANIZATION with respect to QUALITY CONTROL. This document provides guidance to MANUFACTURERS regarding the ACCEPTANCE and CONSTANCY TESTS for the X-RAY EQUIPMENT in a MANUFACTURER supplied QUALITY CONTROL manual. Annex G provides guidance for such a manual.
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
§1020.30 Diagnostic x-ray systems and their major components.
§1020.31 Radiographic equipment.
§1020.32 Fluoroscopic equipment.
§872.1840 Collimator, X-Ray Class 1 EHB
§892.1600 System, X-Ray, Angiographic Class 2 IZI
§892.1610 Collimator, Automatic, Radiographic Class 2 IZW
§892.1610 Collimator, Manual, Radiographic Class 2 IZX
§892.1610 Device, Beam Limiting, X-Ray, Diagnostic Class 2 KPW
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 Image-Intensified Fluoroscopic X-Ray System, Mobile Class 2 OXO
§892.1670 Device, Spot-Film Class 2 IXL
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1720 System, X-Ray, Mobile Class 2 IZL
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
Relevant FDA Guidance and/or Supportive Publications*
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
 Donald Miller
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-3299
  Donald.Miller@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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