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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 12-296
Standard(Included in ASCA pilot)
IEC 60601-2-54 Edition 1.1 2015-04 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
IEC 60601-2-54:2009+A1:2015+A2:2018 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54. The contents of the corrigenda 1 (March 2010) and 2 (June 2011) have been included in this copy.
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FDA recognition of IEC 60601-2-54 Edition 1.1:2015 [Rec# 12-296] will be superseded by recognition of IEC 60601-2-54 Edition 1.1:2015 [Including: Amendment 2 (2018)] [Rec# 12-317]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-296] until September 28, 2021. After this transition period, declarations of conformity to [Rec # 12-296] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1720 System, X-Ray, Mobile Class 2 IZL
§872.1840 Collimator, X-Ray Class 1 EHB
§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
§892.1670 Device, Spot-Film Class 2 IXL
§892.1600 System, X-Ray, Angiographic Class 2 IZI
§892.1650 Image-Intensified Fluoroscopic X-Ray System, Mobile Class 2 OXO
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
§892.1980 Table, Radiographic, Non-Tilting, Powered Class 2 IZZ
§892.1980 Table, Radiographic, Stationary Top Class 2 IXQ
§892.1980 Table, Radiographic, Tilting Class 2 IXR
§892.1980 Table, Radiologic Class 2 KXJ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices Conformance with IEC Standards, Issued May 2019.
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
FDA Technical Contact
 Donald Miller
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.