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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 053 Date of Entry 12/23/2019 
FR Recognition Number 12-317
Standard(Included in ASCA)
IEC  60601-2-54 Edition 1.2 2018-06 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
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators.
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FDA recognition of IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION [Rec# 12-317] will be superseded by recognition of IEC 60601-2-54 Edition 2.0 2022-09 [Rec# 12-348]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-317] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 12-317] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1680 System, X-Ray, Stationary Class 2 KPR
§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
§892.1980 Table, Radiographic, Stationary Top Class 2 IXQ
§892.1980 Table, Radiographic, Tilting Class 2 IXR
§892.1980 Table, Radiographic, Non-Tilting, Powered Class 2 IZZ
§892.1980 Table, Radiologic Class 2 KXJ
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. Guidance for Industry and Food and Drug Administration Staff: Medical X-Ray Imaging Devices Conformance with IEC Standards, Issued May 2019.

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
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.