| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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12-296
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| 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 |
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Scope/Abstract| 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. |
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| Extent of Recognition
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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. |
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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. |
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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 |
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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. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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