IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04

Standard Organization:

IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Recognition Date2016-06-27
Recognition List043
Recognition Number12-296
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG Radiology
FDA Tech  Donald Miller   FDA/OMPT/CDRH/OIR/   301-796-3299   Donald.Miller@fda.hhs.gov

Rationale:

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Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§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
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
§892.1720 System, X-Ray, Mobile Class 2 IZL
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1670 Device, Spot-Film Class 2 IXL
§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
§892.1610 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
§892.1600 System, X-Ray, Angiographic Class 2 IZI
§872.1840 Collimator, X-Ray Class 1 EHB

FDA Guidance:

There is no relevant guidance developed at this time.


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