| 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 Date | 2016-06-27 |
| Recognition List | 043 |
| Recognition Number | 12-296 |
| 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 |
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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.
| 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 |
| There is no relevant guidance developed at this time. |