| 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 [Including: Amendment 2 (2018)] |
| Recognition Number | Radiology |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 12-317 |
| 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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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.
| 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. |