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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 061 Date of Entry 12/18/2023 
FR Recognition Number 12-348
Standard(Included in ASCA)
IEC  60601-2-54 Edition 2.0 2022-09
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
This document 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 document.

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 document. The scope of this document also excludes radiotherapy simulators.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
203.9.101 X-RAY EQUIPMENT specified for RADIOSCOPY
203.9.102 X-RAY EQUIPMENT specified for RADIOGRAPHY
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.

This standard is recognized in part because:

- 203.9.101 is in conflict with an existing regulation, 21 CFR 1020.32(g) Source-skin distance (1).
- 203.9.101 is in conflict with an existing published final guidance, see Section IV. Section A Electronic Products - Performance Standards; Row 4 of Table 3; Row 12 of Table 4 in FDA guidance #2 listed below.
- 203.9.102 is in conflict with an existing regulation, 21 CFR 1020.32(i) Source-skin distance (2).
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 System, X-Ray, Stationary Class 2 KPR
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§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
21 CFR 1020.32 Fluoroscopic equipment
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.

3. Guidance for Industry and Food and Drug Administration Staff: Policy Clarification for Certain Fluoroscopic Equipment Requirements, 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.