| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
059
|
Date of Entry 12/19/2022
|
|
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 |
|
Scope/AbstractThis 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 |
|
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 (or is not recognized at all) 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 the guidance #2 listed below. |
|
Transition Period
| FDA recognition of IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION [Rec# 12-317] will be superseded by recognition of IEC 60601-2-54 Edition 2.0 2022-09 [Rec# 12-348]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-317] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 12-317] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 21 CFR 1020.32 Fluoroscopic equipment |
| §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 |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
Class 2
|
MQB
|
| §892.1680 |
System, X-Ray, Stationary
|
Class 2
|
KPR
|
| §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
|
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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