| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
053
|
Date of Entry 12/23/2019
|
|
FR Recognition Number
|
12-317
|
| Standard | (Included in ASCA) |
IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy |
|
Scope/Abstract| 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. |
|
| Extent of Recognition
|
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. |
|
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| FDA recognition of IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION [Rec# 12-317] will be superseded by recognition of IEC 60601-2-54 Edition 2.0 2022-09 [Rec# 12-348].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 |
| §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.
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. |
|
|
