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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 12-309
Standard(Included in ASCA pilot)
IEC 60601-2-28 Edition 3.0 2017-06
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Scope/Abstract
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging.

Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. 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
Complete standard
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FDA recognition of IEC 60601-2-28 Edition 2.0 [Rec# 12-204] will be superseded by recognition of IEC 60601-2-28 Edition 2.1 [Rec# 12-309]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-204] until September 28, 2021. After this transition period, declarations of conformity to [Rec# 12-204] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1760 Assembly, Tube Housing, X-Ray, Diagnostic Class 1 ITY
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.
FDA Technical Contact
 Richard V. Kaczmarek
  FDA/OMPT/CDRH/OIR/DMQS/PMBR/
  301-796-5891
  richard.kaczmarek@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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