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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 013 Date of Entry 11/08/2005 
FR Recognition Number 12-6
IEC  60806 First edition 1984-01
Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
This standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES containing ROTATING ANODE X-RAY TUBES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA.

Unless otherwise specified, this standard is applicable to an X-RAY TUBE ASSEMBLY with a brand-new ROTATING ANODE X-RAY TUBE.

This standard does not apply to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES for special applications, when for example steeper variations of the AIR KERMA RATE or particular distributions are intended.
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FDA recognition of IEC 60806 First edition 1984-01 [Rec# 12-6] will be superseded by recognition of IEC 60806 Edition 2.0 2022-11 [Rec# 12-350]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-6] until July 6, 2025. After this transition period, declarations of conformity to [Rec# 12-6] 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*
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
 James Graves
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.