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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 060 Date of Entry 05/29/2023 
FR Recognition Number 12-350
IEC  60806 Edition 2.0 2022-11
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis
This document is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES.
NOTE 1 If, for certain MEDICAL ELECTRICAL SYSTEMS, special radiation fields are required such that the scope of IEC 60806 does not apply (e. g., using CT collimators with bow-tie filters), the appropriate system particular standard applies.

This document specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value.
NOTE 2 In practical use AIR KERMA or AIR KERMA RATE are the most practical physical measures to quantify X-RAY PATTERNS.

In case multiple FOCAL SPOTS are not super-imposed, each FOCAL SPOT has its own REFERENCE AXIS. Then the maximum RADIATION FIELD can be given for each FOCAL SPOT separately.
NOTE 3 The maximum symmetrical RADIATION FIELD can change from its initial value as the X-RAY TUBE ages through use.
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FDA recognition of IEC 60806 First edition 1984-01 [Rec# 12-6] will be superseded by recognition of IEC 60806 Edition 2.0 2022-11 [Rec# 12-350].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.