Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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12-350
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Standard | |
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 |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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FDA recognition of IEC 60806 First edition 1984-01 [Rec# 12-6] will be superseded by recognition of IEC 60806 Edition 2.0 2022-11 [Rec# 12-350].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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1760 |
Assembly, Tube Housing, X-Ray, Diagnostic
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Class 1
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ITY
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |