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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 056 Date of Entry 06/07/2021 
FR Recognition Number 12-335
Standard
IEC  60336 Edition 5.0 2020-12
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
Scope/Abstract
This document applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV.

This document describes the test methods employing digital detectors for determining:
a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0;
b) LINE SPREAD FUNCTIONS;
c) one-dimensional MODULATION TRANSFER FUNCTIONS;
d) FOCAL SPOT PINHOLE RADIOGRAMS,
and the means for indicating compliance.

In informative annexes, STAR PATTERN imaging and BLOOMING VALUE are described.
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.
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
  CDRH/OPEQ/OIDRH/DRH/DXRS
  301-796-4443
  James.Graves@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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