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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.
Transition Period
FDA recognition of IEC 60336 Edition 4.0 [Rec# 12-260] will be superseded by recognition of IEC 60336 Edition 5.0 [Rec# 12-335]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-260] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 12-260] will not be accepted.
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
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