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/AbstractThis 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
|
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
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |