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IEC 60336:2020

(Main)

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics

Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics

IEC 60336:2020 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.
IEC 60336:2020 cancels and replaces the fourth edition published in 2005. This edition constitutes a technical revision.
The significant changes of this fifth edition with respect to the previous edition are detailed in Clause E.6. These changes are:
a) introduction of digital detectors and discretization errors;
b) fewer normative requirements;
c) support for both SLIT CAMERA and PINHOLE CAMERA;
d) reintroduction of distorted (skewed) FOCAL SPOT;
e) keeping of STAR PATTERNS and BLOOMING VALUE as informative.
The contents of the corrigendum of June 2022 have been included in this copy.

Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des foyers et caractéristiques connexes

L'IEC 60336:2020 s’applique aux FOYERS des GAINES EQUIPEES à usage médical, pour diagnostic médical, fonctionnant à des POTENTIELS D’ACCELERATION DE TUBES RADIOGENES inférieurs ou égaux à 150 kV.
Le présent document décrit les méthodes d’essai ayant recours à des détecteurs numériques dans la détermination des:
a) dimensions des FOYERS en matière de VALEURS NOMINALES DE FOYER, variant de 0,1 à 3,0;
b) FONCTIONS DE DISTRIBUTION LINEAIRE;
c) FONCTIONS DE TRANSFERT DE MODULATION suivant une dimension;
d) RADIOGRAMMES A STENOPE,
et des moyens d’indiquer la conformité.
Les annexes informatives décrivent la MIRE ETOILE et la VALEUR DE DISPERSION.
L'IEC 60336:2020 annule et remplace la quatrième édition parue en 2005. Cette édition constitue une révision technique.
Les modifications majeures présentées dans cette cinquième édition par rapport à l’édition précédente sont énumérées dans l’Article E.6. Ces modifications sont:
a) introduction des détecteurs numériques et des erreurs de discrétisation;
b) exigences normatives moins nombreuses;
c) informations d’accompagnement relatives aux CAMERAS A FENTE et aux CAMERAS A STENOPE;
d) réintroduction de FOYER déformé (non linéaire);
e) conservation des MIRES ETOILES et de la VALEUR DE DISPERSION comme documents informatifs.
Le contenu du corrigendum de juin 2022 a été pris en considération dans cet exemplaire.

General Information

Status
Published
Publication Date
16-Dec-2020
ICS
11.040.50 - Radiographic equipment
Technical Committee
SC 62B - Medical imaging equipment, software, and systems
Drafting Committee
MT 32 - TC 62/SC 62B/MT 32
Current Stage
PPUB - Publication issued
Start Date
22-Dec-2020
Completion Date
17-Dec-2020
Ref Project

Relations

Corrected By
IEC 60336:2020/COR1:2022 - Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
Effective Date
05-Sep-2023
Revises
IEC 60336:2005/COR1:2006 - Corrigendum 1 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
Effective Date
05-Sep-2023
Revises
IEC 60336:2005 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
Effective Date
05-Sep-2023

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IEC 60336:2020 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
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IEC 60336 ®
Edition 5.0 2020-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Focal spot dimensions and related characteristics

Appareils électromédicaux – Gaines équipées pour diagnostic médical –
Dimensions des foyers et caractéristiques connexes

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IEC 60336 ®
Edition 5.0 2020-12
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment – X-ray tube assemblies for medical diagnosis –

Focal spot dimensions and related characteristics

Appareils électromédicaux – Gaines équipées pour diagnostic médical –

Dimensions des foyers et caractéristiques connexes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-9162-7

– 2 – IEC 60336:2020 © IEC 2020
CONTENTS
FOREWORD . 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Determinations for the evaluation of the FOCAL SPOT characteristics . 9
4.1 Statement of the FOCAL SPOT characteristics . 9
4.2 Longitudinal axis of the X-RAY TUBE ASSEMBLY . 9
4.3 REFERENCE AXIS of the X-RAY TUBE ASSEMBLY . 9
4.4 Direction of evaluation for the FOCAL SPOT length . 9
4.5 Direction of evaluation for the FOCAL SPOT width . 10
4.6 Directions of evaluation for distorted FOCAL SPOTS. 10
5 FOCAL SPOT camera set-up . 10
5.1 Overview. 10
5.2 Diaphragm of the SLIT CAMERA . 10
5.3 Diaphragm of the PINHOLE CAMERA. 11
5.4 Receptor . 12
5.5 Test arrangement . 12
5.5.1 Position of the slit or pinhole diaphragm normal to the REFERENCE AXIS . 12
5.5.2 Position of the slit or pinhole diaphragm along the REFERENCE AXIS . 13
5.5.3 Orientation of the slit or pinhole diaphragm . 14
5.5.4 Position and orientation of the receptor of the DIGITAL FOCAL SPOT
DETECTOR. 14
5.6 Total uncertainty of the camera set-up . 15
6 Production of RADIOGRAMS . 16
6.1 Overview. 16
6.2 Operating conditions . 16
6.2.1 X-RAY TUBE ASSEMBLY . 16
6.2.2 LOADING FACTORS . 16
6.2.3 Special LOADING FACTORS . 17
6.2.4 Special arrangements . 17
6.3 Production of FOCAL SPOT SLIT RADIOGRAMS, FOCAL SPOT PINHOLE RADIOGRAMS
and FOCAL SPOT LINE SPREAD FUNCTIONS . 17
6.3.1 DIGITAL FOCAL SPOT DETECTOR requirements for FOCAL SPOT SLIT
RADIOGRAMS . 17
6.3.2 DIGITAL FOCAL SPOT DETECTOR requirements for FOCAL SPOT PINHOLE
RADIOGRAMS . 17
6.3.3 Determination of the RADIOGRAMS and of the LINE SPREAD FUNCTIONS . 18
6.4 Statement of compliance of the FOCAL SPOT PINHOLE RADIOGRAM. 18
6.5 Statement of compliance of LINE SPREAD FUNCTIONS . 18
7 Determination of FOCAL SPOT dimensions and NOMINAL FOCAL SPOT VALUES . 19
7.1 Overview. 19
7.2 Measurement and determination of FOCAL SPOT dimensions . 19
7.3 Specified NOMINAL FOCAL SPOT VALUEs . 19
7.3.1 Nominal values . 19
7.3.2 Actual dimensions . 20
7.4 Statement of compliance . 21
7.5 Marking of compliance . 21

8 Determination of the MODULATION TRANSFER FUNCTION . 22
8.1 Overview. 22
8.2 Calculation and presentation of the MODULATION TRANSFER FUNCTION . 22
8.3 Statement of compliance . 22
9 Alternative measurement methods for determining NOMINAL FOCAL SPOT VALUES . 23
Annex A (informative) Alignment to the REFERENCE AXIS . 24
Annex B (informative) FOCAL SPOT STAR RADIOGRAM . 26
B.1 Overview. 26
B.2 Test EQUIPMENT . 26
B.2.1 STAR PATTERN CAMERA . 26
B.2.2 RADIOGRAPHIC FILM . 27
B.2.3 Position of the STAR PATTERN CAMERA normal to the REFERENCE AXIS . 27
B.2.4 Position of the STAR PATTERN CAMERA in REFERENCE DIRECTION . 27
B.2.5 Alignment of the STAR PATTERN CAMERA . 27
B.2.6 Position of the RADIOGRAPHIC FILM . 28
B.2.7 Operating conditions . 28
B.2.8 Production of the FOCAL SPOT STAR RADIOGRAM . 28
Annex C (informative) STAR PATTERN RESOLUTION LIMIT . 29
C.1 Overview. 29
C.2 Measurement . 29
C.3 Determination of the STAR PATTERN RESOLUTION LIMIT . 30
C.3.1 Determination of the magnification . 30
C.3.2 STAR PATTERN RESOLUTION LIMIT for standard magnification . 30
C.3.3 STAR PATTERN RESOLUTION LIMIT for finite magnification . 30
C.3.4 Presentation of STAR PATTERN RESOLUTION LIMIT . 31
Annex D (informative) BLOOMING VALUE . 32
D.1 Overview. 32
D.2 Determination of the BLOOMING VALUE . 32
Annex E (informative) Historical background . 33
E.1 Overview.
...

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