EN IEC 60336:2021

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.

Medizinische elektrische Geräte - Röntgenstrahler für medizinische Diagnostik - Abmessungen von Brennflecken und zugehörige Kennwerte

Dieses Dokument gilt für BRENNFLECKE von RÖNTGENSTRAHLERN für den medizinischen Gebrauch für die medizinische Diagnostik, die bei einer RÖNTGENRÖHRENSPANNUNG bis einschließlich 150 kV betrieben werden. Dieses Dokument beschreibt die Prüfverfahren, bei welchen digitale Detektoren verwendet werden zur Ermittlung von: a) Abmessungen von BRENNFLECKEN hinsichtlich BRENNFLECK-NENNWERTEN, im Bereich von 0,1 bis 3,0; b) LINIENBILDFUNKTION; c) eindimensionale MODULATIONSÜBERTRAGUNGSFUNKTION; d) BRENNFLECK-LOCHBLENDENAUFNAHMEN, und die Mittel zum Nachweis der Übereinstimmung. In informativen Anhängen sind STERNAUFNAHMEN und BLOOMING-WERT beschrieben.

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.

Medicinska električna oprema - Rentgenske naprave za medicinsko diagnostiko - Mere žariščnih točk in s tem povezane značilnosti (IEC 60336:2020)

General Information

• Status: Published
• Publication Date: 04-Feb-2021
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 05-Feb-2021
• Completion Date: 05-Feb-2021
• Ref Project: SIST EN IEC 60336:2021 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics (IEC 60336:2020)

Relations

• Replaces: EN 60336:2005 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
• Effective Date: 07-Jun-2022
• Corrected By: EN IEC 60336:2021/AC:2022-07 - Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensions and related characteristics
• Effective Date: 12-Jul-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2021
Nadomešča:
SIST EN 60336:2006
Medicinska električna oprema - Rentgenske naprave za medicinsko diagnostiko -
Mere žariščnih točk in s tem povezane značilnosti (IEC 60336:2020)
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot
dimensions and related characteristics (IEC 60336:2020)
Medizinische elektrische Geräte - Röntgenstrahler für medizinische Diagnostik -
Kennwerte von Brennflecken (IEC 60336:2020)
Appareils électromédicaux - Gaines équipées pour diagnostic médical - Dimensions des
foyers et caractéristiques connexes (IEC 60336:2020)
Ta slovenski standard je istoveten z: EN IEC 60336:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60336

NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2021
ICS 11.040.50 Supersedes EN 60336:2005 and all of its amendments
and corrigenda (if any)
English Version
Medical electrical equipment - X-ray tube assemblies for medical
diagnosis - Focal spot dimensions and related characteristics
(IEC 60336:2020)
Appareils électromédicaux - Gaines équipées pour Medizinische elektrische Geräte - Röntgenstrahler für
diagnostic médical - Dimensions des foyers et medizinische Diagnostik - Kennwerte von Brennflecken
caractéristiques connexes (IEC 60336:2020)
(IEC 60336:2020)
This European Standard was approved by CENELEC on 2021-01-21. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60336:2021 E
European foreword
The text of document 62B/1138/CDV, future edition 5 of IEC 60336, prepared by SC 62B "Diagnostic
imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN IEC 60336:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-10-21
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-01-21
document have to be withdrawn
This document supersedes EN 60336:2005 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60336:2020 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-28:2017 NOTE Harmonized as EN IEC 60601-2-28:2019 (not modified)
IEC 60336:2005 NOTE Harmonized as EN 60336:2005 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60417 - Graphical symbols for use on equipment. - -
Index, survey and compilation of the single
sheets.
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + A12 2014
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
- -  + corrigendum Mar. 2010
+ A1 2013  + A1 2013
- -  + AC 2014
- -  + A11 2016
IEC 60613 2010 Electrical and loading characteristics of X- EN 60613 2010
ray tube assemblies for medical diagnosis
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
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

IEC 60336:2020 © IEC 2020 – 3 –
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.
...