EN IEC 60806:2023

Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis

This International Standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA. This standard specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value. NOTE 1 AIR KERMA or AIR KERMA RATE are the only practical verifiable physical quantities for X-RAY SOURCES. X-RAY SOURCES must be tested independently from MEDICAL ELECTRICAL SYSTEMS. Conversion to the characteristics of the X-RAY IMAGE RECEPTOR used in a MEDICAL ELECTRICAL SYSTEM may be done in addition. In case multiple FOCAL SPOTS are not super-imposed, each focal spot has its own REFERENCE AXIS. Then the maximum RADIATION FIELD may be given for each FOCAL SPOT separately NOTE 2 The maximum symmetrical RADIATION FIELD may change from its initial value as the X-RAY TUBE ages through use. NOTE 3 If, for certain MEDICAL ELECTRICAL SYSTEMs the scope of IEC 60806 does not fit, then the special RADIATION FIELD requirements could be incorporated in the MEDICAL ELECTRICAL SYSTEM particular standard. However, a statement on the RADIATION FIELD while referring IEC 60806 is then no longer possible.

Bestimmung des maximalen symmetrischen Strahlenfeldes von Röntgenstrahlern und Strahlern einschließlich Blendensystem für medizinische Diagnostik

Dieses Dokument ist anwendbar für STRAHLER EINSCHLIESSLICH BLENDENSYSTEM und RÖNTGENSTRAHLER. ANMERKUNG 1 Falls für bestimmte MEDIZINISCHE ELEKTRISCHE SYSTEME besondere STRAHLENFELDER erforderlich sind, so dass diese nicht in den Anwendungsbereich der IEC 60806 fallen (z. B. bei Verwendung von CT-Kollimatoren mit Bowtie-Filtern), gilt die entsprechende Systemnorm. Dieses Dokument legt ein Verfahren zur Ermittlung des größten, geometrisch symmetrischen STRAHLENFELDES in einem angegebenen Abstand vom BRENNFLECK fest, in dem die prozentuale LUFTKERMALEISTUNG entlang der Hauptachsen des STRAHLENFELDES nicht unter einen zulässigen Wert absinkt. ANMERKUNG 2 In der Praxis sind LUFTKERMA oder LUFTKERMALEISTUNG die praktischsten physikalischen Größen zur Quantifizierung von RÖNTGENSTRAHLENRELIEF. Wenn sich mehrere BRENNFLECKE nicht überlagern, hat jeder Brennfleck seine eigene REFERENZACHSE. Dann kann das maximale STRAHLENFELD für jeden BRENNFLECK separat angegeben werden. ANMERKUNG 3 Das maximale symmetrische STRAHLENFELD kann von seinem Ausgangswert abweichen, da die RÖNTGENRÖHRE durch Benutzung altert.

Détermination du champ de rayonnement maximal symétrique des gaines équipées et des ensembles radiogènes utilisés en diagnostic médical

L'IEC 60806:2022 s'applique aux ENSEMBLES RADIOGENES et aux GAINES EQUIPEE. Le présent document spécifie une méthode pour la détermination du plus grand CHAMP DE RAYONNEMENT de géométrie symétrique à une distance spécifiée du FOYER pour laquelle le pourcentage de DEBIT DE KERMA dans l’air le long des axes principaux du CHAMP DE RAYONNEMENT, ne diminue pas pour atteindre une valeur inférieure aux valeurs autorisées. S'il n'y a pas superposition de FOYERS multiples, chaque FOYER possède son propre axe de référence. Ainsi, le CHAMP DE RAYONNEMENT maximal peut être donné individuellement pour chaque FOYER. L'IEC 60806:2022 annule et remplace la première édition parue en 1984. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) ajout des détecteurs à semiconducteur dont l'usage s'est répandu depuis la première édition de 1984.

Določanje maksimuma simetričnega sevalnega polja rentgenskih cevi in rentgenskih žarkov za medicinsko diagnostiko (IEC 60806:2022)

Ta mednarodni standard se uporablja za RENTGENSKE VIRE in RENTGENSKE CEVI za MEDICINSKO DIAGNOSTIČNO RADIOLOGIJO za tehnike, pri katerih bo RENTGENSKI VZOREC prejet istočasno v vseh točkah OBMOČJA SPREJEMA SLIKE.
Ta standard določa metodo za določanje maksimuma geometrično simetričnega SEVALNEGA POLJA na določeni razdalji od GORIŠČA, pri katerem odstotek STOPNJE KERME V ZRAKU vzdolž glavnih osi SEVALNEGA POLJA ne pade pod dovoljeno vrednost.
OPOMBA 1: KERMA V ZRAKU ali STOPNJA KERME V ZRAKU sta edini praktično preverljivi fizikalni količini za VIRE RENTGENSKIH ŽARKOV. VIRE RENTGENSKIH ŽARKOV je treba preskusiti neodvisno od ELEKTROMEDICINSKIH SISTEMOV. Dodatno se lahko izvede pretvorba v značilnosti RECEPTORJA RENTGENSKE SLIKE, ki se uporablja v ELEKTROMEDICINSKEM SISTEMU.
V primeru, da več GORIŠČ ni prekritih, ima vsaka goriščna točka svojo REFERENČNO OS. Maksimum SEVALNEGA POLJA se tako lahko poda za vsako GORIŠČE posebej.
OPOMBA 2: Maksimum simetričnega SEVALNEGA POLJA se lahko spremeni od svoje začetne vrednosti, ko se RENTGENSKA CEV z uporabo stara.
OPOMBA 3: Če področje uporabe standarda IEC 60806 za določene ELEKTROMEDICINSKE SISTEME ni primerno, se lahko posebne zahteve za SEVALNO POLJE vključijo v poseben standard za ELEKTROMEDICINSKE SISTEME. Vendar izjava o SEVALNEM POLJU ob sklicevanju na IEC 60806 potem ni več mogoča.

General Information

• Status: Published
• Publication Date: 12-Jan-2023
• 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: 13-Jan-2023
• Completion Date: 13-Jan-2023
• Ref Project: SIST EN IEC 60806:2023 - Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis (IEC 60806:2022)

Relations

• Replaces: EN 60806:2004 - Determination of the maximum symmetrical radiation field from a rotating anode X-ray tube for medical diagnosis
• Effective Date: 19-Jan-2021

Overview

EN IEC 60806:2023 (CLC adoption of IEC 60806:2022) specifies a standardized method to determine the maximum symmetrical radiation field produced by X‑ray tube assemblies and X‑ray source assemblies used in medical diagnostic radiology. The standard defines how to measure the greatest geometrically symmetrical radiation field at a specified distance from the focal spot such that the percentage air kerma rate along the major axes does not fall below a permitted value. It applies when the X‑ray pattern is received simultaneously across the entire image reception area and recognizes practical test quantities (air kerma / air kerma rate).

Key topics and technical requirements

• Scope and applicability: Applies to X‑ray tube and X‑ray source assemblies used in diagnostic imaging; special system cases (e.g., CT bow‑tie filters) may be handled by system‑specific standards.
• Measurement basis: Uses AIR KERMA and AIR KERMA RATE as the verifiable physical quantities to quantify X‑ray patterns.
• Geometry and orientation: Measurement along two orthogonal major axes (X and Y) in the measuring plane, intersecting at the reference axis; accounts for multiple focal spots (each focal spot can have its own reference axis).
• Determination method: Defines the procedure to find the greatest geometrically symmetrical radiation field at a specified distance where the relative air kerma rate along major axes meets permitted values.
• Instrumentation and conditions: Specifies detector types (including solid‑state detectors introduced in the second edition), measuring arrangement and measuring conditions required for reproducible results.
• Reporting and compliance: Includes requirements for a clear statement of compliance and notes that the maximum field may change as the X‑ray tube ages.

Practical applications

• Ensures consistent, reproducible determination of the usable radiation field for diagnostic X‑ray sources.
• Supports product design and verification for manufacturers of X‑ray tube assemblies and X‑ray source assemblies.
• Used by test laboratories, clinical physicists, regulatory bodies and conformity assessment bodies for device evaluation, acceptance testing and quality assurance.
• Helps define image receptor coverage and optimize clinical workflows while managing radiation protection considerations (e.g., avoiding unintended exposure outside the image area).

Who should use this standard

• X‑ray equipment manufacturers and R&D teams
• Medical device test laboratories and calibration facilities
• Hospital clinical engineers and medical physicists
• Regulatory agencies and conformity assessors

Related standards

• IEC 60336 (focal spot dimensions and related characteristics)
• IEC 60601‑1 and amendments (medical electrical equipment safety)
• IEC 60601‑1‑3 (radiation protection in diagnostic X‑ray equipment)
• IEC 60613 (electrical/loading characteristics of X‑ray tube assemblies)
• IEC TR 60788 (medical electrical equipment glossary)

Keywords: EN IEC 60806:2023, maximum symmetrical radiation field, X‑ray tube assemblies, X‑ray source assemblies, air kerma rate, focal spot, medical diagnostic radiology.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2023
Določanje maksimuma simetričnega sevalnega polja rentgenskih cevi in
rentgenskih žarkov za medicinsko diagnostiko (IEC 60806:2022)
Determination of the maximum symmetrical radiation field of X-ray tube assemblies and
X-ray source assemblies for medical diagnosis (IEC 60806:2022)
Bestimmung des maximalen symmetrischen Strahlungsfeldes von einer Drehanoden-
Röntgenröhre für medizinische Diagnostik (IEC 60806:2022)
Détermination du champ de rayonnement symétrique maximal des ensembles de tubes
à rayons X ou des ensembles radiogène utilisés en diagnostic médical (IEC 60806:2022)
Ta slovenski standard je istoveten z: EN IEC 60806:2023
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 60806

NORME EUROPÉENNE
EUROPÄISCHE NORM January 2023
ICS 11.040.50 Supersedes EN 60806:2004
English Version
Determination of the maximum symmetrical radiation field of X-
ray tube assemblies and X-ray source assemblies for medical
diagnosis
(IEC 60806:2022)
Détermination du champ de rayonnement maximal Bestimmung des maximalen symmetrischen
symétrique des gaines équipées et des ensembles Strahlungsfeldes von einer Drehanoden-Röntgenröhre für
radiogènes utilisés en diagnostic médical medizinische Diagnostik
(IEC 60806:2022) (IEC 60806:2022)
This European Standard was approved by CENELEC on 2023-01-03. 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,
Türkiye 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
© 2023 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60806:2023 E
European foreword
The text of document 62B/1298/FDIS, future edition 2 of IEC 60806, 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 60806:2023.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2023-10-03
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2026-01-03
document have to be withdrawn
This document supersedes EN 60806:2004 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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60806:2022 was approved by CENELEC as a European
Standard without any modification.
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 60336 2020 Medical electrical equipment - X-ray tube EN IEC 60336 2021
assemblies for medical diagnosis - Focal
spot dimensions and related characteristics
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
+ A2 2020  + A2 2021
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
+ A2 2021  + A2 2021
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 60806 ®
Edition 2.0 2022-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Determination of the maximum symmetrical radiation field of X-ray tube

assemblies and X-ray source assemblies for medical diagnosis

Détermination du champ de rayonnement maximal symétrique des gaines

équipées et des ensembles radiogènes utilisés en diagnostic médical

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-6095-1

– 2 – IEC 60806:2022 © IEC 2022
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Maximum symmetrical RADIATION FIELD . 6
4.1 Orientation of the maximum symmetrical RADIATION FIELD . 6
4.2 Determination of the maximum symmetrical RADIATION FIELD . 7
5 Measurement of the distribution of AIR KERMA RATE . 7
5.1 Detector . 7
5.2 Measuring arrangement . 8
5.3 Measuring conditions . 9
6 Statement of compliance . 9
Annex A (informative) Background . 10
A.1 Overview. 10
A.2 Second edition . 10
Index of defined terms . 11

Figure 1 – Orientation of the maximum symmetrical RADIATION FIELD . 6
Figure 2 – Typical distribution of the relative AIR KERMA RATE along the major axis X of
a maximum symmetrical RADIATION FIELD . 7
Figure 3 – Measuring arrangement . 8

Table 1 – RADIATION QUALITY . 9

IEC 60806:2022 © IEC 2022 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
DETERMINATION OF THE MAXIMUM SYMMETRICAL
RADIATION FIELD OF X-RAY TUBE ASSEMBLIES AND X-RAY
SOURCE ASSEMBLIES FOR MEDICAL DIAGNOSIS

FOREWORD
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rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC 60806 has been prepared by subcommittee 62B: Diagnostic imaging equipment, of IEC
technical committee 62: Electrical equipment in medical practice. It is an International Standard.
This second edition cancels and replaces the first edition published in 1984. This edition
constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous
edition:
a) addition of solid state detectors as they have become more common since the first edition
of 1984.
– 4 – IEC 60806:2022 © IEC 2022
The text of this document is based on the following documents:
Draft Report on voting
62B/1298/FDIS 62B/1305/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs.
...