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 Strahlungsfeldes von einer Drehanoden-Röntgenröhre für medizinische Diagnostik

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)

General Information

Status
Published
Publication Date
12-Jan-2023
Current Stage
6060 - Document made available - Publishing
Start Date
13-Jan-2023
Completion Date
13-Jan-2023

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SLOVENSKI STANDARD
SIST EN IEC 60806:2023
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
SIST EN IEC 60806:2023 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60806:2023
---------------------- Page: 2 ----------------------
SIST EN IEC 60806:2023
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
---------------------- Page: 3 ----------------------
SIST EN IEC 60806:2023
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.
---------------------- Page: 4 ----------------------
SIST EN IEC 60806:2023
EN IEC 60806:2023 (E)
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
---------------------- Page: 5 ----------------------
SIST EN IEC 60806:2023
---------------------- Page: 6 ----------------------
SIST EN IEC 60806:2023
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 60806:2023
– 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

---------------------- Page: 8 ----------------------
SIST EN IEC 60806:2023
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

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their

preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

may participate in this preparatory work. International, governmental and non-governmental organizations liaising

with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for

Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence between

any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent

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.
---------------------- Page: 9 ----------------------
SIST EN IEC 60806:2023
– 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.
...

SLOVENSKI STANDARD
oSIST prEN IEC 60806:2022
01-marec-2022
Določanje maksimuma simetričnega sevalnega polja rentgenskih cevi in
rentgenskih žarkov za medicinsko diagnostiko

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 symétrique maximal des ensembles de tubes
à rayons X ou des ensembles radiogène utilisés en diagnostic médical
Ta slovenski standard je istoveten z: prEN IEC 60806:2021
ICS:
11.040.50 Radiografska oprema Radiographic equipment
oSIST prEN IEC 60806:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN IEC 60806:2022
---------------------- Page: 2 ----------------------
oSIST prEN IEC 60806:2022
62B/1267/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60806 ED2
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2021-12-24 2022-03-18
SUPERSEDES DOCUMENTS:
62B/1231/CD, 62B/1242A/CC
IEC SC 62B : DIAGNOSTIC IMAGING EQUIPMENT
SECRETARIAT: SECRETARY:
Germany Ms Regina Geierhofer
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62C
Other TC/SCs are requested to indicate their interest, if any,
in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for
Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which

they are aware and to provide supporting documentation.
TITLE:

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

assemblies for medical diagnosis
PROPOSED STABILITY DATE: 2032
NOTE FROM TC/SC OFFICERS:

Copyright © 2021 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this

electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions.

You may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without

permission in writing from IEC.
---------------------- Page: 3 ----------------------
oSIST prEN IEC 60806:2022
IEC CDV 60806 © IEC:2021 – 2 – 62B/1267/CDV
2 CONTENTS

4 1 Scope .............................................................................................................................. 5

5 2 Normative references ....................................................................................................... 5

6 3 Terms and definitions ...................................................................................................... 5

7 4 Maximum symmetrical RADIATION FIELD ............................................................................. 6

8 4.1 Orientation of the maximum symmetrical RADIATION FIELD ........................................ 6

9 4.2 Determination of the maximum symmetrical RADIATION FIELD ................................... 7

10 5 Measurement of the distribution of AIR KERMA RATE........................................................... 7

11 5.1 Detector .................................................................................................................. 7

12 5.2 Measuring conditions .............................................................................................. 8

13 6 Statement of compliance .................................................................................................. 9

14 Annex A (informative) Background ..................................................................................... 10

15 A.1 Introduction .......................................................................................................... 10

16 A.2 Second edition ...................................................................................................... 10

17 Index of defined terms .......................................................................................................... 11

19 Figure 1 – Orientation of the maximum symmetrical RADIATION FIELD ...................................... 6

20 Figure 2 – Typical distribution of the relative AIR KERMA RATE along the major axis X of a

21 maximum symmetrical RADIATION FIELD ................................................................................... 7

22 Figure 3 – Measuring arrangement ......................................................................................... 9

24 Table 1 – RADIATION QUALITY .................................................................................................. 8

---------------------- Page: 4 ----------------------
oSIST prEN IEC 60806:2022
IEC CDV 60806 © IEC:2021 – 3 – 62B/1267/CDV
26 INTERNATIONAL ELECTROTECHNICAL COMMISSION
27 ____________
29 DETERMINATION OF THE MAXIMUM SYMMETRICAL RADIATION FIELD OF
30 X-RAY TUBE ASSEMBLIES AND X-RAY SOURCE ASSEMBLIES FOR MEDICAL
31 DIAGNOSIS
35 FOREWORD

36 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all

37 national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co -operation

38 on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other

39 activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available

40 Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their prepa ration is entrusted to technical

41 committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work.

42 International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation.

43 IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions

44 determined by agreement between the two organizations.

45 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international consensus

46 of opinion on the relevant subjects since each technical committee has representation from all interested IEC National

47 Committees.

48 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees

49 in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate,

50 IEC cannot be held responsible for the way in which they are used or for any mi sinterpretation by any end user.

51 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications transparently

52 to the maximum extent possible in their national and regional publications. Any divergence between a ny IEC Publication

53 and the corresponding national or regional publication shall be clearly indicated in the latter.

54 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity assessment

55 services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by

56 independent certification bodies.

57 6) All users should ensure that they have the latest edition of this publication.

58 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members

59 of its technical committees and IEC National Committees for any personal injury, property damage or other damage of

60 any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the

61 publication, use of, or reliance upon, this IEC Publication or any other IEC Publications.

62 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable

63 for the correct application of this publication.

64 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights.

65 IEC shall not be held responsible for identifying any or all such patent rights.

66 International Standard IEC 60806 has been prepared by subcommittee 62B: Diagnostic imaging

67 equipment, of IEC technical committee Electrical equipment in medical practice.

68 This second edition cancels and replaces the first edition published in 1984 and constitutes a technical

69 revision.

70 This edition includes the following significant technical changes with respect to the previous edition:

71 Since 1984, the first edition, considerable developments have been taken place in dete ctor technology.

72 So instead of RADIOGRAPHIC FILM, solid state detectors are generally used; the second edition thus

73 applies such detectors, while keeping the alternative of RADIOGRAPHIC FILM.
74 The text of this standard is based on the following documents:
FDIS Report on voting
62B/XXX/FDIS 62B/XXX/RVD

76 Full information on the voting for the approval of this standard can be found in the report on voting

77 indicated in the above table.
---------------------- Page: 5 ----------------------
oSIST prEN IEC 60806:2022
IEC CDV 60806 © IEC:2021 – 4 – 62B/1267/CDV

78 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

79 The committee has decided that the contents of this publication will remain unchanged until the stability

80 date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the specific

81 publication. At this date, the publication will be
82 reconfirmed,
83 withdrawn,
84 replaced by a revised edition, or
85 amended.

87 The National Committees are requested to note that for this publication the stability date is 2032.

88 THIS TEXT IS INCLUDED FOR THE INFORMATION OF THE NATIONAL COMMITTEES AND WILL BE DELETED AT THE

89 PUBLICATION STAGE.
---------------------- Page: 6 ----------------------
oSIST prEN IEC 60806:2022
IEC CDV 60806 © IEC:2021 – 5 – 62B/1267/CDV
92 DETERMINATION OF THE MAXIMUM SYMMETRICAL RADIATION FIELD OF
93 X-RAY TUBE ASSEMBLIES AND X-RAY SOURCE ASSEMBLIES FOR MEDICAL
94 DIAGNOSIS
98 1 Scope

99 This International Standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES, for

100 use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received

101 simultaneously in all points of the IMAGE RECEPTION AREA.

102 This standard specifies a method for the determination of the greatest geometrically symmetrical

103 RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE

104 along the major axes of the RADIATION FIELD does not fall below a permitted value.

105 NOTE 1 AIR KERMA or AIR KERMA RATE are the only practical verifiable physical quantities for X-RAY SOURCES. X-RAY SOURCES

106 must be tested independently from MEDICAL ELECTRICAL SYSTEMS. Conversion to the characteristics of the X-RAY IMAGE

107 RECEPTOR used in a MEDICAL ELECTRICAL SYSTEM may be done in addition.

108 In case multiple FOCAL SPOTS are not super-imposed, each focal spot has its own REFERENCE AXIS.

109 Then the maximum RADIATION FIELD may be given for each FOCAL SPOT separately

110 NOTE 2 The maximum symmetrical RADIATION FIELD may change from its initial value as the X-RAY TUBE ages through use.

111 NOTE 3 If, for certain MEDICAL ELECTRICAL SYSTEMs the scope of IEC 60806 does not fit, then the special RADIATION FIELD

112 requirements could be incorporated in the MEDICAL ELECTRICAL SYSTEM particular standard. However, a statement on the

113 RADIATION FIELD while referring IEC 60806 is then no longer possible.
114 2 Normative references

115 The following documents are referred to in the text in such a way that some or all their content

116 constitutes requirements of this document. For dated references, only the edition cited applies. For

117 undated references, the latest edition of the referenced document (including any amendments) applies.

118 IEC 60336:2020, Medical electrical equipment – X-ray tube assemblies for medical diagnosis – Focal

119 spot dimensions and related characteristics
120 IEC 60601-1:2005, Medi
...

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