AS/NZS 4184.3.

1:2002

AS/NZS 4184.3.1
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Australian/New Zealand Standard™
Evaluation and routine testing in
medical imaging departments
Part 3.1: Acceptance tests—Imaging
performance of X-ray equipment for
radiographic and radioscopic systems
(IEC 61223-3-1:1999, MOD)

AS/NZS 4184.3.1:2002
This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee
HE-008, Diagnostic Ionizing Imaging Equipment. It was approved on behalf of the
Council of Standards Australia on 18 March 2002 and on behalf of the Council of
Standards New Zealand on 27 February 2002. It was published on 20 May 2002.

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The following interests are represented on Committee HE-008:
Australasian College of Physical Scientists and Engineers in Medicine
Australian Dental Association
Australian Institute of Radiography
Australian Radiation Protection and Nuclear Safety Agency
Australian and New Zealand Society of Nuclear Medicine
Department of Defence (Australia)
Department of Health, W.A.
Department of Human Services, Vic.
Diagnostic Imaging Association of Australasia
Medical Industry Association of Australia
Ministry of Economic Development, New Zealand
New South Wales Department of Public Works and Services
National Radiation Laboratory, New Zealand
Queensland Health
Royal Australian and New Zealand College of Radiologists
United Dental Hospital of Sydney
University of Sydney – Faculty of Dentistry

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on the back cover.

This Standard was issued in draft form for comment as DR 99318.

AS/NZS 4184.3.1:2002

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Australian/New Zealand Standard™
Evaluation and routine testing in
medical imaging departments
Part 3.1: Acceptance tests—Imaging
performance of X-ray equipment for
radiographic and radioscopic systems
(IEC 61223-3-1:1999, MOD)

First published as AS/NZS 4184.3.1:2002.

COPYRIGHT
© Standards Australia/Standards New Zealand
All rights are reserved. No part of this work may be reproduced or copied in any form or by any
means, electronic or mechanical, including photocopying, without the written permission of the
publisher.
Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001
and Standards New Zealand, Private Bag 2439, Wellington 6020
ISBN 0 7337 4493 1

ii

PREFACE
This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HE008, Diagnostic Ionizing Imaging Equipment. It is one of an ever-expanding series of acceptance and
performance assessment Standards for use within health care facilities.
This Standard has been reproduced, with national modifications, from IEC 61223-3-1:1999,
Evaluation and routine testing in medical imaging departments, Part 3-1: Acceptance imaging
performance of X-ray equipment for radiographic and radioscopic systems.

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Appendix ZZ lists the variations between this Standard and IEC 61223-3-1. These changes are
indicated by a rule in the margin against each Clause affected.
In the text of this Standard, the following print types are used:
(a)

Requirements, compliance with which can be tested and definitions
…………………………………………………………...………………in large roman type

(b)

Explanations, advice, introductions, general statements, exceptions and references
…………………………………………………………………..……………in smaller roman type

(c)

Headings of sub-clauses and text specifications
……………………………………………………………………………………in italic type

(d)

Terms used throughout the Standard, which have been defined in Clause 3 or the Index of
Defined Terms (see Annex A)
…………………………….…………………...…………………………... IN SMALL CAPITALS

As this publication has been reproduced from an International Standard, the following modifications
apply:
(i)

Its number does not appear on each page of text and its identity is shown only on the cover and
title page.

(ii)

In the source text ‘this part of IEC 61223’ should read ‘this Australian/New Zealand Standard’.

(iii)

A full point substitutes for a comma when referring to a decimal marker.

The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of
the annex or appendix to which they apply. A ‘normative’ annex or appendix is an integral part of a
Standard, whereas an ‘informative’ annex or appendix is only for information and guidance.
The references to international Standards should be replaced by references to the following
Australian/New Zealand Standards.
Reference to International Standard

Australian/New Zealand Standard

IEC

AS/NZS

60336

X-ray tube assemblies for medical
diagnosis – Characteristics of focal
spots

4274

X-ray tube assemblies for medical
diagnosis – Characteristics of focal spots

60471
60471-1

Graphical symbols for use on equipment —
Part 1: Overview and application

60522

Inherent filtration of an X-ray tube
assembly

60580

Area exposure product meter

60601
60601-1

Medical electrical equipment
Part 1: General requirements for safety

3200
Medical electrical equipment
3200.1.0 Part 1.0: General requirements for safety –
Parent Standard

iii

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IEC
60601-1-3 Part 1: General requirements for safety
3. Collateral standard: General
requirements for radiation protection in
diagnostic X-ray equipment
60601-2-7 Part 2: Particular requirements for the
safety of high-voltage generators of
diagnostic X-ray generators
60601-2-28 Part 2: Particular requirements for the
safety of X-ray source assemblies and
X-ray tube assemblies for medical
diagnosis

AS/NZS
3200.1.3 Part 1.3: General requirements for safety
Collateral Standard: Requirements for
radiation protection in diagnostic X-ray
equipment
3200.2.7 Part 2.7: Particular requirements for safety
– High voltage generators of diagnostic Xray generators
3200.2.28 Part 2.28: Particular requirements for
safety — X-ray source assemblies and Xray tube assemblies for medical diagnosis
generators

60788

Medical radiology – Terminology

60878

Graphical symbols for electrical
equipment in medical practice

4334

Graphic symbols for use on medical
electrical equipment

61223

Evaluation and routine testing in
medical imaging departments
Part 1: General aspects

4184

Evaluation and routine testing in medical
imaging departments
Part 1: General aspects

Medical diagnostic X-ray equipment —
Radiation conditions for use in the
determination of characteristics

4358

Light metals and their alloys — Code of
designation based on chemical symbols

61223-1
61267

ISO
2092

4184.1

Medical diagnostic X-ray equipment
Radiation conditions for use in the
determination of characteristics

iv

CONTENTS
INTRODUCTION .................................................................................................................... v i
Clause

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1

Scope and object ............................................................................................................. 1
1.1

Scope ..................................................................................................................... 1

1.2

Object ..................................................................................................................... 1

2

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

3

Terminology ..................................................................................................................... 3

4

5

3.1

Degree of requirements........................................................................................... 3

3.2

Use of terms ........................................................................................................... 3

3.3

Defined terms ......................................................................................................... 3

General aspects of ACCEPTANCE TESTS ............................................................................. 4
4.1

General conditions to be considered in test procedures ........................................... 4

4.2

Documents and data for the tests ............................................................................ 4

4.3

Test conditions........................................................................................................ 4

4.4

Test parameters..................................................................................................

4.5

Test equipment including PHANTOMS ( ATTENUATION devices) and TEST DEVICES ....... 6

4.6

Evaluating the test results ..................................................................................... 7

5

Test methods for RADIOGRAPHY EQUIPMENT ..................................................................... 8
5.1

Visual and functional tests..................................................................................... 8

5.2

*X -RAY TUBE VOLTAGE ............................................................................................. 8

5.3

*T OTAL FILTRATION ................................................................................................. 9

5.4

*F OCAL SPOT of the X- RAY TUBE .............................................................................. 9

5.5

*Limitation and indication of the extent of the X-RAY BEAM ..................................... 10

5.6

*Linearity and reproducibility of TRANSMISSION KERMA or RADIATION OUTPUT ............. 12

5.7

*ATTENUATION RATIO of material between the PATIENT and the X- RAY
IMAGE RECEPTOR ....................................................................................................

13

5.8

*AUTOMATIC EXPOSURE CONTROL ( AEC ) .................................................................... 13

5.9

L INE PAIR RESOLUTION for DIRECT RADIOGRAPHY ...................................................... 15

5.10 * AIR KERMA area product indicator ....................................................................... 15
6

Test methods for RADIOSCOPY EQUIPMENT ...................................................................... 15
6.1

Visual and functional tests.................................................................................... 15

6.2

X- RAY TUBE VOLTAGE ............................................................................................. 16

6.3

T OTAL FILTRATION ................................................................................................. 16

6.4

F OCAL SPOT of the X- RAY TUBE .............................................................................. 16

6.5

Functioning of the AUTOMATIC EXPOSURE RATE CONTROL ( AERC ) .............................. 16

6.6

Limitation of the extent of the X-RAY BEAM ............................................................ 17

v

Clause
Clause

6.7

6.7
Clause
6.7
6.8
6.8

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6.8
6.9
6.9
6.10
6.10
6.9

7
7
7
8
8

A
TTENUATION RATIO
RATIO of
PATIENT and
RAY
A TTENUATION
of material
material between
between the
the PATIENT
and the
the XX- RAY
IMAGE
IMAGE RECEPTOR
RECEPTOR ....................................................................................................
................................................................................................... 2
18
TTENUATION
RATIO
PATIENT
RAY
A
of
material
between
the
and
the
XRATE
at
*AIR
IR KERMA
KERMA
RATE....................................................................................................
ENTRANCE PLANE
PLANE of
RAY IMAGE
IMAGE INTENSIFIER
INTENSIFIER
at the
the ENTRANCE
of the
the XX- RAY
*A
IMAGE
RECEPTOR
23
RADIOSCOPY
for
.....................................................................................................
for RADIOSCOPY .................................................................................................... 23
18
IR KERMAAIR
RATE
ENTRANCE
PLANE of with
RAY
IMAGE
INTENSIFIER
at the
the X*A
KERMA
RATE
RADIOSCOPY
RAY
IMAGE
INTENSIFIER
for
X................
24
*Entrance
AIR KERMA
RATE for RADIOSCOPY with X- RAY IMAGE INTENSIFIER ............... 23
19
*Entrance
RADIOSCOPY
for
.....................................................................................................
IR
KERMA
ENTRANCE
PLANE
RAY
IMAGE
INTENSIFIER
A
at
the
of
the
Xfor
ENTRANCE
PLANE
RAY XIMAGE
INTENSIFIER
A IR KERMA AIR
at the
of the X-with
for
KERMA
RATE for
RADIOSCOPY
RAY IMAGE
INTENSIFIER
................ 24
*Entrance
CINERADIOGRAPHY
CINERADIOGRAPHY or other INDIRECT
INDIRECT RADIOGRAPHY
RADIOGRAPHY systems (excluding digital

or other
systems (excluding digital
systems)
25
IR KERMA...............................................................................................................
at the ENTRANCE PLANE of the X- RAY IMAGE INTENSIFIER for
6.10 A
systems)
..............................................................................................................
20
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
or
other
systems
(excluding
digital
AIR
KERMA
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
for
or
other
systems
6.11
Entrance
AIR KERMA for CINERADIOGRAPHY or other INDIRECT RADIOGRAPHY systems 25
6.11 systems)
Entrance ...............................................................................................................
(excluding
(excluding digital
digital systems)
systems) ....................................................................................
.................................................................................... 20
20
AIR
KERMA
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
for
or
other
systems
6.11
Entrance
for
with
6.12
*L
INE PAIR
PAIR RESOLUTION
RESOLUTION
RADIOSCOPY
RAY IMAGE
IMAGE INTENSIFIER
INTENSIFIER and
for RADIOSCOPY
with XX- RAY
and for
for
6.12 (excluding
*LINE
digital systems)
....................................................................................
25
CINERADIOGRAPHY
CINERADIOGRAPHY or
INDIRECT RADIOGRAPHY
RADIOGRAPHY systems
or other
other INDIRECT
systems (excluding
(excluding digital
digital
systems)
...............................................................................................................
26
INE PAIR...............................................................................................................
RESOLUTION for RADIOSCOPY with X- RAY IMAGE INTENSIFIER and for
6.12 *L
systems)
21
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
or
other
systems
(excluding
digital
RESOLUTION
6.13
*L OW
OW CONTRAST
CONTRAST
RESOLUTION for
RADIOSCOPY with
RAY IMAGE
IMAGE INTENSIFIER
INTENSIFIER and
for RADIOSCOPY
with XX- RAY
and for
for 26
6.13 systems)
*L
...............................................................................................................
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
other
systems
(excluding
digital
CINERADIOGRAPHY or
INDIRECT
RADIOGRAPHY
or other
systems (excluding digital
systems)
...............................................................................................................
OW CONTRAST
RESOLUTION for RADIOSCOPY with X- RAY IMAGE INTENSIFIER and for 27
6.13 *L
systems)
...............................................................................................................
22
CINERADIOGRAPHY
INDIRECT
RADIOGRAPHY
or
other
systems
(excluding
digital
A
area
28
6.14
IR KERMA
KERMA
A IR
area product
product indicator
indicator ...........................................................................
........................................................................... 27
23
6.14 systems)
...............................................................................................................
TOMOGRAPHY
EQUIPMENT
......................................................
28
Additional
tests
required
for
EQUIPMENT ...................................................... 28
23
Additional
tests required
for TOMOGRAPHY
A IR KERMA
area product
indicator ...........................................................................
6.14
7.1
*Requirements
.........................................................................................................
28
7.1 *Requirements
.........................................................................................................
23
Additional
tests required
for TOMOGRAPHY EQUIPMENT ...................................................... 28
7.2 Test
Test method
method .............................................................................................................
............................................................................................................. 24
29
7.2
7.1
*Requirements
......................................................................................................... 28
Test
report
and
of
29
TestTest
report
and statement
statement
of compliance
compliance ........................................................................
........................................................................ 29
24
7.2
method
.............................................................................................................

8 Test report and statement of compliance ........................................................................ 29
Annex A
A (normative)
(normative)
Terminology –
– Index
Index of
of defined
defined terms
terms ...............................................
............................................... 31
36
Annex
Terminology
Annex B
B (informative)
(informative) Test
Test parameters,
parameters, symbols
symbols and
and units
units .................................................
................................................. 34
39
Annex
Annex
A (normative)
Terminology
– Index of defined
terms ............................................... 36
DEVICES
.............................................
40
Annex C
C (informative)
(informative) Examples
Examples of
of low
low contrast
contrast TEST
DEVICES
............................................ 39
35
Annex
Annex
B (informative)
Test parameters,
symbols TEST
and units
.................................................
Annex
D
(informative)
Examples
of
requirements
(accuracy,
tolerances,
discrepancies)
Annex C
D (informative)
(informative) Examples
Examples of low
requirements
(accuracy,
tolerances,
discrepancies)
TEST
DEVICES
.............................................
Annex
contrast
according of
to actual
actual
IEC standards
standards
or state
state
of the
the art
art ........................
......................... 40
42
according
to
IEC
or
of
37
Annex
D
(informative)
Examples
of
requirements
(accuracy,
tolerances,
discrepancies)
Annex
E
(informative)
Bibliography
.....................................................................................
46
Annex E (informative) according
Bibliography
.....................................................................................
41
to actual
IEC standards or state of the art ......................... 42
Annex E (informative) Bibliography ..................................................................................... 46
Tables
Tables
B.1
B.1 Test
Test parameters,
parameters, symbols
symbols and
and units...........................................................................
units........................................................................... 39
34
Tables
FOCAL
SPOT
NOMINAL
FOCAL
SPOT
VALUES
dimensions
for
..................
D.1
Typical
values
of
37
D.1 Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES .................. 42
B.1 Test parameters, symbols and units........................................................................... 39
D.2
Values
for
the
discrepancy
parameters
X
,
Y
and
Z
according
to
IEC
60601-1-3
..........
43
D.2 Values for the discrepancy parameters X , Y and Z according to IEC 60601-1-3 .......... 38
D.1 Typical values of FOCAL SPOT dimensions for NOMINAL FOCAL SPOT VALUES .................. 42
D.3
TRANSMISSION KERMA
KERMA index
index .......................................................
....................................................... 43
38
D.3 Typical
Typical values
values for
for the
the TRANSMISSION
D.2 Values for the discrepancy parameters X , Y and Z according to IEC 60601-1-3 .......... 43
ATTENUATION
RATIO
PATIENT
D.4
Typical
values
for
the
of
material
between
the
D.4 Typical values for the ATTENUATION RATIO of material between the PATIENT
KERMA index ....................................................... 43
D.3 Typical
values
for the TRANSMISSION
and
RAY IMAGE
IMAGE RECEPTOR
RECEPTOR ..................................................................................
and the
the XX- RAY
.................................................................................. 44
39
D.4 Typical values for the ATTENUATION RATIO of material between the PATIENT
and the X- RAY IMAGE RECEPTOR .................................................................................. 44
Figures
Figures
1
Measuring arrangement
arrangement for
for RADIOGRAPHY
RADIOGRAPHY and
RADIOSCOPY EQUIPMENT
EQUIPMENT for
AIR KERMA
KERMA
1
Measuring
and RADIOSCOPY
for AIR
Figures
measurements...........................................................................................................
measurements........................................................................................................... 31
26
RADIOGRAPHY
RADIOSCOPY
EQUIPMENT
AIR KERMA
12
Measuring
arrangement
for
and
for
RADIOGRAPHY
RADIOSCOPY
EQUIPMENT
Measuring
arrangement
for
and
to
test
geometry
2
Measuring arrangement for RADIOGRAPHY and RADIOSCOPY EQUIPMENT to test geometry
measurements...........................................................................................................
31
and
32
and resolutions
resolutions ..........................................................................................................
.......................................................................................................... 27
RADIOGRAPHY
RADIOSCOPY
EQUIPMENT
23
Measuring
arrangement
for
and
to
test
geometry
L
INE PAIR
PAIR RESOLUTION
RESOLUTION TEST
TEST DEVICE
DEVICE .............................................................................
............................................................................. 33
28
3
L INE
and resolutions .......................................................................................................... 32
OMOGRAPHY
LINE
PAIR
RESOLUTION
TEST
DEVICE
4
T
.........................................................
4
T OMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE ......................................................... 34
29
3
L INE PAIR RESOLUTION TEST DEVICE ............................................................................. 33
RAY
FIELD
5
Discrepancies
in
visual
indication
of
the
X..................................................
5
Discrepancies in visual indication of the X- RAY FIELD .................................................. 35
30
4
T OMOGRAPHY LINE PAIR RESOLUTION TEST DEVICE ......................................................... 34
6
Discrepancies
IMAGE RECEPTION
RECEPTION AREA
AREA .................................................
6
Discrepancies in
in covering
covering the
the IMAGE
................................................. 35
30
5
Discrepancies in visual indication of the X- RAY FIELD .................................................. 35
6

Discrepancies in covering the IMAGE RECEPTION AREA ................................................. 35

Appendix ZZ

Appendix ZZ

Variations to IEC 61223-3-1:1999 for application in Australia and New
Zealand ..................................................................................................... 443
Variations to IEC 61223-3-1:1999 for application in Australia and New
Zealand ..................................................................................................... 41

vi

INTRODUCTION

This standard is part of a series of International Standards which give methods of acceptance
testing and constancy testing for subsystems and systems (for example diagnostic X- RAY
EQUIPMENT ), including film processing, used in medical imaging departments.

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Some provisions or statements in this standard require additional information. Such information
is presented in annex D. An asterisk in the left margin of a clause or subclause indicates the
presence of such additional information.

1
AUSTRALIAN/NEW ZEALAND STANDARD

Evaluation and routine testing in medical imaging departments
Part 3.1:
Acceptance tests — Imaging performance of X-ray equipment for
radiographic and radioscopic systems (IEC 61223-3-1:1999, MOD)

1

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1.1

Scope and object
Scope

This part of IEC 61223 applies to those components of X- RAY EQUIPMENT which influence the
image quality and PATIENT dose of diagnostic X-ray systems using radiographic and radioscopic
imaging systems.
This standard applies to the performance of X- RAY EQUIPMENT in the ACCEPTANCE TEST on the
following medical diagnostic X- RAY EQUIPMENT and ASSOCIATED EQUIPMENT :

radiography equipment, for example:
• stationary radiography EQUIPMENT ;
• mobile radiography EQUIPMENT ;
• skull radiography EQUIPMENT ;
• lung radiography EQUIPMENT ;
• TOMOGRAPHY EQUIPMENT – excluding COMPUTED TOMOGRAPHY ;
• radiography devices ( SPOTFILM DEVICES ) in RADIOSCOPY EQUIPMENT ;
• angiography EQUIPMENT (excluding DSA function);
• CINERADIOGRAPHY equipment;

RADIOSCOPY EQUIPMENT ,

including:

• combined radiographic and radioscopic EQUIPMENT .
This standard applies to the generation of X- RADIATION and ACCESSORIES of digital systems. It
does not apply to any digital image acquisition or image processing parts of the above
mentioned diagnostic X- RAY EQUIPMENT .
NOTE – Since the characterization of digital detectors and image processing is still under development, this will be
included in a later edition of this standard.

This standard does not apply to mammographic X- RAY EQUIPMENT , RADIOTHERAPY simulators,
nor to dental X- RAY EQUIPMENT .
1.2

Object

This standard defines:
a) the parameters which describe the performance of X- RAY EQUIPMENT with regard to imaging
properties and PATIENT dose;
b) methods of testing whether measured quantities related to those parameters comply with
the specified tolerances.

COPYRIGHT

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This is a free preview. Purchase the entire publication at the link below:

AS/NZS 4184.3.1:2002, Evaluation and routine
testing in medical imaging departments
Acceptance tests - Imaging performance of X-ray
equipment for radiographic and radioscopic
systems

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