AS/NZS 4434.

1:1996
IEC 976:1989

Australian/New Zealand Standard

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Medical electrical equipment—

Medical electron accelerators

Part 1: Functional performance

characteristics
[ IEC title: Medical electrical equipment—Medical electron
accelerators — Functional performance characteristics]
 AS/NZS 4434.1:1996

This Joint Australian/New Zealand Standard was prepared by Joint Technical

Committee HT/23, Medical Diagnostic Imaging Equipment. It was approved on
behalf of the Council of Standards Australia on 16 September 1996 and on behalf
of the Council of Standards New Zealand on 26 July 1996. It was published on
5 November 1996.

The following interests are represented on Committee HT/23:

Australasian College of Physical Scientists and Engineers in Medicine
Australian Academy of Dento-Maxillo-Facial Radiologists
Australian Chamber of Commerce and Industry
Australian Dental Association
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Australian Dental Industry Association

Australian Institute of Radiography
Australian and New Zealand Society of Nuclear Medicine
Australian Radiation Laboratory
Department of Defence, Australia
Department of Public Works and Services, N.S.W.
Environment Protection Authority, N.S.W.
Health Department, W.A.
Ministry of Commerce, New Zealand
Ministry of Health, New Zealand
Queensland Health
Radiation Health Standing Committee, Australia
Royal Australasian College of Radiologists
South Australian Health Commission
United Dental Hospital of Sydney
University of Sydney

Review of Standards. To keep abreast of progress in industry, Joint Australian/

New Zealand Standards are subject to periodic review and are kept up to date by the
issue of amendments or new editions as necessary. It is important therefore that
Standards users ensure that they are in possession of the latest edition, and any
amendments thereto.
Full details of all Joint Standards and related publications will be found in the Standards
Australia and Standards New Zealand Catalogue of Publications; this information is
supplemented each month by the magazines ‘The Australian Standard’ and ‘Standards
New Zealand’, which subscribing members receive, and which give details of new
publications, new editions and amendments, and of withdrawn Standards.
Suggestions for improvements to Joint Standards, addressed to the head office of either
Standards Australia or Standards New Zealand, are welcomed. Notification of any
inaccuracy or ambiguity found in a Joint Australian/New Zealand Standard should be
made without delay in order that the matter may be investigated and appropriate action
taken.

This Standard was issued in draft form for comment as DR 96123.

 AS/NZS 4434.1:1996

Australian/New Zealand Standard

This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Medical electrical equipment—

Medical electron accelerators

Part 1: Functional performance

characteristics

PUBLISHED JOINTLY BY:

STANDARDS AUSTRALIA
1 The Crescent,
Homebush NSW 2140 Australia
STANDARDS NEW ZEALAND
Level 10, Standards House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7337 0769 6
 ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee,
HT/23, on Medical Diagnostic Imaging Equipment, as a Joint Standard.
This Standard is identical with and has been reproduced from IEC 976:1989, Medical electrical
equipment— Medical electron accelerators — Functional performance characteristics .
Under arrangements made between Standards Australia/Standards New Zealand and the IEC, as well
as certain other Standards organizations, users of this Standard are advised that the number of this
Standard is not reproduced on each page; its identity is shown only on the cover.
For the purpose of this Standard, the IEC text should be modified as follows:
(a) Terminology The words ‘this Australian/New Zealand Standard’ should replace the words
‘this International Standard’ wherever they appear.
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(b) Decimal marker Substitute a full point for a comma where it appears as a decimal marker.
(c) References 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
or other publication
IEC AS/NZS
601 Medical electrical equipment 3200 Approval and test specification—
Medical electrical equipment
601-1 Part 1: General requirements for 3200.1.0 General requirements for safety
safety
601-2-1 Part 2: Particular requirements for —
medical electron accelerators in the
range 1 MeV to 50 MeV. Section
One —General. Section Two —
Radiation safety for equipment
788 Medical radiology— Terminology —
977 Medical electrical equipment— 4434 Medical electrical equipment —
Medical electron accelerators in the Medical electron accelerators
range 1 MeV to 50 MeV — Guidelines 4434.2 Part 2: Periodic function performance
for functional performance testing
characteristics

 Copyright STANDARDS AUSTRALIA/ STANDARDS NEW ZEALAND

Users of Standards are reminded that copyright subsists in all Standards Australia and Standards New Zealand publications and software.
Except where the Copyright Act allows and except where provided for below no publications or software produced by
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Up to 10 percent of the technical content pages of a Standard may be copied for use exclusively in-house by purchasers of the
Standard without payment of a royalty or advice to Standards Australia or Standards New Zealand.
Inclusion of copyright material in computer software programs is also permitted without royalty payment provided such programs
are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that material used is from the current edition of the Standard and that it is updated whenever the Standard
is amended or revised. The number and date of the Standard should therefore be clearly identified.
The use of material in print form or in computer software programs to be used commercially, with or without payment, or in commercial
contracts is subject to the payment of a royalty. This policy may be varied by Standards Australia or Standards New Zealand at any time.
 iii

CONTENTS
Page
Clause
1 Scope and object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .. .. .... 1
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .... .... 1
1.2 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .... .... 1
1.3 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 2
2 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... . . .... ... 2
2.1 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .... .. ...... 2
2.2 Degree of requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ...... .. 3
3 General information to the USER . . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 3
3.1 Available NOMINAL ENERGIES and ABSORBED DOSE RATES . . . . .. ... .. ..... . 3
3.2 Available RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 3
3.3 NORMAL TREATMENT DISTANCE . . . . . . . . . . . . . . . . . . . . . ...... ........ 3
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3.4 Available FILTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... .. .... .. 3

3.5 Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .. .. .... 4
3.6 Influencing quantities . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... ... 4
3.7 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . ... .. ... 4
3.8 Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .. .. .... 4
4 Standardized test conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ...... .. 4
4.1 Angle settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... .... .. .. 4
4.2 Properties and positioning of the PHANTOM . . . . . . . . . . . . . ... ... .. ...... 4
4.3 Positioning of measuring points . . . . . . . . . . . . . . . . . . . . . ...... ........ 4
4.4 RADIATION DETECTORS . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ...... .. 5
4.5 STANDARD MEASUREMENT DEPTHS . . . . . . . . . . . . . . . . . . . .. .... ........ 5
4.6 RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ... .... . 5
4.7 Adjustments during test . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 5
5 DOSE MONITORING SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... ... 5
5.1 Reproducibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... . .... .. . 6
5.2 Proportionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... .... .. .. 7
5.3 Dependence on angular positions . . . . . . . . . . . . . . . . . . . . . ..... ........ 7
5.4 Dependence on GANTRY rotation . . . . . . . . . . . . . . . . . . . . . ..... ........ 9
5.5 Dependence on the shape of the RADIATION FIELD . . . . . . . . . .. ... .. ..... . 9
5.6 Stability of calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ...... .. 10
5.7 Stability in MOVING BEAM RADIOTHERAPY . . . . . . . . . . . . . . .. .... . ....... 12
6 Depth ABSORBED DOSE characteristics . . . . . . . . . . . . . . . . . . . . . ..... ........ 13
6.1 X- RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . ... .. ... 13
6.2 ELECTRON RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... ... 15
7 Uniformity of RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 17
7.1 X- RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . ... .. ... 17
7.2 ELECTRON RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... ... 22
7.3 Penumbra of RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . ...... ........ 24
8 Indication of RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . . . . . ...... ........ 25
8.1 X- RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . ... .. ... 25
8.2 ELECTRON RADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...... ..... ... 28
8.3 Geometry of the BEAM LIMITING SYSTEM for X-RADIATION . . .. .. .. . .. ..... 30
8.4 Illuminance and penumbra of the LIGHT FIELD . . . . . . . . . . . ..... . .... .... 30
9 Indication of the RADIATION BEAM AXIS . . . . . . . . . . . . . . . . . . . .. .... ........ 31
9.1 Indication on entry to the PATIENT . . . . . . . . . . . . . . . . . . . .. .... ........ 31
9.2 Indication on exit from the PATIENT . . . . . . . . . . . . . . . . . . ... ... ........ 33
 iv
Page
Clause
10 ISOCENTRE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
10.1 Displacement of the RADIATION BEAM AXIS from the ISOCENTRE . . . . . . . . . . . 33
10.2 Indication of the ISOCENTRE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
11 Indication of distance along the RADIATION BEAM AXIS . . . . . . . . . . . . . . . . . . . . . . 35
11.1 Indicating device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
11.2 Additional indicating device for equipment with variable distance between
RADIATION SOURCE and ISOCENTRE and for NON- ISOCENTRIC equipment . . . . . . 36
12 Zero position of rotational scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
12.1 Information to the USER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
12.2 Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
13 Congruence of opposed RADIATION FIELDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
13.1 Information to the USER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
13.2 Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
14 Movements of the PATIENT table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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14.1 Vertical movement of the table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

14.2 ISOCENTRIC rotation of the table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
14.3 Parallelism of table rotational axes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
14.4 Rigidity of the table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

FIGURES 1 to 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

APPENDIX A — Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
APPENDIX B — Format for presentation of functional performance values . . . . . . . . . . . . . 58

First publi shed as AS/NZS 4434.1:1996.

 1

Medical electrical equipment—Medical electron accelerators

Part 1:
Functional performance characteristics
INTRODUCTION

Standards containing safety requirements for MEDICAL ELECTRON ACCELERATORS have been
published by the IEC, details of which will be found in the Preface.

The present standard specifies methods of test and methods of disclosure of functional
performance of ELECTRON ACCELERATORS intended for RADIOTHERAPY . It permits a direct
comparison between the performance data of equipment of different manufacture.

Since this standard does not contain safety requirements it has not been numbered in the
IEC 601 publication series. It describes aspects of functional performance of ELECTRON
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ACCELERATORS and the way in which they should be presented. It also includes test methods and
conditions suitable for type tests. These test methods are suggested test methods and alternative
methods may be equally appropriate, but the specified functional performance characteristics of the
MEDICAL ELECTRON ACCELERATORS shall be related to these test methods and conditions. Tests
specified in this standard are not necessarily appropriate for ensuring that any individual ELECTRON
ACCELERATOR conforms with the declared functional performance during the course of its working
lifetime. Guidance on the values which may be expected are given in the Report, IEC
Publication 977.

1 Scope and object

1.1 Scope

1.1.1 This standard applies to MEDICAL ELECTRON ACCELERATORS when used, for therapy
purposes, in human medical practice.

1.1.2 This standard applies to ELECTRON ACCELERATORS which deliver a RADIATION BEAM
of either X- RADIATION OR ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV
to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s −1 and 1 Gy s −1 at 1 m from
the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm
from the RADIATION SOURCE .

1.1.3 The present standard describes a set of measurements requiring two to three months’
work to complete. It specifies test procedures to be performed by the manufacturer at the
design and construction stage of a MEDICAL ELECTRON ACCELERATOR but does not specify
acceptance tests to be performed after installation at the purchaser’s site. The accompanying
report, IEC Publication 977, however, does suggest that many of the test procedures are
appropriate for acceptance tests.

1.1.4 The measurement conditions described in the present standard differ from those currently in
use. This applies particularly to the PHANTOM position for measurements and the measurement
of distances from the ISOCENTRE . These new conditions should be substituted for and not be
added to present methods.

1.2 Object

This standard specifies test procedures for the determination and disclosure of functional
performance characteristics, knowledge of which is deemed necessary for proper application

COPYRIGHT
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AS/NZS 4434.1:1996, Medical electrical equipment

- Medical electron accelerators Functional
performance characteristics
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