AS/NZS 4358:1996

IEC 1267:1994

Australian/New Zealand Standard

This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Medical diagnostic X-ray

equipment—Radiation conditions
for use in the determination of
characteristics
 AS/NZS 4358:1996

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 13 October 1995 and on behalf of the Council
of Standards New Zealand on 11 September 1995. It was published on 5 January 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 and New Zealand Society of Nuclear Medicine
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Australian Chamber of Commerce and Industry

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

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details of new publications, new editions and amendments, and of withdrawn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 95128.

 AS/NZS 4358:1996

Australian/New Zealand Standard

This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Medical diagnostic X-ray

equipment—Radiation conditions
for use in the determination of
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 0170 1
 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.
It is identical with and has been reproduced from IEC 1267:1994 Medical diagnostic X-ray
equipment—Radiation conditions for use in the determination of 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.
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

(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 or Joint Australian/New Zealand Standards:

Reference to International Standard Australian/New Zealand Standard

or other publication

IEC AS
601 Medical electrical equipment 3200 Approval and test specification—
Medical electrical equipment
601 - 1 Part 1: General requirements for safety 3200.1 (NZS 6150) Part 1: General
601-1/Amd.1 Amendment 1 (1991) requirements for safety

731 Medical electrical equipment— —

Dosimeters with ionization chambers as
used in radiotherapy
731/Amd.1 Amendment 1 (1987)

788 Medical radiology—Terminology —

AS/NZS
1223 Evaluation and routine testing in 4184 Evaluation and routine testing in
medical imaging departments medical imaging departments
1223.1 Part 1: General aspects 4184.1 Part 1: General aspects

ISO
2092 Light metals and their alloys—Code of —
designation based on chemical symbols

The term ‘informative’ has been used in this Standard to define the application of the Annex to which it
applies. An ‘informative’ Annex is for information and guidance only.
 iii

CONTENTS
Page
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Clause

1 Scope and object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

3 Terminology . . . . . . . . . . . . . .. .. .. . .. .. . .. . .. . . .. . .. . . .. .. . .. .. . .. . . . .. 4
3.1 Degree of requirements .. .. .. . .. .. . .. . .. . . .. . .. . ..... . . .. .. .. . . . .. 4
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

3.2 Use of terms . . . . . . . . .. .. .. . .. .. . .. . .. . . .. . .. . ..... . .. .. . .. . . . .. 4

3.3 Defined terms . . . . . . . .. .. .. . .. .. . .. . .. . . .. . .. . .. .. . . ..... .. . . . .. 4

4 Common aspects - Adjustment procedures . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . 5

4.1 Standard RADIATION CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . 5
4.2 Adjustment procedure to establish standard RADIATION CONDITIONS . . . . . .. .. .. . 5
4.3 RADIATION DETECTOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . 5

5 Standard RADIATION QUALITIES RQR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . .. 6

5.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 6
5.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 6
5.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 6
5.4 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 7
5.5 Generation and verification of the standard RADIATION QUALITIES RQR . .. .. .. . .. 8

6 Standard RADIATION QUALITIES RQA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . .. 8

6.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 8
6.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 9
6.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 9
6.4 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. ... .. 10
6.5 Generation and verification of the standard RADIATION QUALITIES RQA . .. .. .. . .. 10

7 Standard RADIATION CONDITIONS RQN . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. .. .. .. . 12

7.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. ....... 12
7.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. ....... 12
7.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. ....... 12
7.4 Test equipment (DIAPHRAGMS) . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. . .. .. . . 13
7.5 Generation of the standard RADIATION CONDITIONS RQN . . . . . . . . .. . .. ....... 13

8 Standard RADIATION CONDITIONS RQB . . . . . . . . . . . . . . . . . . . . .... .. .. . .. ... .. .. 13

8.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. .. . .. ... .. .. 13
8.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. .. . .. ... .. .. 13
8.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. .. . .. ... .. .. 14
8.4 Test equipment (DIAPHRAGMS) . . . . . . . . . . . . . . . . . . . . . . .. .. .. . .. . .. .. .. 14
8.5 Generation of the standard RADIATION CONDITIONS RQB . . .... .. .. . .. ... .. .. 14

9 Standard RADIATION CONDITION RQN-M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

9.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
 iv

Clause Page

9.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.4 Test equipment (DIAPHRAGMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
9.5 Generation of the standard RADIATION CONDITION RQN-M . . . . . . . . . . . . . . . . . . . 16

10 Standard RADIATION CONDITION RQB-M . . . . . . . . . . . . . . . . . . . .... .. . . ... . .. .. .. 16

10.1 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... .. . . ... ..... .. 16
10.2 Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .. .. . . ... ..... .. 16
10.3 Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . .. . . ... ..... .. 16
10.4 Test equipment (DIAPHRAGM ) . . . . . . . . . . . . . . . . . . . . . . .. . .. . . ... .. .. . .. 17
10.5 Generation of the standard RADIATION CONDITION RQB-M . .... .. . . ... ..... .. 17

Tables
1 Characterization of standard RADIATION QUALITIES RQR 2 to RQR 10 . . . . . . . . . . . . . . . 7
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

2 Parameters for achieving standard RADIATION QUALITIES RQR 2 to RQR 10 . . . . . . . . . . 7

3 Characterization of standard RADIATION QUALITIES RQA 2 to RQA 10 . . . . . . . . . . . . . . . 9
4 Parameters for achieving standard RADIATION QUALITIES RQA 2 to RQA 10 . . . . . . . . . . 10

Figures
1 Measuring arrangement for achieving standard RADIATION QUALITIES RQR 2 to RQR 10 . 18
2 Measuring arrangement for achieving standard RADIATION QUALITIES RQA 2 to RQA 10 . 19
3 Measuring arrangement for applying RADIATION CONDITIONS RQN 2 to RQN 10 . . . . . . . . 20
4 Measuring arrangement for applying RADIATION CONDITIONS RQB 2 to RQB 10 . . . . . . . . 21
5 Measuring arrangement for applying RADIATION CONDITION RQN-M . . . . . . . . . . . . . . . . 22
6 Measuring arrangement for applying RADIATION CONDITION RQB-M . . . . . . . . . . . . . . . . . 23
7 Adjustment procedure to establish standard RADIATION CONDITIONS . . . . . . . . . . . . . . . . 24

Annexes
A Terminology - Index of defined terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
B Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
C Application of standard RADIATION CONDITIONS in the medical field . . . . . . . . . . . . . . . . . 29

First publi shed as AS/NZS 4358:1996.

 Copyri ght STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND

Users of Standards are reminded that copyri ght subsists in all Standards Austr alia and Standards New Zealand publications and
soft ware. Except where the Copyright Act all ows and except where provided for below no publications or soft ware produced by
Standards Australi a or Standards New Zealand may be reproduced, stored in a retri eval system in any form or transmitt ed by any
means without pri or permission in wri ti ng fr om Standards Australi a or Standards New Zealand. Permission may be conditi onal on an
appropri ate royalty payment. Austr alian requests for permission and information on commercial software royalti es should be dir ected
to the head offi ce of Standards Austr alia. New Zealand requests should be directed to Standards New Zealand.
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 Australi a or Standards New Zealand.
Inclusion of copyright materi al in computer software programs is also permit ted wit hout royalty payment provided
such programs are used exclusively in-house by the creators of the programs.
Care should be taken to ensure that materi al used is fr om the current edit ion 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 identif ied.
The use of material in pri nt form or in computer soft ware programs to be used commercially, with or without payment, or in
commercial contr acts is subject to the payment of a royalty. This policy may be vari ed by Standards Austr alia or Standards
New Zealand at any time.
 1

AUSTRALIAN/NEW ZEALAND STANDARD

INTRODUCTION

To establish characteristics, aspects or properties of associated equipment or to have available radiation

beams for physical and medical investigations, sets of well-defined radiation conditions can offer an
important tool in many situations.

From a regulation and standardization point of view there is a need:

– to have available well-defined RADIATION COND ITIONS that can be used internationally to specify
standards of operation of X-RAY EQUIPM ENT;
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

– to provide a basis for the harmonization of existing national standards;

– to provide uniform sets of RADIATION CO NDITIONS (a dictionary of RADIATION CO NDITIONS) to

describe and judge the performance of X-RAY EQUIPMEN T for the benefit of MA NUFACTURERS, USERS,
PATIENTS and health protection authorities;

– to solve communication problems between M ANUFACTURERS, USERS and regulatory authorities,

stemming from a lack of internationally accepted definitions and test methods.

From an application point of view commonly accepted sets of RADIATION COND ITIONS would in general find
use in:

– QUALITY CONTROL tests by MANUFACTURERS;

– installation and ACCEPTANCE TESTS ;
– calibration of test instrumentation;
– type approval tests (where required);
– inspection and tests by regulatory authorities and testing institutes;

– physical and medical studies in physical laboratories and medical facilities;

– determination of characteristics of ASSOCIATED EQUIPME NT.

Standard RADIATION CONDITIONS can benefit a number of potential users, such as:

– MANUFACTURERS of X-RAY EQUIPME NT;

– MANUFACTURERS of X-ray test instrumentation;
– research laboratories:
– testing institutes:
– USERS;
– government regulatory authorities:
– service organizations;
– standardization organizations.

Some provisions and statements in the body of this International Standard require additional information.
Such information is presented in annex B called “Rationale”. An asterisk in the left-hand margin of a clause
or subclause indicates the presence of such additional information.

A comprehensive survey for the application of all standard RADIATION CO NDITIONS in the medical field is
given in annex C.

COPYRIGHT
 2

MEDICAL DIAGNOSTIC X-RAY EQUIPMENT –

RADIATION CONDITIONS FOR USE IN THE DETERMINATION

OF CHARACTERISTICS

1. Scope and object

* 1.1 Scope

This International Standard applies to test procedures which, for the determination of characteristics of
systems or components of medical diagnostic X-RAY EQUIPM ENT, require well-defined RADIATION
CONDITIONS.
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Except for mammography, this standard does not apply to conditions where discontinuities in radiation
absorption of elements are deliberately used to modify properties of the RADIATION BEAM (for example by
rare earth filters).

Speed measurements of screen-film systems are not included in this standard. This topic will be covered
by an ISO standard.

* 1.2 Object

This standard deals with methods for generating RADIATION BEAMS with RADIATION CON DITIONS which can be
used under test conditions typically found in test laboratories or in manufacturing facilities for the
determination of characteristics of medical diagnostic X-RAY EQUIPME NT.

Examples of such RADIATION COND ITIONS are those emerging from the X-RAY TUBE ASSEMB LY or RADIATION
CONDITIONS that simulate those emerging from an EXIT SURFACE of the PATIENT .

The most complete specification of RADIATION COND ITIONS is given by the spectral distribution of the
RADIATION BEAM . Since the characterization of typical X- RAY SPECTRA is such a difficult measurement
problem, this standard expresses RADIATION CON DITIONS in terms of a modified HALF- VALUE LAYER technique
or, where applicable, with water phantoms with regard to defined geometric conditions.

This standard describes both primary RADIATION CO NDITIONS, which to a good approximation are free of
SCATTERED RADIATION (RQR and RQA ) and, for PATIENT simulation. RADIATION CON DITIONS containing
SCATTERED RADIATION (RQ N, RQ B, RQ N-M and RQB -M).

It is crucial to be aware that in the presence of SCATTERED RADIATION the characteristics of X-RADIATION in
terms of fractions of PRIMARY RADIATION and SCATTERED RADIATION depend on the position and nature of
any ADDED FILTER or PHANTOM . It is therefore obvious that AIR KERMA measurements in such RADIATION
BEAMS need careful consideration.

Clauses 5 and 6 deal with RADIATION CON DITIONS which are essentially free of SCATTERED RADIATION. Due
to the spatial homogeneity of these RADIATION COND ITIONS, the APPLICATION DISTANCE does not influence
the RADIATION COND ITIONS to a significant extent. These RADIATION CON DITIONS are called RADIATION
QUALITIES .

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

AS/NZS 4358:1996, Medical diagnostic X-ray

equipment - Radiation conditions for use in the
determination of characteristics
This is a free 8 page sample. Access the full version at http://infostore.saiglobal.com.

Looking for additional Standards? Visit SAI Global Infostore

Subscribe to our Free Newsletters about Australian Standards® in Legislation; ISO, IEC, BSI and more
Do you need to Manage Standards Collections Online?
Learn about LexConnect, All Jurisdictions, Standards referenced in Australian legislation
Do you want to know when a Standard has changed?
Want to become an SAI Global Standards Sales Affiliate?

Learn about other SAI Global Services:

LOGICOM Military Parts and Supplier Database

Metals Infobase Database of Metal Grades, Standards and Manufacturers
Materials Infobase Database of Materials, Standards and Suppliers
Database of European Law, CELEX and Court Decisions

Need to speak with a Customer Service Representative - Contact Us