AS/NZS 4194:1994

IEC 1157:1992

Australian/New Zealand Standard

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Requirements for the declaration

of the acoustic output of medical
diagnostic ultrasonic equipment
 AS/NZS 4194:1994

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

Committee HT/17, Ultrasonic Medical Equipment. It was approved on behalf of the
Council of Standards Australia on 8 April 1994 and on behalf of the Council of
Standards New Zealand on 24 April 1994. It was published on 11 July 1994.
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The following interests are represented on Committee HT/17:

CSIRO—Department of Radiophysics, Australia

Public Works Department, N.S.W.

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details of new publications, new editions and amendments, and of withdrawn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.
 AS/NZS 4194:1994

Australian/New Zealand Standard

This is a free 6 page sample. Access the full version at http://infostore.saiglobal.com.

Requirements for the declaration

of the acoustic output of medical
diagnostic ultrasonic equipment

First publi shed as Joint Standard AS/NZS 4194:1994.

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 7262 8897 7
 ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee HT/17 on
Ultrasonic Medical Equipment, and issued as a Joint Standard under the terms of the Active Cooperation
Agreement between Standards Australia and Standards New Zealand.

This Standard is identical with and has been reproduced from IEC 1157:1992, Requirements for the declaration
of the acoustic output of medical diagnostic ultrasonic equipment.

Under arrangements made between Standards Australia/Standards New Zealand and ISO/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 and title page.

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 word ‘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 or Joint Australian/New Zealand Standards:

Reference to International Standard Australian or Joint Australian/New Zealand Standard

or other publication
IEC —
469 Pulse techniques and apparatus
469 Part 1: Pulse terms and definitions
854 Methods of measuring the performance of —
ul t ra s on i c p u l s e -e ch o d i a g no s t i c
equipment
1102 Measurement and characterization of —
ultrasonic fields using hydrophones in the
frequency range 0,5 MHz to 15 MHz
1161 Ultrasonic power measurement in liquids —
in the frequency range 0,5 MHz to
25 MHz

The terms ‘normative’ and ‘informative’ have been used in this Standard to define the application of the annex
to which they apply. A ‘normative’ annex is an integral part of a Standard, whereas an ‘informative’ annex is
only for information and guidance.

 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 Copyri ght Act all ows and except where provided for below no publications or software produced by
Standards Australi a or Standards New Zealand may be reproduced, stored in a retri eval system in any form or tr ansmit ted 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 directed
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 royalt y or advice to Standards Australi a or Standards New Zealand.
Inclusion of copyri ght materi al in computer software programs is also permitt ed 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 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 contracts is subject to the payment of a royalty. This policy may be vari ed by Standards Austr alia or Standards New
Zealand at any ti me.
 iii

CONTENTS

Clause Page

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

2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Definitions and symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

4 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
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4.1 General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

4.2 Requirements for the declaration of acoustic output information . . . . . . . . . . . . . 10

4.2.1 Information to be declared in technical data sheets . . . . . . . . . . . . . . . 10

4.2.2 Information to be declared in the accompanying literature/manual . . . . 10

4.2.3 Background information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

5 Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

6 Declaration exemption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

7 Test methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

8 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

8.1 Presentation of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Annexes

A Presentation of acoustic output information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

B Declaration requirements for complex systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

C Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

(PAGE iv IN THE HARD COPY IS BLANK)

 1

STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND

Australian/New Zealand Standard

Requirements for the declaration of the acoustic output of medical
diagnostic ultrasonic equipment

1 Scope

This International Standard is applicable to medical diagnostic ultrasonic equipment.

It establishes requirements for the declaration of the acoustic output information:

— to be presented in technical data sheets supplied to prospective purchasers of

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equipment by manufacturers;

— to be declared in the accompanying literature/manual supplied by manufacturers;

— as background information to be made available on request to interested parties by

manufacturers.

It also gives exemption conditions for equipment generating low acoustic output levels.

2 Normative references

The following normative documents contain provisions which, through reference in this text,
constitute provisions of this International Standard. At the time of publication, the editions
indicated were valid. All normative documents are subject to revision, and parties to
agreements based on this International Standard are encouraged to investigate the possibility
of applying the most recent editions of the normative documents indicated below. Members of
IEC and ISO maintain registers of currently valid International Standards.

IEC 469-1: 1987, Pulse techniques and apparatus. Part 1: Pulse terms and definitions.

IEC 854: 1986, Methods of measuring the performance of ultrasonic pulse-echo diagnostic
equipment.

IEC 1102: 1991, Measurement and characterization of ultrasonic fields using hydrophones in
the frequency range 0,5 MHz to 15 MHz.

IEC 1161: 1992, Ultrasonic power measurement in liquids in the frequency range 0,5 MHz
to 25 MHz.

3 Definitions and symbols

For the purpose of this International Standard, the following definitions apply.

Figures 1 to 4 illustrate some of the defined parameters given below.

COPYRIGHT
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AS/NZS 4194:1994, Requirements for the

declaration of the acoustic output of medical
diagnostic ultrasonic equipment
This is a free 6 page sample. Access the full version at http://infostore.saiglobal.com.

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