AS/NZS 3200.2.

17:1994
IEC 601-2-17:1989

Australian/New Zealand Standard

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Approval and test specifications—

Medical electrical equipment

Part 2.17: Particular requirements

for safety—Remote-controlled
automatically-driven gamma-ray
afterloading equipment
[IEC title: Medical electrical equipment, Part 2: Particular
requirements for the safety of remote-controlled automatically-driven
gamma-ray afterloading equipment]
 AS/NZS 3200.2.17:1994

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 30 May 1994 and on behalf of the Council
of Standards New Zealand on 27 June 1994. It was published on 22 August 1994.

The following interests are represented on Committee HT/23:

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Australian Academy of Dento-Maxillo-Facial Radiologists

Australian and New Zealand Society of Nuclear Medicine
Australian Chamber of Commerce and Industry
Australian College of Physical Scientists and Engineers in Medicine
Australian Dental 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, 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details of new publications, new editions and amendments, and of withdrawn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.
 AS/NZS 3200.2.17:1994

Australian/New Zealand Standard

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

Approval and test specifications—

Medical electrical equipment

Part 2.17: Particular requirements

for safety—Remote-controlled
automatically-driven gamma-ray
afterloading equipment

First publi shed as Joint Standard AS/NZS 3200.2.17:1994.

Incorporating:
Amdt 1—1997

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 9051 3
 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 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 601-2-17:1989, Medical
electrical equipment , Part 2: Particular requirements for the safety of remote-controlled
automatically-driven gamma-ray afterloading equipment.
This Standard is one of a series of Approval and Test Specifications issued by Standards Australia
and Standards New Zealand for various categories of medical equipment. It is supplementary to
AS/NZS 3200.1:1990, Approval and test specification—Medical electrical equipment , Part 1:
General requirements for safety.
The international Standard IEC 601-2-17 modifies and supplements the corresponding Clauses of
IEC 601-1:1988, Medical electrical equipment, Part 1: General requirements for safety which has
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been adopted as AS/NZS 3200.1, hereinafter referred to as the General Standard. The requirements
of a Particular Standard take priority, where appropriate, over those of the General Standard.
In the text of this Standard, the following print types are used:
(i) Requirements, compliance with which can be tested and definitions . . . . in large roman type
(ii) Explanations, advice, introductions, general statements,
exceptions and references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . in smaller roman type

(iii) Headings of sub-clauses and text specifications . . . . . . . . . . . . . . . . . . . . . . . in italic type

(iv) Terms used throughout the Standard, which have been defined in
Clause 2 and which are also in the index . . . . . . . . . . . . . . . . . . . . . . . IN SMALL CAPITALS

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, inside 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 words
‘this International Standard’ wherever they appear.
(b) Decimal marker Substitute a full point for a comma where it appears as a decimal marker.
Both the Appendices to this Standard, AA1 and AA2, are for information and guidance only.

 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 wit hout prior permission in writ ing from Standards Austr alia or Standards New Zealand. Permission may be condit ional on
an appropri ate royalty payment. Austr alian requests for permission and informati on on commercial soft ware royalt ies should be
directed to the head off ice of Standards Austr alia. New Zealand requests should be dir ected 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 royalt y 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

Page
INTRODUCTION .... .. ... .. ..... ..... .................. .... .. .... ....... 1
SECTION O NE —G ENERAL
Clause
1 Scope and object . . . . . . . . . . . . . . . . . . . . . . . . . ..... . .... . ... . ... .. . ... .. 1
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . .... . .... ..... . .... 1
1.2 Object . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . .... . .. .. .. .. . . .. .. 2
1.3 Particular Standards . . . . . . . . . . . . . . . . . ..... . ... . . .... .. ... . .... 2
1.5 Collateral Standards . . . . . . . . . . . . . . . . ..... . .... . .... ..... . .. .. 2
2 Terminology and definitions . . . . . . . . . . . . . . . . . .... . . .... . .... ..... . . ... 3
3 General requirements . . . . . . . . . . . . . . . . . . . . . . ..... . .... . .... .. ... . .. .. 3
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4 General requirements for tests . . . . . . . . . . . . . . . . .... . .... . .... ..... . ... . 3

5 Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . .... . . ... . .. .. . . ... 3
6 Identification, marking and documents . . . . . . . . . .. ... . . ... . . ... ..... . .... 4
6.1 Marking on the outside of EQUIPMENT . . . . .. .. . .. .. . .. .. ... .. . .... 4
6.7 Indicator lights and push-buttons . . . . . . . .. .. . . ... . . ... . ..... . .... 5
6.8 ACCOMPANYING DOCUMENTS . . . . . . . . . . . .... . .... . .... ..... . .... 5
7 Power input . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... . .... . .... .. ... . .... 7

SECTION TWO—ENVIRONMENTAL CONDITIONS

8 Basic safety categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
9 Removable protective means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
10 Environmental conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

SECTION THREE —PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

SECTION FOUR —PROTECTION AGAINST MECHANICAL HAZARDS

SECTION FIVE—PROTECTION AGAINST HAZARDS FROM UNWANTED OR

EXCESSIVE RADIATION
29 X-radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
30 Alpha, beta, gamma, neutron radiation and other particle radiation . . . . . . . . . . . . . . . 8
30.1 Protection in NORMAL USE and NORMAL CONDITION . . . . . . . . . . . . . . . . . . . 9
30.1.1 Limitation of LEAKAGE RADIATION from the STORAGE CONTAINER ( S) . . . . . . . 9
30.1.2 Indication of the position of RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . . . 9
30.1.3 Key control of possibility of pre-setting CONTROLLING TIMER , and of selection,
confirmation and movement of RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . 10
30.1.4 TREATMENT TIME . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
30.1.5 Indications by the CONTROLLING TIMER and of TREATMENT TIME . . . . . . . . . . 11
30.1.6 Selection and confirmation of CHANNELS , RADIOACTIVE SOURCES and positions
and movements of RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . 11
30.1.7 INITIATION, CONTINUATION , INTERRUPTION , and TERMINATION (OF IRRADIATION) 12
30.1.8 Distant INTERRUPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
30.2 Protection against other than NORMAL USE . . . . . . . . . . . . . . . . . . . . . . . . . 13
30.2.1 Rendering the TREATMENT CONTROL PANEL inoperative . . . . . . . . . . . . . . . . 13
 iv

Clause Page
30.2.2 Protection
of RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
30.3 Protection
in NORMAL USE while in SINGLE FAULT CONDITION . . . . . . . . . . . . 13
30.3.1 against failure of the SUPPLY MAINS . . . . . . . . . . . . . . . . . . . .
Protection . . 14
30.3.2 against failure of CONTROLLING TIMER . . . . . . . . . . . . . . . . . .
Protection . . 14
30.3.3 Protection
against failure of the positional accuracy and movement of the
RADIOACTIVE SOURCES and of the SOURCE DRIVE MECHANISM . . . . . . . . . . . . 15
30.3.4 Protection against failure of the couplings of the CHANNELS and the SOURCE
APPLICATORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
30.3.5 Protection against failure of the connections (if any) to the RADIOACTIVE
SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
30.3.6 Protection against failure of INTERLOCKS . . . . . . . . . . . . . . . . . . . . . . . . . . 16
30.3.7 Indication of SINGLE FAULT CONDITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
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36 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

SECTION SIX—PROTECTION AGAINST HAZARDS OF IGNITION OF

FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN —PROTECTION AGAINST EXCESSIVE TEMPERATURES AND

OTHER SAFETY HAZARDS

SECTION EIGHT—ACCURACY OF OPERATING DATA AND

PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.1.1 Information on GAMMA IRRADIATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.1.2 Scales and units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.1.3 Indication of selection of CHANNELS , RADIOACTIVE SOURCES , and the positions
and movements of RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.1.4 Information required for limiting the IRRADIATION during transit of the
RADIOACTIVE SOURCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
50.2 Agreement between indicated values and effective values . . . . . . . . . . . . . . . 18
50.2.1 Position of RADIOACTIVE SOURCES within SOURCE APPLICATORS . . . . . . . . . . 18
50.2.2 CONTROLLING TIMERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
51 Protection against hazardous output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

SECTION N INE—ABNORMAL OPERATION AND FAULT CONDITIONS;

ENVIRONMENTAL TESTS

SECTION TEN —CONSTRUCTIONAL REQUIREMENTS

APPENDIX AA—Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
AA1 Index of terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
AA2 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
 1

AUSTRALIAN/NEW ZEALAND STANDARD

Approval and test specifications—Medical electrical equipment

Part 2.17: Particular requirements for safety—Remote-controlled

automatically-driven gamma-ray afterloading equipment

INTRODUCTION

This Particular Standard has been amended from the third draft on the basis of discussions held
by WG 4 in Zurich from 5th to 7th March 1986 and as decided at the meeting of SC 62C in
Budapest. It is intended to supplement the General Standard for safety of medical electrical
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equipment (IEC 601-1, second edition (1988) with amendments 1 (1991) and 2 (1995)). As stated
in Sub-clause 1.3 of the General Standard, the requirements of this Particular Standard take
priority, where appropriate, over those of the General Standard.

The numbers of sections, clauses and sub-clauses of this publication refer to the relevant clauses
of IEC Publication 601-1. As in the General Standard, defined terms are printed in small capitals.

SECTION ONE—GENERAL

1 Scope and object

This clause of the General Standard applies except as follows:

1.1 Scope

Addition:

1.1.1 This Particular Standard specifies requirements for the safety of remote-controlled
automatically-driven EQUIPMENT for gamma-ray therapy of human subjects using
AFTERLOADING .

1.1.2 This Standard specifies requirements for AFTERLOADING EQUIPMENT

— which contains and uses only gamma-ray SEALED RADIOACTIVE SOURCES ,

— which automatically drives the gamma-ray SEALED RADIOACTIVE SOURCE (S ) from a

STORAGE CONTAINER to a treatment position inside the SOURCE APPLICATOR ( S),

— which is designed for connection to a PATIENT , and

— with which movements of the RADIOACTIVE SOURCE ( S ) are carried out automatically by
the EQUIPMENT according to a prescribed programme using a powered mechanism whose
changes are controlled by the CONTROLLING TIMER(S ) and TIMING DEVICES that are either
programmable electronic systems (computer or microprocessors) or non-programmable
systems (see also note to Sub-clause 3.2).

This Standard is not intended to apply to EQUIPMENT with neutron RADIOACTIVE SOURCES .

COPYRIGHT
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AS/NZS 3200.2.17:1994, Approval and test

specification - Medical electrical equipment
Particular requirements for safety -
This is a free 7 page sample. Access the full version at http://infostore.saiglobal.com.

Remote-controlled automatically-driven
gamma-ray afterloading equipment

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