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AS/NZS 3824:1998

IEC 61859:1997

Australian/New Zealand Standard™


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Guidelines for radiotherapy


treatment rooms design
AS/NZS 3824:1998

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


Committee HE/3, Medical Electrical Equipment. It was approved on behalf of the
Council of Standards Australia on 1 May 1998 and on behalf of the Council of
Standards New Zealand on 7 May 1998. It was published on 5 July 1998.

The following interests are represented on Committee HE/3:


Australasian College of Physical Scientists and Engineers in Medicine
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Australasian Society for Ultrasound in Medicine


Australian Dental Association
Australian Institute of Radiography
Australian Radiation Laboratory
Australian Society of Anaesthetists
College of Biomedical Engineering Institution of Engineers Australia
Commonwealth Department of Health and Family Services
Department of Defence (Australia)
Medical Industry Association of Australia
Ministry of Commerce, New Zealand
Royal Australasian College of Surgeons
Royal Australasian College of Radiologists

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publications, new editions and amendments, and of withdrawn Standards.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 97445.


AS/NZS 3824:1998

Australian/New Zealand Standard™


This is a free 9 page sample. Access the full version at http://infostore.saiglobal.com.

Guidelines for radiotherapy


treatment rooms design

First published as AS/NZS 3824:1998.

Published jointly by:

Standards Australia
1 The Crescent,
Homebush NSW 2140 Australia

Standards New Zealand


Level 10, Radio New Zealand House,
155 The Terrace,
Wellington 6001 New Zealand
ISBN 0 7337 1987 2
ii

PREFACE

This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee
HE/3, Medical Electrical Equipment.
This Standard is identical with and has been reproduced from IEC 61859:1997, Guidelines for
radiotherapy treatment rooms design.
The even numbered pages of the original publication are in French and are omitted from this
version. Some other pages of the original, which relate to IEC administrative matters, are also
omitted from this edition.
As this publication has been reproduced from an International Standard, the following modifications
apply:
(a) Its number does not appear on each page of text and its identity is shown on the cover and
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title page.
(b) The words ‘this Australian/New Zealand Standard’ should replace the words ‘this International
Standard’ wherever they appear.
(c) Substitute a full point for a comma where it appears as a decimal marker.
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/NZS
60601-1-2 Medical electrical equipment 3200 Approval and test
Part 1: General requirements for specification — Medical electrical
safety — equipment
2. Collateral standard: 3200.1.2 Part 1.2: General requirements for
Electromagnetic compatibility — safety — Collateral Standard:
Requirements and tests Electromagnetic compatibility —
Requirements and tests
60601-2-1 Medical electrical equipment —
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
60601-2-8 Medical electrical equipment 3200 Approval and test
Part 2: Particular requirements for specification — Medical electrical
the safety of therapeutic X-ray equipment
generators 3200.2.8 Part 2.8: Particular requirements for
safety — Therapeutic X-ray generators

60601-2-11 Medical electrical equipment —


Part 2: Particular requirements for
the safety of gamma beam
radiotherapy equipment
iii

IEC AS/NZS
60601-2-17 Medical electrical equipment 3200 Approval and test
Part 2: Particular requirements for specifications — Medical electrical
the safety of remote-controlled equipment
automatically driven gamma-ray 3200.2.17 Part 2.17: Particular requirements for
afterloading equipment safety — Remote-controlled
automatically-driven gamma-ray
afterloading equipment
Clause 10 of the IEC document is headed ‘Reference documents’. The documents listed are not
International Standards and do not appear in the text of the document. More appropriately, the
clause should be considered to be a bibliography.
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© 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
Standards Australia or Standards New Zealand may be reproduced, stored in a retrieval system in any form or transmitted by any means
without prior permission in writing from Standards Australia or Standards New Zealand. Permission may be conditional on an
appropriate royalty payment. Australian requests for permission and information on commercial software royalties should be directed to
the head office of Standards Australia. 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 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.
iv

CONTENTS
Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v

Clause
1 Scope and object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Collateral and Particular Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Electrical requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
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2.1 SUPPLY MAINS .............................................. 2


2.2 Isolation from the SUPPLY MAINS ................................. 2
2.3 Electromagnetic compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.4 TREATMENT ROOM lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.5 Electrical FIXED MAINS SOCKET- OUTLETS ............................ 3
3 Environmental requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1 Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.2 Temperature, pressure and humidity requirements ................... 4
3.3 Air filtration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.4 Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.5 Cleaning requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
3.6 Fire protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.7 Magnetic field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.8 Floor covering and wall coating . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4 TREATMENT ROOM entrance system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.1 Entrance barrier system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.2 TREATMENT ROOM entrance INTERLOCKS ............................ 5
4.3 D ISPLAY of entrance INTERLOCK status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.4 Motorized TREATMENT Room door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5 Movable floor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6 A CCESSORIES handling and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
7 Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.1 Video and audio surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.2 PATIENT alignment system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.3 Indicator lights and warning signs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
7.4 Access ducts to the TREATMENT ROOM ............................. 7
8 Protection against IONIZING RADIATION outside the TREATMENT ROOM ........... 8
9 Information to be given by the RADIOTHERAPY EQUIPMENT MANUFACTURER ....... 8
10 Reference documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
v

INTRODUCTION

Particular Standards establish requirements for RADIOTHERAPY EQUIPMENT to ensure safety


during its use. RADIOTHERAPY EQUIPMENT generally consists of several parts, not all of
which are installed in the TREATMENT ROOM, i.e. the installation involves several rooms. If
these rooms are not all correctly designed and constructed, PATIENTS, OPERATORS and
other persons may be exposed to danger.

This technical report establishes requirements which should be complied with by the
designer of the RADIOTHERAPY installation, taking into account the safety requirements for
RADIOTHERAPY EQUIPMENT described in other IEC Standards.

Unless otherwise specified in the purchase contract, the RADIOTHERAPY EQUIPMENT


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MANUFACTURER is only responsible for the accuracy of the information given to the
organizations in charge of designing and building the RADIOTHERAPY installation.

At the time of installation of the RADIOTHERAPY EQUIPMENT, the USER should be able to
demonstrate that the requirements defined in this technical report are met.
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vi

NOTES
1

AUSTRALIAN/NEW ZEALAND STANDARD

GUIDELINES FOR RADIOTHERAPY


TREATMENT ROOMS DESIGN

1 Scope and object

1.1 Scope

This technical report applies only to those aspects of the installation ensuring the safety of
the PATIENT, the OPERATOR and other persons during the RADIOTHERAPY EQUIPMENT use.
General construction requirements are not addressed in this technical report.
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The installations considered in this technical report are those in which are located
RADIOTHERAPY EQUIPMENT delivering IONIZING RADIATION used for therapeutic purpose, such
as MEDICAL ELECTRON ACCELERATORS, GAMMA BEAM THERAPY EQUIPMENT AND GAMMA- RAY
AFTERLOADING EQUIPMENT. R ADIOTHERAPY SIMULATOR installations are not included in this
technical report.

A particular RADIOTHERAPY EQUIPMENT installation may generally consist of several rooms,


such as:

— the TREATMENT ROOM in which the RADIATION BEAM is emitted and in which the
PATIENT is located during the IRRADIATION, including all enclosed spaces where a
person could remain inadvertently during the IRRADIATION;
— the control room in which the TREATMENT CONTROL PANEL is located and from
which the OPERATOR controls the IRRADIATION and other functions of the
RADIOTHERAPY EQUIPMENT;

— other rooms which may contain other parts of the RADIOTHERAPY EQUIPMENT , but
where IRRADIATION is not carried out.

1.2 Object

This technical report establishes recommendations to be complied with by rooms where


RADIOTHERAPY EQUIPMENT is to be installed and which complement the safety requirements
for the RADIOTHERAPY EQUIPMENT installed. This technical report addresses environmental
protection, RADIATION protection outside the TREATMENT ROOM and some aspects of the
electrical safety HAZARDS.

1.3 Collateral and Particular Standards

According to the nature of the RADIOTHERAPY EQUIPMENT installed in the TREATMENT ROOM,
this technical report should be read in conjunction with the following Collateral and
Particular Standards:

IEC 60601-1-2: 1993, Medical electrical equipment — Part 1: General requirements for
safety — 2. Collateral standard: Electromagnetic compatibility — Requirements and tests

IEC 60601-2-11: 1981, Medical electrical equipment — 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

IEC 60601-2-8: 1987, Medical electrical equipment — Part 2: Particular requirements for
the safety of therapeutic X-ray generators

COPYRIGHT
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AS/NZS 3824:1998, Guidelines for radiotherapy


treatment rooms design
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