IEC 60601-2-17:2004

Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment

The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment.

Appareils électromédicaux - Partie 2-17: Règles particulières de sécurité des appareils projecteurs de sources radioactives à chargement différé automatique utilisés en brachythérapie

L'utilisation d'appareils projecteurs de sources pour la brachythérapie peut exposer les patients à un risque si l'appareil ne parvient pas à délivrer la dose nécessaire au patient, ou si la conception de l'appareil ne répond pas aux normes de sécurité électrique et mécanique. L'appareil peut également être dangereux pour les personnes situées à proximité, si l'appareil lui-même ne parvient pas à contenir la (ou les) source(s) radioactive(s) convenablement dans le (ou les) récipient(s) de stockage et/ou s'il y a des défauts dans la conception de la salle de traitement. La présente Norme Particulière établit des exigences auxquelles il convient que les constructeurs se conforment dans la conception et la construction des appareils projecteurs de sources destinés à être utilisés dans des procédures de brachythérapie temporaires; elle ne tente pas de définir leurs exigences de performance optimales. Elle a pour objet d'identifier les caractéristiques de conception qui sont considérées, actuellement, comme essentielles pour le fonctionnement en toute sécurité de tels appareils. Elle fixe des limites sur la dégradation des performances de l'appareil au-delà desquelles on peut présumer qu'une condition de défaut existe, et où un verrouillage fonctionne ensuite pour renvoyer la (ou les) source(s) radioactive(s) dans le (ou les) récipient(s) de stockage, puis pour empêcher un fonctionnement continu de l'appareil.

General Information

• Status: Published
• Publication Date: 28-Jan-2004
• ICS: 11.040.60 - Therapy equipment
• ICS: 19.100 - Non-destructive testing
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 27-Nov-2013

Relations

• Revised: IEC 60601-2-17:2013 - Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD 60601-2-17
Second edition
2004-01
Medical electrical equipment –
Part 2-17:
Particular requirements for the safety of
automatically-controlled brachytherapy
afterloading equipment
Reference number
Publication numbering
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INTERNATIONAL IEC
STANDARD 60601-2-17
Second edition
2004-01
Medical electrical equipment –
Part 2-17:
Particular requirements for the safety of
automatically-controlled brachytherapy
afterloading equipment
 IEC 2004  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale V
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue

– 2 – 60601-2-17  IEC:2004(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5

SECTION ONE – GENERAL
1 Scope and object .6
2 Terminology and definitions .8
4 General requirements for tests.10
5 Classification .10
6 Identification, marking and documents .11

SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .15

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.15
30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radiation .15

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.25

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.28

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

Appendix L (normative) References – Publications mentioned in this standard.29

Bibliography .30
Index of defined terms.31

60601-2-17  IEC:2004(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-17 has been prepared by subcommittee 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1989, and its
Amendment 1 (1996). Consideration has been given to new IEC standards, amendments to
existing IEC standards, developments in technology and clinical usage, and various hazards
encountered and envisaged since the preparation of the first edition.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/363/FDIS 62C/366/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.

– 4 – 60601-2-17  IEC:2004(E)
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH ARE DEFINED IN CLAUSE
2 OR IN THE GENERAL STANDARD IEC 60601-1, ITS COLLATERAL OR PART 2 STANDARDS,
OR IN IEC 60788: SMALL CAPITALS.
NOTE Attention is drawn to the existence, in some countries, of legislation containing requirements for:
– IONIZING RADIATION safety which may not align with the provisions of this Particular Standard, and
– maintenance, quality assurance and other related subjects, which are not covered by this Standard.
The committee has decided that the contents of this publication will remain unchanged until
2008. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
60601-2-17  IEC:2004(E) – 5 –
INTRODUCTION
The use of AFTERLOADING EQUIPMENT for BRACHYTHERAPY purposes may expose PATIENTS
to danger if the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The
EQUIPMENT may also cause danger to persons in the vicinity if the EQUIPMENT itself fails to
contain the RADIOACTIVE SOURCE(S) adequately within the STORAGE CONTAINER(S) and/or if
there are inadequacies in the design of the TREATMENT ROOM.
This Particular Standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of AFTERLOADING EQUIPMENT for use in temporary BRACHY-
THERAPY procedures; it does not attempt to define their optimum performance requirements.
Its purpose is to identify those features of design that are regarded, at the present time, as
essential for the safe operation of such EQUIPMENT. It places limits on the degradation of
EQUIPMENT performance beyond which it can be presumed that a fault condition exists and
where an INTERLOCK then operates to return the RADIOACTIVE SOURCE(S) to the STORAGE
CONTAINER(S) and afterwards to prevent continued operation of the EQUIPMENT.

– 6 – 60601-2-17  IEC:2004(E)
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
1.1.101 This Particular Standard specifies requirements for the safety of automatically-
controlled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
1.1.102 This Standard specifies requirements for automatically-controlled AFTERLOADING
EQUIPMENT
– which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE
SOURCES,
– which automatically drives the sealed radioactive source(s) from a storage container to a
treatment position inside the source applicator(s) and returns the source(s) to the storage
container,
– 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 SUB-SYSTEMS (PESS) (computer or microprocessors) or
non-programmable systems.
1.1.103 This Standard specifies requirements for EQUIPMENT intended to be
– used under the supervision of QUALIFIED PERSONS;
– maintained at predetermined intervals;
– subject to regular checks by the user.
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the
EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
1.1.104 The requirements of this Standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT
PARAMETERS, and
– the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are)
known.
60601-2-17  IEC:2004(E) – 7 –
This Standard includes requirements intended to ensure that the prescribed values of the
TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that:
– the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE
APPLICATOR in the selected configuration relative to the SOURCE AP
...

IEC 60601-2-17
Edition 2.0 2004-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-17: Particular requirements for the safety of automatically-controlled
brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Règles particulières de sécurité des appareils projecteurs de
sources radioactives à chargement différé automatique utilisés en
brachythérapie
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IEC 60601-2-17
Edition 2.0 2004-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-17: Particular requirements for the safety of automatically-controlled
brachytherapy afterloading equipment

Appareils électromédicaux –
Partie 2-17: Règles particulières de sécurité des appareils projecteurs de
sources radioactives à chargement différé automatique utilisés en
brachythérapie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
V
CODE PRIX
ICS 11.040.60; 19.100 ISBN 2-8318-8207-9
– 2 – 60601-2-17 © CEI:2004
SOMMAIRE
AVANT-PROPOS.4
INTRODUCTION.8

SECTION UN – GÉNÉRALITÉS
1 Domaine d’application et objet.10
2 Terminologie et définitions.14
4 Exigences générales relatives aux essais.20
5 Classification.20
6 Identification, marquage et documentation .22

SECTION DEUX – CONDITIONS D’ENVIRONNEMENT
10 Conditions d'environnement .30

SECTION TROIS – PROTECTION CONTRE LES RISQUES DE CHOCS
ÉLECTRIQUES
SECTION QUATRE – PROTECTION CONTRE LES RISQUES MÉCANIQUES

SECTION CINQ – PROTECTION CONTRE LES RISQUES DUS AUX
RAYONNEMENTS NON DESIRÉS OU EXCESSIFS
29 Rayonnements X .32
30 RAYONNEMENTS alpha, bêta, gamma, NEUTRONIQUE et d'autres particules.32

SECTION SIX – PROTECTION CONTRE LES RISQUES D’IGNITION DE MÉLANGES
ANESTHÉSIQUES INFLAMMABLES
SECTION SEPT – PROTECTION CONTRE LES TEMPÉRATURES EXCESSIVES ET
AUTRES RISQUES
SECTION HUIT – PRÉCISION DES CARACTÉRISTIQUES DE FONCTIONNEMENT
ET PROTECTION CONTRE LES CARACTÉRISTIQUES DE SORTIE
DANGEREUSES
50 Précision des caractéristiques de fonctionnement .54

SECTION NEUF – FONCTIONNEMENT ANORMAL ET CONDITIONS DE DÉFAUT;
ESSAIS D’ENVIRONNEMENT
52 Fonctionnement anormal et conditions de défaut .58
SECTION DIX – RÉGLES DE CONSTRUCTION

Annexe L (normative) Références – Publications mentionnées dans la présente norme.62

Bibliographie.64
Index des termes définis .66

60601-2-17 © IEC:2004 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9

SECTION ONE – GENERAL
1 Scope and object .11
2 Terminology and definitions .15
4 General requirements for tests.21
5 Classification .21
6 Identification, marking and documents .23

SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .31

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.33
30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radiation .33

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.55

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.59

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

Appendix L (normative) References – Publications mentioned in this standard.63

Bibliography .65
Index of defined terms.67

– 4 – 60601-2-17 © CEI:2004
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
___________
APPAREILS ÉLECTROMÉDICAUX –
Partie 2-17: Règles particulières de sécurité des appareils
projecteurs de sources radioactives à chargement différé
automatique utilisés en brachythérapie

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