EN 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.

Medizinische elektrische Geräte - Teil 2-17: Besondere Festlegungen für die Sicherheit ferngesteuerter, automatisch betriebener Afterloading-Geräte für die Brachytherapie

Appareils électromédicaux - Partie 2-17: Règles particulières de sécurité des appareils projecteurs de brachythérapie avec contrôles automatiques

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.

Medicinska električna oprema - 2-17. del: Posebne varnostne zahteve za avtomatsko krmiljeno napravo za brahiterapijo z naknadnim polnjenjem (IEC 60601-2-17:2004)

General Information

• Status: Withdrawn
• Publication Date: 05-Apr-2004
• Withdrawal Date: 28-Feb-2007
• ICS: 11.040.60 - Therapy equipment
• ICS: 19.100 - Non-destructive testing
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Parallel Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-17:2004 - Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)

Relations

• Replaces: EN 60601-2-17:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-17:1996/A1:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment
• Effective Date: 29-Jan-2023
• Replaced By: EN 60601-2-17:2015 - Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2004
1DGRPHãþD
SIST EN 60601-2-17:1998
SIST EN 60601-2-17:1998/A1:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
DYWRPDWVNRNUPLOMHQRQDSUDYR]DEUDKLWHUDSLMR]QDNQDGQLPSROQMHQMHP,(&

Medical electrical equipment - Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
Medizinische elektrische Geräte - Teil 2-17: Besondere Festlegungen für die Sicherheit
ferngesteuerter, automatisch betriebener Afterloading-Geräte für die Brachytherapie (IEC
60601-2-17:2004)
Appareils électromédicaux - Partie 2-17: Règles particulières de sécurité des appareils
projecteurs de brachythérapie avec contrôles automatiques (CEI 60601-2-17:2004)
Ta slovenski standard je istoveten z: EN 60601-2-17:2004
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-17
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2004
ICS 11.040.60; 19.100 Supersedes EN 60601-2-17:1996 + A1:1996

English version
Medical electrical equipment
Part 2-17: Particular requirements for the safety
of automatically-controlled brachytherapy afterloading equipment
(IEC 60601-2-17:2004)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-17: Règles particulières Teil 2-17: Besondere Festlegungen
de sécurité des appareils projecteurs für die Sicherheit ferngesteuerter,
de brachythérapie automatisch betriebener
avec contrôles automatiques Afterloading-Geräte für die Brachytherapie
(CEI 60601-2-17:2004) (IEC 60601-2-17:2004)

This European Standard was approved by CENELEC on 2004-03-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-17:2004 E
Foreword
The text of document 62C/363/FDIS, future edition 2 of IEC 60601-2-17, prepared by SC 62C,
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical
equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved
by CENELEC as EN 60601-2-17 on 2004-03-01.
This European Standard supersedes EN 60601-2-17:1996 + A1:1996.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2004-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-03-01
In this 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 EN 60601-1, ITS COLLATERAL OR PART 2 STANDARDS, OR IN IEC 60788: SMALL
CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-17:2004 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-1-3 NOTE  Harmonized as EN 60601-1-3:1994 (not modified).
__________
- 3 - EN 60601-2-17:2004
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:1990/A2:1995:
IEC 60788 1984 Medical radiology - Terminology HD 501 S1 1988

IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
A1 2000 A1 2001
IEC 62083 2000 Medical electrical equipment EN 62083 2001
Requirements for the safety of
radiotherapy treatment planning systems
Replacement in Annex ZA of EN 60601-1:1990/A2:1995:
IEC 60601-1 1988 Medical electrical equipment  EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1991  A1 1993
+ corr. July 1994
A2 1995  A2 1995
+ corr. June 1995
A13 1996
IEC 60601-1-1 2000 Medical electrical equipment EN 60601-1-1 2001
Part 1-1: General requirements for safety -
Collateral standard: Safety requirements
for medical electrical systems

IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety -
Collateral standard: Programmable
electrical medical systems
A1 1999 A1 1999
NORME CEI
INTERNATIONALE
IEC
60601-2-17
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2004-01
Appareils électromédicaux –
Partie 2-17:
Règles particulières de sécurité des appareils
projecteurs de sources radioactives à chargement
différé automatique utilisés en brachythérapie

Medical electrical equipment –
Part 2-17:
Particular requirements for the safety of
automatically-controlled brachytherapy
afterloading equipment
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
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électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
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Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-17  IEC:2005 – 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

60601-2-17  IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –

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

FOREWORD
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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.
This bilingual version (2005-09) replaces the English version.
...