EN 60601-2-11:1997

SLOVENSKI STANDARD
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DRSUHPR
]DWHUDSLMR]JDPDåDUNL,(&
Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma
beam therapy equipment (IEC 60601-2-11:1997)
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die
Strahlensicherheit von Gamma-Bestrahlungseinrichtungen (IEC 60601-2-11:1997)
Appareils électromédicaux - Partie 2-11: Règles particulières de sécurité pour les
appareils de gammathérapie (IEC 60601-2-11:1997)
Ta slovenski standard je istoveten z: EN 60601-2-11:1997
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.60 Terapevtska oprema Therapy equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

NORME
CEI
INTERNATIONALE
IEC
60601-2-11
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
1997-08
Appareils électromédicaux –
Partie 2:
Règles particulières de sécurité
pour les appareils de gammathérapie
Medical electrical equipment –
Part 2:
Particular requirements for the safety
of gamma beam therapy equipment
 IEC 1997 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
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
CODE PRIX
Commission Electrotechnique Internationale
X
PRICE CODE
International Electrotechnical Commission
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-11 © IEC:1997 – 3 –
CONTENTS
Page
FOREWORD . 9
INTRODUCTION. 11
Clause
SECTION ONE – GENERAL
1 Scope and object. 13
2 Terminology and definitions . 17
4 General requirements for tests. 19
5 Classification . 23
6 Identification, marking and documents. 25
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .31
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
16 ENCLOSURES and PROTECTIVE COVERS . 33
18 Protective earthing, functional earthing and potential equalization . 33
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 33
20 Dielectric strength. 35
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength . 35
22 Moving parts. 37
27 Pneumatic and hydraulic power . 39
28 Suspended masses. 39

60601-2-11 © IEC:1997 – 5 –
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 RADIATION safety requirements . 41
29.1 Protection of the PATIENT against incorrect ABSORBED DOSE
in the TREATMENT VOLUME. 41
29.1.1 SOURCE CARRIER or SHUTTER . 41
29.1.2 BEAM OFF and BEAM ON conditions . 45
29.1.3 Control of IRRADIATION . 45
29.1.4 STATIONARY RADIOTHERAPY and MOVING BEAM RADIOTHERAPY . 51
29.1.5 Beam distributing systems. 53
29.1.6 WEDGE FILTERS . 55
29.1.7 BEAM APPLICATORS. 57
29.1.8 Facilities for starting IRRADIATION. 57
29.1.9 Facilities for INTERRUPTION OF IRRADIATION . 57
29.1.10 Facilities for TERMINATION OF IRRADIATION . 59
29.1.11 Unplanned TERMINATION OF IRRADIATION. 59
29.1.12 Facilities for checking INTERLOCK systems . 61
29.2 Protection of the PATIENT against STRAY RADIATION in the RADIATION BEAM. 63
29.2.1 RELATIVE SURFACE DOSE . 63
29.3 Protection of the PATIENT against RADIATION outside the RADIATION BEAM. 65
29.3.1 LEAKAGE RADIATION through BEAM LIMITING DEVICES
during IRRADIATION . 65
EAKAGE RADIATION RADIATION BEAM
29.3.2 L outside the maximum . 67
29.4 RADIATION safety for persons other than PATIENTS . 69
29.4.1 Indication of BEAM OFF and BEAM ON conditions. 69
29.4.2 STRAY RADIATION in the BEAM OFF condition . 71
29.4.3 Safety in setting operating states. 73
29.4.4 RADIATION SOURCE and RADIATION HEAD . 73
29.4.5 Radioactive materials used in the construction of the EQUIPMENT. 75
29.4.6 Environmental protection. 77
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

60601-2-11 © IEC:1997 – 7 –
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
57 MAINS PARTS, components and layout. 79
Figures
101 LEAKAGE RADIATION. 81
102 The 16 measurement points of the average LEAKAGE RADIATION. 83
103 Test plane orthogonal to the RADIATION BEAM AXIS at the NORMAL TREATMENT DISTANCE. 85
104 Location of test points for SITE TEST of item a) 2) of 29.3.2. 87
Appendix/Annex
L References – Publications mentioned in this standard . 89
AA Index of terms . 91

60601-2-11 © IEC:1997 – 9 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety
of gamma beam therapy equipment
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-11 has been prepared by subcommittee 62C: High energy
radiation equipment and equipment for nuclear medicine, of IEC technical committee 62:
Electrical equipment in medical practice.
The second edition cancels and replaces the first edition published in 1987, amendment 1
(1988) and amendment 2 (1993).
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62C/173/FDIS 62C/192/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table.
Annex AA is for information only.
In this Particular Standard the following print types are used:
– Requirements, compliance with which can be tested, and definitions: in roman type;
– Notes, explanations, advice, introductions, general statements, exceptions and references: in smaller type;
– Test specifications: in italic type;
–TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN
CLAUSE 2 AND IN IEC 60601-1 OR IEC 60788: SMALL CAPITALS.

60601-2-11 © IEC:1997 – 11 –
INTRODUCTION
The use of GAMMA BEAM THERAPY EQUIPMENT for RADIOTHERAPY 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 RADIATION
adequately 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 GAMMA BEAM THERAPY EQUIPMENT. Clause 29 states tolerance
limits beyond which INTERLOCKS must prevent, INTERRUPT or TERMINATE IRRADIATION in order to
avoid an unsafe condition. TYPE TESTS which are performed by the MANUFACTURER, and/or SITE
TESTS, which are not necessarily performed by the MANUFACTURER, are specified for each
requirement.
Clause 29 does not attempt to define the optimum performance requirements for a GAMMA
BEAM THERAPY EQUIPMENT for use in RADIOTHERAPY. Its purpose is to identify those features of
design which are regarded at the present time as essential for the safe operation of such
EQUIPMENT. It places limits on the degradation of EQUIPMENT performance at which it can be
presumed that a fault condition applies, e.g. a component failure, and where an INTERLOCK then
operates to prevent continued operation of the EQUIPMENT.
It should be understood that, before installation, a MANUFACTURER can provide a compliance
certificate relating only to TYPE TESTS. Data available from SITE TESTS should be incorporated in
the ACCOMPANYING DOCUMENTS SITE TEST
, in the form of a report, by those who test the
EQUIPMENT after installation.
The relationship of this Particular Standard with IEC 60601-1 (including the amendments) and
the Collateral Standards is explained in 1.3.
...