IEC 60601-2-11:2013
(Main)Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It 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, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It 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. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
Appareils électromédicaux - Partie 2-11: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de gammathérapie
La CEI 60601-2-11:2013 s'applique à la sécurité de base et aux performances essentielles des appareils de gammathérapie, y compris les appareils de radiothérapie stéréotaxique multi-sources. La présente norme particulière, partie de la série 60601, définit des exigences que les fabricants sont tenus de respecter dans la conception et la construction des appareils de gammathérapie. Elle indique les limites de tolérance au-delà desquelles des verrouillages doivent empêcher, interrompre ou terminer l'irradiation de manière à éviter une situation dangereuse. Les essais de type effectués par le fabricant ou les essais sur le site qui ne sont pas nécessairement effectués par le fabricant, sont spécifiés pour chacune des exigences. Cette Norme ne vise pas à définir des exigences de performances optimales pour les appareils de gammathérapie utilisés en radiothérapie. Il a pour objet d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils. Il fixe des limites de détérioration des performances des appareils, auxquelles il peut être présumé qu'une condition de défaut existe, par exemple, la défaillance d'un composant, et pour laquelle un verrouillage entre alors en action pour arrêter le fonctionnement. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-11 parue en 1997 et l'amendement 1:2004. La présente édition constitue une révision technique qui met la présente norme en conformité avec la troisième édition de la CEI 60601-1 et ses normes collatérales.
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IEC 60601-2-11 ®
Edition 3.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-11: Particular requirements for the basic safety and essential performance
of gamma beam therapy equipment
Appareils électromédicaux –
Partie 2-11: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de gammathérapie
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IEC 60601-2-11 ®
Edition 3.0 2013-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-11: Particular requirements for the basic safety and essential performance
of gamma beam therapy equipment
Appareils électromédicaux –
Partie 2-11: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de gammathérapie
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX X
ICS 11.040.60 ISBN 978-2-83220-584-6
– 2 – 60601-2-11 © IEC:2013
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 11
201.5 General requirements for testing of ME EQUIPMENT . 12
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 18
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 18
201.10 Protection against unwanted and excessive radiation HAZARDS . 20
201.11 Protection against excessive temperatures and other HAZARDS . 38
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 39
201.13 HAZARDOUS SITUATIONS and fault conditions . 39
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTESM (PEMS) . 39
201.15 Construction of ME EQUIPMENT . 40
201.16 ME SYSTEMS . 40
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 40
Annexes . 45
Annex B (informative) Sequence of testing . 45
Index of defined terms used in this particular standard. 46
Figure 201.101 – Leakage radiation . 40
Figure 201.102 – Points for the measurement of average leakage . 42
Figure 201.103 – Test plane orthogonal to the RADIATION BEAM AXIS at the NORMAL
TREATMENT DISTANCE . 43
Figure 201.104 – Location of test points for SITE TEST of item 201.10.2.5.2.2 . 43
Figure 201.105 – Matrix measurement points for beam off and beam on conditions to
be specified at the floor level, ISOCENTER level and 1 m above the ISOCENTER level (see
requirement 201.10.2.4.2) . 44
Table 201.101 – Colours of TREATMENT CONTROL PANEL . 14
Table 201.102 – Subclauses in this particular standard requiring the provision of
information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and the technical
description . 14
Table 201.103 – Subclauses where data is described that is required in the technical
description to support Clause 201.10 site test compliance . 17
60601-2-11 © IEC:2013 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-11: Particular requirements for the basic safety
and essential performance of gamma beam therapy equipment
FOREWORD
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International Standard IEC 60601-2-11 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 third edition cancels and replaces the second edition of IEC 60601-2-11 published in
1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings
this standard in line with the third edition of IEC 60601-1 and its collateral standards.
The text of this standard is based on the following documents:
FDIS Report on voting
62C/552/FDIS 62C/558/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 – 60601-2-11 © IEC:2013
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this
...
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