EN 60601-2-11:2015

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.

Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die Strahlensicherheit von Gammabestrahlungseinrichtungen

Appareils électromédicaux - Part 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.

Medicinska električna oprema - 2-11. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za gama radioterapijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI KLINIČNIH OPREME ZA GAMA RADIOTERAPIJO v kombinaciji s z opremo za STEREOTAKTIČNO RADIOTERAPIJO Z VEČ VIRI (v nadaljevanju: ELEKTROMEDICINSKA OPREMA).
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v poglavjih 7.2.13 in 8.4.1 splošnega standarda.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62C - IEC_SC_62C
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-11:2015 - Medical electrical equipment - Part 2-11: Particular requirements for basic safety and essential performance of gamma beam therapy equipment

Relations

• Replaces: EN 60601-2-11:1997 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
• Effective Date: 29-Jan-2023
• Replaces: EN 60601-2-11:1997/A1:2004 - Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-11:1998
SIST EN 60601-2-11:1998/A1:2005
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLRSUHPH]DJDPDUDGLRWHUDSLMR
Medical electrical equipment - Part 2-11: Particular requirements for basic safety and
essential performance of gamma beam therapy equipment
Medizinische elektrische Geräte - Teil 2-11: Besondere Festlegungen für die
Strahlensicherheit von Gamma-Bestrahlungseinrichtungen
Appareils électromédicaux - Part 2-11: Règles particulières de sécurité de base et de
performances essentielles pour les appareils de gammathérapie
Ta slovenski standard je istoveten z: EN 60601-2-11:2015
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.

EUROPEAN STANDARD EN 60601-2-11

NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60 Supersedes EN 60601-2-11:1997
English Version
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)
Appareils électromédicaux - Part 2-11: Exigences Medizinische elektrische Geräte - Teil 2-11: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Strahlensicherheit von Gamma-
essentielles des appareils de gammathérapie Bestrahlungseinrichtungen
(IEC 60601-2-11:2013) (IEC 60601-2-11:2013)
This European Standard was approved by CENELEC on 2015-04-14. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-11:2015 E
Foreword
The text of document 62C/552/FDIS, future edition 3 of IEC 60601-2-11, 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 approved by
CENELEC as EN 60601-2-11:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-01-14
national level by publication of an identical national
standard or by endorsement
(dow) 2018-04-14
• latest date by which the national standards conflicting with
the document have to be withdrawn

This document supersedes EN 60601-2-11:1997.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, which is an integral part
of this document.
Endorsement notice
The text of the International Standard IEC 60601-2-11:2013 was approved by CENELEC as a
European Standard without any modification.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.

Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic
- -  + corrigendum Mar. 2010
safety and essential performance -
Collateral Standard: Radiation protection in
diagnostic X-ray equipment
Addition to Annex ZA of EN 60601-1:2006:
IEC 61217 -  Radiotherapy equipment - Coordinates, EN 61217 -
movements and scales
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993
concerning medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.
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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