EN 60601-2-11:1997/A1:2004

Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

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

Appareils électromédicaux - Partie 2-11: Règles particulières de sécurité pour les appareils de gammathérapie

Medicinska električna oprema – 2-11. del: Posebne varnostne zahteve za opremo za terapijo z žarki gama

General Information

• Status: Withdrawn
• Publication Date: 20-Sep-2004
• Withdrawal Date: 31-Aug-2007
• ICS: 11.040.60 - Therapy equipment
• ICS: 13.280 - Radiation protection
• 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 60601-2-11:1998/A1:2005 - Medical electrical equipment -- Part 2-11: Particular requirements for the safety of gamma beam therapy equipment

Relations

• Replaced By: 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
• Effective Date: 28-Jan-2023
• Amends: EN 60601-2-11:1997 - 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 SIST EN 60601-2-
11:1998/A1:2005
STANDARD
januar 2005
Medicinska električna oprema – 2-11. del: Posebne varnostne zahteve za
opremo za terapijo z žarki gama
(istoveten EN 60601-2-11:1997/A1:2004)
Medical electrical equipment - Part 2-11: Particular requirements for the safety of
gamma beam therapy equipment
ICS 11.040.50; 11.040.60; 13.280 Referenčna številka
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

EUROPEAN STANDARD EN 60601-2-11/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2004

ICS 11.040.60; 13.280
English version
Medical electrical equipment
Part 2-11: Particular requirements for the safety
of gamma beam therapy equipment
(IEC 60601-2-11:1997/A1:2004)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-11: Règles particulières Teil 2-11: Besondere Festlegungen
de sécurité pour les appareils für die Strahlensicherheit
de gammathérapie von Gamma-Bestrahlungseinrichtungen
(CEI 60601-2-11:1997/A1:2004) (IEC 60601-2-11:1997/A1:2004)

This amendment A1 modifies the European Standard EN 60601-2-11:1997; it was approved by
CENELEC on 2004-09-01. CENELEC members are bound to comply with the CEN/CENELEC Internal
Regulations which stipulate the conditions for giving this amendment 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 amendment 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 60601-2-11:1997/A1:2004 E

Foreword
The text of document 62C/372/FDIS, future amendment 1 to IEC 60601-2-11:1997, 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 amendment A1 to EN 60601-2-11:1997 on 2004-09-01.
The following dates were fixed:
– latest date by which the amendment has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2005-06-01
– latest date by which the national standards conflicting
with the amendment have to be withdrawn (dow) 2007-09-01
__________
Endorsement notice
The text of amendment 1:2004 to the International Standard IEC 60601-2-11:1997 was approved by
CENELEC as an amendment to the European Standard without any modification.
__________
INTERNATIONAL IEC
STANDARD 60601-2-11
AMENDMENT 1
2004-07
Amendment 1
Medical electrical equipment –
Part 2-11:
Particular requirements for the safety
of gamma beam therapy equipment
© IEC 2004 Droits de reproduction réservés ⎯ Copyright - all rights reserved
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 K
International Electrotechnical Commission
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For price, see current catalogue

– 2 – 60601-2-11 Amend. 1 © IEC:2004(E)
FOREWORD
This amendment has been prepared by subcommittee 62C: Equipment for radiotherapy,
nuclear medicine and radiation dosimetry, of IEC technical committee 62: Electrical equipment
in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62C/372/FDIS 62C/375/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
___________
INTRODUCTION
This amendment is applicable to equipment for multi-source STEREOTACTIC treatment including
radiosurgery and RADIOTHERAPY (MSSR). STEREOTAXIS is defined as a method for locating
points within the human body using an external three-dimensional frame of reference.
•••• Though multi-source STEREOTACTIC RADIOTHERAPY equipment is included in the scope of
this part of IEC 60601, some requirements and definitions have turned out to be
inadequate for current equipment of this very special type. This amendment introduces
new terminology in this area.
Modifications to test principles or procedures have not been considered.
Page 13
1.1 Scope
bb)
Add, after the existing text , the following new paragraph:
This standard applies also to multi-source STEREOTACTIC RADIOTHERAPY equipment used to
IRRADIATE a single ISOCENTRE simultaneously with more than one SEALED RADIOACTIVE SOURCE.
The sources may be stationary or moving.

60601-2-11 Amend. 1 © IEC:2004(E) – 3 –
Page 17
2 Terminology and definitions
Replace the existing text of definitions 2.101 and 2.102 by the following:
2.101
BEAM OFF
condition in which the RADIATION SOURCES are fully shielded, and are also in a position in
which they can be secured
2.102
BEAM ON
condition in which the RADIATION SOURCES are fully exposed for RADIOTHERAPY
Add, on page 19, the following new definitions:
2.122
HELMET
three-dimensional multi-source ISOCENTRIC BEAM LIMITING SYSTEM (MIBLS) used in MSSR for
treatment of a human head
2.123
REPOSITIONING
movement and adjustment of the STEREOTACTIC frame with respect to the MIBLS to alter the
intended treatment volume
2.124
REPOSITIONING POINT
retracted position of the MIBLS where REPOSITIONING of the frame is possible
2.125
REPOSITIONING TIME
added time the equipment needs to move from the BEAM ON condition to the REPOSITIONING
POINT, to achieve REPOSITIONING and to return from the REPOSITIONING POINT to the BEAM ON
condition
2.126
STEREOTAXIS
STEREOTACTIC
method for locating points within the human body using an external, three-dimensional frame
of reference
2.127
TRANSITION TIME
time between when the SHUTTER is opened and the MIBLS or SOURCE CARRIER is in the
TREATMENT position
2.128
TRANSITION RADIATION
dose received during the TRANSITION TIME

– 4 – 60601-2-11 Amend. 1 © IEC:2004(E)
Page 23
5 Classification
5.2 According to the degree of protection against electric shock:
Replace the existing text by the following:
EQUIPMENT within the scope of this standard shall be TYPE B EQUIPMENT except for MSSR,
which shall be TYPE B EQUIPMENT or TYPE BF EQUIPMENT.
Page 25
6.3 Marking of controls and instruments
aa)
1) Add the following sentence:
This applies in case of MSSR, with the exception of PATIENT SUPPORT and when needed for
patient treatment.
2) Add the following sentence:
For MSSR: IEC 61217 shall be used where applicable.
3) Add the following sentence:
This requirement is not applicable for MSSR.
4) Add the following sentence:
This requirement is not applicable for MSSR.
Page 27
6.8.2 INSTRUCTIONS FOR USE
aa)
10) Add, on page 29, the following sentence:
This requirement is not applicable for MSSR;

60601-2-11 Amend. 1 © IEC:2004(E) – 5 –
Page 29
6.8.3 Technical description
a) General
aa) To assist the USER’S RADIOLOGICAL PROTECTION adviser, the following data shall be
provided:
c) Add the following sentence:
In case of MSSR the maximum ABSORBED DOSE RATE for the maximum cr
...