Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

Medizinische elektrische Geräte - Teil 2-68: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von röntgenstrahlungsbasierten Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit Elektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid- Strahlentherapiesystemen

Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de radiothérapie à rayonnement X assistée par imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par faisceau de radionucléides

L'IEC 60601-2-68:2014 s'applique à la sécurité de base et aux performances essentielles des appareils de radiothérapie assistée par imagerie médicale (IGRT) destinés à être utilisés avec les appareils de radiothérapie externes (EBE). La présente norme particulière couvre les aspects de sécurité des dispositifs d'imagerie à rayonnement X sous kilotension et sous mégatension dans une relation géométrique connue avec les EBE à des fins de IGRT. Elle couvre les aspects de communication et les relations entre les EBE et les dispositifs d'imagerie à rayonnement X fixés ou non directement fixés, mais présents dans la même zone protégée contre le rayonnement que les EBE, et dédiés à être utilisés uniquement avec ces appareils. La présente norme particulière traite des appareils de radiothérapie assistée par imagerie médicale en temps réel, en ligne et hors ligne. Elle couvre les procédures de réduction du risque de confiance excessive envers le système d'appareils de radiothérapie assistée par imagerie médicale. Par exemple, le fabricant fournit une interface interactive destinée à l'interaction des utilisateurs avec la correction proposée par le système.

Medicinska električna oprema - 2-68. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih naprav pri slikovno vodeni radioterapiji z elektronskimi pospeševalniki, napravami za lahkoionsko radioterapijo in napravami za radionuklidno radioterapijo

Ta mednarodni standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI rentgenskih naprav pri SLIKOVNO VODENI RADIOTERAPIJI za uporabo s TELERADIOTERAPEVTSKO OPREMO (EBE). Ta standard obravnava varnostne vidike kilovoltažnih (kV) in megavoltažnih (MV) naprav za rentgensko slikanje v znanem geometrijskem odnosu z EBE za namen slikovno vodene radioterapije (IGRT). Obravnava vidike komunikacije in odnosov med TELERADIOTERAPEVTSKO OPREMO in napravami za rentgensko slikanje, neposredno ali posredno pritrjenimi, ki so v enakem pred SEVANJEM zaščitenem območju kot TELERADIOTERAPEVTSKA OPREMA in so namenjene samo uporabi s to opremo.
Ta standard obravnava opremo za IGRT V REALNEM ČASU, IGRT S POVEZAVO in IGRT BREZ POVEZAVE. Zajema postopke za zmanjšanje tveganja pretiranega zanašanja na TELERADIOTERARAPEVTSKI SISTEM IGRT (X-IGRT EBS). Na primer, proizvajalec bo zagotovil interaktiven vmesnik za uporabniško interakcijo s korekcijo, ki jo predlaga sistem.
Če je poglavje ali podpoglavje namenjeno obravnavi SISTEMOV EBE X-IGRT, bo to zapisano v vsebini poglavja ali podpoglavja. Če ni zapisano, poglavje ali podpoglavje obravnava samo OPREMO X-IGRT.
Ta standard z vključenimi TIPSKIMI PRESKUSI in PRESKUSI NA MESTU UPORABE se uporablja za PROIZVAJALSKE in nekatere vgradne vidike SISTEMOV EBE X-IGRT, ki
• so namenjeni NORMALNI UPORABI, pri čemer jih pod vodstvom ustrezno licenciranih ali KVALIFICIRANIH OSEB upravljajo OPERATERJI z zahtevanimi veščinami za določeno medicinsko uporabo, za določene opredeljene klinične namene, npr. STACIONARNA RADIOTERAPIJA ali RADIOTERAPIJA S PREMIČNIM ŽARKOM,
• se vzdržujejo v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO,
• so predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih izvaja KVALIFICIRANA OSEBA.
OPOMBA: V tem standardu se vsa sklicevanja na obrat nanašajo na obrat v prostorih ODGOVORNE ORGANIZACIJE.

General Information

Status
Published
Publication Date
28-May-2015
Current Stage
6060 - Document made available
Due Date
29-May-2015
Completion Date
29-May-2015

Buy Standard

Standard
EN 60601-2-68:2015
English language
67 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN 60601-2-68:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNLKQDSUDYSULVOLNRYQRYRGHQLUDGLRWHUDSLML]
HOHNWURQVNLPLSRVSHãHYDOQLNLQDSUDYDPL]DODKNRLRQVNRUDGLRWHUDSLMRLQ
QDSUDYDPL]DUDGLRQXNOLGQRUDGLRWHUDSLMR

Medical electrical equipment - Part 2-68: Particular requirements for basic safety and

essential 63 performance of X-ray Based Image Guided Radiotherapy 64 equipment for

use with electron accelerators, light ion beam 65 therapy equipment and radionuclide

beam therapy equipment

Medizinische elektrische Geräte - Teil 2-68: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von röntgenstrahlungsbasierten
Geräten für die bildgesteuerte Strahlentherapie zur Verwendung mit
Elektronenbeschleunigern, Leichtionen-Strahlentherapiesystemen und Radionuklid-
Strahlentherapiesystemen

Appareils électromédicaux - Partie 2-68: Exigences particulières pour la sécurité de base

et les performances essentielles des appareils de radiothérapie guidés par image

radiologique, destinés à être utilisés avec les accélérateurs d'électrons, les appareils de

thérapie par faisceau ionique lumineux et les appareils de thérapie par faisceau
provenant de radionucléides
Ta slovenski standard je istoveten z: EN 60601-2-68:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
SIST EN 60601-2-68:2015 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-2-68:2015
---------------------- Page: 2 ----------------------
SIST EN 60601-2-68:2015
EUROPEAN STANDARD EN 60601-2-68
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.040.60
English Version
Medical electrical equipment - Part 2-68: Particular requirements
for the basic safety and essential performance of X-ray-based
image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide
beam therapy equipment
(IEC 60601-2-68:2014)

Appareils électromédicaux - Partie 2-68: Exigences Medizinische elektrische Geräte - Teil 2-68: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des appareils de radiothérapie à rayonnement wesentlichen Leistungsmerkmale von

X assistée par imagerie médicale, destinés à être utilisés röntgenstrahlungsbasierten Geräten für die bildgesteuerte

avec les accélérateurs d'électrons, les appareils de thérapie Strahlentherapie zur Verwendung mit

par faisceau d'ions légers et les appareils de thérapie par Elektronenbeschleunigern, Leichtionen-

faisceau de radionucléides Strahlentherapiesystemen und Radionuklid-
(IEC 60601-2-68:2014) Strahlentherapiesystemen
(IEC 60601-2-68:2014)

This European Standard was approved by CENELEC on 2014-10-09. 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 60601-2-68:2015 E
---------------------- Page: 3 ----------------------
SIST EN 60601-2-68:2015
EN 60601-2-68:2015
Foreword

The text of document 62C/595/FDIS, future edition 1 of IEC 60601-2-68 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 60601-2-68:2015.
The following dates are fixed:
• latest date by which the document has to be (dop) 2015-11-29
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-05-29
• latest date by which the national
standards conflicting with the
document have to be withdrawn

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.

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 60601-2-68:2014 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 60336:2005 NOTE Harmonized as EN 60336:2005 (not modified).
IEC 60364-7-710:2002 NOTE Harmonized as HD 60364-7-710:2012 (modified).
IEC 60522:1999 NOTE Harmonized as EN 60522:1999 (not modified).
IEC 62220-1:2003 NOTE Harmonized as EN 62220-1:2004 (not modified).
Superseded by EN 62220-1-1:2015 (IEC 62220-1-1:2015): DOW = 2018-04-16.
---------------------- Page: 4 ----------------------
SIST EN 60601-2-68:2015
EN 60601-2-68:2015
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
Publication Year Title EN/HD Year
Annex ZA of EN 60601-1:2006 applies except as follows:
Amendment:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral Standard: Radiation protection in
diagnostic X-ray equipment
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
+A1 2013 +A1 2015
safety and essential performance -
Collateral standard: Usability
Addition:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012 + A1 2013
+ A1/AC 2014
+A12 2014
IEC 60601-2-1 2009 Medical electrical equipment - - -
Part 2-1: Particular requirements
for the basic safety and essential
performance of electron accelerators
in the range 1 MeV to 50 MeV
IEC 60601-2-4 2010 Medical electrical equipment - EN 60601-2-4 2011
Part 2-4: Particular requirements for the
basic safety and essential performance of
cardiac defibrillators
IEC 60601-2-44 2009 Medical electrical equipment - EN 60601-2-44 2009
Part 2-44: Particular requirements for the
+A11 2011
basic safety and essential performance of
+A1 2012 X-ray equipment for computed tomography +A1 2012
---------------------- Page: 5 ----------------------
SIST EN 60601-2-68:2015
EN 60601-2-68:2015
Publication Year Title EN/HD Year
IEC 60731 2011 Medical electrical equipment - Dosimeters EN 60731 2012
with ionization chambers as used in
radiotherapy
IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 60976 2007 Medical electrical equipment - Medical EN 60976 2007
electron accelerators - Functional
performance characteristics
IEC 61217 2011 Radiotherapy equipment - Coordinates, EN 61217 2012
movements and scales
IEC 61223-3-5 2004 Evaluation and routine testing in medical EN 61223-3-5 2004
imaging departments -
Part 3-5: Acceptance tests - Imaging
performance of computed tomography
X-ray equipment
IEC 61262-7 1995 Medical electrical equipment - EN 61262-7 1995
Characteristics of electro-optical X-ray
image intensifiers -
Part 7: Determination of the modulation
transfer function
IEC 62083 2009 Medical electrical equipment - EN 62083 2009
Requirements for the safety of
radiotherapy treatment planning systems
IEC 62274 2005 Medical electrical equipment - Safety of EN 62274 2005
radiotherapy record and verify systems
IEC 62366 2007 Medical devices - Application of usability - -
engineering to medical devices
IEC 62396-1 2012 Process management for avionics - - -
Atmospheric radiation effects -
Part 1: Accommodation of atmospheric
radiation effects via single event effects
within avionics electronic equipment
IEC 62563-1 2009 Medical electrical equipment - Medical EN 62563-1 2010
image display systems -
Part 1: Evaluation methods
---------------------- Page: 6 ----------------------
SIST EN 60601-2-68:2015
EN 60601-2-68:2015
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.
---------------------- Page: 7 ----------------------
SIST EN 60601-2-68:2015
---------------------- Page: 8 ----------------------
SIST EN 60601-2-68:2015
IEC 60601-2-68
Edition 1.0 2014-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-68: Particular requirements for the basic safety and essential performance

of X-ray-based image-guided radiotherapy equipment for use with electron
accelerators, light ion beam therapy equipment and radionuclide beam therapy
equipment
Appareils électromédicaux –

Partie 2-68: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils de radiothérapie à rayonnement X assistée par

imagerie médicale, destinés à être utilisés avec les accélérateurs d’électrons, les

appareils de thérapie par faisceau d’ions légers et les appareils de thérapie par

faisceau de radionucléides
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.60 ISBN 978-2-8322-1839-6

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 9 ----------------------
SIST EN 60601-2-68:2015
– 2 – IEC 60601-2-68:2014 © IEC 2014
CONTENTS

FOREWORD ........................................................................................................................... 3

INTRODUCTION ..................................................................................................................... 5

201.1 Scope, object and related standards ....................................................................... 7

201.2 Normative references .............................................................................................. 9

201.3 Terms and definitions............................................................................................ 10

201.4 General requirements ........................................................................................... 18

201.5 General requirements for testing ME EQUIPMENT .................................................... 19

201.6 Classification of me equipment and me systems ................................................... 19

201.7 ME EQUIPMENT identification, marking and documents ............................................ 19

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ..................................... 25

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS ........... 28

201.10 Protection against unwanted and excessive radiation HAZARDS ............................. 32

201.11 Protection against excessive temperatures and other HAZARDS ............................. 34

201.12 Accuracy of controls and instruments and protection against hazardous

outputs ................................................................................................................. 34

201.13 Hazardous situations and fault conditions for me equipment ................................. 34

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ............................................. 35

201.15 Construction of me equipment............................................................................... 35

201.16 ME SYSTEMS .......................................................................................................... 35

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ........................... 35

201.101 Reference data for X-IGRT ..................................................................................... 36

201.102 X-IGRT IMAGING ...................................................................................................... 40

201.103 IGRT analysis and correction ................................................................................. 47

203 RADIATION protection in diagnostic X-RAY EQUIPMENT ............................................. 51

206 Usability ................................................................................................................ 52

Annex B (informative) Sequence of testing .......................................................................... 54

Annex I (informative) ME SYSTEMS aspects ........................................................................... 54

Annex AA (informative) Particular guidance and rationale .................................................... 55

Annex BB (informative) Measuring CTDI ................................................................... 57

free air

Bibliography .......................................................................................................................... 58

Index of defined terms used in this standard ......................................................................... 59

Figure 201.101 – PATIENT SUPPORT movements .................................................................... 53

Table 201.101 – Data required in the technical description ................................................... 22

Table 201.102 – Clauses and subclauses in this particular standard that require the

provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and

the technical description ....................................................................................................... 23

Table 201.103 – Example test pattern for CTDI
for kV ................................................. 45
free air
---------------------- Page: 10 ----------------------
SIST EN 60601-2-68:2015
IEC 60601-2-68:2014 © IEC 2014 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-68: Particular requirements for the basic safety and essential
performance of X-ray-based image-guided radiotherapy equipment
for use with electron accelerators, light ion beam therapy equipment
and radionuclide beam therapy equipment
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). 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. 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 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 IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International standard IEC 60601-2-68 has been prepared by IEC subcommittee 62C

Equipment for radiotherapy, nuclear medicine and radiation dosimetry of IEC technical

committee 62: Electrical equipment in medical practice.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/595/FDIS 62C/602/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.
---------------------- Page: 11 ----------------------
SIST EN 60601-2-68:2015
– 4 – IEC 60601-2-68:2014 © IEC 2014

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 standard, the term

– “clause” means one of the seventeen numbered divisions within the table of contents,

inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);

– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all

subclauses of Clause 7).

References to clauses within this standard are preceded by the term “Clause” followed by the

clause number. References to subclauses within this particular standard are by number only.

In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.

The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC

Directives, Part 2. For the purposes of this standard, the auxiliary verb:

– “shall” means that compliance with a requirement or a test is mandatory for compliance

with this standard;

– “should” means that compliance with a requirement or a test is recommended but is not

mandatory for compliance with this standard;

– “may” is used to describe a permissible way to achieve compliance with a requirement or

test.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title

indicates that there is guidance or rationale related to that item in Annex AA.

A list of all parts of the IEC 60601 series, published under the general title Medical electrical

equipment, can be found on the IEC website.

The committee has decided that the contents of this publication will remain unchanged until

the stability 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.
---------------------- Page: 12 ----------------------
SIST EN 60601-2-68:2015
IEC 60601-2-68:2014 © IEC 2014 – 5 –
INTRODUCTION

Modern RADIOTHERAPY practices utilize information from various imaging modalities, acquired

prior to initiating administration of the therapy, to plan the treatment. The imaging provides

information about the location of the TARGET VOLUME and other anatomical features so that a

treatment plan can be developed that provides an optimal dose distribution to have the best

chance of achieving the intended effect of treatment while minimizing side effects.

However, difficulties arise when trying to administer the RADIATION, since TARGET

VOLUMES/critical structures are constantly moving within the body. For example, in parts of the

body moving with respiration, the TARGET VOLUMES/critical structures may change position or

shape during the RADIATION BEAM delivery throughout any given fraction. Furthermore, a

course of therapy may extend over many days, during which the TARGET VOLUME/PATIENT may

shrink or grow and/or move. Hence, the exact location of the TARGET VOLUME/critical

structures may change between the time of treatment planning imaging and the actual

administration of a treatment.

IMAGE-GUIDED RADIOTHERAPY (IGRT) combines planar or volumetric imaging during the course

of RADIOTHERAPY in order to adjust the treatment delivery based on the PATIENT anatomy and

PATIENT position. This enables the OPERATOR and/or EXTERNAL BEAM EQUIPMENT (EBE) to adjust

the RADIATION BEAM delivery based on the imaging information, such as the position of the

TARGET VOLUME, critical organs and/or other reference features, to compensate for anatomical

changes including internal organ motions and/or treatment setup uncertainties. The increased

accuracy and precision achieved allows higher doses of RADIATION to be delivered to the

TARGET VOLUME and a reduction in the margin of healthy cells affected by the RADIATION. This

is often used in conjunction with other monitoring equipment.

This particular standard establishes requirements to be complied with by MANUFACTURERS in

the design and construction of X-RAY IGRT EQUIPMENT (X-IGRT).

This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray

imaging devices in a known geometrical relationship with an EXTERNAL BEAM EQUIPMENT such

as an ELECTRON ACCELERATOR, medical light ion beam equipment or RADIONUCLIDE BEAM

THERAPY EQUIPMENT, for the purpose of IGRT. It covers aspects of communication and

relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or

not directly attached to but in the same RADIATION shielded area as, and dedicated for use

only with, the EXTERNAL BEAM EQUIPMENT.

This particular standard applies to X-ray based IGRT equipment used in-room for IGRT

purposes. This particular standard does not apply to standard CT scanners, which are not

used for IGRT. However if a CT scanner is used in-room with a linear (electron) accelerator

(linac) for IGRT then this particular standard applies.

When performing a HAZARD ANALYSIS, the MANUFACTURER should consider relevant diagnostic

standards. For example, IMAGE DISPLAY DEVICE quality is specified in IEC documents in

regards to diagnostic use (e.g. IEC 62563-1:2009, Ed. 1.0). However, since IGRT usage may

or may not require such high requirements it is left to the MANUFACTURER to specify what is

required for use with their X-IGRT EQUIPMENT.

This particular standard deals with the safety aspect of image acquisitions, image analysis,

data transfer and treatment replanning or EBE/PATIENT repositioning.

This particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE

X-IGRT.
X-IGRT EQUIPMENT is also related to the following current standards:

– IEC 62083, Medical electrical equipment – Requirements for the safety of radiotherapy

treatment planning systems
---------------------- Page: 13 ----------------------
SIST EN 60601-2-68:2015
– 6 – IEC 60601-2-68:2014 © IEC 2014
– IEC 61217, Radiotherapy equipment – Coordinates, movements and scales

– IEC 62274, Medical electrical equipment – Safety of radiotherapy record and verify

systems

– IEC 60976, Medical electrical equipment – Medical electron accelerators – Functional

performance characteristics

– IEC TR 60977, Medical electrical equipment – Medical electron accelerators – Guidelines

for functional performance characteristics.

This particular standard may give rise to amendments to some of the above standards.

This particular standard will focus on the safety aspects of the primary function of X-IGRT. It

will not focus on emerging technologies within the field so as to not hinder progress, yet it will

define a safe way of achieving X-IGRT.
---------------------- Page: 14 ----------------------
SIST EN 60601-2-68:2015
IEC 60601-2-68:2014 © IEC 2014 – 7 –
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-68: Particular requirements for the basic safety and essential
performance of X-ray-based image-guided radiotherapy equipment
for use with electron accelerators, light ion beam therapy equipment
and radionuclide beam therapy equipment
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray

based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE).

This particular standard covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray

imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It

covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT

and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION

shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT.

This particular standard deals with equipment for REAL-TIME X-IGRT, ONLINE X-IGRT and OFFLINE

X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EXTERNAL BEAM

SYSTEM (X-IGRT EBS). For example the manufacturer will provide an interactive interface for

user interaction with the correction suggested by the system.
If a c
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.