SIST EN 60601-2-1:2015
Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS - intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), - that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of XRADIATION and/or ELECTRON RADIATION having - NOMINAL ENERGY in the range 1 MeV to 50 MeV, - maximum ABSORBED DOSE RATES between 0,001 Gy × s-1 and 1 Gy × s-1 at 1 m from the RADIATION SOURCE, - NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION SOURCE, and - intended to be - for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, - maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, - subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im Bereich von 1 MeV bis 50 MeV
Appareils électromédicaux -- Partie 2-1: Règles particulières pour la sécurité de base et les performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV
La CEI 60601-2-1:2009 s'applique à la sécurité de base et aux performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV, et utilisés pour le traitement des patients. La présente norme particulière décrit les exigences auxquelles il convient que les fabricants se conforment dans la conception et la construction des accélérateurs d'électrons utilisés en radiothérapie; elle ne vise pas à définir des exigences de performances optimales. Son objet est d'identifier les caractéristiques de conception reconnues actuellement comme essentielles pour la sécurité de fonctionnement de tels appareils électromédicaux. Elle fixe des limites de détérioration des performances des appareils électromédicaux qui seraient la conséquence d'une condition de défaut, pour lesquelles un verrouillage doit entrer en action pour empêcher l'appareil em de continuer à fonctionner. Cette troisième édition annule et remplace la deuxième édition publiée en 1998 et son Amendement 1 (2002). Elle constitue une révision technique. Cette troisième édition aborde les questions suivantes non traitées dans les éditions antérieures: - l'alignement avec les nouvelles normes collatérales pertinentes; - les nouvelles technologies en radiothérapie, y compris la radiochirurgie stéréotaxique (SRT) et la radiothérapie stéréotaxique (SRS), la radiothérapie de conformation avec modulation d'intensité de dose (IMRT), les dispositifs d'imagerie numérique et la radiothérapie cinétique (thérapie dynamique).
Medicinska električna oprema - 2-1. del: Posebne zahteve za osnovno varnost in bistvene lastnosti elektronskih pospeševalnikov v območju od 1 MeV do 50 MeV
Ta standard se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTRONSKIH POSPEŠEVALNIKOV (v nadaljevanju »ELEKTROMEDICINSKA OPREMA«) v razponu od 1 MeV do 50 MeV za zdravljenje PACIENTOV. Ta standard z vključenimi TIPSKIMI PRESKUSI in PRESKUSI NA MESTU UPORABE se uporablja za proizvodnjo in določene vidike namestitve ELEKTRONSKIH POSPEŠEVALNIKOV (ki so namenjeni za RADIOTERAPIJO v okviru zdravljenja ljudi in pri katerih lahko PROGRAMLJIVI ELEKTRONSKI PODSISTEMI (PESS) samodejno nadzirajo izbiro in PRIKAZ parametrov delovanja), ki v OBIČAJNIH RAZMERAH in pri OBIČAJNI UPORABI oddajajo SEVALNE SNOPE RENTGENSKIH in/ali ELEKTRONSKIH ŽARKOV in vključujejo: – NOMINALNO ENERGIJO v razponu od 1 MeV do 50 MeV, – največje HITROSTI ABSORBIRANE DOZE od 0,001 Gy × s-1 do 1 Gy × s-1 na razdalji 1 m od VIRA SEVANJA, – OBIČAJNE RAZDALJE ZA ZDRAVLJENJE (NTD) od 0,5 m do 2 m od VIRA SEVANJA ter so predvideni za OBIČAJNO UPORABO, pri čemer jih morajo pod vodstvom ustrezno licenciranih ali KVALIFICIRANIH OSEB upravljati UPRAVLJAVCI z zahtevanimi veščinami za določeno medicinsko uporabo, za določene opredeljene klinične namene (npr. STACIONARNA RADIOTERAPIJA ali RADIOTERAPIJA S PREMIČNIM ŽARKOM), in morajo biti vzdrževani v skladu s priporočili, podanimi v NAVODILIH ZA UPORABO, ter predmet rednih pregledov zagotavljanja kakovosti, delovanja in umerjanja, ki jih opravi KVALIFICIRANA OSEBA.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-2-1:2015
01-december-2015
1DGRPHãþD
SIST EN 60601-2-1:2002
SIST EN 60601-2-1:2002/A1:2003
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLHOHNWURQVNLKSRVSHãHYDOQLNRYYREPRþMXRG0H9GR0H9
Medical electrical equipment -- Part 2-1: Particular requirements for basic safety and
essential performance of electron accelerators in the range 1 MeV to 50 MeV
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Elektronenbeschleunigern im
Bereich von 1 MeV bis 50 MeV
Appareils électromédicaux -- Partie 2-1: Règles particulières pour la sécurité de base et
les performances essentielles des accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
Ta slovenski standard je istoveten z: EN 60601-2-1:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-2-1:2015
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SIST EN 60601-2-1:2015
EUROPEAN STANDARD EN 60601-2-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040.60 Supersedes EN 60601-2-1:1998
English Version
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 60601-2-1:2009 + A1:2014)
Appareils électromédicaux - Partie 2-1: Exigences Medizinische elektrische Geräte - Teil 2-1: Besondere
particulières de sécurité de base et de performances Festlegungen für die Sicherheit einschließlich der
essentielles pour les accélérateurs d'électrons dans la wesentlichen Leistungsmerkmale von
gamme de 1 MeV à 50 MeV Elektronenbeschleunigern
(IEC 60601-2-1:2009 + A1:2014) im Bereich von 1 MeV bis 50 MeV
(IEC 60601-2-1:2009 + A1:2014)
This European Standard was approved by CENELEC on 2015-09-15. 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 60601-2-1:2015 E
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SIST EN 60601-2-1:2015
EN 60601-2-1:2015
European foreword
The text of document 62C/474/FDIS, future edition 3 of IEC 60601-2-1, and the text of document
62C/532/CDV, future IEC 60601-2-1/A1, prepared by SC 62C "Equipment for radiotherapy, nuclear
medicine and radiation dosimetry", of IEC/TC 62 "Electrical equipment in medical practice" were
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-1:2015.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2016-06-15
national level by publication of an identical national
standard or by endorsement
(dow) 2018-09-15
• latest date by which the national standards conflicting with
the document have to be withdrawn
This document supersedes EN 60601-2-1:1998.
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 Standards IEC 60601-2-1:2009 and IEC 60601-2-1:2009/A1:2014 were
approved by CENELEC as a European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60976:2007 NOTE Harmonized as EN 60976:2007 (not modified).
IEC 62366 NOTE Harmonized as EN 62366.
2
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SIST EN 60601-2-1:2015
EN 60601-2-1:2015
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.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
IEC/TR 60788 2004 Medical electrical equipment - Glossary - -
of defined terms
IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
3
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SIST EN 60601-2-1:2015
EN 60601-2-1:2015
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.
4
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SIST EN 60601-2-1:2015
IEC 60601-2-1
®
Edition 3.1 2014-07
FINAL VERSION
VERSION FINALE
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
Appareils électromédicaux –
Partie 2-1: Exigences particulières de sécurité de base et de performances
essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à
50 MeV
IEC 60601-2-1:2009-10+AMD1:2014-07 CSV(en-fr)
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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
201.1 Scope, object and related standards . 8
201.2 Normative references . 10
201.3 Terms and definitions. 11
201.4 General requirements . 14
201.5 General requirements for testing ME EQUIPMENT . 14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 21
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 22
201.10 Protection against unwanted and excessive radiation HAZARDS . 25
201.11 Protection against excessive temperatures and other HAZARDS . 47
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 47
201.13 HAZARDOUS SITUATIONS and fault conditions . 48
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 48
201.15 Construction of ME EQUIPMENT . 49
201.16 ME SYSTEMS . 49
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 49
206 Usability . 50
Annexes . 60
Annex B (informative) Sequence of testing . 60
Annex I (informative) ME SYSTEMS aspects . 60
Bibliography . 61
Index of defined terms . 62
Figure 201.101 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION
(201.10.1.2.102.1) . 52
Figure 201.102 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION
(201.10.1.2.102.2) . 53
Figure 201.103 – Elevation view – Application of LEAKAGE RADIATION requirements
(201.10.1.2.103 and 201.10.1.2.104) . 54
Figure 201.104 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION (201.10.1.2.103.2.1) . 55
Figure 201.105 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 56
Figure 201.106 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION (201.10.1.2.103.2.2) . 57
Figure 201.107 – 24 measurement points for averaging LEAKAGE RADIATION outside
area M (201.10.1.2.103.3). 58
Figure 201.108 – ME EQUIPMENT movements and scales . 59
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Table 201.101 – Colours of indicator lights and their meaning for ME EQUIPMENT . 16
Table 201.102 – Data required in the technical description to support Clause 201.10
SITE TEST compliance . 18
Table 201.103 – Clauses and subclauses in this particular standard that require the
provision of information in the ACCOMPANYING DOCUMENTS, INSTRUCTIONS FOR USE and
the technical description . 20
Table 201.104 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION (see
Figure 201.101) . 40
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see
Figure 201.102) . 40
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
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
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.
This Consolidated version of IEC 60601-2-1 bears the edition number 3.1. It consists of
the third edition (2009-10) [documents 62C/474/FDIS and 62C/480/RVD] and its
amendment 1 (2014-07) [documents 62C/532/CDV and 62C/562/RVC]. The technical
content is identical to the base edition and its amendment.
This Final version does not show where the technical content is modified by
amendment 1. A separate Redline version with all changes highlighted is available in
this publication.
This publication has been prepared for user convenience.
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International Standard IEC 60601-2-1 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.
This third edition addresses the following issues not covered in previous editions:
– alignment with the new relevant collateral standards;
– new technologies in radiotherapy, including:
• stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT);
• intensity modulated radiotherapy (IMRT);
• electronic imaging devices (e.g. EPID);
• moving beam radiotherapy (dynamic therapy).
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.
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.
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The committee has decided that the contents of the base publication and its amendment 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.
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INTRODUCTION
The use of ELECTRON ACCELERATORS for RADIOTHERAPY purposes may expose PATIENTS to
danger if the ME EQUIPMENT fails to deliver the required dose to the PATIENT, or if the ME
design does not satisfy standards of electrical and mechanical safety. The ME
EQUIPMENT
EQUIPMENT may also cause danger to persons in the vicinity if the ME 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 ELECTRON ACCELERATORS for use in RADIOTHERAPY; it does not
attempt to define their optimum performance requirements. Its purpose is to identify those
features of design that are regarded, at the present time, as essential for the safe operation of
such ME EQUIPMENT. It places limits on the degradation of ME EQUIPMENT performance beyond
which it can be presumed that a fault condition exists and where an INTERLOCK then operates
to prevent continued operation of the ME EQUIPMENT.
Clause 201.10 contains limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE
in order to insure ESSENTIAL PERFORMANCE is maintained to avoid an unsafe
IRRADIATION
condition. TYPE TESTS that are performed by the MANUFACTURER, and/or SITE TESTS, which are
not necessarily performed by the MANUFACTURER, are SPECIFIED for each requirement. It is
understood that SITE TESTS may or may not be required of the MANUFACTURER, per the
agreement between the MANUFACTURER and end user.
Given that before installation a MANUFACTURER cannot provide SITE TEST data, data available
SITE TESTS should be incorporated in the ACCOMPANYING DOCUMENTS, in the form of a SITE
from
TEST report, by those who test the ME EQUIPMENT at installation.
This International Standard was first published in 1981. It was amended in 1984 and 1990. A
second edition was published in 1998 and amended in 2002. This third edition is prompted by
the need to align this particular standard with the third edition of the general standard,
IEC 60601-1:2005.
IEC 60976 and IEC/TR 60977 are closely related to this standard. The former specifies test
methods and reporting formats for performance tests of ELECTRON ACCELERATORS for use in
RADIOTHERAPY, with the aim of providing uniform methods for conducting such tests. The latter
is not a standard per se, but suggests performance values, measured per the methods
specified in IEC 60976, that could be achievable with present technology.
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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
201.1 Scope, object and related standards
1)
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
ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to
PATIENTS.
50 MeV, used for treatment of
This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
to the manufacture and some installation aspects of ELECTRON ACCELERATORS
– intended for RADIOTHERAPY in human medical practice, including those in which the
selection and DISPLAY of operating parameters can be controlled automatically by
PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-
RADIATION and/or ELECTRON RADIATION having
• NOMINAL ENERGY in the range 1 MeV to 50 MeV,
–1 –1
• maximum ABSORBED DOSE RATES between 0,001 Gy × s and 1 Gy × s at 1 m from
the RADIATION SOURCE,
• NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION
SOURCE,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED
PERSONS by OPERATORS having the required skills for a particular medical application,
for particular specified clinical purposes, e.g. STATIONARY RADIOTHERAPY or MOVING
BEAM RADIOTHERAPY,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR
USE,
• subject to regular quality assurance performance and calibration checks by a
QUALIFIED PERSON.
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE
ORGANIZATION’S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance.
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IEC 61271 gives guidance on the designation of ME EQUIPMENT movements; the marking of
scales, their zero positions and the direction of movement with increasing value (see
201.7.4.101).
IEC 60676 specifies methods of testing and disclosure of functional performance of medical
ELECTRON ACCELERATORS. The standard is intended to facilitate comparisons of accelerator-
based ME EQUIPMENTs of different manufacture. IEC 60676 contains no safety requirements,
and is therefore not required for compliance with this particular standard. It should also be
noted (as stated in the Introduction to IEC 60976:2007) that tests specified in IEC 60976 are
not necessarily appropriate for ensuring that any individual medical ELECTRON ACCELERATOR
conforms to the declared functional performance during the course of its working lifetime.
NOTE 3 IEC/TR 60977, Medical electrical equipment – Medical electron accelerators – Guidelines for functional
performance characteristics, is a related technical report that provides performance guidelines. It shall not be
construed as a standard.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTRON ACCELERATORS in the range 1 MeV to 50 MeV and to
specify tests to check compliance to those requirements.
NOTE The adoption of this standard helps to ensure that the ME EQUIPMENT
• maintains PATIENT safety during ME EQUIPMENT movements and failure of the SUPPLY MAINS,
• delivers the pre-selected RADIATION TYPE, NOMINAL ENERGY, and ABSORBED DOSE,
• delivers the RADIATION in accordance with the pre-selected relationship of the RADIATION BEAM to the PATIENT,
by utilizing STATIONARY RADIOTHERAPY, MOVING BEAM RADIOTHERAPY, RADIATION BEAM modifying devices, etc.,
without causing unnecessary risk to the PATIENT, the OPERATOR, other persons or the environment.
201.1.3 Collateral standards
Addition:
Collateral standards published after the date of publication of this standard shall only apply
subject to further amendment to this standard.
This particular standard refers to those applicable collateral standards that are listed in
clause 2 of the general standard and clause 201.2 of this particular standard.
IEC 60601-1-6 apply as modified in Clauses 206. IEC 60601-1-3, IEC 60601-1-8 and 60601-
2
do not apply. All other published collateral standards in the IEC 60601-1 series apply as
1-10
published.
201.1.4 Particular standards
Replacement:
In the IEC 60601 series, particular standards may modify, replace or delete requirements
contained in the general standard and collateral standards as appropriate for the particular
ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements.
—————————
2
IEC 60601-1-10, Medical electrical equipment – Part 1-10: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers
---------------------- Page: 15 ----------------------
SIST EN 60601-2-1:2015
– 10 – IEC 60601-2-1:2009
+AMD1:2014 CSV IEC 2014
A requirement of a particular standard takes priority over the general standard.
For brevity, IEC 60601-1 is referred to in this particular standard as the general standard.
Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this particular standard corresponds to
that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the
content of Clause 1 of the general standard) or applicable collateral standard with the prefix
“20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in
this particular standard addresses t
...
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