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 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. 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 medical electrical equipment. It places limits on the degradation of medical electrical 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. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. 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) and moving beam radiotherapy (dynamic therapy).

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

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).

General Information

• Status: Published
• Publication Date: 12-Oct-2009
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: SC 62C - Equipment for radiotherapy, nuclear medicine and radiation dosimetry
• Drafting Committee: WG 1 - TC 62/SC 62C/WG 1
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 28-Oct-2020

Relations

• Amended By: IEC 60601-2-1:2009/AMD1:2014 - Amendment 1 - 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
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-1:2020 - 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
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-1:1998 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-1:1998/AMD1:2002 - Amendment 1 - Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-1 ®
Edition 3.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by
any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or
IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
please contact the address below or your local IEC member National Committee for further information.

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IEC 60601-2-1 ®
Edition 3.0 2009-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XB
CODE PRIX
ICS 11.040.60 ISBN 978-2-88910-212-9
– 2 – 60601-2-1 © IEC:2009
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 .47
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).47
201.15 Construction of ME EQUIPMENT .48
201.16 ME SYSTEMS .48
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS .48
206 Usability.50
Annexes .59
Annex B (informative) Sequence of testing .59
Annex I (informative) ME SYSTEMS aspects .59
Bibliography.60
Index of defined terms .61

Figure 201.101 – Limits of STRAY X-RADIATION during ELECTRON IRRADIATION
(201.10.1.2.102.1) .51
Figure 201.102 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION
(201.10.1.2.102.2) .
Figure 201.103 – Elevation view – Application of LEAKAGE RADIATION requirements
(201.10.1.2.103 and 201.10.1.2.104) .53
Figure 201.104 – 24 measurement points for averaging LEAKAGE RADIATION during X-
RADIATION (201.10.1.2.103.2.1) .54
Figure 201.105 – Limits of LEAKAGE RADIATION through the BEAM LIMITING DEVICES during
ELECTRON IRRADIATION (201.10.1.2.103.2.2).55
Figure 201.106 – Measurement points for averaging LEAKAGE RADIATION during
ELECTRON IRRADIATION (201.10.1.2.103.2.2).56
Figure 201.107 – 24 measurement points for averaging LEAKAGE RADIATION outside
area M (201.10.1.2.103.3).57
Figure 201.108 – ME EQUIPMENT movements and scales .58

Table 201.101 – Colours of indicator lights and their meaning for ME EQUIPMENT.16

60601-2-1 © IEC:2009 – 3 –
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) .39
Table 201.105 – Limits of RELATIVE SURFACE DOSE during X-IRRADIATION (see
Figure 201.102) .39

– 4 – 60601-2-1 © IEC:2009
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,
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...

IEC 60601-2-1 ®
Edition 3.1 2014-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form

or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or

your local IEC member National Committee for further information.

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ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
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International Standards for all electrical, electronic and related technologies.

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IEC 60601-2-1 ®
Edition 3.1 2014-07
CONSOLIDATED
VERSION
VERSION
CONSOLIDÉE
colour
inside
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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-1771-9

IEC 60601-2-1 ®
Edition 3.1 2014-07
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-2-1:2009
+AMD1:2014 CSV  IEC 2014
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

+AMD1:2014 CSV  IEC 2014
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

– 4 – IEC 60601-2-1:2009
+AMD1:2014 CSV  IEC 2014
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 Organizati
...