IEC 60601-2-8:2010

Medical electrical equipment - Part 2-8: Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Appareils électromédicaux - Partie 2-8: Exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant dans la gamme de 10 kV à 1 MV

La CEI 60601-2-8:2010 établit des exigences particulières pour la sécurité de base et les performances essentielles des équipements à rayonnement X de thérapie fonctionnant à des hautes tensions radiogènes nominales comprises entre 10 kV et 1 MV quand ils sont reliés à un réseau d'alimentation fournissant du courant alternatif. Elle établit des exigences pour la précision et à la reproductibilité des caractéristiques dans la mesure où celles-ci sont en relation avec la qualité de rayonnement et les grandeurs liées au rayonnement ionisant émis et où elles doivent donc être considérées comme des aspects de la sécurité. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-8. Cette édition constitue une révision technique qui aligne la présente norme sur la troisième édition de la CEI 60601-1 et ses normes collatérales.

General Information

• Status: Published
• Publication Date: 09-Nov-2010
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic 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: PPUB - Publication issued
• Start Date: 30-Nov-2010
• Completion Date: 10-Nov-2010

Relations

• Amended By: IEC 60601-2-8:2010/AMD1:2015 - Amendment 1 - Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-8:1987 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-8:1987/AMD1:1997 - Amendment 1 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-8 ®
Edition 2.0 2010-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-8: Particular requirements for the basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
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.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
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 la CEI ou du Comité national de la CEI du pays du demandeur.
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IEC 60601-2-8 ®
Edition 2.0 2010-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-8: Particular requirements for the basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
W
CODE PRIX
ICS 11.040.50 ISBN 978-2-88912-238-7
– 2 – 60601-2-8 Ó IEC:2010
CONTENTS
FOREW ORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT. 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 30
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 30
201.13 HAZARDOUS SITUATIONS and fault conditions . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS ) . 31
201.15 Construction of ME EQUIPMENT . 31
201.16 ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Bibliography . 32
Index of defined terms used in this particular standard . 33

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE and TYPE TEST compliance . 10
Table 201.102 – Permissible LEAKAGE RADIATION . 16
Table 201.103 – Permissible LEAKAGE RADIATION from X-RAY TUBE ASSEMBLIES with
BEAM LIMITING DEVICES . 18
Table 201.104 – Overview of measurements . 29

60601-2-8 Ó IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
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
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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 60601-2-8 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 second edition cancels and replaces the first edition of IEC 60601-2-8. This edition
constitutes a technical revision which brings this standard in line with the third edition of
IEC 60601-1 and its collateral standards.

– 4 – 60601-2-8 Ó IEC:2010
The text of this particular standard is based on the following documents:
FDIS Report on voting
62C/499/FDIS 62C/505/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
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 standa
...

IEC 60601-2-8 ®
Edition 2.1 2015-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-8: Particular requirements for the basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
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.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
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
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
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Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

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La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

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IEC 60601-2-8 ®
Edition 2.1 2015-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 2-8: Particular requirements for the basic safety and essential performance

of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances

essentielles des équipements à rayonnement X de thérapie fonctionnant dans la

gamme de 10 kV à 1 MV
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.50 ISBN 978-2-8322-2949-1

IEC 60601-2-8 ®
Edition 2.1 2015-09
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-8: Particular requirements for the basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV

Appareils électromédicaux –
Partie 2-8: Exigences particulières pour la sécurité de base et les performances
essentielles des équipements à rayonnement X de thérapie fonctionnant dans la
gamme de 10 kV à 1 MV
– 2 – IEC 60601-2-8:2010+AMD1:2015 CSV
 IEC 2015
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
INTRODUCTION TO THE AMENDMENT . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 8
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 15
201.11 Protection against excessive temperatures and other HAZARDS . 30
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 30
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 30
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 30
201.15 Construction of ME EQUIPMENT . 30
201.16 ME SYSTEMS . 31
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 31
Bibliography . 32
Index of defined terms used in this particular standard. 33

Table 201.101 – Data required in the technical description to support Clause 201.10
SITE and TYPE TEST compliance . 10
Table 201.102 – Permissible LEAKAGE RADIATION . 16
Table 201.103 – Permissible LEAKAGE RADIATION from X-RAY TUBE ASSEMBLIES with
BEAM LIMITING DEVICES . 18
Table 201.104 – Overview of measurements . 29

 IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-8: Particular requirements for the basic safety and essential
performance of therapeutic X-ray equipment operating
in the range 10 kV to 1 MV
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 the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-8 edition 2.1 contains the second edition (2010-11) [documents 62C/499/FDIS and
62C/505/RVD] and its amendment 1 (2015-09) [docum
...