SIST EN 60601-2-8:2015

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.

Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen im Bereich von 10 kV bis 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

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.

Medicinska električna oprema - 2-8. del: Posebne zahteve za osnovno varnost in bistvene lastnosti terapevtske rentgenske opreme, ki deluje v območju od 10 kV do 1 MV

Ta mednarodni standard se nanaša na osnovno varnost in bistvene lastnosti terapevtske RENTGENSKE OPREME z NAZIVNO NAPETOSTJO RENTGENSKE CEVI v razponu od 10 kV do 1 MV, ko je priključena na NAPAJALNO OMREŽJE z izmeničnim tokom, v nadaljevanju: MEDICINSKA ELEKTRIČNA (ME) OPREMA.
OPOMBA: Ta standard obravnava TELERADIOTERAPIJO IN BRAHITERAPIJO.
Če je točka ali podtočka namenjena samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini točke ali podtočke. Če ni zapisano, točka ali podtočka obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME.

General Information

• Status: Published
• Publication Date: 16-Aug-2015
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 27-Jul-2015
• Due Date: 01-Oct-2015
• Completion Date: 17-Aug-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN 60601-2-8:2015 - 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

Relations

• Replaces: SIST EN 60601-2-8:1998/A1:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV - Amendment A1 (IEC 60601-2-8:1987/A1:1997)
• Effective Date: 07-Jun-2022
• Replaces: SIST EN 60601-2-8:1998 - Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987)
• Effective Date: 01-Sep-2015
• Amended By: SIST EN 60601-2-8:2015/A1:2016 - 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 (IEC 60601-2-8:2010/A1:2015)
• Effective Date: 06-Aug-2014

Overview

EN 60601-2-8:2015 (adopting IEC 60601-2-8:2010) is a European harmonized particular standard for medical electrical equipment used in therapeutic X‑ray applications. It defines the basic safety and essential performance requirements for therapeutic X‑ray equipment with nominal tube voltages from 10 kV to 1 MV when connected to alternating current mains. The standard covers teletherapy and brachytherapy systems, and addresses radiation‑related performance parameters (accuracy, reproducibility and radiation quality) as elements of safety.

Key Topics

• Scope and applicability: Therapeutic X‑ray equipment operating 10 kV–1 MV, connected to AC mains; replaces EN 60601-2-8:1997 and aligns with IEC 60601‑1 (3rd edition).
• Safety and essential performance: Requirements that designers and manufacturers must meet to ensure patient and operator safety.
• Radiation protection: Limits and test methods related to leakage radiation, containment and shielding; requirements that trigger interlocks or termination of irradiation when unsafe conditions are detected.
• Accuracy and reproducibility: Performance requirements for delivered dose, radiation quality and measurement repeatability insofar as they affect safety.
• Interlocks and protective functions: Mandatory interlocks and safety features to prevent, interrupt or terminate irradiation if defined limits are exceeded.
• Testing and documentation: Type and site test guidance, technical descriptions required to demonstrate compliance (including measurements and test data).
• Construction and EMC: Electrical and mechanical safety, temperature limits, electromagnetic compatibility and PEMS considerations.
• Normative references and measurement uncertainty: Links to measurement guidance (e.g., GUM) and radiotherapy coordinate/movement standards.

Applications

Who uses EN 60601-2-8:2015:

• Manufacturers and product designers of therapeutic X‑ray and radiotherapy equipment (teletherapy & brachytherapy).
• Regulatory and conformity assessment bodies assessing compliance with EU medical device directives (coverage of Essential Requirements of Directive 93/42/EEC is indicated).
• Medical physicists and hospital engineering teams responsible for acceptance testing, commissioning and routine quality assurance.
• Test laboratories and certification bodies performing type, site and leakage radiation testing.

Practical uses:

• Design validation, risk mitigation and safety feature specification.
• Preparing technical documentation for CE marking and regulatory submissions.
• Developing acceptance test procedures and QA schedules for clinical deployment.

Related Standards (if applicable)

• IEC 60601-1 (general standard for medical electrical equipment)
• IEC 60601-2-1 (electron accelerators, 1 MeV–50 MeV)
• IEC 61217 (radiotherapy equipment coordinates, movements and scales)
• ISO/IEC Guide 98-3 (GUM) (uncertainty of measurement)

Keywords: EN 60601-2-8:2015, IEC 60601-2-8, therapeutic X‑ray equipment, radiotherapy safety, teletherapy, brachytherapy, leakage radiation, medical electrical equipment, essential performance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2015
1DGRPHãþD
SIST EN 60601-2-8:1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLWHUDSHYWVNHUHQWJHQVNHRSUHPHNLGHOXMHYREPRþMXRGN9
GR09
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
Medizinische elektrische Geräte - Teil 2-8: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Therapie-Röntgeneinrichtungen
im Bereich von 10 kV bis 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
Ta slovenski standard je istoveten z: EN 60601-2-8:2015
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-8

NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.50 Supersedes EN 60601-2-8:1997
English Version
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
(IEC 60601-2-8:2010)
Appareils électromédicaux - Partie 2-8: Exigences Medizinische elektrische Geräte - Teil 2-8: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des équipements à rayonnement X de thérapie wesentlichen Leistungsmerkmale von Therapie-
fonctionnant dans la gamme de 10 kV à 1 MV Röntgeneinrichtungen im Bereich von 10 kV bis 1 MV
(IEC 60601-2-8:2010) (IEC 60601-2-8:2010)
This European Standard was approved by CENELEC on 2015-04-14. 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 60601-2-8:2015 E
Foreword
The text of document 62C/499/FDIS, future edition 2 of IEC 60601-2-8, prepared by SC 62C, "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry", of IEC TC 62, "Electrical equipment in
medical practice", was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
The following dates are fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2016-01-14
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2018-04-14
This document supersedes EN 60601-2-8:1997.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC 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 see informative Annex ZZ, which is an integral part of this
document.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-8:2010 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 60601-2-17 NOTE  Harmonized as EN 60601-2-17.
__________
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 with the following exceptions:
Publication Year Title EN/HD Year
Addition:
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
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 61217 - Radiotherapy equipment - Coordinates, EN 61217 -
movements and scales
ISO/IEC Guide 98-3 2008 Uncertainty of measurement - - -
Part 3: Guide to the expression of uncertainty
in measurement (GUM:1995)
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.
NOTE Presumption of conformity with Essential Requirements 13.1 to 13.6 should depend on the
manufacturer confirming the accuracy of the accompanying documents in all relevant languages.
WARNING: Other requirements and other EU Directives can be applied to the products falling within the
scope of this standard.
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
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 60601-2-8 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 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.
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.
60601-2-8 Ó IEC:2010 – 5 –
INTRODUCTION
X-RAY EQUIPMENT for RADIOTHERAPY purposes is used for TELETHERAPY, where the RADIATION
SOURCE is far from the tissues to the treated (usually more than 50 cm), and also for
BRACHYTHERAPY, where the RADIATION SOURCE is positioned within or adjacent to the tissue to
be treated. This particular standard covers X-RAY EQUIPMENT for both TELETHERAPY and
BRACHYTHERAPY.
The use of X-RAY EQUIPMENT for RADIOTHERAPY purposes may expose the PATIENT to danger if
the equipment fails to deliver the required dose to the PATIENT, or if the equipment design
does not satisfy standards of electrical and mechanical safety. The equipment may also cause
danger to persons in the vicinity if the 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 the MANUFACTURERS
in the design and construction of therapeutic X-RAY EQUIPMENT. Subclause 201.10.1 contains
limits beyond which INTERLOCKS prevent, INTERRUPT or TERMINATE IRRADIATION in order to
avoid an unsafe condition.
Subclause 201.10.1 does not attempt to define 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 equipment. It places limits on the degradation of
equipment performance beyond which it can be presumed that a fault condition exists, e.g. a
component failure, and where an INTERLOCK then operates to prevent continued operation of
the equipment.
It should be understood that, before installation, a MANUFACTURER can provide a compliance
certificate relating only to TYPE TESTS: data available from SITE TESTS should be incorporated
in the ACCOMPANYING DOCUMENTS, in the form of a SITE TEST report, by those who test the
equipment at installation.
– 6 – 60601-2-8 Ó IEC:2010
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
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
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, hereafter referred to as ME EQUIPMENT.
NOTE This standard covers TELETHERAPY and BRACHYTHERAPY.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular basic safety and essential
performance requirements for therapeutic X-RAY EQUIPMENT. 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.
201.1.3 Collateral standards
Addition:
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.
2)
IEC 60601-1-3 and IEC 60601-1-10 do not apply. All other published collateral standards in
the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:
—————————
1)
The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
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

60601-2-8 Ó IEC:2010 – 7 –
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.
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 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 the content of Clause 4 of the IEC 60601-1-2 collateral
standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601-1-3 collateral standard, etc.). The changes to the text of the general standard are
SPECIFIED by the use of the following words:
"Replacement" means that the clause or subclause of the general standard or applicable
collateral standard is replaced completely by the text of this particular standard.
"Addition" means that the text of this particular standard is additional to the requirements of
the general standard or applicable collateral standard.
"Amendment" means that the clause or subclause of the general standard or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses, figures or tables which are additional to those of the general standard are
numbered starting from 201.101. However, due to the fact that definitions in the general
standard are numbered 3.1 through 3.139, additional definitions in this standard are
numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and
additional items aa), bb), etc.
Subclauses, figures or tables which are additional to those of a collateral standard are
numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for
IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
The term "this standard" is used to make reference to the general standard, any applicable
collateral standards and this particular standard taken together.
Where there is no corresponding clause or subclause in this particular standard, the clause or
subclause of the general standard or applicable collateral standard, although possibly not
relevant, applies without modification; where it is intended that any part of the general
standard or applicable collateral standard, although possibly relevant, is not to be applied, a
statement to that effect is given in this particular standard.
201.2 Normative references
Clause 2 of the general standard applies, except as follows:
Addition:
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
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

– 8 – 60601-2-8 Ó IEC:2010
IEC 61217, Radiotherapy equipment – Coordinates, movements and scales
ISO/IEC Guide 98-3:2008, Uncertainty of measurement – Part 3: Guide to the expression of
uncertainty in measurement (GUM:1995)
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC TR 60788:2004 apply, except as follows.
NOTE An index of defined terms is found beginning on page 33.
Addition:
201.3.201
BRACHYTHERAPY
RADIOTHERAPY using one or more RADIATION SOURCES with the RADIATION SOURCE/sources
inside or close to the TARGET VOLUME
NOTE BRACHYTHERAPY techniques include INTERSTITIAL, INTRACAVITARY, SUPERFICIAL or INTRALUMINAL
RADIOTHERAPY.
201.3.202
INTERSTITIAL RADIOTHERAPY
RADIOTHERAPY with RADIATION SOURCES inserted within the TARGET VOLUME
201.2.203
INTRACAVITARY RADIOTHERAPY
RADIOTHERAPY in which one or more RADIATION SOURCES, with or without SOURCE APPLICATORS,
are introduced into a body cavity through a natural or artificial opening
201.3.204
INTRALUMINAL RADIOTHERAPY
RADIOTHERAPY in which one or more RADIATION SOURCES, with or without SOURCE APPLICATORS,
are introduced into a body lumen such as a blood vessel, air way, or the gastrointestinal tract
201.3.205
SOURCE APPLICATOR
device to bring one or more RADIATION SOURCES into the intended positions
NOTE A SOURCE APPLICATOR may include protective shielding.
201.3.206
TELERADIOTHERAPY
TELETHERAPY
RADIOTHERAPY with a large RADIATION SOURCE TO SKIN DISTANCE, usually not less than 50 cm
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
Additional subclause:
60601-2-8 Ó IEC:2010 – 9 –
201.4.101 Conventional meaning of electrical quantities
In this particular standard, unless otherwise indicated, values of X-RAY TUBE VOLTAGE refer to
peak values.
201.5 General requirements for testing of ME EQUIPMENT
Clause 5 of the general standard applies, except as follows:
201.5.1 TYPE TESTS
Addition:
201.5.1.101 Test grades
Three grades of TYPE TEST and two of SITE TEST procedures are SPECIFIED in 201.10 of this
particular standard; their requirements are as follows:
– TYPE TEST grade A: an analysis of ME EQUIPMENT design, as related to the SPECIFIED
radiation safety provisions, which shall result in a statement included in the technical
description, regarding the working principles or constructional means by which the
requirement is fulfilled;
– TYPE TEST/SITE TEST grade B: visual inspection or functional test or measurement of the
ME EQUIPMENT. The test shall be in accordance with the procedure SPECIFIED in this
particular standard and shall be based on operating states, including fault condition states,
which are achievable only without interference with the circuitry or construction of the
ME EQUIPMENT;
– TYPE TEST/SITE TEST grade C: functional test or measurement of the ME EQUIPMENT. The
test shall be in accordance with the principle SPECIFIED in this particular standard. The SITE
TEST procedure shall be included in the technical description. When the procedure
involves operating states that require interference with the circuitry or the construction of
the ME EQUIPMENT, the test should be performed by, or under the direct supervision of, the
MANUFACTURER or the MANUFACTURER’S agent.
Table 201.101 summarises the data required in the technical description to support Clause
201.10 SITE TEST compliance.
201.5.4 Other conditions
Addition:
aa) The ACCOMPANYING DOCUMENTS shall include
1) statements resulting from TYPE TESTS: grade A;
2) details of and results from TYPE TESTS: grade B and grade C;
3) SPECIFIC procedures and test conditions for SITE TESTS grade C;
4) instructions on how to generate a described fault condition or, if not practicable, how
to generate a test signal as close as practicable to the source of the signal that
would have generated it, with a statement confirming that the test signal simulates
the one that would be produced in a particular fault condition;
NOTE In some cases, one test signal may simulate more than one fault condition.
5) instructions on how to reset the ME EQUIPMENT for NORMAL USE after the completion of
the SITE TEST and how to verify this condition.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

– 10 – 60601-2-8 Ó IEC:2010
NOTE The person responsible for the SITE TESTS should record the results in a report which should be included
with the ACCOMPANYING DOCUMENTS; in addition, the SITE TEST report should contain at least the following: name
and address of the RESPONSIBLE ORGANIZATION site; MODEL OR TYPE REFERENCE of the equipment; name, status and
employment address of all personnel taking part in the tests, and date of their participation; environmental and
power supply conditions; the actual conditions, when test conditions, procedures or devices differ from those given
by the MANUFACTURER, or where the information cannot be derived from this particular standard.
Table 201.101 – Data required in the technical description to support
Clause 201.10 SITE and TYPE TEST compliance
SPECIFIC
Statement Details of, and Details of ,and
procedures and
Compliance
regarding data results from, results from,
test conditions
subclause from TYPE TESTS TYPE TESTS or SITE TYPE TEST grade
for SITE TESTS
grade A TESTS grade B C
grade C
201.10.1.2.101 Ŧ
201.10.1.2.102 Ŧ
201.10.1.2.103.1 Ŧ
201.10.1.2.103.2 Ŧ
201.10.1.2.104 Ŧ
201.10.1.2.105.1 Ŧ  Ŧ
201.10.1.2.105.2 Ŧ  Ŧ
201.10.1.2.105.3 Ŧ  Ŧ
201.10.1.2.105.4 Ŧ  Ŧ
201.10.1.2.105.5 Ŧ
201.10.1.2.105.6 Ŧ Ŧ
201.10.1.2.105.7 Ŧ
201.10.1.2.105.8 Ŧ
201.10.1.2.106 Ŧ Ŧ
201.10.1.2.107 Ŧ Ŧ
201.10.1.2.108 Ŧ
201.10.1.2.109.1 Ŧ  Ŧ
201.10.1.2.109.2 Ŧ
201.10.1.2.109.3 Ŧ Ŧ
201.10.1.2.109.4 b), d) d) a), b), c)
201.10.1.2.109.5 a), b), c), d), e), f)
201.10.1.2.109.6 a), c)  a), b), c)
201.10.1.2.109.7 Ŧ  Ŧ
201.10.1.2.110.1 Ŧ
201.10.1.2.110.2.1 Ŧ  Ŧ
201.10.1.2.110.2.2 Ŧ  Ŧ
201.10.1.2.110.2.3 Ŧ  Ŧ
201.10.1.2.110.3.1 Ŧ  Ŧ
201.10.1.2.110.3.2 Ŧ Ŧ
201.10.1.2.110.3.3 Ŧ  Ŧ
201.10.1.2.110.4 Ŧ  Ŧ
201.10.1.2.110.5 Ŧ  Ŧ
201.10.1.2.110.6 Ŧ  Ŧ
201.10.1.2.110.7.1 Ŧ
201.10.1.2.110.7.2 Ŧ
60601-2-8 Ó IEC:2010 – 11 –
SPECIFIC
Statement Details of, and Details of ,and
procedures and
Compliance regarding data results from, results from,
test conditions
subclause
from TYPE TESTS TYPE TESTS or SITE TYPE TEST grade
for SITE TESTS
grade A TESTS grade B C
grade C
201.10.1.2.111.1 Ŧ
201.10.1.2.111.2 Ŧ Ŧ
201.10.1.2.111.3 Ŧ Ŧ
201.10.1.2.111.4 Ŧ Ŧ
201.10.1.2.111.5 Ŧ
201.10.1.2.111.6 Ŧ Ŧ
201.10.1.2.111.7 Ŧ
201.10.1.2.112.1  Ŧ
201.10.1.2.112.2  Ŧ
201.10.1.2.112.3  Ŧ
NOTE Ŧ requirement of subclause having no other identification.

201.5.5 Supply voltages, type of current, nature of supply, frequency
Addition:
aa) For all tests for the measurement of AIR KERMA and AIR KERMA RATE in air for compliance
with requirements on LEAKAGE RADIATION and stray radiation it is assumed that the SUPPLY
MAINS used for the test is delivering its output at its nominal values.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.2.2 Identification
Addition:
X-RAY TUBES and X-RAY TUBE HOUSING/assemblies shall be supplied to the RESPONSIBLE
ORGANIZATION together with ACCOMPANYING DOCUMENTS.
Any information given on the X-RAY TUBE HOUSING shall not differ from that also given in the
ACCOMPANYING DOCUMENTS and shall indicate accurately the data applying to the X-RAY TUBE
assembled in the X-RAY TUBE HOUSING. It shall be the responsibility of the organization
assembling the X-RAY TUBE into the X-RAY TUBE HOUSING to ensure that this information is
accurate, and make such changes as may be necessary in the event of X-RAY TUBE
replacement. See also 201.10.1.2.105.8.
X-RAY TUBES shall carry the following markings (not applicable to X-RAY TUBE ASSEMBLIES
intended for BRACHYTHERAPY):
· name or trademark of the MANUFACTURER;
· MODEL OR TYPE REFERENCE;
– 12 – 60601-2-8 Ó IEC:2010
· individual identification.
The above markings may be given in the form of a combined designation explained in the
ACCOMPANYING DOCUMENTS.
X-RAY TUBE HOUSINGS shall carry the following markings (not applicable to X-RAY TUBE
ASSEMBLIES intended for BRACHYTHERAPY):
– name or trademark of MANUFACTURER or supplier;
– type and SERIAL NUMBER of X-RAY TUBE HOUSING;
– maximum permissible voltage of X-RAY TUBE HOUSING.
X-RAY TUBE ASSEMBLIES shall carry the following markings (not applicable to X-RAY TUBE
ASSEMBLIES intended for BRACHYTHERAPY):
– name or trademark of MANUFACTURER or supplier;
– type and SERIAL NUMBER of X-RAY TUBE;
– maximum permissible X-RAY TUBE VOLTAGE;
– nominal value of the permanent FILTRATION of the X-RAY TUBE ASSEMBLY in quality
equivalent FILTRATION;
– position of FOCAL SPOT.
X-RAY TUBE ASSEMBLIES intended for BRACHYTHERAPY shall carry the following markings:
– type and SERIAL NUMBER of X-RAY TUBE ASSEMBLY;
The ACCOMPANYING DOCUMENTS of X-RAY TUBE ASSEMBLIES intended for BRACHYTHERAPY shall
state:
– maximum permissible X-RAY TUBE VOLTAGE;
– nominal value of the permanent FILTRATION of the X-RAY TUBE ASSEMBLY in quality
equivalent FILTRATION;
– position of FOCAL SPOT relative to the outside of the X-RAY TUBE ASSEMBLY.
NOTE Since X-RAY TUBE ASSEMBLIES intended for BRACHYTHERAPY are small and the X-RAY TUBE and the X-RAY
TUBE HOUSING are of an integral design not intended to be serviced in the field it would be impractical and
unnecessary to mark the tube and the housing separately.
The nominal value of the permanent FILTRATION in the SPECIFIED range of operating voltages
shall be indicated in the form of quality equivalent FILTRATION as follows:
– in thickness of aluminium for therapeutic X-RAY TUBES for operation at voltages within the
range from 10 kV up to and including 150 kV;
– exceptionally, in thickness of beryllium or another substance, e.g. molybdenum, for
therapeutic X-RAY TUBES when the tube window is composed substantially of beryllium or
this other substance;
– in thickness of copper for therapeutic X-RAY TUBES for operation at voltages within the
range from 150 kV up to and including 1 MV.
Where there is a significant variation in permanent FILTRATION of the X-RAY TUBE over the
entire range of voltages, this variation should be stated in the ACCOMPANYING DOCUMENTS.
In cases where, for convenience, permanent FILTRATION is indicated in thickness of other
material, e.g. iron, the quality equivalent FILTRATION of aluminium or copper according to the
operating range of voltages shall also be given.
201.7.2.6 Connection to the SUPPLY MAINS
Addition:
60601-2-8 Ó IEC:2010 – 13 –
For therapeutic X-RAY EQUIPMENT that is SPECIFIED to be permanently installed, the information
required in subclause 7.2.6 of the general standard need only be stated in the ACCOMPANYING
DOCUMENTS.
201.7.2.7 Electrical input power from the SUPPLY MAINS
Addition:
For therapeutic X-RAY EQUIPMENT that is SPECIFIED to be permanently installed, the information
required in subclause 7.2.7 of the general standard need only be stated in the ACCOMPANYING
DOCUMENTS.
If compliance with this standard is to be marked on the outside of the X-RAY EQUIPMENT, such
marking shall be made in combination with the MODEL OR TYPE REFERENCE as follows:
MODEL OR TYPE REFERENCE IEC 60601-2-8:2010
Marking indicating compliance of equipment, or subassembly thereof, with the requirements of
this standard shall be made only if compliance of the ME EQUIPMENT or the subassembly is
complete.
201.7.4 Marking of controls and instruments
Additional subclause:
201.7.4.101 Provision of scales and indications for moving parts
Each scaled DISPLAY of any value of a parameter relating to X-RADIATION output that is
provided on the TREATMENT CONTROL PANEL shall have only one scale in a unit of only one kind
and/or its decimal subdivisions.
Except for ME EQUIPMENT intended to be used as BRACHYTHERAPY devices, the following shall
be provided:
a) a mechanical scale, or a numerical indication, for each available movement;
b) a LIGHT FIELD indication of the X-ray field, where an adjustable BEAM APPLICATOR is
provided;
c) a mechanical scale, or a numerical indication, of the RADIATION SOURCE TO SKIN DISTANCE.
The designation, direction of increasing value and zero position of all movements shall comply
with IEC 61217.
NOTE Since X-RAY TUBE ASSEMBLIES intended for BRACHYTHERAPY are placed inside the PATIENT or very close to
the skin of the PATIENT the provisions required by this subclause are not relevant for this type of devices.
Compliance is checked by inspection.
201.7.8.1 Colours of indicator lights
Addition:
NOTE Subclauses 201.10.1.2.105.6 and 201.10.1.2.111 of this particular standard, and 7.8 and 15.4.4 of the
general standard, deal with indicators and indicator lights.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Addition:
– 14 – 60601-2-8 Ó IEC:2010
The ACCOMPANYING DOCUMENTS shall clearly state the identity of the therapeutic X-RAY
EQUIPMENT, or subassembly thereof, to which they refer.
The ACCOMPANYING DOCUMENTS shall state the language(s) in which they were originally
approved by the MANUFACTURER and shall give a reference identifying at least one original
version.
NOTE Attention is drawn to the fact that ACCOMPANYING DOCUMENTS in a language other than that in which they
are supplied and approved by the MANUFACTURER of the ME EQUIPMENT or subassembly need a careful check by an
expert who, wherever possible, should be authorized by the MANUFACTURER to act in this capacity.
201.7.9.3.1 General
Addition:
The technical description shall contain appropriate instructions for the connection of the
therapeutic X-RAY EQUIPMENT to the SUPPLY MAINS.
The position of a reference centre as the centre of a sphere of 10 mm radius containing the
FOCAL SPOT shall be described in the ACCOMPANYING DOCUMENTS.
NOTE In this particular standard the centre of the sphere is referred to as the reference centre and is used only to
describe applicable distances for the requirements on LEAKAGE RADIATION, see 201.10.1.2.101.
For BRACHYTHERAPY devices the MANUFACTURER shall describe the position of the FOCAL SPOT
and state the accuracy of this position in the ACCOMPANYING DOCUMENTS.
Additional subclause:
201.7.9.101 Statement of compliance
Any statement of compliance of a therapeutic X-RAY EQUIPMENT with this standard shall be
made in the following form:
Therapeutic X-RAY EQUIPMENT MODEL OR TYPE REFERENCE IEC 60601-2-8:2010
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:
201.8.4.3 ME EQUIPMENT intended to be connected to a power source by a plug
Addition:
Detachable HIGH VOLTAGE CABLE CONNECTIONS shall be designed so that the use of TOOLS is
required to disconnect them.
Provision shall be made to prevent the appearance of an unacceptably HIGH VOLTAGE in the
MAINS PART or in any other low voltage circuit as a result of a defect or transient phenomenon
in the HIGH VOLTAGE circuit.
NOTE This can be achieved for example:
– by provision of a winding layer or a conductive screen connected to the PROTECTIVE EARTH TERMINAL between
HIGH VOLTAGE and low voltage circuits;
– by provision of a voltage limiting device across terminals to which external devices are connected and
between which an excessive voltage might arise if the external path becomes discontinuous.
Compliance shall be checked by inspection of design data and construction.

60601-2-8 Ó IEC:2010 – 15 –
201.8.8.3 Dielectric strength
Addition:
The dielectric strength of the electrical insulation of HIGH VOLTAGE circuits shall be sufficient to
withstand the test voltages for the durations given in item a) of 201.8.8.3.
The test shall be made without an X-RAY TUBE connected and with a test voltage of 1,2 times
the NOMINAL X-RAY TUBE VOLTAGE of the therapeutic X-RAY EQUIPMENT.
If the therapeutic X-RAY EQUIPMENT can be tested only with the X-RAY TUBE connected and if
the X-RAY TUBE does not allow the therapeutic X-RAY EQUIPMENT to be tested with a test
voltage of 1,2 times the NOMINAL X-RAY TUBE VOLTAGE, the test voltage may be lower but not
less than 1,1 times that voltage.
Item a)
Addition:
The HIGH VOLTAGE circuits of therapeutic X-RAY EQUIPMENT shall be tested by applying a test
voltage of 50 % of its final value according to 8.8.3 of the general standard, and increasing it
during a time of 10 s to the final value, which then shall be maintained for duration of 15 min.
201.8.10 Components and wiring
Additional subclause:
201.8.10.101 Accessible HIGH VOLTAGE cables
Accessible HIGH VOLTAGE cables carrying X-RAY TUBE CURRENT shall incorporate a flexible
–1
conductive screen having a maximum resistance of 1 Wm covered with a non-conductive
material capable of protecting the screen against mechanical damage in NORMAL USE.
The screen shall be connected to the conductive enclosure of the HIGH VOLTAGE GENERATOR
and to that of the X-RAY TUBE ASSEMBLY.
Compliance shall be checked by visual inspection and by measurement.
The flexible conductive screen is not to be recognized as satisfying a requirement for a
protective earth connection between the devices connected by the cable.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.4.1 General
Addition:
The INSTRUCTIONS FOR USE shall indicate the maximum permitted inclination for stability and
the recommendation to apply wheel locks or brakes during NORMAL USE of the ME EQUIPMENT.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies, except as follows:

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