SIST EN 60601-2-28:2010

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010)

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE ASSEMBLIES and to components thereof: - hereafter referred to as ME EQUIPMENT; - intended for medical diagnosis and imaging. 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.

Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die medizinische Diagnostik (IEC 60601-2-28:2010)

Appareils éléctromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base et les performances essentielles des gaines équipées pour diagnostic médical (CEI 60601-2-28:2010)

La CEI 60601-2-28:2010 établit des exigences particulières relatives à la sécurité de base et aux performances essentielles des gaines équipées pour diagnostic médical. Cette deuxième édition annule et remplace la première édition parue en 1993. La présente édition constitue une révision technique. La seconde édition de la présente norme particulière a été établie pour correspondre à la CEI 60601-1:2005 (la troisième édition de la CEI 60601-1), qui est désignée comme la norme générale.

Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih naprav za zdravniške preglede (IEC 60601-2-28:2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RENGENTSKIH NAPRAV in njihovih komponent: - v nadaljevanju ME OPREMO; - namenjeno za zdravniške preglede in slikanje. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru, tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.

General Information

• Status: Withdrawn
• Publication Date: 12-Jul-2010
• Withdrawal Date: 04-Sep-2022
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 02-Sep-2022
• Due Date: 25-Sep-2022
• Completion Date: 05-Sep-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: EN 60601-2-28:2010 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Relations

• Replaced By: SIST EN IEC 60601-2-28:2020 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2017)
• Effective Date: 01-Oct-2019
• Replaces: SIST EN 60601-2-28:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• Effective Date: 01-Apr-2013
• Replaces: SIST EN 60601-2-28:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• Effective Date: 28-Jan-2023
• Revised: SIST EN IEC 60601-2-28:2020 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2017)
• Effective Date: 16-Jun-2015
• Replaces: SIST EN 60601-2-28:1995 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-28:2010
01-september-2010
1DGRPHãþD
SIST EN 60601-2-28:1995
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLUHQWJHQVNLKQDSUDY]D]GUDYQLãNHSUHJOHGH,(&

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and
essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-
28:2010)
Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die
medizinische Diagnostik (IEC 60601-2-28:2010)
Appareils éléctromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base
et les performances essentielles des gaines équipées pour diagnostic médical (CEI
60601-2-28:2010)
Ta slovenski standard je istoveten z: EN 60601-2-28:2010
ICS:
11.040.50 Radiografska oprema Radiographic equipment
SIST EN 60601-2-28:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-2-28:2010

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SIST EN 60601-2-28:2010

EUROPEAN STANDARD
EN 60601-2-28

NORME EUROPÉENNE
May 2010
EUROPÄISCHE NORM

ICS 11.040.55 Supersedes EN 60601-2-28:1993


English version


Medical electrical equipment -
Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
(IEC 60601-2-28:2010)


Appareils éléctromédicaux -  Medizinische elektrische Geräte -
Partie 2-28: Exigences particulières Teil 2-28: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des gaines équipées pour diagnostic von Röntgenstrahlern für die medizinische
médical Diagnostik
(CEI 60601-2-28:2010) (IEC 60601-2-28:2010)




This European Standard was approved by CENELEC on 2010-04-01. 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 Central Secretariat 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 Central Secretariat 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels


© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-28:2010 E

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SIST EN 60601-2-28:2010
EN 60601-2-28:2010 - 2 -
Foreword
The text of document 62B/778/FDIS, future edition 2 of IEC 60601-2-28, prepared by SC 62B, Diagnostic
imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the
IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-28 on 2010-04-01.
This European Standard supersedes EN 60601-2-28:1993.
The second edition of this particular standard has been prepared to fit EN 60601-1:2006, which is
referred to as the general standard.
When the first edition was developed, mainly X-RAY TUBE ASSEMBLIES holding a glass insert were
considered and EN 60601-1:1990 was in place. While the variety of modern X-RAY TUBE ASSEMBLIES
and technologies has increased, the third edition of the general standard requires the MANUFACTURER
to perform RISK MANAGEMENT. The technical modifications versus the first edition of EN 60601-2-28
account for these changes.
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.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-01-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2013-04-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
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:

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SIST EN 60601-2-28:2010
- 3 - EN 60601-2-28:2010
– “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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-28:2010 was approved by CENELEC as a European
Standard without any modification.
__________

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SIST EN 60601-2-28:2010
EN 60601-2-28:2010 - 4 -
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replacement:

IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment

Addition:

IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots


IEC 60522 - Determination of the permanent filtration EN 60522 -
of X-ray tube assemblies


IEC 60613 2010 Electrical and loading characteristics EN 60613 2010
of X-ray tube assemblies for medical
diagnosis


IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

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SIST EN 60601-2-28:2010
- 5 - EN 60601-2-28:2010
Annex ZZ
(informative)

Coverage of Essential Requirements of EC 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 as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.

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SIST EN 60601-2-28:2010

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SIST EN 60601-2-28:2010
IEC 60601-2-28
®
Edition 2.0 2010-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE


Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential performance
of X-ray tube assemblies for medical diagnosis

Appareils électromédicaux –
Partie 2-28: Exigences particulières pour la sécurité de base et les performances
essentielles des gaines équipées pour diagnostic médical

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
R
CODE PRIX
ICS 11.040.55 ISBN 2-8318-1082-2
® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-2-28:2010
– 2 – 60601-2-28 © IEC:2010
CONTENTS
FOREWORD.3
201.1 Scope, object and related standards.5
201.2 Normative references .6
201.3 Terms and definitions .7
201.4 General requirements.7
201.5 General requirements for testing ME EQUIPMENT.7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 ME EQUIPMENT identification, marking and documents.8
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.10
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.11
201.10 Protection against unwanted and excessive radiation HAZARDS.12
201.11 Protection against excessive temperatures and other HAZARDS.12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .13
201.13 HAZARDOUS SITUATIONS and fault conditions .13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13
201.15 Construction of ME EQUIPMENT .13
201.16 ME SYSTEMS.13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.13
203 RADIATION protection in diagnostic X-RAY EQUIPMENT .13
Annexes .14
Annex AA (informative) Test of X-RAY TUBE ASSEMBLIES for pressure-related RISKS.15
Index of defined terms used in this particular standard.17

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SIST EN 60601-2-28:2010
60601-2-28 © IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis


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 60601-2-28 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1993. This edition
constitutes a technical revision.
The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the
third edition of IEC 60601-1), which is referred to as the general standard.
When the first edition was developed, mainly X-RAY TUBE ASSEMBLIES holding a glass insert
were considered and IEC 60601-1:1988 (the second edition of the general standard) was in
place. While the variety of modern X-RAY TUBE ASSEMBLIES and technologies has increased,
the third edition of the general standard requires the MANUFACTURER to perform RISK
. The technical modifications versus the first edition of IEC 60601-2-28 account
MANAGEMENT
for these changes.

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SIST EN 60601-2-28:2010
– 4 – 60601-2-28 © IEC:2010
The text of this standard is based on the following documents:
FDIS Report on voting
62B/778/FDIS 62B/784/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 amendment and the base 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.

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SIST EN 60601-2-28:2010
60601-2-28 © IEC:2010 – 5 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis



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 X-RAY
TUBE ASSEMBLIES and to components thereof:
– hereafter referred to as ME EQUIPMENT;
– intended for medical diagnosis and imaging.
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.
NOTE This International Standard is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE
ASSEMBLIES and X-RAY TUBE HEADS.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for X-RAY TUBE ASSEMBLIES for medical diagnosis.
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.
IEC 60601-1-3 applies as modified in Clause 203. IEC 60601-1-2, IEC 60601-1-6,
IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-10 and IEC 60601-1-11 do not apply. All other
published collateral standards in the IEC 60601-1 series apply as published.
NOTE 101 IEC 60601-1-2 does not apply because RISKS for the X-RAY TUBE ASSEMBLY outside the system may
only be indicative of RISKS for the system due to the difference in electromagnetic environment.
NOTE 102 IEC 60601-1-6 and IEC 60601-1-8 do not apply because X-RAY TUBE ASSEMBLIES are not operated as a
stand-alone device.
NOTE 103 X-RAY TUBE ASSEMBLIES are not in the scope of IEC 60601-1-10 and IEC 60601-1-11.
—————————
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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SIST EN 60601-2-28:2010
– 6 – 60601-2-28 © IEC:2010
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.
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 60601-1-2 collateral standard,
203.4 in this particular standard addresses the content of Clause 4 of the 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:
Replacement:

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SIST EN 60601-2-28:2010
60601-2-28 © IEC:2010 – 7 –
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic
X-ray equipment
Addition:
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis –
Characteristics of focal spots
IEC 60522, Determination of the permanent filtration of X-ray tube assemblies
IEC 60613:2010, Electrical and loading characteristics of X-ray tube assemblies for medical
diagnosis
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in the general standard,
applicable collateral standards, IEC 60613:2010 and IEC/TR 60788:2004 apply.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
SSENTIAL PERFORMANCE
201.4.3 E
Addition:
The entity X-RAY TUBE ASSEMBLY itself does not have ESSENTIAL PERFORMANCE. Whether
characteristics of an X-RAY TUBE ASSEMBLY must be considered ESSENTIAL PERFORMANCE,
depends on the X-ray system and HIGH-VOLTAGE GENERATOR characteristics combined with the
X-RAY TUBE ASSEMBLY.
201.4.11 Power input
Subclause 4.11 of the general standard does not apply.
201.5 General requirements for testing ME EQUIPMENT
Clause 5 of the general standard applies except as follows.
201.5.7 Humidity preconditioning treatment
Addition:
For those X-RAY TUBE ASSEMBLIES that are to be used only in controlled environments, as to be
SPECIFIED in the ACCOMPANYING DOCUMENTS, no humidity preconditioning is required.
The ACCOMPANYING DOCUMENTS shall include the time period that the room environmental
operating conditions must be maintained prior to applying power to the X-RAY TUBE ASSEMBLY.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.

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SIST EN 60601-2-28:2010
– 8 – 60601-2-28 © IEC:2010
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
Clause 6 of the general standard applies, except as follows:
201.6.2 Protection against electric shock
Addition:
X-RAY TUBE ASSEMBLIES shall be classified as CLASS I equipment.
201.7 ME EQUIPMENT identification, marking and documents
Clause 7 of the general standard applies, except as follows:
201.7.1 General
201.7.1.1 USABILITY of the identification, marking and documents
Subclause 7.1.1 of the general standard does not apply.
NOTE The user interface is part of the X-RAY EQUIPMENT, but not of the X-RAY TUBE ASSEMBLY.
201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.2.5 ME EQUIPMENT intended to receive power from other equipment
Addition:
The marking required in subclause 7.2.5 of the general standard may be replaced by a
description of the interface to the power supply in the ACCOMPANYING DOCUMENTS as required
in 201.7.9.3.101.
201.7.2.11 Mode of operation
Subclause 7.2.11 of the general standard does not apply.
NOTE X-RAY TUBE ASSEMBLIES are not operated as a stand alone device.
Additional subclauses:
201.7.2.101 Marking of X-RAY TUBES
The markings on the X-RAY TUBE shall remain readable when the X-RAY TUBE is dismantled
from the X-RAY TUBE HOUSING after a period of NORMAL USE.
The markings shall enable individual products, series or types to be correlated with their
ACCOMPANYING DOCUMENTS.
RAY TUBES shall be provided with the following markings:
X-
• name or trademark of the MANUFACTURER;
• MODEL OR TYPE REFERENCE;
• individual identification.
The above markings may be given in the form of a combined designation explained in the
ACCOMPANYING DOCUMENTS.

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SIST EN 60601-2-28:2010
60601-2-28 © IEC:2010 – 9 –
201.7.2.102 Marking on the outside of X-RAY TUBE ASSEMBLIES
X-RAY TUBE ASSEMBLIES shall be provided with the following markings:
MANUFACTURER;
• name or trademark of the
• MODEL OR TYPE REFERENCE;
• individual identification;
• NOMINAL X-RAY TUBE VOLTAGE for which the X-RAY TUBE ASSEMBLY is designed;
• indication of the polarity of the cable receptacles;
• PERMANENT FILTRATION according to IEC 60522;
• NOMINAL FOCAL SPOT VALUE(S) according to IEC 60336.
NOTE The requirement to mark the position of FOCAL SPOTs on the X-RAY TUBE ASSE
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