IEC 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

IEC 60601-2-28:2010

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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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– 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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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-
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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
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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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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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– 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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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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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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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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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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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 ASSEMBLY has not been taken over
from the first edition (1993) of this particular standard because this method is only indicative versus the drawing as
required in 201.7.9.3.101 n).
201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts
201.7.3.2 HIGH VOLTAGE parts
Subclause 7.3.2 of the general standard does not apply.
NOTE While the inside of an X-RAY TUBE ASSEMBLY is being worked on, the assembly is normally not energized.
Even if the assembly is energized, only trained service personnel is allowed to perform the work, so safe operation
is assured.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.2 Instructions for use
201.7.9.2.2 Warning and safety notices
Replacement of the second paragraph of this subclause:
For X-RAY TUBE ASSEMBLIES, the ACCOMPANYING DOCUMENTS shall include a warning statement
to the effect: “WARNING: To avoid the risk of electric shock, this equipment must only be
connected to a supply with protective earth.”
NOTE X-RAY TUBE ASSEMBLIES normally do not connect to a SUPPLY MAINS.
Additional subclause:
201.7.9.2.101 Instructions for use of X-RAY TUBE ASSEMBLIES
The instructions for use of an X-RAY TUBE ASSEMBLY shall state the following data as
appropriate to the INTENDED USE:
a) SINGLE LOAD RATING;
b) SERIAL LOAD RATING;
c) NOMINAL RADIOGRAPHIC ANODE INPUT POWER according to IEC 60613:2010;
d) NOMINAL CT ANODE INPUT POWER according to IEC 60613:2010;
e) NOMINAL CT SCAN POWER INDEX according to IEC 60613:2010.
201.7.9.3 Technical description
Additional subclause:

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– 10 – 60601-2-28 © IEC:2010
201.7.9.3.101 Technical description of X-RAY TUBE ASSEMBLIES
The technical descriptions of X-RAY TUBE ASSEMBLIES shall specify the following data:
a) the identity of the TARGET material(s) that characterize the RADIATION SPECTRUM;
b) the REFERENCE AXIS;
c) the TARGET ANGLE(S);
d) NOMINAL FOCAL SPOT VALUE(S) according to IEC 60336;
e) PERMANENT FILTRATION according to IEC 60522;
f) QUALITY EQUIVALENT FILTRATION of parts which are or could become ADDED FILTERS and
method of mounting/dismounting such, if applicable;
NOTE 1 The preceding two FILTRATION requirements cover the requirements specified in 7.3 of
IEC 60601-1-3:2008.
g) NOMINAL X-RAY TUBE VOLTAGE;
h) data concerning the HIGH VOLTAGE required from the HIGH-VOLTAGE GENERATOR or the type
designation of suitable supply equipment;
i) type-designation or specification of the HIGH VOLTAGE connectors;
j) requirements for the HIGH-VOLTAGE GENERATOR, for supplying the filament(s), for rotating
the ANODE (when appropriate) and for auxiliary equipment (such as cooling unit, or a fan),
appropriate for the safe application of the X-RAY TUBE ASSEMBLY as defined in the RISK
MANAGEMENT FILE;
k) CATHODE EMISSION CHARACTERISTIC;
NOTE 2 For the 4 preceding items, for an X-RAY TUBE ASSEMBLY which comes built in into an X-ray system with
HIGH-VOLTAGE GENERATOR, normally no data are required. If the X-RAY TUBE ASSEMBLY is sold to an OEM-system
MANUFACTURER, then normally an elaborate interface specification will be included.
l) ENVELOPE VOLTAGE according to IEC 60613:2010, if applicable;
m) ENVELOPE CURRENT according to IEC 60613:2010, if applicable;
n) principal dimensions and interfaces in the form of a drawing; this drawing also shows the
REFERENCE AXIS, the position and the accuracy of the position of the FOCAL SPOT(s);
o) mass with and without additional components;
p) CONTINUOUS ANODE INPUT POWER according to IEC 60613:2010 at the highest value of
NOMINAL X-RAY TUBE VOLTAGE under any operating condition;
q) classifications according to Clause 6 of the general standard;
r) polarity of high-voltage connections;
s) limits for the conditions for transport and storage;
t) precautions to be observed before the first LOADING upon completion of the installation of
an X-RAY TUBE ASSEMBLY, and special procedures for conditioning the X-RAY TUBE, if
appropriate;
u) NOMINAL CONTINUOUS INPUT POWER according to IEC 60613:2010.
NOTE 3 As equipment (example: BEAM LIMITING DEVICE) which is - electrically or mechanically - attached to the
X-RAY TUBE ASSEMBLY can affect compliance of the X-RAY TUBE ASSEMBLY with this standard, the technical
description of the X-RAY TUBE ASSEMBLY in this chapter lists those specifications and interfaces which might affect
compliance of the X-RAY TUBE ASSEMBLY. This is not an exhaustive list of technical descriptions, as such equipment
attached to the X-RAY TUBE ASSEMBLY might pose additional requirements on interfacing.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
Clause 8 of the general standard applies, except as follows:

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