IEC 60601-2-28:2010
(Main)Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
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 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. 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.
Appareils électromédicaux - Partie 2-28: Exigences particulières pour la sécurite de base et les performances essentielles des gaines équipées pour diagnostic médical
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.
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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
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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
– 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
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,
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agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-28 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.
– 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.
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.
– 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:
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.
– 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.
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:
– 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:
60601-2-28 © IEC:2010 – 11 –
201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
Addition:
NOTE Measurements on the X-RAY TUBE ASSEMBLY outside the system are only indicative of measurements on the
system, due to the difference in electrical connections.
201.8.8 Insulation
201.8.8.3 Dielectric strength
Addition:
For X-RAY TUBE ASSEMBLIES, Subclause 201.8.8.3 from particular standards pertaining to
ME EQUIPMENT for which the X-RAY TUBE ASSEMBLY is intended shall be applied.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
Clause 9 of the general standard applies, except as follows:
201.9.5 Expelled parts HAZARD
201.9.5.1 Protective means
Addition:
201.9.5.1.101 Protective housing
The kinetic energy stored in the rotating system of the ANODE, and the high temperatures
occurring during operation, are potential causes of expelled parts.
201.9.5.2 Cathode ray tubes
Subclause 9.5.2 of the general standard does not apply.
NOTE An X-RAY TUBE is not a CATHODE ray tube.
201.9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure
201.9.7.1 General
Addition:
NOTE Pressure can be caused by excessive energy inputs and certain malfunctions, including those resulting in
disintegration of the X-RAY TUBE.
The thermal energy stored in the rotating system of the ANODE, and high temperatures occurring during operation
coupled with a malfunction, are potential sources of excessive pressure and in consequence of leakage of the
insulating medium.
201.9.7.5 Pressure vessels
Addition:
NOTE Pressure in the X-RAY TUBE ASSEMBLY should not result in an unacceptable RISK, when incorporated in the
system. X-RAY TUBE ASSEMBLY MANUFACTURERS may test for pressure-related RISKS, but, as protective means may
also be provided by the system, and as the application of the X-RAY TUBE ASSEMBLY is system-dependent, these
test results are only indicative of the RISK at system level. Considerations on the tests which may be applied are
given in Annex AA.
– 12 – 60601-2-28 © IEC:2010
201.9.7.7 Pressure-relief device
Addition:
X-RAY TUBE ASSEMBLIES shall either comply with items a) to g) of subclause 9.7.7 of the
general standard, or be provided with other means to respond to one or more critical levels of
thermal energy or pressure, for example by sensing predetermined levels of temperature,
volume or pressure of the insulating medium inside the X-RAY TUBE HOUSING.
If other means than a PRESSURE RELIEF DEVICE are used, then the following shall be provided:
– a SPECIFIED signal for the ME EQUIPMENT for which the X-RAY TUBE ASSEMBLY is intended,
when a critical level has been reached
– a statement in the ACCOMPANYING DOCUMENTS addressing the RISK associated with this
critical level.
Compliance is checked by inspection and functional test.
Replacement:
h) if a pressure relief device is used, the number of cycles to be tested is as follows:
1) for a single-event pressure-relief device (e.g., bursting disk): this undergoes a single
test by definition;
2) for a pressure-relief device that resets, but that signals the tube as having failed and
requiring replacement (either tube or system SW or HW prohibits further exposures):
the number of test cycles is 5;
3) for a pressure-relief device that resets and the tube can continue to be used: the
number of test cycles is 1 000.
NOTE The modified requirement in item h) (1 000 instead of 100 000 cycles) is reasonable because in practicable
use even a few actuations of the pressure relief device would result in subsequent replacement of the X-RAY TUBE
ASSEMBLY.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies.
201.11 Protection against excessive temperatures and other HAZARDS
Clause 11 of the general standard applies except as follows:
201.11.1 Excessive temperatures in ME EQUIPMENT
201.11.1.1 Maximum temperature during NORMAL USE
Addition:
The limitations of temperatures do not apply inside the protective housing of the X-RAY TUBE
ASSEMBLY.
The temperature of the painted surface of an X-RAY TUBE ASSEMBLY which can unintentionally
be touched during INTENDED USE may exceed the values in Table 23 of the general standard
but shall not exceed 85 °C.
NOTE 1 Table 23 of IEC 60601-1:2005 does not cover painted metal surfaces. However, reference [38] in
IEC 60601-1:2005: EN 563, "Safety of machinery – Temperatures of touchable surfaces – Ergonomic data to
60601-2-28 © IEC:2010 – 13 –
establish temperature limit values for hot surfaces", indicates a maximum temperature of 85 °C for a painted metal
surface and for a typical maximum contact period of 1 second.
In NORMAL USE Table 23 does not apply for X-RAY TUBE ASSEMBLIES protected by GUARDS.
NOTE 2 Service personnel are aware of the risks involved when a GUARD is removed.
201.12 Accuracy of controls and instruments and protection against hazardous
outputs
Clause 12 of the general standard applies.
201.13 HAZARDOUS SITUATIONS and fault conditions
Clause 13 of the general standard applies.
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
Clause 14 of the general standard applies.
201.15 Construction of ME EQUIPMENT
Clause 15 of the general standard applies.
201.16 ME SYSTEMS
Clause 16 of the general standard applies.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Clause 17 of the general standard applies except as follows:
Replacement:
The MANUFACTURER shall address In the RISK MANAGEMENT PROCESS the RISKS associated with:
– the electromagnetic phenomena existing at the locations where the X-RAY TUBE ASSEMBLY
is intended to be used as indicated in the ACCOMPANYING DOCUMENTS; and
– the introduction by the X-RAY TUBE ASSEMBLY of electromagnetic phenomena into the
environment that might degrade the performance of other devices, electrical equipment
and systems.
NOTE 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.
Compliance is checked by inspection of the RISK MANAGEMENT FILE.
203 RADIATION protection in diagnostic X-RAY EQUIPMENT
IEC 60601-1-3:2008 applies, except as follows:
– 14 – 60601-2-28 © IEC:2010
203.4 General requirements
203.4.1 Statement of compliance
Replacement:
If, for X-RAY TUBE ASSEMBLIES, compliance with this standard is to be stated, the statement
shall be made in the following form:
X-RAY TUBE ASSEMBLY . *), IEC 60601-2-28:2010
* MODEL OR TYPE REFERENCE
If means other than those described in this standard have been used to achieve equivalent
safety, the variations shall be mentioned in the ACCOMPANYING DOCUMENTS when stating
compliance with this standard.
Annexes
The annexes of the general standard apply.
60601-2-28 © IEC:2010 – 15 –
Annex AA
(informative)
Test of X-RAY TUBE ASSEMBLIES for pressure-related RISKS
AA.1 Overview
The evaluation of pressure related RISKS determines whether or not testing is required. If
testing is required, this particular standard does not prescribe a mandatory, generally-valid
test for pressure, implosion or explosion, because there are too many different types of X-RAY
TUBES, X-RAY TUBE ASSEMBLIES, X-RAY SOURCE ASSEMBLIES and X-RAY EQUIPMENT
configurations, with – consequently – different test setups. Instead, the tests mentioned in this
annex are for information only. As the tests are based on long-standing practice and
experience, they may nevertheless often be considered representative for the situation to be
analysed.
ANUFACTURERs can choose the test mentioned in this annex, as long as the RISK
M
MANAGEMENT FILE states and reasons, that the test performed is appropriate.
AA.2 General considerations
Whether a test is appropriate depends on many conditions. These conditions must be
mentioned with the test performed, with a reasoning (calculations, experience, …) as to the
appropriateness. All known weak spots of the X-RAY TUBE HOUSING shall be subject to testing,
i.e. they may not be modified for the test (more than one test set-up may be necessary to fulfil
this requirement).
These conditions are (attention: not an exhaustive list):
a) temperature of the ANODE;
b) ANODE SPEED;
c) type of medium enveloping the X-RAY TUBE (oil, water, …);
d) temperature of medium enveloping the X-RAY TUBE;
e) electrical condition of the X-RAY TUBE
• HIGH VOLTAGE (on or off, value of voltage, .);
• filament supply (on or off, value of current, .);
• rotor-unit energized or not;
f) weak spots of the X-RAY TUBE HOUSING (weakest spot can be the RADIATION APERTURE, or
mechanical joints, …);
g) parts to be contained (fractured ANODE, medium enveloping the X-RAY TUBE, .);
h) X-RAY EQUIPMENT configuration (BEAM LIMITING DEVICE, protective covers, location of the X-
RAY TUBE ASSEMBLY (under table, overhead, in a CT-gantry,.)).
AA.3 General start conditions for the typical tests
Out of the list of start conditions below, it will be clear that safety devices (e.g. temperature-
cut-out) must be made in-active for certain test conditions or combinations of test conditions.
a) The X-RAY TUBE has been loaded such that the maximum permitted temperature for the
medium enveloping the X-RAY TUBE is attained and maintained for at least 10 min.
b) The ANODE of the ROTATING ANODE X-RAY TUBE rotates at the maximum SPECIFIED ANODE
SPEED.
– 16 – 60601-2-28 © IEC:2010
c) HIGH VOLTAGE is on.
d) Filament is energised.
e) Rotor unit is energised.
f) The X-RAY TUBE shall then be further loaded for 2 min at the corresponding highest
SPECIFIED ANODE INPUT POWER.
g) Disintegration of the X-RAY TUBE is then induced.
AA.4 Disintegration inducement of X-RAY TUBES
Preferably the disintegration of the ENVELOPE of the X-RAY TUBE is induced by disintegration of
the ANODE (e.g. by a higher than maximum SPECIFIED ANODE SPEED), as this situation presents
often the highest RISK on expelled parts. Alternatively the ENVELOPE of the X-RAY TUBE is
disintegrated by, for example, mechanical impact on a part forming part of the ENVELOPE of
the X-RAY TUBE.
AA.5 Pass/fail criteria
Whether expelled parts or fragments, or the escape of insulating/cooling medium poses a
RISK, depends on the system-configuration the X-RAY TUBE ASSEMBLY makes part of.
60601-2-28 © IEC:2010 – 17 –
Index of defined terms used in this particular standard
NOTE The definitions used in this particular standard may be looked up at .
ACCOMPANYING DOCUMENTS .IEC 60601-1:2005, 3.4
ANODE. IEC/TR 60788:2004, rm-22-06
ANODE INPUT POWER .IEC 60613:2010, 3.13
ANODE SPEED . IEC/TR 60788:2004, rm-36-35
BASIC SAFETY .IEC 60601-1:2005, 3.10
BEAM LIMITING DEVICE . IEC/TR 60788:2004, rm-37-28
CATHODE . IEC/TR 60788:2004, rm-22-05
CATHODE EMISSION CHARACTERISTIC .IEC 60613:2010, 3.4
CLASS I .IEC 60601-1:2005, 3.13
CONTINUOUS ANODE INPUT POWER.IEC 60613:2010, 3.19
ENVELOPE.IEC 60613:2010, 3.5
ENVELOPE CURRENT .IEC 60613:2010, 3.6
ENVELOPE VOLTAGE.IEC 60613:2010, 3.7
ESSENTIAL PERFORMANCE .IEC 60601-1:2005, 3.27
FILTRATION .IEC 60601-1-3:2008, 3.24
FOCAL SPOT . IEC/TR 60788:2004, rm-20-13s
HAZARD .IEC 60601-1:2005, 3.39
HAZARDOUS SITUATION .IEC 60601-1:2005, 3.40
HIGH VOLTAGE.IEC 60601-1:2005, 3.41
HIGH-VOLTAGE GENERATOR . IEC/TR 60788:2004, rm-21-01
INTENDED USE .IEC 60601-1:2005, 3.44
LEAKAGE CURRENT .IEC 60601-1:2005, 3.47
LOADING .IEC 60601-1-3:2008, 3.34
MANUFACTURER .IEC 60601-1:2005, 3.55
MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) .IEC 60601-1:2005, 3.63
MEDICAL ELECTRICAL SYSTEM (ME SYSTEM) .IEC 60601-1:2005, 3.64
MODEL OR TYPE REFERENCE.IEC 60601-1:2005, 3.66
NOMINAL CONTINUOUS INPUT POWER .IEC 60613:2010, 3.18
NOMINAL CT ANODE INPUT POWER .IEC 60613:2010, 3.16
NOMINAL CT SCAN POWER INDEX .IEC 60613:2010, 3.21
NOMINAL FOCAL SPOT VALUE . IEC/TR 60788:2004, rm-20-14
NOMINAL RADIOGRAPHIC ANODE INPUT POWER.IEC 60613:2010, 3.15
NOMINAL X-RAY TUBE VOLTAGE.IEC 60601-1-3:2008, 3.42
NORMAL USE .IEC 60601-1:2005, 3.71
PATIENT AUXILIARY CURRENT .
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