IEC 60601-2-28:2017
(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 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is interpreted as X-ray tube assemblies in this particular standard. 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. The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred to as the general standard. Apart from the changes related to the amendment of IEC 60601-1, changes related to technical improvements are also included.
Appareils électromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base et les performances essentielles des gaines équipées pour diagnostic médical
L'IEC 60601-2-28:2017 s’applique à la sécurité de base et aux performances essentielles des gaines équipées et de leurs composants, destinés au diagnostic médical et à l’imagerie. Lorsque la norme générale IEC 60601-1 et la norme collatérale IEC 60601-1-3, font référence aux appareils EM, cela doit être interprété comme une référence aux gaines equipées dans la présente norme particulière. Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils EM ou uniquement aux systèmes EM, son titre et son contenu l’indiquent. Si cela n’est pas le cas, l’article ou le paragraphe s’applique à la fois aux appareils EM et aux systèmes EM, selon le cas. La troisième édition de la présente norme particulière a été établie pour correspondre à l’IEC 60601-1:2005 et à l'IEC 60601-1:2005/AMD1:2012 (troisième édition amendée de l’IEC 60601-1), qui est désignée comme la norme générale. Outre les modifications relatives à l’amendement de l’IEC 60601-1, les modifications relatives aux améliorations techniques sont également incluses.
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IEC 60601-2-28 ®
Edition 3.0 2017-06
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential performance
of X-ray tube assemblies for medical diagnosis
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IEC 60601-2-28 ®
Edition 3.0 2017-06
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55 ISBN 978-2-8322-4473-9
– 2 – IEC 60601-2-28:2017 RLV IEC 2017
CONTENTS
FOREWORD . 3
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 ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive RADIATION HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 18
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 19
201.15 Construction of ME EQUIPMENT . 19
201.16 ME SYSTEMS . 19
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 19
203 RADIATION protection in diagnostic X-RAY EQUIPMENT. 20
Annexes . 21
Annex AA (informative) Test of X-RAY TUBE ASSEMBLIES for pressure-related RISKS
expelled parts-related and/or tube implosion-related RISKS . 21
Bibliography . 22
Index of defined terms used in this particular standard . 24
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
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patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 60601-2-28:2017 RLV IEC 2017
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 third edition cancels and replaces the second edition published in 2010. This edition
constitutes a technical revision.
The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred
to as the general standard. Apart from the changes related to the amendment of IEC 60601-1,
changes related to technical improvements are also included.
The text of this standard is based on the following documents:
FDIS Report on voting
62B/1040/FDIS 62B/1051/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 Clause 7 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.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.
– 6 – IEC 60601-2-28:2017 RLV IEC 2017
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
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 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.
Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to
ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. 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 document 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 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 apply 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, IEC 60601-1-
11 and IEC 60601-1-12 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.
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
NOTE 103 X-RAY TUBE ASSEMBLIES are not in the scope of IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12.
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 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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 3.147, additional definitions in this document 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 document” 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
NOTE Informative references are listed in the Bibliography.
– 8 – IEC 60601-2-28:2017 RLV IEC 2017
Clause 2 of the general standard applies, except as follows:
Replacement:
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
IEC 60601-1-3:2008/AMD1:2013
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
Clause 3 of the general standard applies, except as follows:
For the purposes of this document, the terms and definitions given in the general standard,
applicable collateral standards, IEC 60613:2010, IEC 60522, IEC 60336 and
IEC TR 60788:2004 apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 24.
201.3.71
NORMAL USE
Addition:
Note 1 to entry: Where used in this document, the defined term NORMAL USE is understood to only apply to the X-
RAY TUBE ASSEMBLY as it operates in X-RAY EQUIPMENT.
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 shall be considered ESSENTIAL PERFORMANCE,
depends on the X-ray system and HIGH-VOLTAGE GENERATOR characteristics combined with the
X-RAY TUBE ASSEMBLY.
201.4.4 EXPECTED SERVICE LIFE
Addition:
EXPECTED SERVICE LIFE may also be based on metrics related to use.
NOTE 101 Examples of use: number of scans, radiographs, PATIENT exams.
NOTE 102 X-RAY TUBE ASSEMBLIES are consumables, i.e. their use leads ultimately to their replacement. By
design, an X-RAY TUBE ASSEMBLY maintains BASIC SAFETY throughout its life and its replacement.
NOTE 103 EXPECTED SERVICE LIFE typifies the estimated replacement times of a population of X-RAY TUBE
ASSEMBLIES. EXPECTED SERVICE LIFE is based on a statistical analysis of the survival of e.g. 5 % of the X-RAY TUBE
ASSEMBLIES in the population.
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:
201.5.5 Supply voltages, type of current, nature of supply, frequency
Addition to paragraph 5.5 f):
A HIGH-VOLTAGE GENERATOR which is not SPECIFIED in the ACCOMPANYING DOCUMENTS can be
used if the characteristics which are essential for a given test are equivalent to the SPECIFIED
HIGH-VOLTAGE GENERATOR.
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.
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
201.5.9.2 ACCESSIBLE PARTS
Subclause 5.9.2 of the general standard does not apply.
NOTE Parts accessibility of the X-RAY TUBE ASSEMBLY will necessarily be evaluated as integrated in specific X-RAY
EQUIPMENT.
– 10 – IEC 60601-2-28:2017 RLV IEC 2017
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
201.7.2.2 Identification
Replacement of the first paragraph by:
The X-RAY TUBE ASSEMBLY shall be marked with:
– the name or trademark and address of the MANUFACTURER;
– a MODEL OR TYPE REFERENCE;
– an individual identification;
– the date of manufacture.
NOTE 101 See ISO 15223-1 for symbols for MANUFACTURER, serial number, lot or batch, year of manufacture, and
use by date.
NOTE 102 See also 201.7.2.102.
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.
Subclause 7.2.5 of the general standard does not apply.
NOTE For applicable requirements, see 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.
201.7.2.14 HIGH VOLTAGE TERMINAL DEVICES
Replacement:
HIGH VOLTAGE cable connections between the X-RAY TUBE ASSEMBLY and the HIGH-VOLTAGE
GENERATOR accessible in NORMAL USE shall be marked with symbol IEC 60417-5036 (2002-10)
(see Table D.1, symbol 24) unless a tool is required for removal of the cable connection.
201.7.2.15 Cooling conditions
Addition:
Marking of cooling conditions is not required if the cooling unit and the X-RAY TUBE ASSEMBLY
have been designed for compatibility.
NOTE A cooling unit is a standalone device or integral part of the X-RAY TUBE ASSEMBLY which provides increased
cooling capability of the X-RAY TUBE ASSEMBLY.
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
RAY TUBE HOUSING after a period of NORMAL USE.
from the X-
The markings shall enable individual products, series or types to be correlated with their
ACCOMPANYING DOCUMENTS.
X-RAY TUBES shall be provided with the following markings:
• 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.
201.7.2.102 Marking on the outside of X-RAY TUBE ASSEMBLIES
X-RAY TUBE ASSEMBLIES shall be provided with the following markings:
• name or trademark of the MANUFACTURER;
• 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.
• if there is more than one HIGH VOLTAGE cable receptacle, indication of the polarity of the
HIGH VOLTAGE cable receptacles;
– 12 – IEC 60601-2-28:2017 RLV IEC 2017
• FOCAL SPOT size(s). If the FOCAL SPOT size(s) are in the range of NOMINAL FOCAL SPOT
VALUES in IEC 60336, then mark the FOCAL SPOT size(s) as 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). See further 201.7.2.2 and 203.7.3.
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 are allowed to perform the work, so safe
operation is assured.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Replacement:
ME EQUIPMENT shall be accompanied by documents containing at least the instructions for use
and a technical description. The ACCOMPANYING DOCUMENTS shall be regarded as a part of the
ME EQUIPMENT.
The ACCOMPANYING DOCUMENTS may be provided with the X-RAY TUBE ASSEMBLY, or they may
be integrated into the ACCOMPANYING DOCUMENTS of any ME SYSTEM for which the X-RAY TUBE
ASSEMBLY is compatible.
If an X-RAY TUBE ASSEMBLY is intended to receive its power from other equipment in an
ME SYSTEM, or otherwise puts special requirements on the supporting ME SYSTEM, the
ACCOMPANYING DOCUMENTS shall sufficiently specify such other equipment to ensure
compliance with the requirements of this document.
NOTE 101 The purpose of the ACCOMPANYING DOCUMENTS is to promote the safe use of the ME EQUIPMENT during
its EXPECTED SERVICE LIFE.
The ACCOMPANYING DOCUMENTS shall identify the ME EQUIPMENT by including, as applicable,
the following:
– name or trade-name of the MANUFACTURER and contact information to which the
RESPONSIBLE ORGANIZATION can refer;
– MODEL OR TYPE REFERENCE.
NOTE 102 Contact information can be e.g. a telephone number, email address, address or website, where the
MANUFACTURER can be contacted.
ACCOMPANYING DOCUMENTS may be provided electronically, e.g. a file on an electronic medium.
If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT FILE shall
include consideration on which information also needs to be provided as hard copy or as
markings on the ME EQUIPMENT.
EXAMPLE Information to cover emergency operation.
NOTE 103 ACCOMPANYING DOCUMENTS provided electronically might not be acceptable in all jurisdictions.
NOTE 104 Instead of the USABILITY ENGINEERING PROCESS (IEC 60601-1-6 is not applicable for an X-RAX TUBE
ASSEMBLY), the RISK MANAGEMENT PROCESS (based on ISO 14971) is the carrier of the considerations. ISO
14971:2007, 4.2 (INTENDED USE) and C.2.29 (human factors) cover the USABILITY aspects of X-RAY TUBE ASSEMBLIES
sufficiently.
The ACCOMPANYING DOCUMENTS shall specify special skills, training and knowledge required of
the intended OPERATOR or the RESPONSIBLE ORGANIZATION and restrictions on locations or
environments in which the ME EQUIPMENT can be used.
The ACCOMPANYING DOCUMENTS shall be written at a level consistent with the education,
training and any special needs of the person(s) for whom they are intended.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and, when provided
electronically, by inspection of the RISK MANAGEMENT FILE.
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 101 X-RAY TUBE ASSEMBLIES normally do not connect to a SUPPLY MAINS.
201.7.9.2.3 ME EQUIPMENT SPECIFIED for connection to a separate power supply
Subclause 7.9.2.3 of the general standard does not apply.
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Subclause 7.9.2.14 of the general standard applies, except as follows:
– the second paragraph;
– the Note.
201.7.9.2.17 ME EQUIPMENT emitting RADIATION
Subclause 7.9.2.17 of the general standard does not apply.
NOTE RADIATION intensity and distribution are governed at system level. Nature and type of the RADIATION are
SPECIFIED in 201.7.9.3.101 a).
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.
– 14 – IEC 60601-2-28:2017 RLV IEC 2017
201.7.9.3 Technical description
Additional subclause:
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) FOCAL SPOT size(s);
If the FOCAL SPOT size(s) are in the range of NOMINAL FOCAL SPOT VALUES in IEC 60336,
then state the FOCAL SPOT size(s) as NOMINAL FOCAL SPOT VALUE(S) according to
IEC 60336;
e) PERMANENT FILTRATION according to IEC 60522 or the thickness(es) of the material(s)
concerned, together with its/their chemical symbol(s);
f) QUALITY EQUIVALENT FILTRATION of parts which are or could become ADDED FILTERS and
method of mounting/dismounting such, if applicable;
NOTE 101 The preceding two FILTRATION requirements cover 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 for cooling unit, or a
fan purposes), appropriate for the safe application of the X-RAY TUBE ASSEMBLY as defined
in the RISK MANAGEMENT FILE;
k) CATHODE EMISSION CHARACTERISTIC;
NOTE 102 For the 4 preceding items, (h) to k)), 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) if applicable, any requirements that shall be fulfilled prior to applying power to the X-RAY
TUBE ASSEMBLY, e.g. the time period that the room environmental operating conditions shall
be maintained, precautions to be observed before the first LOADING upon completion of the
installation of an X-RAY TUBE ASSEMBLY, special procedures for conditioning the X-RAY
TUBE, if appropriate;
u) NOMINAL CONTINUOUS INPUT POWER according to IEC 60613:2010.
NOTE 103 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 document, the technical
description of the X-RAY TUBE ASSEMBLY in this clause 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:
201.8.2 Requirements related to power sources
201.8.2.1 Connection to a separate power source
Subclause 8.2.1 of the general standard does not apply.
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.
Amendment to Table 6 of the general standard:
For PEAK WORKING VOLTAGES U >14 140 V, the HIGH VOLTAGE circuits of the X-RAY TUBE
ASSEMBLY are tested at 110 % of the NOMINAL X-RAY TUBE VOLTAGE of the X-RAY TUBE ASSEMBLY,
where the voltage is raised over a period of 10 s or less, and is then maintained for 3 min.
201.8.9 CREEPAGE DISTANCES and AIR CLEARANCES
201.8.9.3 Spaces filled by insulating compound
Addition:
Subclause 8.9.3 is not applicable for testing HIGH VOLTAGE circuits of X-RAY TUBE ASSEMBLIES.
NOTE 201.8.8.3 describes HIGH VOLTAGE testing of X-RAY TUBE ASSEMBLIES.
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:
– 16 – IEC 60601-2-28:2017 RLV IEC 2017
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.
RISK ANALYSIS in the RISK MANAGEMENT FILE shall include the criteria for expelled parts or liquid
spilled that would result in an unacceptable RISK.
NOTE The kinetic and thermal energy stored in the rotating system of the ANODE, coupled with a malfunction, are
potential sources of disintegration of the X-RAY TUBE, and in consequence, RISKS of parts being expelled. X-RAY
TUBE ASSEMBLY MANUFACTURERS can test for such RISKS, but, as protective means can also be provided by the ME
SYSTEM, and as the application of the X-RAY TUBE ASSEMBLY is system-dependent, these test results are only
indicative of the RISKS at the system level. Considerations regarding the tests which can be applied for RISK
MANAGEMENT purposes are given in Annex AA.
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:
An X-RAY TUBE ASSEMBLY is not a pressure vessel. However, 9.7.5 regarding pressure vessels
may be applied.
RISK ANALYSIS in the RISK MANAGEMENT FILE shall include the criteria for liquid spilled or other
consequences that would result in an unacceptable RISK.
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. X-RAY TUBE ASSEMBLY MANUFACTURERS may can test for
pressure-related RISKS, but, as protective means may can also be provided by the ME SYSTEM, and as the
application of the X-RAY TUBE ASSEMBLY is system-dependent, these test results are only indicative of the RISKS at
the system level. Considerations regarding the tests which may can be applied for RISK MANAGEMENT purposes are
given in Annex AA.
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.
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.
Replacement of item h) and of the compliance statement:
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 practice even a few actuations of the pressure-relief device would result in subsequent replacement of the X-
RAY TUBE ASSEMBLY.
Compliance is checked by inspection, and where necessary, by functional test.
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:
ME EQUIPMENT
201.11.1 Excessive temperatures in
Addition:
NOTE According to 4.6 of the general standard, the RISK MANAGEMENT process can determine that the X-RAY TUBE
ASSEMBLY is subject to the requirements for TYPE B APPLIED PARTS.
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
INTENDED USE may exceed the values in Table 23 of the general standard
be touched during
but shall not exceed 85 °C.
NOTE 101 Table 23 of the general standard does not cover painted metal surfaces. However, reference [38] in
the general standard: EN 563, indicates a maximum temperature of 85 °C for a painted metal surface and for a
typical maximum contact period of 1 second. EN 563 has been withdrawn; It has been replaced by ISO 13732-1.
For the temperature considerations above, the same conclusion holds.
In NORMAL USE Table 23 does not apply for X-RAY TUBE ASSEMBLIES protected by GUARDS.
NOTE 102 Service personnel are aware of the RISKS involved when a GUARD is removed.
– 18 – IEC 60601-2-28:2017 RLV IEC 2017
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
In NORMAL CONDITION 201.11.1.1 applies. In SINGLE FAULT CONDITION 201.13.1.2 applies.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Subclause 11.8 of the general standard does not apply.
NOTE In case of interruption of the power to the X-RAY TUBE ASSEMBLY, it is up to the ME SYSTEM to maintain
BASIC SAFETY, ESSENTIAL PERFORMANCE and to prevent HAZARDOUS SITUATIONS; an X-RAY TUBE ASSEMBLY cannot
maintain these aspects in this case.
201.12 Accuracy of controls and instruments and protection against
hazardous outputs
Clause 12 of the general standard applies, except as follows:
201.12.2 USABILITY of ME EQUIPMENT
Subclause 12.2 of the general standard does not apply.
201.12.3 ALARM SYSTEMS
Subclause 12.3 of the general standard does not apply.
201.12.4 Protection against hazardous output
201.12.4.5 Diagnostic or therapeutic RADIATION
201.12.4.5.2 Diagnostic X-RAY EQUIPMENT
Replacement:
X-RAY TUBE ASSEMBLIES shall comply with IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013.
Compliance is checked as SPECIFIED in IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013.
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
Clause 13 of the general stan
...
IEC 60601-2-28 ®
Edition 3.0 2017-06
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 3.0 2017-06
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
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-4288-9
– 2 – IEC 60601-2-28:2017 IEC 2017
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 . 8
201. 6 Classification of ME EQUIPMENT and ME SYSTEMS . 8
201. 7 ME EQUIPMENT identification, marking and documents . 9
201. 8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201. 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 14
201. 10 Protection against unwanted and excessive RADIATION HAZARDS . 15
201. 11 Protection against excessive temperatures and other HAZARDS . 15
201. 12 Accuracy of controls and instruments and protection against hazardous
outputs . 16
201. 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 16
201. 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 17
201. 15 Construction of ME EQUIPMENT . 17
201. 16 ME SYSTEMS . 17
201. 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 17
203 RADIATION protection in diagnostic X-RAY EQUIPMENT. 18
Annexes . 20
Annex AA (informative) Test of X-RAY TUBE ASSEMBLIES for expelled parts-related
and/or tube implosion-related RISKS . 20
Bibliography . 22
Index of defined terms used in this particular standard . 23
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
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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 third edition cancels and replaces the second edition published in 2010. This edition
constitutes a technical revision.
The third edition of this particular standard has been prepared to fit IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012 (the amended third edition of IEC 60601-1), which is referred
to as the general standard. Apart from the changes related to the amendment of IEC 60601-1,
changes related to technical improvements are also included.
– 4 – IEC 60601-2-28:2017 IEC 2017
The text of this standard is based on the following documents:
FDIS Report on voting
62B/1040/FDIS 62B/1051/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 Clause 7 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.
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
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY TUBE
ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging.
Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to
ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. 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 document 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 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013 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, IEC 60601-1-
11 and IEC 60601-1-12 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, IEC 60601-1-11 and IEC 60601-1-12.
___________
The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance.
– 6 – IEC 60601-2-28:2017 IEC 2017
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 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 are 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 document 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 3.147, additional definitions in this document 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 document” 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
NOTE Informative references are listed in the Bibliography.
Clause 2 of the general standard applies, except as follows:
Replacement:
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
IEC 60601-1-3:2008/AMD1:2013
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
Clause 3 of the general standard applies, except as follows:
For the purposes of this document, the terms and definitions given in the general standard,
applicable collateral standards, IEC 60613:2010, IEC 60522, IEC 60336, and
IEC TR 60788:2004 apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
NOTE An index of defined terms is found beginning on page 24.
201.3.71
NORMAL USE
Addition:
Note 1 to entry: Where used in this document, the defined term NORMAL USE is understood to only apply to the X-
RAY TUBE ASSEMBLY as it operates in X-RAY EQUIPMENT.
201.4 General requirements
Clause 4 of the general standard applies, except as follows:
201.4.3 ESSENTIAL PERFORMANCE
Addition:
The entity X-RAY TUBE ASSEMBLY itself does not have ESSENTIAL PERFORMANCE. Whether
RAY TUBE ASSEMBLY shall be considered ESSENTIAL PERFORMANCE,
characteristics of an X-
depends on the X-ray system and HIGH-VOLTAGE GENERATOR characteristics combined with the
X-RAY TUBE ASSEMBLY.
– 8 – IEC 60601-2-28:2017 IEC 2017
201.4.4 EXPECTED SERVICE LIFE
Addition:
EXPECTED SERVICE LIFE may also be based on metrics related to use.
NOTE 101 Examples of use: number of scans, radiographs, PATIENT exams.
NOTE 102 X-RAY TUBE ASSEMBLIES are consumables, i.e. their use leads ultimately to their replacement. By
design, an X-RAY TUBE ASSEMBLY maintains BASIC SAFETY throughout its life and its replacement.
NOTE 103 EXPECTED SERVICE LIFE typifies the estimated replacement times of a population of X-RAY TUBE
ASSEMBLIES. EXPECTED SERVICE LIFE is based on a statistical analysis of the survival of e.g. 5 % of the X-RAY TUBE
ASSEMBLIES in the population.
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:
201.5.5 Supply voltages, type of current, nature of supply, frequency
Addition to paragraph 5.5 f):
A HIGH-VOLTAGE GENERATOR which is not SPECIFIED in the ACCOMPANYING DOCUMENTS can be
used if the characteristics which are essential for a given test are equivalent to the SPECIFIED
HIGH-VOLTAGE GENERATOR.
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.
201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS
201.5.9.2 ACCESSIBLE PARTS
Subclause 5.9.2 of the general standard does not apply.
NOTE Parts accessibility of the X-RAY TUBE ASSEMBLY will necessarily be evaluated as integrated in specific X-RAY
EQUIPMENT.
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
201.7.2.2 Identification
Replacement of the first paragraph by:
The X-RAY TUBE ASSEMBLY shall be marked with:
– the name or trademark and address of the MANUFACTURER;
– a MODEL OR TYPE REFERENCE;
– an individual identification;
– the date of manufacture.
NOTE 101 See ISO 15223-1 for symbols for MANUFACTURER, serial number, lot or batch, year of manufacture, and
use by date.
NOTE 102 See also 201.7.2.102.
201.7.2.5 ME EQUIPMENT intended to receive power from other equipment
Subclause 7.2.5 of the general standard does not apply.
NOTE For applicable requirements, see 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.
201.7.2.14 HIGH VOLTAGE TERMINAL DEVICES
Replacement:
HIGH VOLTAGE cable connections between the X-RAY TUBE ASSEMBLY and the HIGH-VOLTAGE
GENERATOR accessible in NORMAL USE shall be marked with symbol IEC 60417-5036 (2002-10)
(see Table D.1, symbol 24) unless a tool is required for removal of the cable connection.
201.7.2.15 Cooling conditions
Addition:
Marking of cooling conditions is not required if the cooling unit and the X-RAY TUBE ASSEMBLY
have been designed for compatibility.
– 10 – IEC 60601-2-28:2017 IEC 2017
NOTE A cooling unit is a standalone device or integral part of the X-RAY TUBE ASSEMBLY which provides increased
cooling capability of the X-RAY TUBE ASSEMBLY.
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.
X-RAY TUBES shall be provided with the following markings:
• 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.
201.7.2.102 Marking on the outside of X-RAY TUBE ASSEMBLIES
X-RAY TUBE ASSEMBLIES shall be provided with the following markings:
• NOMINAL X-RAY TUBE VOLTAGE for which the X-RAY TUBE ASSEMBLY is designed;
• if there is more than one HIGH VOLTAGE cable receptacle, indication of the polarity of the
HIGH VOLTAGE cable receptacles;
• FOCAL SPOT size(s). If the FOCAL SPOT size(s) are in the range of NOMINAL FOCAL SPOT
VALUES in IEC 60336, then mark the FOCAL SPOT size(s) as NOMINAL FOCAL SPOT VALUE(S)
according to IEC 60336.
NOTE See further 201.7.2.2 and 203.7.3.
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 are allowed to perform the work, so safe
operation is assured.
201.7.9 ACCOMPANYING DOCUMENTS
201.7.9.1 General
Replacement:
ME EQUIPMENT shall be accompanied by documents containing at least the instructions for use
ACCOMPANYING DOCUMENTS shall be regarded as a part of the
and a technical description. The
ME EQUIPMENT.
The ACCOMPANYING DOCUMENTS may be provided with the X-RAY TUBE ASSEMBLY, or they may
be integrated into the ACCOMPANYING DOCUMENTS of any ME SYSTEM for which the X-RAY TUBE
ASSEMBLY is compatible.
If an X-RAY TUBE ASSEMBLY is intended to receive its power from other equipment in an
ME SYSTEM, or otherwise puts special requirements on the supporting ME SYSTEM, the
ACCOMPANYING DOCUMENTS shall sufficiently specify such other equipment to ensure
compliance with the requirements of this document.
NOTE 101 The purpose of the ACCOMPANYING DOCUMENTS is to promote the safe use of the ME EQUIPMENT during
its EXPECTED SERVICE LIFE.
The ACCOMPANYING DOCUMENTS shall identify the ME EQUIPMENT by including, as applicable,
the following:
– name or trade-name of the MANUFACTURER and contact information to which the
RESPONSIBLE ORGANIZATION can refer;
– MODEL OR TYPE REFERENCE.
NOTE 102 Contact information can be e.g. a telephone number, email address, address or website, where the
MANUFACTURER can be contacted.
ACCOMPANYING DOCUMENTS may be provided electronically, e.g. a file on an electronic medium.
If the ACCOMPANYING DOCUMENTS are provided electronically, the RISK MANAGEMENT FILE shall
include consideration on which information also needs to be provided as hard copy or as
markings on the ME EQUIPMENT.
EXAMPLE Information to cover emergency operation.
NOTE 103 ACCOMPANYING DOCUMENTS provided electronically might not be acceptable in all jurisdictions.
NOTE 104 Instead of the USABILITY ENGINEERING PROCESS (IEC 60601-1-6 is not applicable for an X-RAX TUBE
ASSEMBLY), the RISK MANAGEMENT PROCESS (based on ISO 14971) is the carrier of the considerations. ISO
14971:2007, 4.2 (INTENDED USE) and C.2.29 (human factors) cover the USABILITY aspects of X-RAY TUBE ASSEMBLIES
sufficiently.
The ACCOMPANYING DOCUMENTS shall specify special skills, training and knowledge required of
the intended OPERATOR or the RESPONSIBLE ORGANIZATION and restrictions on locations or
environments in which the ME EQUIPMENT can be used.
The ACCOMPANYING DOCUMENTS shall be written at a level consistent with the education,
training and any special needs of the person(s) for whom they are intended.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS and, when provided
electronically, by inspection of the RISK MANAGEMENT FILE.
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 101 X-RAY TUBE ASSEMBLIES normally do not connect to a SUPPLY MAINS.
201.7.9.2.3 ME EQUIPMENT SPECIFIED for connection to a separate power supply
Subclause 7.9.2.3 of the general standard does not apply.
– 12 – IEC 60601-2-28:2017 IEC 2017
201.7.9.2.14 ACCESSORIES, supplementary equipment, used material
Subclause 7.9.2.14 of the general standard applies, except as follows:
– the second paragraph;
– the Note.
201.7.9.2.17 ME EQUIPMENT emitting RADIATION
Subclause 7.9.2.17 of the general standard does not apply.
NOTE RADIATION intensity and distribution are governed at system level. Nature and type of the RADIATION are
SPECIFIED in 201.7.9.3.101 a).
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:
RAY TUBE ASSEMBLIES
201.7.9.3.101 Technical description of X-
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) FOCAL SPOT size(s);
If the FOCAL SPOT size(s) are in the range of NOMINAL FOCAL SPOT VALUES in IEC 60336,
then state the FOCAL SPOT size(s) as NOMINAL FOCAL SPOT VALUE(S) according to
IEC 60336.
e) PERMANENT FILTRATION according to IEC 60522 or the thickness(es) of the material(s)
concerned, together with its/their chemical symbol(s);
f) QUALITY EQUIVALENT FILTRATION of parts which are or could become ADDED FILTERS and
method of mounting/dismounting such, if applicable;
NOTE 101 The preceding two FILTRATION requirements cover 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;
HIGH-VOLTAGE GENERATOR, for supplying the filament(s), for rotating
j) requirements for the
the ANODE (when appropriate) and for auxiliary equipment (such as for cooling purposes),
appropriate for the safe application of the X-RAY TUBE ASSEMBLY as defined in the RISK
MANAGEMENT FILE;
k) CATHODE EMISSION CHARACTERISTIC;
NOTE 102 For the 4 preceding items,(h) to k)), 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) if applicable, any requirements that shall be fulfilled prior to applying power to the X-RAY
TUBE ASSEMBLY, e.g. the time period that the room environmental operating conditions shall
be maintained, precautions to be observed before the first LOADING upon completion of the
installation of an X-RAY TUBE ASSEMBLY, special procedures for conditioning the X-RAY
TUBE;
u) NOMINAL CONTINUOUS INPUT POWER according to IEC 60613:2010.
NOTE 103 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 document, the technical
description of the X-RAY TUBE ASSEMBLY in this clause 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:
201.8.2 Requirements related to power sources
201.8.2.1 Connection to a separate power source
Subclause 8.2.1 of the general standard does not apply.
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
Amendment to Table 6 of the general standard:
For PEAK WORKING VOLTAGES U >14 140 V, the HIGH VOLTAGE circuits of the X-RAY TUBE
ASSEMBLY are tested at 110 % of the NOMINAL X-RAY TUBE VOLTAGE of the X-RAY TUBE ASSEMBLY,
where the voltage is raised over a period of 10 s or less, and is then maintained for 3 min.
– 14 – IEC 60601-2-28:2017 IEC 2017
201.8.9 CREEPAGE DISTANCES and AIR CLEARANCES
201.8.9.3 Spaces filled by insulating compound
Addition:
Subclause 8.9.3 is not applicable for testing HIGH VOLTAGE circuits of X-RAY TUBE ASSEMBLIES.
NOTE 201.8.8.3 describes HIGH VOLTAGE testing of X-RAY TUBE ASSEMBLIES.
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
Addition:
RISK ANALYSIS in the RISK MANAGEMENT FILE shall include the criteria for expelled parts or liquid
spilled that would result in an unacceptable RISK.
NOTE The kinetic and thermal energy stored in the rotating system of the ANODE, coupled with a malfunction, are
potential sources of disintegration of the X-RAY TUBE, and in consequence, RISKS of parts being expelled. X-RAY
TUBE ASSEMBLY MANUFACTURERS can test for such RISKS, but, as protective means can also be provided by the ME
SYSTEM, and as the application of the X-RAY TUBE ASSEMBLY is system-dependent, these test results are only
indicative of the RISKS at the system level. Considerations regarding the tests which can be applied for RISK
MANAGEMENT purposes are given in Annex AA.
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:
An X-RAY TUBE ASSEMBLY is not a pressure vessel. However, 9.7.5 regarding pressure vessels
may be applied.
RISK ANALYSIS in the RISK MANAGEMENT FILE shall include the criteria for liquid spilled or other
consequences that would result in an unacceptable RISK.
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 pressure and in
consequence of leakage of the insulating medium. X-RAY TUBE ASSEMBLY MANUFACTURERS can test for pressure-
related RISKS, but, as protective means can also be provided by the ME SYSTEM, and as the application of the X-
RAY TUBE ASSEMBLY is system-dependent, these test results are only indicative of the RISKS at the system level.
Considerations regarding the tests which can be applied for RISK MANAGEMENT purposes are given in Annex AA.
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.
Replacement of item h) and of the compliance statement:
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 practice
even a few actuations of the pressure-relief device would result in subsequent replacement of the X-RAY TUBE
ASSEMBLY.
Compliance is checked by inspection, and where necessary, by functional test.
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
Addition:
NOTE According to 4.6 of the general standard, the RISK MANAGEMENT process can determine that the X-RAY TUBE
ASSEMBLY is subject to the requirements for TYPE B APPLIED PARTS.
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.
an X-RAY TUBE ASSEMBLY which can unintentionally
The temperature of the painted surface of
be touched during INTENDED USE may exceed the values in Table 23 of the general standard
but shall not exceed 85 °C.
NOTE 101 Table 23 of the general standard does not cover painted metal surfaces. However, reference [38] in
the general standard: EN 563, indicates a maximum temperature of 85 °C for a painted metal surface and for a
– 16 – IEC 60601-2-28:2017 IEC 2017
typical maximum contact period of 1 second. EN 563 has been withdrawn; It has been replaced by ISO 13732-1.
For the temperature considerations above, the same conclusion holds.
In NORMAL USE Table 23 does not apply for X-RAY TUBE ASSEMBLIES protected by GUARDS.
NOTE 102 Service personnel are aware of the RISKS involved when a GUARD is removed.
201.11.1.2 Temperature of APPLIED PARTS
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
Replacement:
In NORMAL CONDITION 201.11.1.1 applies. In SINGLE FAULT CONDITION 201.13.1.2 applies.
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT
Subclause 11.8 of the general standard does not apply.
NOTE In case of interruption of the power to the X-RAY TUBE ASSEMBLY, it is up to the ME SYSTEM to maintain
BASIC SAFETY, ESSENTIAL PERFORMANCE and to prevent HAZARDOUS SITUATIONS; an X-RAY TUBE ASSEMBLY cannot
maintain these
...
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