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)

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.

Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die medizinische Diagnostik (IEC 60601-2-28:2017)

Appareils électromédicaux - Partie 2-28 : Exigences particulières pour la sécurité de base et les performances essentielles des gaines équipées pour diagnostic médical (IEC 60601-2-28:2017)

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

Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko (IEC 60601-2-28:2017)

Standard IEC 60601-2-28:2010 določa posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko. Druga izdaja razveljavlja in nadomešča prvo izdajo, objavljeno leta 1993. Ta izdaja je tehnično popravljena izdaja. Ta druga izdaja tega standarda je bila pripravljena tako, da se ujema s standardom IEC 60601-1:2005 (tretjo izdajo standarda IEC 60601-1), ki se uporablja kot splošni standard.

General Information

Status
Published
Publication Date
24-Nov-2019
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
04-Oct-2019
Due Date
09-Dec-2019
Completion Date
25-Nov-2019

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SLOVENSKI STANDARD
SIST EN IEC 60601-2-28:2020
01-januar-2020
Nadomešča:
SIST EN 60601-2-28:2010
Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti rentgenskih sestavov za medicinsko diagnostiko (IEC 60601-2-
28:2017)

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)

Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die
medizinische Diagnostik (IEC 60601-2-28:2017)

Appareils électromédicaux - Partie 2-28 : Exigences particulières pour la sécurité de

base et les performances essentielles des gaines équipées pour diagnostic médical (IEC

60601-2-28:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-28:2019
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 60601-2-28:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN IEC 60601-2-28:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 60601-2-28:2020
EUROPEAN STANDARD EN IEC 60601-2-28
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2019
ICS 11.040.55 Supersedes EN 60601-2-28:2010 and all of its
amendments and corrigenda (if any)
English Version
Medical electrical equipment - Part 2-28: Particular requirements
for the basic safety and essential performance of X-ray tube
assemblies for medical diagnosis
(IEC 60601-2-28:2017)

Appareils électromédicaux - Partie 2-28 : Exigences Medizinische elektrische Geräte - Teil 2-28: Besondere

particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles des gaines équipées pour diagnostic médical wesentlichen Leistungsmerkmale von Röntgenstrahlern für

(IEC 60601-2-28:2017) die medizinische Diagnostik
(IEC 60601-2-28:2017)

This European Standard was approved by CENELEC on 2019-08-07. CENELEC members are bound to comply with the CEN/CENELEC

Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 60601-2-28:2019 E
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SIST EN IEC 60601-2-28:2020
EN IEC 60601-2-28:2019 (E)
European foreword

The text of document 62B/1040/FDIS, future edition 3 of IEC 60601-2-28, prepared by SC 62B

"Diagnostic imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was

submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-

28:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-05-07

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-08-07

document have to be withdrawn
This document supersedes EN 60601-2-28:2010.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60601-2-28:2017 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9
IEC 60601-1-10 NOTE Harmonized as EN 60601-1-10
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010 (not modified)
ISO 13732-1 NOTE Harmonized as EN ISO 13732-1
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SIST EN IEC 60601-2-28:2020
EN IEC 60601-2-28:2019 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
The annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Addition
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 -
assemblies for medical diagnosis -
Characteristics of focal spots
IEC 60522 - Determination of the permanent filtration of EN 60522 -
X-ray tube assemblies
IEC TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
Replacement
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
+EN 60601-1-2010
3:2008/corrigendum
Mar. 2010
+A11 2016
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SIST EN IEC 60601-2-28:2020
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SIST EN IEC 60601-2-28:2020
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

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
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SIST EN IEC 60601-2-28:2020
– 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

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SIST EN IEC 60601-2-28:2020
IEC 60601-2-28:2017  IEC 2017 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-28: Particular requirements for the basic safety
and essential performance of X-ray tube assemblies for medical diagnosis
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 60601-2-28 has been prepared by subcommittee 62B: Diagnostic

imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.

This 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.
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SIST EN IEC 60601-2-28:2020
– 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.
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SIST EN IEC 60601-2-28:2020
IEC 60601-2-28:2017  IEC 2017 – 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
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.
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SIST EN IEC 60601-2-28:2020
– 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:
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SIST EN IEC 60601-2-28:2020
IEC 60601-2-28:2017  IEC 2017 – 7 –
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.
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SIST EN IEC 60601-2-28:2020
– 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.
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SIST EN IEC 60601-2-28:2020
IEC 60601-2-28:2017  IEC 2017 – 9 –
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.
---------------------- Page: 15 ----------------------
SIST EN IEC 60601-2-28:2020
– 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 MAN
...

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