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 is also available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
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

IEC 60601-2-28:2017 est disponible sous forme de IEC 60601-2-28:2017 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
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.

General Information

Status
Published
Publication Date
15-Jun-2017
Current Stage
PPUB - Publication issued
Start Date
16-Jun-2017
Completion Date
16-Jun-2017
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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
IEC 60601-2-28:2017-06(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

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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

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

the latter.

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

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

services carried out by independent certification bodies.

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

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

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

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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.
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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.
---------------------- Page: 7 ----------------------
– 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:
---------------------- Page: 8 ----------------------
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.
---------------------- Page: 9 ----------------------
– 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.
---------------------- Page: 10 ----------------------
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: 11 ----------------------
– 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 accompan
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