EN 60601-2-28:2010

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

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

Appareils éléctromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base et les performances essentielles des gaines équipées pour diagnostic médical

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

Medicinska električna oprema - 2-28. del: Posebne zahteve za osnovno varnost in bistvene lastnosti rentgenskih naprav za zdravniške preglede (IEC 60601-2-28:2010)

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI RENGENTSKIH NAPRAV in njihovih komponent: - v nadaljevanju ME OPREMO; - namenjeno za zdravniške preglede in slikanje. Če je klavzula ali podklavzula izrecno namenjena samo za uporabo za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te klavzule ali podklavzule to tudi navedla. V nasprotnem primeru, tako klavzula ali podklavzula veljata za ustrezno ME OPREMO in ME SISTEME.

General Information

• Status: Withdrawn
• Publication Date: 06-May-2010
• Withdrawal Date: 31-Mar-2013
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Parallel Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-Aug-2022
• Completion Date: 07-Aug-2022
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-2-28:2010 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010)

Relations

• Replaces: EN 60601-2-28:1993 - Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-28:2019 - Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
• Effective Date: 01-Oct-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2010
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SIST EN 60601-2-28:1995
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ELVWYHQHODVWQRVWLUHQWJHQVNLKQDSUDY]D]GUDYQLãNHSUHJOHGH,(&

Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and
essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-
28:2010)
Medizinische elektrische Geräte - Teil 2-28: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Röntgenstrahlern für die
medizinische Diagnostik (IEC 60601-2-28:2010)
Appareils éléctromédicaux - Partie 2-28: Exigences particulières pour la sécurité de base
et les performances essentielles des gaines équipées pour diagnostic médical (CEI
60601-2-28:2010)
Ta slovenski standard je istoveten z: EN 60601-2-28:2010
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-28
NORME EUROPÉENNE
May 2010
EUROPÄISCHE NORM
ICS 11.040.55 Supersedes EN 60601-2-28:1993

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 60601-2-28:2010)
Appareils éléctromédicaux -  Medizinische elektrische Geräte -
Partie 2-28: Exigences particulières Teil 2-28: Besondere Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
des gaines équipées pour diagnostic von Röntgenstrahlern für die medizinische
médical Diagnostik
(CEI 60601-2-28:2010) (IEC 60601-2-28:2010)

This European Standard was approved by CENELEC on 2010-04-01. 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 Central Secretariat 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 Central Secretariat 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, Romania, Slovakia, Slovenia,
Spain, Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Management Centre: Avenue Marnix 17, B - 1000 Brussels

© 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-28:2010 E
Foreword
The text of document 62B/778/FDIS, future edition 2 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 was approved by CENELEC as EN 60601-2-28 on 2010-04-01.
This European Standard supersedes EN 60601-2-28:1993.
The second edition of this particular standard has been prepared to fit EN 60601-1:2006, which is
referred to as the general standard.
When the first edition was developed, mainly X-RAY TUBE ASSEMBLIES holding a glass insert were
considered and EN 60601-1:1990 was in place. While the variety of modern X-RAY TUBE ASSEMBLIES
and technologies has increased, the third edition of the general standard requires the MANUFACTURER
to perform RISK MANAGEMENT. The technical modifications versus the first edition of EN 60601-2-28
account for these changes.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent
rights.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
(dop) 2011-01-01
national standard or by endorsement
– latest date by which the national standards conflicting
(dow) 2013-04-01
with the EN have to be withdrawn
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of
tables is also in a smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED:
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of
Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination
of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb:

- 3 - EN 60601-2-28:2010
– “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.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-28:2010 was approved by CENELEC as a European
Standard without any modification.
__________
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application 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  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Annex ZA of EN 60601-1:2006 applies, except as follows:

Publication Year Title EN/HD Year

Replacement:
IEC 60601-1-3 2008 Medical electrical equipment - EN 60601-1-3 2008
Part 1-3: General requirements for basic + corr. March 2010
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
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 EN 60522 -
of X-ray tube assemblies
IEC 60613 2010 Electrical and loading characteristics EN 60613 2010
of X-ray tube assemblies for medical
diagnosis
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
- 5 - EN 60601-2-28:2010
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
IEC 60601-2-28 ®
Edition 2.0 2010-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential performance
of X-ray tube assemblies for medical diagnosis

Appareils électromédicaux –
Partie 2-28: Exigences particulières pour la sécurité de base et les performances
essentielles des gaines équipées pour diagnostic médical

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
R
CODE PRIX
ICS 11.040.55 ISBN 2-8318-1082-2
– 2 – 60601-2-28 © IEC:2010
CONTENTS
FOREWORD.3
201.1 Scope, object and related standards.5
201.2 Normative references .6
201.3 Terms and definitions .7
201.4 General requirements.7
201.5 General requirements for testing ME EQUIPMENT.7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .8
201.7 ME EQUIPMENT identification, marking and documents.8
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.10
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS.11
201.10 Protection against unwanted and excessive radiation HAZARDS.12
201.11 Protection against excessive temperatures and other HAZARDS.12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs .13
201.13 HAZARDOUS SITUATIONS and fault conditions .13
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .13
201.15 Construction of ME EQUIPMENT .13
201.16 ME SYSTEMS.13
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.13
203 RADIATION protection in diagnostic X-RAY EQUIPMENT .13
Annexes .14
Annex AA (informative) Test of X-RAY TUBE ASSEMBLIES for pressure-related RISKS.15
Index of defined terms used in this particular standard.17

60601-2-28 © IEC:2010 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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 internati
...