SIST EN 60601-1-3:2008

SLOVENSKI STANDARD
01-julij-2008
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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)
Medizinische elektrische Geräte - Teil 1-3: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Strahlenschutz
von diagnostischen Röntgengeräten (IEC 60601-1-3:2008)
Appareils électromédicaux - Partie 1-3: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Radioprotection dans les appareils a
rayonnement X de diagnostic (CEI 60601-1-3:2008)
Ta slovenski standard je istoveten z: EN 60601-1-3:2008
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-1-3
NORME EUROPÉENNE
April 2008
EUROPÄISCHE NORM
ICS 11.040.50; 13.280 Supersedes EN 60601-1-3:1994

English version
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)
Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-3: Exigences générales Teil 1-3: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles - der wesentlichen Leistungsmerkmale -
Norme collatérale: Radioprotection Ergänzungsnorm: Strahlenschutz
dans les appareils à rayonnement X von diagnostischen Röntgengeräten
de diagnostic (IEC 60601-1-3:2008)
(CEI 60601-1-3:2008)
This European Standard was approved by CENELEC on 2008-03-01. 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, 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

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-3:2008 E
Foreword
The text of document 62B/673/FDIS, future edition 2 of IEC 60601-1-3, 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 60601-1-3 on 2008-03-01.
The following date was fixed:
– latest date by which the EN has to be implemented

at national level by publication of an identical
(dop) 2008-12-01
national standard or by endorsement
This European Standard supersedes EN 60601-1-3:1994. However, EN 60601-1-3:1994 remains valid
until all the Parts 2 that are used in conjunction with it have been withdrawn. No date of withdrawal of
conflicting national standards (dow) has therefore been fixed. However, when Part 1-3 is used for
appliances not covered by a Part 2, EN 60601-1-3:1994 is not to be used after 2009-09-12.
This EN 60601-1-3 has been restructured and aligned to EN 60601-1:2006 and focussed on general
requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements
particular to specific equipment have been removed and will be covered in particular standards. For a
description of the changes, see the mapping in Annex C.
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.
This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to as
the general standard.
In the 60601 series of publications, collateral standards specify general requirements for safety applicable
to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the general
standard (e.g. alarm systems).
In this collateral standard, the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in 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 COLLATERAL STANDARD OR AS NOTED: IN
SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the thirteen 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 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.
- 3 - EN 60601-1-3:2008
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives,
Part 2. For the purposes of this standard, the auxiliary verb
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not mandatory for
compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A are marked
with an asterisk (*).
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-1-3:2008 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 60601-2-7 NOTE Harmonized as EN 60601-2-7:1998 (not modified).
IEC 60601-2-28 NOTE Harmonized as EN 60601-2-28:1993 (not modified).
IEC 60601-2-29 NOTE Harmonized as EN 60601-2-29:1999 (not modified).
IEC 60601-2-32 NOTE Harmonized as EN 60601-2-32:1994 (not modified).
IEC 60601-2-43 NOTE Harmonized as EN 60601-2-43:2000 (not modified).
IEC 60601-2-44 NOTE Harmonized as EN 60601-2-44:2001 (not modified).
IEC 60601-2-45 NOTE Harmonized as EN 60601-2-45:2001 (not modified).
IEC 60580 NOTE Harmonized as EN 60580:2000 (not modified).
IEC 60627 NOTE Harmonized as EN 60627:2001 (not modified).
IEC 61262 NOTE Harmonized in EN 61262 series (not modified).
IEC 62220 NOTE Harmonized in EN 62220 series (not modified).
IEC 62220-1 NOTE Harmonized as EN 62220-1:2003 (not modified).
__________
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.
Publication Year Title EN/HD Year
1) 2)
IEC 60336 - Medical electrical equipment - X-ray tube EN 60336 2005
assemblies for medical diagnosis -
Characteristics of focal spots

IEC 60522 1999 Determination of the permanent filtration of EN 60522 1999
X-ray tube assemblies
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic safety
and essential performance
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
1)
ISO 497 - Guide to the choice of series of preferred - -
numbers and series containing more rounded
values of preferred numbers
1)
Undated reference.
2)
Valid edition at date of issue.

- 5 - EN 60601-1-3:2008
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 60601-1-3
Edition 2.0 2008-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 1-3: General requirements for basic safety and essential performance –
Collateral Standard: Radiation protection in diagnostic X-ray equipment

Appareils électromédicaux –
Partie 1-3: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Radioprotection dans les appareils à
rayonnement X de diagnostic
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
X
CODE PRIX
ICS 11.040.50; 13.280 ISBN 2-8318-9541-3

– 2 – 60601-1-3 © IEC:2008
CONTENTS
FOREWORD.5
INTRODUCTION.8

1 Scope, object and related standards.9
1.1 Scope.9
1.2 Object .9
1.3 Related standards .9
1.3.1 IEC 60601-1 .9
1.3.2 Particular standards .9
2 Normative references .10
3 Terms and definitions .10
4 General requirements .20
4.1 Statement of compliance .20
4.2 Composition of reference materials .20
5 ME EQUIPMENT identification, marking and documents .20
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .20
5.1.1 General .20
5.1.2 Marking requirements in subclauses.20
5.2 ACCOMPANYING DOCUMENTS.20
5.2.1 References in subclauses.21
5.2.2 Dosimetric calibration .21
5.2.3 General requirements for the reference of subassemblies and
ACCESSORIES.21
5.2.4 Instructions for use.22
6 RADIATION management.23
6.1 General .23
6.2 Initiation and termination of the IRRADIATION .24
6.2.1 Normal initiation and termination of the IRRADIATION.24
6.2.2 Safety measures against failure of normal termination of the
IRRADIATION.24
6.3 RADIATION dose and RADIATION QUALITY.24
6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY .24
6.3.2 Reproducibility of the RADIATION output .24
6.4 Indication of operational states.25
6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected .25
6.4.2 Indication of LOADING STATE .25
6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION.25
6.4.4 Indication of automatic modes .25
6.4.5 Dosimetric indications.26
6.5 AUTOMATIC CONTROL SYSTEM .26
6.6 SCATTERED RADIATION reduction .26
6.7 Imaging performance.26
6.7.1 General .26
6.7.2 System performance.26
6.7.3 Nominal focal spot value.27
6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR .27
7 RADIATION QUALITY .27

60601-1-3 © IEC:2008 – 3 –
7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT .27
7.2 Waveform of the X-RAY TUBE VOLTAGE.28
7.3 Indication of FILTER properties .28
7.4 Test for FILTRATION by irremovable materials .29
7.5 Test for ADDED FILTERS and materials.29
7.6 Test for HALF-VALUE LAYER .29
8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD
and IMAGE RECEPTION AREA .29
8.1 General .29
8.2 Enclosure of X-RAY TUBES.29
8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES .30
8.4 Confinement of EXTRA-FOCAL RADIATION .30
8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA .30
8.5.1 General .30
8.5.2 * FOCAL SPOT TO IMAGE RECEPTOR DISTANCE .30
8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE
RECEPTION AREA .30
8.5.4 Positioning of the PATIENT and restriction of the irradiated area.31
9 FOCAL SPOT TO SKIN DISTANCE.31
9.1 General .31
9.2 Information in the ACCOMPANYING DOCUMENTS .31
10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR .31
10.1 General .31
10.2 Information in the ACCOMPANYING DOCUMENTS .31
11 Protection against RESIDUAL RADIATION.32
12 * Protection against LEAKAGE RADIATION .32
12.1 General .32
12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS .32
12.3 Statement of reference LOADING conditions.33
12.4 LEAKAGE RADIATION in the LOADING STATE .33
12.5 LEAKAGE RADIATION when not in the LOADING STATE .34
13 Protection against STRAY RADIATION .34
13.1 General .34
13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA.34
13.3 Protection by distance .35
13.4 * Designated SIGNIFICANT ZONES OF OCCUPANCY .35
13.5 Handgrips and control devices .36
13.6 * Test for STRAY RADIATION.36

Annex A (informative) General guidance and rationale.38
Annex B (normative) Values of the series R'10 and R'20, ISO 497 .40
Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1.41

Bibliography.43

Index of defined terms used in this collateral standard.45

– 4 – 60601-1-3 © IEC:2008
Figure 1 – Example of presentation of data on STRAY RADIATION.37

Table 1 – Subclauses containing requirements for marking.20
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS .21
Table 3 – HALF-VALUE LAYERS in X-RAY EQUIPMENT.28

60601-1-3 © IEC:2008 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-3: General requirements for basic safety
and essential performance –
Collateral Standard:
Radiation protection in diagnostic X-ray equipment

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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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 60601-1-3 has been prepared by IEC subcommittee 62B:
Diagnostic imaging equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition constitutes a collateral standard to IEC 60601-1: Medical electrical
equipment – Part 1: General requirements for basic safety and essential performance
hereafter referred to as the general standard.
This document cancels and replaces the first edition of IEC 60601-1-3, published in 1994
(which replaced IEC 407 issued in 1973). It constitutes a technical revision. This edition has
been restructured and aligned to IEC 60601-1(2005) and focussed on general
requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT.
Requirements particular to specific equipment have been removed and will be covered in
particular standards. For a description of the changes, see the mapping in Annex C.

– 6 – 60601-1-3 © IEC:2008
The text of this collateral standard is based on the following documents:
FDIS Report on voting
62B/673/FDIS 62B/683/RVD
Full information on the voting for the approval of this collateral 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 the 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. alarm systems).
In this collateral 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 COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the thirteen 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 collateral standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard;
– “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
– “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
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.

60601-1-3 © IEC:2008 – 7 –
The committee has decided that the contents of this edition and the base publication will
remain unchanged until the maintenance result 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
– 8 – 60601-1-3 © IEC:2008
INTRODUCTION
The requirements in this collateral Standard concern protective measures to be taken by the
MANUFACTURER in the design and construction of medical diagnostic X-RAY EQUIPMENT and its
subassemblies. They relate to the application of the X-RADIATION generated, both deliberately
and incidentally, in fulfilling the medical purpose of the EQUIPMENT. Additional measures are
necessary to regulate the generation processes themselves. These are described in the
general requirements for safety, IEC 60601-1, and, where appropriate, in particular
requirements for the EQUIPMENT concerned. The second edition of this collateral standard is
focused on general requirements for RADIATION PROTECTION. The aim of the revision was to
restrict to those requirements that apply to all diagnostic X-RAY EQUIPMENT. In consequence,
most of the clauses have been reduced compared with the first edition of this standard, owing
to the exclusion of content specific to projection RADIOGRAPHY and RADIOSCOPY.
Implementation shall be considered in the RISK MANAGEMENT process or by using particular
standards.
The recommended principles governing the use of RADIATION for medical purposes, as stated
1)
in Publication 60 of the International Commission on Radiological Protection (ICRP)[17] ,
Chapter 4, have been taken into account. The implementation of these principles is
essentially determined in the prevailing circumstances at the point of use. It requires
judgements to be made by the user and the establishment of measures and working practices
part of which are connected with the construction of EQUIPMENT. The requirements in this
collateral Standard are intended to be consistent with generally accepted good practice in the
administration of X-RADIATION in medicine.
In some cases, the formulation of the requirements is deliberately designed to provide scope
for accommodating local laws and regulations at the time of installation and commissioning.
Several of the requirements include provisions for relevant technical information to be
included in ACCOMPANYING DOCUMENTS.
RESPONSIBLE ORGANIZATIONs for medical diagnostic X-RAY EQUIPMENT should be aware that
effective protection against IONIZING RADIATION requires the consideration of many aspects
additional to the construction of the EQUIPMENT. Among these are the following:
• compatibility of components and correct installation of EQUIPMENT;
• the protective properties of rooms where X-RAY EQUIPMENT is installed;
• measures for monitoring and maintaining the safety and effectiveness of EQUIPMENT
throughout its life, with particular attention to components that can deteriorate
progressively with time and use;
• the need in appropriate circumstances for PROTECTIVE CLOTHING to be worn by staff and for
suitable devices to be used to protect PATIENTS;
• the keeping of appropriate records concerning the usage of the EQUIPMENT and the results
of tests, with systematic review and the application of corrective action when necessary;
• the training of staff in the principles of RADIATION PROTECTION and in the correct use of
EQUIPMENT, including any PROTECTIVE DEVICES provided.
Further advice on these aspects can be found in ICRP Publications 33[15], 34[16], 60[17],
73[18], 85[21], 87[22] and 93[23].
Readers of this collateral standard are reminded that, in accordance with IEC 60601-1,
Clause 5, all the test procedures described are TYPE TESTS, intended to be carried out in a
dedicated testing environment in order to determine compliance. Tests to be carried out by
MANUFACTURERS to ensure compliance during production or installation and tests for detecting
non-compliance subsequently to delivery, are not included.
—————————
1)
Figures in square brackets refer to the Bibliography.

60601-1-3 © IEC:2008 – 9 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-3: General requirements for basic safety
and essential performance –
Collateral Standard:
Radiation protection in diagnostic X-ray equipment

1 Scope, object and related standards
1.1 Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment,
where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance
of medical procedures.
1.2 Object
The object of this collateral standard is to specify general requirements that are in addition to
those of the general standard and to serve as the basis for particular standards.
The object of this collateral standard is to establish general requirements for protection
against X-RADIATION in X-RAY EQUIPMENT, in order that the IRRADIATION of the human PATIENT,
the OPERATOR, staff and members of the public can be kept as low as reasonably achievable,
without jeopardizing the benefit of the RADIOLOGICAL procedure. Particular standards may
specify their appropriate values and/or measures for general requirements specified in this
collateral standard. The implementation of the general requirements or the reference to the
particular standard instead, shall be justified in the RISK MANAGEMENT process.
This collateral standard considers RADIATION PROTECTION aspects related to X-RADIATION only.
Requirements for the control of the electrical energy used to generate X-RADIATION, which is
also an important aspect of RADIATION PROTECTION, are included in IEC 60601-1 and in
particular standards for the safety and ESSENTIAL PERFORMANCE of the EQUIPMENT concerned.
1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
• "the general standard" designates IEC 60601-1 alone;
• "this collateral standard" designates IEC 60601-1-3 alone;
• "this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
– 10 – 60601-1-3 © IEC:2008
2 Normative references
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.
IEC 60336, Medical electrical equipment – X-ray tube assemblies for medical diagnosis-
Characteristics of focal spots
IEC 60522:1999, Determination of the permanent filtration of X-ray tube assemblies
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60788:2004, Medical electrical equipment – Glossary of defined terms
ISO 497, Guide to the choice of series of preferred numbers and of series containing more
rounded values of preferred numbers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60788:2004 and the following apply.
NOTE An index of defined terms is found beginning on page 45.
3.1
ACCESSIBLE SURFACE
surface of EQUIPMENT or of an EQUIPMENT part that can be easily or accidentally touched by
persons without the use of a TOOL
3.2
ADDED FILTER
removable or irremovable FILTER positioned in the RADIATION BEAM to provide part or all of the
ADDITIONAL FILTRATION
3.3
ADDITIONAL FILTRATION
QUALITY EQUIVALENT FILTRATION due to ADDED FILTERS and other removable materials in the
RADIATION BEAM which are between the RADIATION SOURCE and the PATIENT or a specified plane
3.4
AIR KERMA
K
quotient of dE by dm, where dE is the sum of the initial kinetic energies of all the charged
tr tr
particles liberated by uncharged particles in a mass dm of air, thus
dE
tr
K =
dm
–1
Unit: J kg
The special name for the unit of AIR KERMA is gray (Gy) (ICRU 60) [20]
[IEC 60580:2000, definition 3.2, modified] [8]

60601-1-3 © IEC:2008 – 11 –
3.5
AIR KERMA RATE
&
K
quotient of dK by dt, where dK is the increment of AIR KERMA in the time interval dt, thus
dK
&
K =
dt
–1 –1
Unit: J kg s
–1
If the special name gray is used, the unit of AIR KERMA RATE is gray per second (Gy s ) (ICRU
60) [20]
[IEC 60580:2000, definition 3.3] [8]
3.6
AMBIENT DOSE EQUIVALENT
H*(d)
at a point in a RADIATION FIELD, the DOSE EQUIVALENT that would be produced by corresponding
expanded and aligned field, in the ICRU sphere at a depth, d, on the radius opposing the
direction of the aligned field
–1
Unit: J kg
The special name for the unit of AMBIENT DOSE EQUIVALENT is sievert (Sv) (ICRU 51)[19]
3.7
ATTENUATION
reduction of a RADIATION QUANTITY upon passage of the RADIATION through matter resulting
from all types of interaction with this matter
NOTE The RADIATION QUANTITY may be, for example, the particle flux density or the energy density. ATTENUATION
does not include the geometric reduction of the RADIATION QUANTITY with distance from the RADIATION SOURCE.
3.8
ATTENUATION EQUIVALENT
δ
thickness of a layer of reference material which, if substituted for the material under
consideration in a beam of specified RADIATION QUALITY and under specified geometrical
conditions, gives the same degree of ATTENUATION. ATTENUATION EQUIVALENT is expressed in
suitable submultiples of the metre together with the reference
3.9
AUTOMATIC CONTROL SYSTEM
in an X-RAY EQUIPMENT, system in which the control or limitation of the electric energy
delivered to an X-RAY TUBE ASSEMBLY depends upon the measurement of one or more
RADIATION QUANTITIES or corresponding physical quantities
3.10
AUTOMATIC EXPOSURE CONTROL
in an X-RAY EQUIPMENT, MODE OF OPERATION in which one or more LOADING FACTORS are
controlled automatically in order to obtain at a pre-selected location a desired quantity of
RADIATION
3.11
BEAM LIMITING DEVICE
device to limit the RADIATION FIELD

– 12 – 60601-1-3 © IEC:2008
3.12
BEAM LIMITING SYSTEM
entirety of parts and their geometrical configuration contributing to the limitation of the
RADIATION BEAM
3.13
CONTINUOUS ANODE INPUT POWER
specified highest ANODE INPUT POWER which can be applied to the ANODE continuously
Unit: W
3.14
CONTROL PANEL
part of EQUIPMENT for the purpose of controlling all, or some, of the functions of the
EQUIPMENT. The CONTROL PANEL may contain devices for indicating and displaying operating
factors
3.15
CONTROLLED AREA
defined area which is part of an area under surveillance and for which access, occupancy and
working conditions are regulated and controlled in order to protect persons against IONIZING
RADIATION
3.16
CURRENT TIME PRODUCT
in MEDICAL RADIOLOGY, quantity of electricity resulting from the LOADING of an X-RAY TUBE,
expressed in milliampere seconds, as the product of the mean X-RAY TUBE CURRENT in
milliamperes and the duration of the LOADING in seconds
3.17
DIAPHRAGM
BEAM LIMITING DEVICE with either a fixed or an adjustable aperture in one plane
3.18
DOSE EQUIVALENT
H
is the product of Q and D, at a point in tissue, where D is the ABSORBED DOSE and Q is the
quality factor at that point, thus
H = Q D.
–1
Unit: J kg
The special name for the unit of DOSE EQUIVALENT is sievert (Sv) (ICRU 51)[19]
3.19
EDGE FILTER
FILTER whose ABSORPTION characteristic as a function of RADIATION ENERGY shows a
discontinuity in the useful photon energy range
3.20
EFFECTIVE IMAGE RECEPTION AREA
part of the IMAGE RECEPTION AREA that is configured to receive an X-RAY PATTERN that can be
processed for display or storage
NOTE 1 In accordance with this convention, the IMAGE RECEPTION AREA of a multi-field X-ray image intensifier
tube is considered to be restricted by the selection of magnification modes, to exclude any portion of the input
screen from which the X-RAY PATTERN is not electronically processed.

60601-1-3 © IEC:2008 – 13 –
NOTE 2 For X-RAY EQUIPMENT based on scanning that varies the position for receiving an X-RAY PATTERN during
the exposure, the EFFECTIVE IMAGE RECEPTION AREA at a certain time during the scan is the area of the image
receptor that is receiving and processing an X-RAY PATTERN at that very moment.
3.21
ENTRANCE SURFACE
in RADIOLOGY, plane or curved surface through which the RADIATION enters an irradiated object
3.22
EXTRA-FOCAL RADIATION
in an X-RAY SOURCE ASSEMBLY, X-RADIATION emitted from the RADIATION SOURCE other than that
emitted from the ACTUAL FOCAL SPOT
3.23
FILTER
in RADIOLOGICAL EQUIPMENT, material or device provided to effect FILTRATION of the RADIATION
BEAM
3.24
FILTRATION
modification of characteristics of IONIZING RADIATION on passing through matter
NOTE FILTRATION may be:
– preferential ABSORPTION of certain components of polyenergetic X-RADIATION accompanying its ATTENUATION;
– a modification of the distribution of RADIATION intensity over the cross-section of a RADIATION BEAM
3.25
FOCAL SPOT TO IMAGE RECEPTOR DISTANCE
distance from the REFERENCE PLANE of an EFFECTIVE FOCAL SPOT to the point at which the
REFERENCE AXIS intersects with the image receptor plane
3.26
FOCAL SPOT TO SKIN DISTANCE
in MEDICAL DIAGNOSTIC RADIOLOGY, distance from the REFERENCE PLANE of an EFFECTIVE FOCAL
SPOT to a plane normal to the REFERENCE DIRECTION and containing the point on the PATIENT
surface nearest to the RADIATION SOURCE
3.27
HALF-VALUE LAYER
thickness of a specified material, which attenuates under NARROW BEAM CONDITIONS X-
RADIATION with a particular spectrum to an extent such that the AIR KERMA RATE, EXPOSURE
RATE or ABSORBED DOSE rate is reduced to one half of the value that is measured without the
material. The HALF-VALUE LAYER (HVL) is expressed in suitable submultiples of the metre
together with the material.
3.28
IMAGE RECEPTION AREA
in RADIOLOGY, surface on which an X-RAY PATTERN is received
3.29
IONIZING RADIATION
RADIATION consisting of directly or indirectly ionizing particles or a mixture of both. By
convention, ultraviolet radiation is excluded
3.30
IRRADIATION
exposing of a living being or matter to RADIATION. In RADIOLOGY, exposing of a living being or
matter to IONIZING RADIATION
Thus: X-IRRADIATION
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3.31
IRRADIATION SWITCH
in RADIOLOGICAL EQUIPMENT, control device provided to initiate and/or stop IRRADIATION
3.32
IRRADIATION TIME
duration of an IRRADIATION determined according to specific methods, usually the time a rate
of a RADIATION QUANTITY exceeds a specified level
3.33
LEAKAGE RADIATION
IONIZING RADIATION which has passed through the PROTECTIVE SHIELDING of a RADI
...