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

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. 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. 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.

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

La présente norme collatérale s'applique aux appareils à rayonnement X et à leurs sous-ensembles, dont les images radiologiques d'un patient humain sont utilisées à des fins de diagnostic, de planification ou de guide pour les procédures médicales. L'objet de la présente norme collatérale est d'établir des exigences générales pour la protection contre les rayonnements X dans les appareils à rayonnement X, afin que l'irradiation des patients humains, de l'opérateur, des membres de l'équipe médicale et des autres personnes présentes puisse être maintenue à un niveau aussi bas que raisonnablement possible, sans compromettre le bénéfice de la procédure radiologique. Des normes particulières peuvent spécifier des valeurs et/ou mesures qui leur sont appropriées par rapport aux exigences générales spécifiées dans la présente norme collatérale. La mise en uvre des exigences générales ou, à la place, la référence à la norme particulière doit être justifiée dans le processus de gestion des risques. La présente norme collatérale traite des aspects de radioprotection liés aux rayonnements X uniquement. Les exigences pour la commande de l'énergie électrique utilisée pour produire le rayonnement X, qui est aussi un aspect important de la radioprotection, figurent dans la CEI 60601-1 et dans les normes particulières pour la sécurité et les performances essentielles des appareils concernés. Ce document annule et remplace la première édition de la CEI 60601-1-3, publiée en 1994 (qui a remplacé la CEI 407 publiée en 1973). Elle constitue une révision technique. La présente édition a été restructurée et alignée avec la CEI 60601-1 (2005) et traite des exigences générales pour la radioprotection qui s'appliquent à tous les appareils à rayonnement X de diagnostic. Les exigences particulières pour des appareils spécifiques ont été enlevées et seront couvertes dans des normes particulières. Pour une description des modifications, voir la correspondance présentée à l'Annexe C.

General Information

• Status: Published
• Publication Date: 25-Jan-2021
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: WG 37 - TC 62/SC 62B/WG 37
• Current Stage: PPUB - Publication issued
• Start Date: 22-Jan-2008
• Completion Date: 31-Jan-2008

Relations

• Amended By: IEC 60601-1-3:2008/AMD2:2021 - Amendment 2 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 05-Sep-2023
• Amended By: IEC 60601-1-3:2008/AMD1:2013 - Amendment 1 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• Effective Date: 05-Sep-2023

Overview

IEC 60601-1-3:2008, titled Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment, is an international standard published by the International Electrotechnical Commission (IEC). This collateral standard addresses critical safety requirements specifically related to radiation protection in diagnostic X-ray equipment. Its primary objective is to ensure that X-ray equipment used for medical imaging-such as diagnosis, treatment planning, and procedural guidance-provides adequate protection against harmful X-radiation exposure.

This standard aims to keep patient, operator, staff, and public radiation doses as low as reasonably achievable (ALARA principle) without compromising the effectiveness of radiological procedures. Applicable to X-ray equipment and relevant subassemblies producing radiological images of human patients, IEC 60601-1-3 defines general requirements and complements existing safety standards related to electrical energy control and performance.

Key Topics

• Radiation Protection Principles
  IEC 60601-1-3 establishes foundational guidelines to minimize exposure to X-radiation for patients, healthcare professionals, and the public, addressing both direct and scatter radiation risks.

• Equipment Identification and Marking
  The standard specifies marking requirements on X-ray equipment and parts, ensuring clear communication of safety and dosimetric information critical for safe operation.

• Radiation Dose Management
  Requirements include adjustment means for radiation dose and quality, reproducibility of X-ray outputs, and providing dosimetric calibration details to support reliable and safe imaging.

• Control of Radiation Exposure
  The document covers initiation and termination of irradiation cycles, safety measures against emission failure, and automatic control systems to guarantee precise and controlled radiation delivery.

• Radiation Beam Limitation and Positioning
  Standards for restricting the X-ray beam size, positioning of the patient, and alignment with image receptors to reduce unnecessary dose exposure are outlined.

• Protection Against Residual, Leakage, and Stray Radiation
  IEC 60601-1-3 provides requirements for limiting residual radiation after exposure, leakage radiation during operation, and stray radiation through shielding, distance, and equipment design.

• Documentation and Instructions
  Manufacturers must provide clear accompanying documents, including instructions for use with radiation protection information, dosimetric calibration data, and limits of beam energy and filtration.

• Alignment with General Medical Electrical Equipment Standards
  This collateral standard complements IEC 60601-1 (medical electrical equipment general requirements) and particular standards that cover device-specific performance and safety aspects.

Applications

IEC 60601-1-3 is essential for manufacturers, medical device testers, regulatory bodies, and healthcare providers involved in the design, testing, certification, and use of diagnostic X-ray systems. Its practical applications include:

• Ensuring the safety of diagnostic X-ray systems by limiting radiation doses during medical imaging procedures such as radiography, fluoroscopy, and computed tomography (CT).
• Providing a framework for radiation protection compliance in hospitals, clinics, and imaging centers to safeguard patients, operators, and staff from unnecessary exposure.
• Supporting risk management processes within healthcare technology to justify the implementation of radiation safety measures.
• Serving as a reference for the development and testing of X-ray device subassemblies like X-ray tubes and image receptors, focusing on their radiation emission properties.
• Guiding the preparation of technical documentation and user instructions, which are crucial for safe operation and maintenance.

Related Standards

• IEC 60601-1: Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
  Provides overarching safety requirements for all medical electrical equipment, including controls for electrical energy generating X-radiation.

• Particular Standards for Specific X-ray Equipment Types
  These documents address radiation protection and performance specifics for individual categories of diagnostic X-ray systems, complementing the general requirements of IEC 60601-1-3.

• ISO 4037: X and Gamma Reference Radiation for Calibrating Dosemeters and Dose Rate Meters
  Supports dosimetric calibration requirements referenced in IEC 60601-1-3.

• IEC 60788: X-ray Equipment, Electrical and Mechanical Safety
  Covers detailed safety considerations specific to X-ray generator components and assemblies.

---

IEC 60601-1-3:2008 is a critical international standard ensuring safe operation and radiation protection in diagnostic X-ray equipment, fostering best practices to minimize risks while supporting effective diagnostic procedures. Compliance with this standard benefits healthcare providers by facilitating safer patient outcomes and adherence to global safety regulations in medical imaging.

Standards Content (Sample)

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
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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
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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
– 14 – 60601-1-3 © IEC:2008
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 RADIATION
SOURCE as well as that which, for some types of X-RAY GENERATORS, has passed through the
RADIATION APERTURE before and after LOADING (for example one containing a grid controlled X-
RAY TUBE)
3.34
LOADING
in an X-RAY GENERATOR, act of supplying electrical energy to the ANODE of an X-RAY TUBE
3.35
LOADING FACTOR
factor influencing by its value the X-RAY TUBE LOAD, for example X-RAY TUBE CURRENT, LOADING
TIME, CONTINUOUS ANODE INPUT POWER, X-RAY TUBE VOLTAGE and PERCENTAGE RIPPLE
3.36
LOADING STATE
for an X-RAY GENERATOR, state from the end of the READY STATE, when the intended function of
the generator is initiated, until the end of the LOADING of the X-RAY TUBE
3.37
LOADING TIME
time determined according to a specific method, during which the ANODE INPUT POWER is
applied to the X-RAY TUBE
3.38
MEASURED VALUE
estimate of the TRUE VALUE of a quantity, derived from the INDICATED VALUE of a meter after
applying all relevant CORRECTION FACTORS
3.39
MEDICAL RADIOLOGY
branch of RADIOLOGY applied to human and veterinary medicine as well as to dentistry and
chiropractic
3.40
MODE OF OPERATION
for X-RAY EQUIPMENT the technical state defined by a configuration of several predetermined
LOADING FACTORS and other settings for RADIOSCOPY or RADIOGRAPHY, selectable
simultaneously by the operation of a single control
NOTE 1 Selection of a particular mode does not necessarily define the values of all the parameters affecting its
use.
NOTE 2 Values defined by selection of a particular mode are not necessarily invariable during its use.
3.41
NARROW BEAM CONDITION
arrangement for the measurement of a RADIATION QUANTITY in a NARROW BEAM of IONIZING
RADIATION
60601-1-3 © IEC:2008 – 15 –
3.42
NOMINAL X-RAY TUBE VOLTAGE
highest permitted X-RAY TUBE VOLTAGE for specific operating conditions
3.43
PATIENT ENTRANCE REFERENCE POINT
point intended to represent the intersection of the X-RAY BEAM AXIS with the ENTRANCE SURFACE
of the PATIENT
NOTE The geometries to be used for various X-RAY EQUIPMENT are given in the particular standards.
3.44
PERCENTAGE RIPPLE
for a HIGH-VOLTAGE GENERATOR, ratio of the difference between the highest and the lowest
values of a rectified voltage waveform during a cycle of the supply to the highest value,
expressed as a percentage
3.45
PERMANENT FILTRATION
the QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed
materials intercepting the X-RAY BEAM, that are not intended to be removed for any application
and are not provided with means for removal in NORMAL USE
3.46
PHANTOM
device intended to simulate parts of the PATIENT for test purposes
3.47
PRIMARY PROTECTIVE SHIELDING
PROTECTIVE SHIELDING for attenuating RESIDUAL RADIATION
3.48
PROTECTED AREA
defined area within an area under surveillance or within a CONTROLLED AREA which is
protected by STRUCTURAL SHIELDING or by distance so that the resulting level of RADIATION is
lower than the ambient level in the overall area of which it is a part
3.49
PROTECTIVE BARRIER
PROTECTIVE SHIELDING in the form of attenuating material provided for RADIOLOGICAL protection
3.50
PROTECTIVE DEVICE
in RADIOLOGY, device for the purpose of RADIOLOGICAL protection
Thus:
− PROTECTIVE CLOTHING:
− PROTECTIVE APRON;
− PROTECTIVE SKIRT;
− PROTECTIVE GLOVE;
− PROTECTIVE GLASSES;
− mobile PROTECTIVE BARRIER
– 16 – 60601-1-3 © IEC:2008
3.51
PROTECTIVE SHIELDING
in RADIOLOGY, material that limits the extent of the RADIATION BEAM or attenuates STRAY
RADIATION
NOTE PROTECTIVE SHIELDING may include materials provided for RADIOLOGICAL protection, or devices or materials
provided for other purposes, which attenuate IONIZING RADIATION.
3.52
QUALITY EQUIVALENT FILTRATION
quantitative indication of the FILTRATION effected by one or several layer(s) of reference
material(s) which, if substituted in a beam of specified RADIATION QUALITY under NARROW BEAM
CONDITION for the material under consideration, give(s) the same RADIATION QUALITY as for the
material under consideration. The QUALITY EQUIVALENT FILTRATION is expressed in suitable
submultiples of the metre together with the reference material(s)
3.53
RADIATION
propagation of emitted energy through space or through a material medium in the form of
waves or in the form of kinetic energy of particles
NOTE When unqualified, the term RADIATION usually refers to
– electromagnetic radiations according to frequency or origin such as: radiofrequency radiation, infra-red
radiation, visible radiation (light), ultraviolet radiation, X-RADIATION, gamma radiation;
– corpuscular radiations according to particles or origin such as: alpha radiation, beta radiation, electron
radiation, neutron radiation.
3.54
RADIATION APERTURE
aperture in the PROTECTIVE SHIELDING of a RADIATION SOURCE or in a BEAM LIMITING DEVICE, that
is intended to give passage to the RADIATION BEAM
3.55
RADIATION BEAM
in RADIOLOGY, spatial region limited in solid angle and containing a flux of IONIZING RADIATION
originating from a RADIATION SOURCE that is considered as a POINT SOURCE. LEAKAGE RADIATION
and SCATTERED RADIATION are considered not to form a RADIATION BEAM.
Thus: X-RAY BEAM
3.56
RADIATION CONDITION
description of RADIATION FIELDS by a set of electrical and geometrical parameters such as X-
RAY TUBE VOLTAGE, TOTAL FILTRATION and geometrical arrangements.
NOTE The term RADIATION CONDITION refers to a description of RADIATION FIELDS and not to a particular
set-up for testi
...

IEC 60601-1-3 ®
Edition 2.2 2021-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 60601-1-3 ®
Edition 2.2 2021-01
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.50; 13.280 ISBN 978-2-8322-9347-8

IEC 60601-1-3 ®
Edition 2.2 2021-01
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
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
– 2 – IEC 60601-1-3:2008+AMD1:2013
+AMD2:2021 CSV  IEC 2021
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
INTRODUCTION to Amendment 1 . 9
INTRODUCTION to Amendment 2 . 9
1 Scope, object and related standards . 10
1.1 Scope . 10
1.2 Object . 10
1.3 Related standards . 10
1.3.1 IEC 60601-1 . 10
1.3.2 Particular standards . 10
2 Normative references . 11
3 Terms and definitions . 11
4 General requirements . 21
4.1 Statement of compliance . 21
4.2 Composition of reference materials . 21
5 ME EQUIPMENT identification, marking and documents . 21
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts . 21
5.1.1 General . 21
5.1.2 Marking requirements in subclauses . 21
5.2 ACCOMPANYING DOCUMENTS . 21
5.2.1 References in subclauses . 22
5.2.2 Dosimetric calibration . 22
5.2.3 General requirements for the reference of subassemblies and
ACCESSORIES . 22
5.2.4 Instructions for use . 23
6 RADIATION management . 24
6.1 General . 24
6.2 Initiation and termination of the IRRADIATION . 25
6.2.1 Normal initiation and termination of the IRRADIATION . 25
6.2.2 Safety measures against failure of normal termination of the
IRRADIATION . 25
6.3 RADIATION dose and RADIATION QUALITY. 25
6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY . 25
6.3.2 Reproducibility of the RADIATION output . 25
6.4 Indication of operational states . 26
6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected . 26
6.4.2 Indication of LOADING STATE . 26
6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION . 26
6.4.4 Indication of automatic modes . 26
6.4.5 Dosimetric indications. 27
6.5 AUTOMATIC CONTROL SYSTEM . 27
6.6 SCATTERED RADIATION reduction . 27
6.7 Imaging performance . 27
6.7.1 General . 27
6.7.2 System performance . 27
6.7.3 Nominal focal spot value. 28

+AMD2:2021 CSV  IEC 2021
6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR . 28
7 RADIATION QUALITY . 28
7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT . 28
7.2 Waveform of the X-RAY TUBE VOLTAGE . 29
7.3 Indication of FILTER properties . 29
7.4 Test for FILTRATION by irremovable materials . 30
7.5 Test for ADDED FILTERS and materials . 30
7.6 Test for HALF-VALUE LAYER . 30
8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD
IMAGE RECEPTION AREA . 30
and
8.1 General . 30
8.2 Enclosure of X-RAY TUBES . 30
8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES . 31
8.4 Confinement of EXTRA-FOCAL RADIATION . 31
8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA . 31
8.5.1 General . 31
8.5.2 * FOCAL SPOT TO IMAGE RECEPTOR DISTANCE . 31
8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE
RECEPTION AREA . 31
8.5.4 Positioning of the PATIENT and restriction of the irradiated area . 32
9 FOCAL SPOT TO SKIN DISTANCE . 32
9.1 General . 32
9.2 Information in the ACCOMPANYING DOCUMENTS . 32
10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 32
10.1 General . 32
10.2 Information in the ACCOMPANYING DOCUMENTS . 32
11 Protection against RESIDUAL RADIATION . 33
12 * Protection against LEAKAGE RADIATION . 33
12.1 General . 33
12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS . 33
12.3 Statement of reference LOADING conditions . 34
12.4 LEAKAGE RADIATION in the LOADING STATE . 34
12.5 LEAKAGE RADIATION when not in the LOADING STATE . 35
13 Protection against STRAY RADIATION . 35
13.1 General . 35
13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA . 35
13.3 Protection by distance . 36
13.4 * Designated SIGNIFICANT ZONES OF OCCUPANCY . 36
13.5 Handgrips and control devices . 37
13.6 * Test for STRAY RADIATION . 37
Annex A (informative) General guidance and rationale . 39
Annex B (normative) Values of the series R'10 and R'20, ISO 497 . 41
Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1 . 42
Bibliography . 44
Index of defined terms used in this collateral standard . 46

Figure 1 – Example of presentation of data on STRAY RADIATION . 38

– 4 – IEC 60601-1-3:2008+AMD1:2013
+AMD2:2021 CSV  IEC 2021
Table 1 – Subclauses containing requirements for marking . 21
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 22
Table 3 – HALF-VALUE LAYERS in X-RAY EQUIPMENT . 29
Table B.1 – Values of the series R'10 and R'20, ISO 497 . 41

+AMD2:2021 CSV  IEC 2021
NTERNATIONAL 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,
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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
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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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
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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.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-1-3 edition 2.2 contains the second edition (2008) [documents 62B/673/FDIS
and 62B/683/RVD], its amendment 1 (2013) [documents 62B/895/CDV and 62B/907/RVC]
and its amendment 2 (2021) [documents 62B/1176/CDV and 62B/1227/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
– 6 – IEC 60601-1-3:2008+AMD1:2013
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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 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 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.
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
MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
– a specific characteristic of all
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 (*).

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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 the base publication and its amendments will
remain unchanged until the maintenance result date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

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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.

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INTRODUCTION to Amendment 1
The purpose of the first amendment to IEC 60601-1-3:2008 is to introduce changes to
reference the first amendment (2012) to IEC 60601-1:2005.

INTRODUCTION to Amendment 2
The purpose of this second amendment to IEC 60601-1-3:2008 is to introduce changes to
reference the second amendment (2020) to IEC 60601-1:2005.

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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

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
RADIATION in X-RAY EQUIPMENT, in order that the IRRADIATION of the human PATIENT,
against X-
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.
RADIATION PROTECTION aspects related to X-RADIATION only.
This collateral standard considers
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 60601-1:2005+A1:2012+A2:2020 alone;
• "this collateral standard" designates IEC 60601-1-3:2008+A1:2013+A2:2021 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.
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2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. 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
Amendment 1:2012
Amendment 2:2020
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+A1:2012+A2:2020, IEC 60788:2004 and the following apply.
NOTE An index of defined terms is found beginning on page 46.
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]

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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
RADIATION FIELD
device to limit the
+AMD2:2021 CSV  IEC 2021
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
ABSORBED DOSE and Q is the
is the product of Q and D, at a point in tissue, where D 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.

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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
+AMD2:2021 CSV  IEC 2021
3.31
IRRADIATION SWITCH
in RADIOLOGICAL EQUIPMENT, control device provided to initiate and/or stop IRRADIATION
3.32
IRRADIATION TIME
IRRADIATION determined according to specific methods, usually the time a rate
duration of an
of a RADIATION QUANTITY exceeds a specified level
3.33
LEAKAGE RADIATION
IONIZING RADIATION which has passed through the PROTECTIVE SHIELDING of a RADIATION
SOURCE as well as that which, for some types of X-RAY GENERATORS, has passed through the
RADIATION APERTURE before and after LOADING (for example one containing a grid controlled X-
RAY TUBE)
3.34
LOADING
in an X-RAY GENERATOR, act of supplying electrical energy to the ANODE of an X-RAY TUBE
3.35
LOADING FACTOR
factor influencing by its value the X-RAY TUBE LOAD, for example X-RAY TUBE CURRENT, LOADING
TIME, CONTINUOUS ANODE INPUT POWER, X-RAY TUBE VOLTAGE and PERCENTAGE RIPPLE
3.36
LOADING STATE
for an X-RAY GENERATOR, state from the end of the READY STATE, when the intended function of
LOADING of the X-RAY TUBE
the generator is initiated, until the end of the
3.37
LOADING TIME
time determined according to a specific method, during which the ANODE INPUT POWER is
applied to the X-RAY TUBE
3.38
MEASURED VALUE
estimate of the TRUE VALUE of a quantity, derived from the INDICATED VALUE of a meter after
applying all relevant CORRECTION FACTORS
3.39
MEDICAL RADIOLOGY
branch of RADIOLOGY applied to human and veterinary medicine as well as to dentistry and
chiropractic
3.40
MODE OF OPERATION
for X-RAY EQUIPMENT the technical state defined by a configuration of several predetermined
LOADING FACTORS and other settings for RADIOSCOPY or RADIOGRAPHY, selectable
simultaneously by the operation of a single control
NOTE 1 Selection of a particular mode does not necessarily define the values of all the parameters affecting its
use.
NOTE 2 Values defined by selection of a particular mode are not necessarily invariable during its use.
3.41
NARROW BEAM CONDITION
arrangement for the measurement of a RADIATION QUANTITY in a NARROW BEAM of IONIZING
RADIATION
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3.42
NOMINAL X-RAY TUBE VOLTAGE
highest permitted X-RAY TUBE VOLTAGE for specific operating conditions
3.43
PATIENT ENTRANCE REFERENCE POINT
RAY BEAM AXIS with the ENTRANCE SURFACE
point intended to represent the intersection of the X-
of the PATIENT
NOTE The geometries to be used for various X-RAY EQUIPMENT are given in the particular standards.
3.44
PERCENTAGE RIPPLE
for a HIGH-VOLTAGE GENERATOR, ratio of the differenc
...

IEC 60601-1-3 ®
Edition 2.1 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
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IEC 60601-1-3 ®
Edition 2.1 2013-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
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
INTERNATIONALE
ICS 11.040.50; 13.280 ISBN 978-2-8322-0765-9

– 2 – 60601-1-3  IEC:2008+A1:2013
CONTENTS
FOREWORD . 5
INTRODUCTION . 8
INTRODUCTION TO AMENDMENT 1 . 9

1 Scope, object and related standards . 10
1.1 Scope . 10
1.2 Object . 10
1.3 Related standards . 10
1.3.1 IEC 60601-1 . 10
1.3.2 Particular standards . 10
2 Normative references . 11
3 Terms and definitions . 11
4 General requirements . 21
4.1 Statement of compliance . 21
4.2 Composition of reference materials . 21
5 ME EQUIPMENT identification, marking and documents . 21
5.1 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts . 21
5.1.1 General . 21
5.1.2 Marking requirements in subclauses . 21
5.2 ACCOMPANYING DOCUMENTS . 21
5.2.1 References in subclauses . 22
5.2.2 Dosimetric calibration . 22
5.2.3 General requirements for the reference of subassemblies and
ACCESSORIES . 22
5.2.4 Instructions for use . 23
6 RADIATION management . 24
6.1 General . 24
6.2 Initiation and termination of the IRRADIATION . 25
6.2.1 Normal initiation and termination of the IRRADIATION . 25
6.2.2 Safety measures against failure of normal termination of the
IRRADIATION . 25
6.3 RADIATION dose and RADIATION QUALITY. 25
6.3.1 Adjustment of RADIATION dose and RADIATION QUALITY . 25
6.3.2 Reproducibility of the RADIATION output . 25
6.4 Indication of operational states . 26
6.4.1 Indication of the X-RAY SOURCE ASSEMBLY selected . 26
6.4.2 Indication of LOADING STATE . 26
6.4.3 Indication of LOADING FACTORS and MODES OF OPERATION . 26
6.4.4 Indication of automatic modes . 26
6.4.5 Dosimetric indications. 27
6.5 AUTOMATIC CONTROL SYSTEM . 27
6.6 SCATTERED RADIATION reduction . 27
6.7 Imaging performance . 27
6.7.1 General . 27
6.7.2 System performance . 27
6.7.3 Nominal focal spot value. 28

60601-1-3  IEC:2008+A1:2013 – 3 –
6.7.4 RADIATION DETECTOR or X-RAY IMAGE RECEPTOR . 28
7 RADIATION QUALITY . 28
7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENT . 28
7.2 Waveform of the X-RAY TUBE VOLTAGE . 29
7.3 Indication of FILTER properties . 29
7.4 Test for FILTRATION by irremovable materials . 30
7.5 Test for ADDED FILTERS and materials . 30
7.6 Test for HALF-VALUE LAYER . 30
8 Limitation of the extent of the X-RAY BEAM and relationship between X-RAY FIELD
and IMAGE RECEPTION AREA . 30
8.1 General . 30
8.2 Enclosure of X-RAY TUBES . 30
8.3 Limiting DIAPHRAGM in X-RAY TUBE ASSEMBLIES . 31
8.4 Confinement of EXTRA-FOCAL RADIATION . 31
8.5 Relationship between X-RAY FIELD and IMAGE RECEPTION AREA . 31
8.5.1 General . 31
8.5.2 * FOCAL SPOT TO IMAGE RECEPTOR DISTANCE . 31
8.5.3 Correspondence between X-RAY FIELD and EFFECTIVE IMAGE
RECEPTION AREA . 31
8.5.4 Positioning of the PATIENT and restriction of the irradiated area . 32
9 FOCAL SPOT TO SKIN DISTANCE . 32
9.1 General . 32
9.2 Information in the ACCOMPANYING DOCUMENTS . 32
10 ATTENUATION of the X-RAY BEAM between the PATIENT and the X-RAY IMAGE
RECEPTOR . 32
10.1 General . 32
10.2 Information in the ACCOMPANYING DOCUMENTS . 32
11 Protection against RESIDUAL RADIATION . 33
12 * Protection against LEAKAGE RADIATION . 33
12.1 General . 33
12.2 Mounting of X-RAY SOURCE ASSEMBLIES and X-RAY IMAGING ARRANGEMENTS . 33
12.3 Statement of reference LOADING conditions . 34
12.4 LEAKAGE RADIATION in the LOADING STATE . 34
12.5 LEAKAGE RADIATION when not in the LOADING STATE . 35
13 Protection against STRAY RADIATION . 35
13.1 General . 35
13.2 Control of X-RAY EQUIPMENT from a PROTECTED AREA . 35
13.3 Protection by distance . 36
13.4 * Designated SIGNIFICANT ZONES OF OCCUPANCY . 36
13.5 Handgrips and control devices . 37
13.6 * Test for STRAY RADIATION . 37

Annex A (informative) General guidance and rationale . 39
Annex B (normative) Values of the series R'10 and R'20, ISO 497 . 41
Annex C (informative) Mapping between this Edition 2 of IEC 60601-1-3 and Edition 1 . 42

Bibliography . 44

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Index of defined terms used in this collateral standard . 46

Figure 1 – Example of presentation of data on STRAY RADIATION . 38

Table 1 – Subclauses containing requirements for marking . 21
Table 2 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS . 22
Table 3 – HALF-VALUE LAYERS in X-RAY EQUIPMENT . 29

60601-1-3  IEC:2008+A1:2013 – 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.
This consolidated version of IEC 60601-1-3 consists of the second edition (2008)
[documents 62B/673/FDIS and 62B/683/RVD] and its amendment 1 (2013) [documents
62B/895/CDV and 62B/907/RVC]. It bears the edition number 2.1.
The technical content is therefore identical to the base edition and its amendment and
has been prepared for user convenience. A vertical line in the margin shows where the
base publication has been modified by amendment 1. Additions and deletions are
displayed in red, with deletions being struck through.

– 6 – 60601-1-3  IEC:2008+A1:2013
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 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 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.
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 (*).

60601-1-3  IEC:2008+A1:2013 – 7 –
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 the base publication and its amendment will
remain unchanged until the maintenance result date indicated on the IEC website under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.

– 8 – 60601-1-3  IEC:2008+A1:2013
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+A1:2013 – 9 –
INTRODUCTION TO AMENDMENT 1
The purpose of the first amendment to IEC 60601-1-3:2008 is to introduce changes to
reference the first amendment (2012) to IEC 60601-1:2005.

– 10 – 60601-1-3  IEC:2008+A1:2013
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 60601-1:2005+A1:2012 alone;
• "this collateral standard" designates IEC 60601-1-3:2008+A1:2013 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.
60601-1-3  IEC:2008+A1:2013 – 11 –
2 Normative references
The following referenced documents, in whole or in part, are normatively referenced in this
document and are indispensable for its application. 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
Amendment 1:2012
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+A1:2012, IEC 60788:2004 and the following apply.
NOTE An index of defined terms is found beginning on page 46.
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]

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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
RADIATION FIELD
device to limit the
60601-1-3  IEC:2008+A1:2013 – 13 –
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.

– 14 – 60601-1-3  IEC:2008+A1:2013
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
RADIOLOGY, plane or curved surface through which the RADIATION enters an irradiated object
in
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
NARROW BEAM CONDITIONS X-
thickness of a specified material, which attenuates under
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
60601-1-3  IEC:2008+A1:2013 – 15 –
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 RADIATION
SOURCE as well as that which, for some types of X-RAY GENERATORS, has passed through the
RADIATION APERTURE before and after LOADING (for example one containing a grid controlled X-
RAY TUBE)
3.34
LOADING
in an X-RAY GENERATOR, act of supplying electrical energy to the ANODE of an X-RAY TUBE
3.35
LOADING FACTOR
factor influencing by its value the X-RAY TUBE LOAD, for example X-RAY TUBE CURRENT, LOADING
TIME, CONTINUOUS ANODE INPUT POWER, X-RAY TUBE VOLTAGE and PERCENTAGE RIPPLE
3.36
LOADING STATE
for an X-RAY GENERATOR, state from the end of the READY STATE, when the intended function of
LOADING of the X-RAY TUBE
the generator is initiated, until the end of the
3.37
LOADING TIME
time determined according to a specific method, during which the ANODE INPUT POWER is
applied to the X-RAY TUBE
3.38
MEASURED VALUE
estimate of the TRUE VALUE of a quantity, derived from the INDICATED VALUE of a meter after
applying all relevant CORRECTION FACTORS
3.39
MEDICAL RADIOLOGY
branch of RADIOLOGY applied to human and veterinary medicine as well as to dentistry and
chiropractic
3.40
MODE OF OPERATION
for X-RAY EQUIPMENT the technical state defined by a configuration of several predetermined
LOADING FACTORS and other settings for RADIOSCOPY or RADIOGRAPHY, selectable
simultaneously by the operation of a single control
NOTE 1 Selection of a particular mode does not necessarily define the values of all the parameters affecting its
use.
NOTE 2 Values defined by selection of a particular mode are not necessarily invariable during its use.
3.41
NARROW BEAM CONDITION
arrangement for the measurement of a RADIATION QUANTITY in a NARROW BEAM of IONIZING
RADIATION
– 16 – 60601-1-3  IEC:2008+A1:2013
3.42
NOMINAL X-RAY TUBE VOLTAGE
highest permitted X-RAY TUBE VOLTAGE for specific operating conditions
3.43
PATIENT ENTRANCE REFERENCE POINT
point intended to represent the intersection of the X-RAY BEAM AXIS with the ENTRANCE SURFACE
of the PATIENT
NOTE The geometries to be used for various X-RAY EQUIPMENT are given in the particular standards.
3.44
PERCENTAGE RIPPLE
for a HIGH-VOLTAGE GENERATOR, ratio of the difference between the highest and the lowest
values of a rectified voltage waveform during a cycle of the supply to the highest value,
expressed as a percentage
3.45
PERMANENT FILTRATION
the QUALITY EQUIVALENT FILTRATION effected in an X-RAY TUBE ASSEMBLY by permanently fixed
materials intercepting the X-RAY BEAM, that are not intended to be removed for any application
and are not provided with means for removal in NORMAL USE
3.46
PHANTOM
device intended to simulate parts of the PATIENT for test purposes
3.47
PRIMARY PROTECTIVE SHIELDING
PROTECTIVE SHIELDING for attenuating RESIDUAL RADIATION
3.48
PROTECTED AREA
CONTROLLED AREA which is
defined area within an area under surveillance or within a
protected by STRUCTURAL SHIELDING or by distance so that the resulting level of RADIATION is
lower than the ambient level in the overall area of which it is a part
3.49
PROTECTIVE BARRIER
PROTECTIVE SHIELDING in the form of attenuating material provided for RADIOLOGICAL protection
3.50
PROTECTIVE DEVICE
in RADIOLOGY, device for the purpose of RADIOLOGICAL protection
Thus:
− PROTECTIVE CLOTHING:
− PROTECTIVE APRON;
− PROTECTIVE SKIRT;
− PROTECTIVE GLOVE;
− PROTECTIVE GLASSES;
− mobile PROTECTIVE BARRIER
60601-1-3  IEC:2008+A1:2013 – 17 –
3.51
PROTECTIVE SHIELDING
in RADIOLOGY, material that limits the extent of the RADIATION BEAM or attenuates STRAY
RADIATION
NOTE PROTECTIVE SHIELDING may include materials provided for RADIOLOGICAL protection, or devices or materials
provided for other purposes, which attenuate IONIZING RADIATION.
3.52
QUALITY EQUIVALENT FILTRATION
quantitative indication of the FILTRATION effected by one or several layer(s) of reference
material(s) which, if substituted in a beam of specified RADIATION QUALITY under NARROW BEAM
CONDITION for the material under consideration, give(s) the same RADIATION QUALITY as for the
material under consideration. The QUALITY EQUIVALENT FILTRATION is expressed in suitabl
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