IEC 61331-3:1998

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing and protective devices for gonads

IEC 61331-3:1998 applies to protective devices such as protective clothing for the protection of persons against X-radiation up to 150 kV, during radiological examinations and interventional procedures. It deals with general requirements on the accompanying documents, and on the design and materials used and with standard sizes, particular design features, minimum attenuation properties of materials, marking and standardized forms of statements of compliance with this standard. IEC 61331-3 covers protective clothing mainly for the protection of the operator, such as protective aprons, protective gloves, and protective mittens. It covers protective devices for gonads mainly for the protection of the patient, such as protective gonad aprons, scrotum shields, ovary shields, shadow shields.

Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical - Partie 3: Vêtements de protection et dispositifs de protection des gonades

La CEI 61331-3:1998 s'applique aux dispositifs de protection radiologique tels que les vêtements de protection radiologique pour la protection des personnes contre les rayonnements X jusqu'à 150 kV, au cours des examens radiologiques et des procédures interventionnelles. La présente norme traite des exigences générales relatives aux documents d'accompagnement concernant la conception ainsi que les matériaux utilisés et des tailles normalisées, des caractéristiques de conception particulières, des propriétés d'atténuation minimales des matériaux, du marquage et des formes normalisées de déclaration de conformité avec la présente norme. Elle couvre les vêtements de protection radiologique principalement destinés à la protection de l'opérateur, tels que les tabliers de protection radiologique, les gants de protection radiologique et les moufles de protection radiologique. Elle couvre aussi les dispositifs de protection radiologique des gonades pour la protection du patient, tels que les tabliers de protection radiologique des gonades, les écrans de protection radiologique du scrotum, les écrans de protection radiologique des ovaires et les écrans de protection anti-rayonnement.

General Information

• Status: Published
• Publication Date: 05-Nov-1998
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Start Date: 07-May-2014
• Completion Date: 26-Oct-2025

Relations

• Revised: IEC 61331-3:2014 - Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL
IEC
STANDARD
61331-3
First edition
1998-11
Protective devices against diagnostic
medical X-radiation –
Part 3:
Protective clothing and protective devices
for gonads
Dispositifs de protection radiologique
contre les rayonnements X pour diagnostic médical –
Partie 3:
Vêtements et dispositifs de protection radiologique
des gonades
Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are
available. For example, edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the
base publication, the base publication incorporating amendment 1 and the base
publication incorporating amendments 1 and 2.
Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken by
the technical committee which has prepared this publication, as well as the list of
publications issued, is to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL
IEC
STANDARD
61331-3
First edition
1998-11
Protective devices against diagnostic
medical X-radiation –
Part 3:
Protective clothing and protective devices
for gonads
Dispositifs de protection radiologique
contre les rayonnements X pour diagnostic médical –
Partie 3:
Vêtements et dispositifs de protection radiologique
des gonades
 IEC 1998  Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
Commission Electrotechnique Internationale
PRICE CODE
S
International Electrotechnical Commission
For price, see current catalogue

– 2 – 61331-3 © IEC:1998(E)
CONTENTS
Page
FOREWORD 4
...................................................................................................................
Clause
1 Scope and object 5
....................................................................................................
1.1 Scope 5
...........................................................................................................
1.2 Object 5
...........................................................................................................
2 Normative references 5
.............................................................................................
3 Terminology 6
...........................................................................................................
3.1 Degree of requirements 6
.................................................................................
3.2 Use of terms 6
................................................................................................
3.3 Defined terms 6
................................................................................................
4 General 6
.................................................................................................................
4.1 ACCOMPANYING DOCUMENTS 6
............................................................................
4.2 Language of the ACCOMPANYING DOCUMENTS 7
.................................................
4.3 General requirement on marking 7
...................................................................
4.4 Design 7
.........................................................................................................
4.5 Materials 7
......................................................................................................
5PROTECTIVE APRONS 8
................................................................................................
5.1 Design 8
..........................................................................................................
5.2 Materials 8
.......................................................................................................
5.3 Dimensions 9
...................................................................................................
5.4 Marking 9
.........................................................................................................
5.5 Statement of compliance 10
...............................................................................
6PROTECTIVE GLOVES 10
................................................................................................
6.1 Design 10
..........................................................................................................
6.2 Materials 11
.......................................................................................................
6.3 Dimensions 11
...................................................................................................
6.4 Marking 11
.........................................................................................................
6.5 Statement of compliance 12
...............................................................................
7PROTECTIVE MITTENS 12
...............................................................................................
7.1 Design 12
..........................................................................................................
7.2 Materials 13
.......................................................................................................
7.3 Dimensions 13
...................................................................................................
7.4 Marking 13
.........................................................................................................
7.5 Statement of compliance 14
...............................................................................
8PROTECTIVE GONAD APRONS 14
.....................................................................................
8.1 Design 14
..........................................................................................................
8.2 Materials 14
.......................................................................................................
8.3 Dimensions 14
...................................................................................................
8.4 Marking 15
.........................................................................................................
8.5 Statement of compliance 15
...............................................................................

61331-3 © IEC:1998(E) – 3 –
Clause Page
9SCROTUM SHIELDS 15
...................................................................................................
9.1 Design 16
..........................................................................................................
9.2 Materials 16
.......................................................................................................
9.3 Dimensions 16
...................................................................................................
9.4 Marking 16
.........................................................................................................
9.5 Statement of compliance 17
..............................................................................
10 OVARY SHIELDS 17
.......................................................................................................
10.1 Design 17
..........................................................................................................
10.2 Materials 17
.......................................................................................................
10.3 Dimensions 17
..................................................................................................
10.4 Marking 17
.........................................................................................................
10.5 Statement of compliance 18
...............................................................................
11 SHADOW SHIELDS 18
.....................................................................................................
11.1 Design 18
..........................................................................................................
11.2Materials 18
.......................................................................................................
11.3Dimensions 18
...................................................................................................
11.4Marking 18
.........................................................................................................
11.5 Statement of compliance 19
...............................................................................
Tables
1 Standard sizes of PROTECTIVE APRONS 9
.........................................................................
2 Standard sizes of PROTECTIVE GLOVES 11
.........................................................................
3 Standard sizes of PROTECTIVE GONAD APRONS 15
..............................................................
Figures
1 Inside dimensions of PROTECTIVE GLOVES 11
....................................................................
2 Inside minimum dimensions of PROTECTIVE MITTENS 13
....................................................
Annexes
A Terminology – Index of defined terms 20
.........................................................................
B Bibliography 21
...............................................................................................................

– 4 – 61331-3 © IEC:1998(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION –
Part 3: Protective clothing and protective devices for gonads
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61331-3 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
The text of this part is based on the following documents:
FDIS Report on voting
62B/347/FDIS 62B/357/RVD
Full information on the voting for the approval of this part can be found in the report on voting
indicated in the above table.
Annex A forms an integral part of this standard.
Annex B is for information only.
A bilingual version of this standard may be issued at a later date.

61331-3 © IEC:1998(E) – 5 –
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION –
Part 3: Protective clothing and protective devices for gonads
1 Scope and object
1.1 Scope
This part of International Standard IEC 61331 applies to PROTECTIVE DEVICES such as
PROTECTIVE CLOTHING for the protection of persons against X-RADIATION up to 150 kV, during
RADIOLOGICAL examinations and interventional procedures.
NOTE – PROTECTIVE DEVICES are not intended by themselves to provide complete protection of persons, but are
used to reduce the dose to persons where other methods of protection against X-RADIATION are insufficient or not
applicable.
1.2 Object
This standard deals with:
– general requirements on the ACCOMPANYING DOCUMENTS, and on design and materials used;
– standard sizes, particular design features, minimum ATTENUATION properties of materials,
marking and standardized forms of statements of compliance with this standard.
It covers PROTECTIVE CLOTHING mainly for the protection of the OPERATOR, such as:
– PROTECTIVE APRONS;
– PROTECTIVE GLOVES;
– PROTECTIVE MITTENS;
and PROTECTIVE DEVICES for gonads for the protection of the PATIENT, such as:
– PROTECTIVE GONAD APRONS;
– SCROTUM SHIELDS;
– OVARY SHIELDS;
– SHADOW SHIELDS.
The latter group of PROTECTIVE DEVICES is intended to be used during RADIOLOGICAL
examinations to minimize the effects of IRRADIATION on the reproductive organs particularly with
regard to genetic damage.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 61331. At the time of publication, the editions indicated
were valid. All normative documents are subject to revision, and parties to agreements based
on this part of IEC 61331 are encouraged to investigate the possibility of applying the most
recent editions of the normative documents indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
IEC 60788:1984, Medical radiology – Terminology
IEC 61331-1:1994, Protective devices against diagnostic medical X-radiation – Part 1:
Determination of attenuation properties of materials

– 6 – 61331-3 © IEC:1998(E)
3 Terminology
3.1 Degree of requirements
In this standard, certain terms which are not printed in SMALL CAPITALS have particular
meanings, as follows:
– "shall" indicates a requirement that is mandatory for compliance;
– "should" indicates a strong recommendation that is not mandatory for compliance;
– "may" indicates a permitted manner of complying with a requirement or of avoiding
the need to comply;
– "specified" is used to indicate definitive information stated by the MANUFACTURER in
ACCOMPANYING DOCUMENTS
or in other documentation relating to the equipment
under consideration, usually concerning its intended purpose, or the
parameters or conditions associated with its use or with testing to determine
compliance.
3.2 Use of terms
In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions
in IEC 60788, in this standard or in other IEC publications referenced in annex A.
NOTE – Attention is drawn to the fact that, in the case that the concept addressed is not strongly confined to the
definition given in one of the publications listed above, the corresponding term is printed in lower case letters.
An index of defined terms used in this standard is given in annex A.
3.3 Defined terms
For the purpose of this part of IEC 61331 the following additional definitions apply.
3.3.1
PROTECTIVE GONAD APRON
PROTECTIVE APRON worn by the PATIENT to protect the region of the gonads as an alternative to
the use of a SCROTUM SHIELD or an OVARY SHIELD; see rm-64-05 of IEC 60788
3.3.2
SHADOW SHIELD
PROTECTIVE DEVICE to intercept the RADIATION BEAM in the areas of the gonads, to be used when
a SCROTUM SHIELD and an OVARY SHIELD cannot be used
3.3.3
PROTECTIVE MITTEN
PROTECTIVE GLOVE with open palm and separated thumb used where full perception of touch is
essential
4 General
4.1 ACCOMPANYING DOCUMENTS
PROTECTIVE DEVICES shall not be provided without ACCOMPANYING DOCUMENTS.
The ACCOMPANYING DOCUMENTS shall contain information on the following:
a) identity of the items of PROTECTIVE DEVICE(S) to which they apply, by reference to type or to
individual items, as appropriate;

61331-3 © IEC:1998(E) – 7 –
b) description of all markings on the items, with explanation of their meanings;
c) INSTRUCTIONS FOR USE, which shall contain:
d) recommendations for storage when not in use;
e) recommendations for methods and materials to be used for cleaning and disinfection;
f) recommended method and frequency of periodic inspection by the USER in order to verify
the maintenance of ATTENUATION properties;
g) particulars of compliance with this standard.
Any information included in the ACCOMPANYING DOCUMENTS that is particularly intended to be
read by the PATIENT, shall be repeated in a separate part containing all such information.
4.2 Language of the ACCOMPANYING DOCUMENTS
This standard contains no requirements concerning the language(s) in which the
ACCOMPANYING DOCUMENTS provided are to be written.
Attention is drawn to the fact that when the ACCOMPANYING DOCUMENTS are written in a
language other than that in which they were originally drafted and approved by the
MANUFACTURER of the PROTECTIVE DEVICES, these documents shall be checked carefully by an
expert who, wherever possible, should be authorized by the MANUFACTURER to act in that
capacity.
The ACCOMPANYING DOCUMENTS shall state the language(s) in which they were originally
drafted, approved or supplied by the MANUFACTURER and shall give a reference identifying at
least one original version.
4.3 General requirement on marking
PROTECTIVE DEVICES shall be marked so that their correlation to the pertaining ACCOMPANYING
DOCUMENTS is ensured.
4.4 Design
4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS should be so designed that they
can be put on and taken off without assistance.
4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT shall be designed so that they can
be easily applied, and they should be designed so that they can be properly placed and, where
necessary, fixed by the PATIENTS themselves.
4.5 Materials
4.5.1 The materials effecting the ATTENUATION shall be homogeneously distributed and shall
contain elements of high atomic number.
4.5.2 The ATTENUATION properties shall not vary under conditions of NORMAL USE.
4.5.3 All outer and inner accessible surfaces of PROTECTIVE DEVICES shall be suitable for
cleaning and disinfection.
4.5.4 It shall not be possible to touch uncovered or uncoated surfaces of metallic lead or lead
compounds.
– 8 – 61331-3 © IEC:1998(E)
5 PROTECTIVE APRONS
NOTE – PROTECTIVE APRONS are intended to be worn by persons who are present in the EXAMINATION ROOM during
RADIOLOGICAL examinations with or without interventional procedures. They are intended primarily to protect the
main part of the body of the OPERATOR. To protect the complete body, additional protective devices have to be
used, for example thyroid shields, protective eye glasses or helmets.
For the purpose of this standard, four different categories of PROTECTIVE APRONS are defined:
– light PROTECTIVE APRONS;
– heavy PROTECTIVE APRONS;
– light closed PROTECTIVE APRONS;
– heavy closed PROTECTIVE APRONS.
NOTE – Light PROTECTIVE APRONS may be worn for example in the operating theatre and in the gypsum room, or if
the SIGNIFICANT ZONE OF OCCUPANCY is protected against STRAY RADIATION by other PROTECTIVE DEVICES, for example
fixed on the X-RAY EQUIPMENT.
5.1 Design
PROTECTIVE APRONS shall consist of one or more layers of protective material and shall be
designed to cover the front part of the body from the throat down to at least the knees, the
entire breastbone and the shoulders.
The width of the protective material on each shoulder shall be not less than 11 cm and these
shoulder pieces shall extend over the back of the shoulders for at least 15 cm.
Unprotected stitch holes fixing parts together shall be allowed only on the back of a PROTECTIVE
APRON.
NOTE – The X-RADIATION through stitch holes fixing the parts together may be neglected on the back because of
the relative movements between the OPERATOR and X-RAY SOURCE.
Closed PROTECTIVE APRONS shall be designed to cover, additionally:
– the sides of the body from not more than 10 cm below the armpit to at least half-way down
the thigh;
– the back down to the knees.
Closed PROTECTIVE APRONS should be designed to permit ventilation. For this purpose,
overlapping fastenings at the sides, the openings of which point towards the back, or a
fastening leaving uncovered a vertical slit in the middle of the back may be provided.
NOTE 1 PROTECTIVE APRONS may consist of two overlapping pieces, a vest and a skirt.
NOTE 2 PROTECTIVE APRONS may have provision for the attachment of additional material to increase the
ATTENUATION EQUIVALENT in areas where sensitive organs may be endangered during particular examinations.
NOTE 3 Closed PROTECTIVE APRONS may have overlapping fastenings at the front.
5.2 Materials
The protective material as well as any fabric covering and binding shall be flexible.
a) The ATTENUATION EQUIVALENT of light PROTECTIVE APRONS shall be not less than
0,25 mm Pb over their entire area.
b) The ATTENUATION EQUIVALENT of heavy PROTECTIVE APRONS shall be not less than
0,35 mm Pb for the front section, and not less than 0,25 mm Pb for the remaining parts.
c) The ATTENUATION EQUIVALENT of light closed PROTECTIVE APRONS shall be not less than
0,25 mm Pb over their entire area.
d) The ATTENUATION EQUIVALENT of heavy closed PROTECTIVE APRONS shall be not less than
0,35 mm Pb for the front section, and not less than 0,25 mm Pb for the remaining parts.

61331-3 © IEC:1998(E) – 9 –
5.3 Dimensions
PROTECTIVE APRONS shall be classified by size in accordance with table 1 and shall conform to
the dimensions given in table 1, according to their size classification.
Table 1 Standard sizes of
– PROTECTIVE APRONS
Standard size Letter Dimensions
symbol cm
AB C
Very short SV 90
Short SS 100
Small Medium SM 110 60 100
Long SL 120
Extra long SE 130
Very short MV 90
Short MS 100
Medium Medium MM 110 60 110
Long ML 120
Extra long ME 130
Short LS 100
Medium LM 110
Large  75        120
Long LL 120
Extra long LE 130
Dimension A is the length from the middle of the shoulder to the lower edge.
Dimension B is the width of the front panel and the width of the back panel of
closed PROTECTIVE APRONS with fasteners at the sides.
Dimension C is the girth of closed PROTECTIVE APRONS with a fastener in the
middle of the front or the back.
Dimensions A, B and C are minimum dimensions.
5.4 Mar
...

IEC 61331-3 ®
Edition 1.0 1998-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Protective devices against diagnostic medical X-radiation –
Part 3: Protective clothing and protective devices for gonads

Dispositifs de protection radiologique contre les rayonnements X pour
diagnostic médical –
Partie 3: Vêtements de protection et dispositifs de protection des gonades

Copyright © 1998 IEC, Geneva, Switzerland

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IEC 61331-3 ®
Edition 1.0 1998-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Protective devices against diagnostic medical X-radiation –

Part 3: Protective clothing and protective devices for gonads

Dispositifs de protection radiologique contre les rayonnements X pour

diagnostic médical –
Partie 3: Vêtements de protection et dispositifs de protection des gonades

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.50 ISBN 978-2-83220-531-0

– 2 – 61331-3 © IEC:1998
CONTENTS
FOREWORD . 4

1 Scope and object . 5
1.1 Scope . 5
1.2 Object . 5
2 Normative references. 5
3 Terminology . 6
3.1 Degree of requirements . 6
3.2 Use of terms . 6
3.3 Defined terms . 6
4 General . 6
4.1 ACCOMPANYING DOCUMENTS . 6
4.2 Language of the ACCOMPANYING DOCUMENTS . 7
4.3 General requirement on marking . 7
4.4 Design . 7
4.5 Materials . 7
5 PROTECTIVE APRONS . 8
5.1 Design . 8
5.2 Materials . 8
5.3 Dimensions . 9
5.4 Marking . 9
5.5 Statement of compliance . 10
6 PROTECTIVE GLOVES . 10
6.1 Design . 10
6.2 Materials . 11
6.3 Dimensions . 11
6.4 Marking . 12
6.5 Statement of compliance . 12
7 PROTECTIVE MITTENS . 13
7.1 Design . 13
7.2 Materials . 13
7.3 Dimensions . 13
7.4 Marking . 14
7.5 Statement of compliance . 14
8 PROTECTIVE GONAD APRONS . 15
8.1 Design . 15
8.2 Materials . 15
8.3 Dimensions . 15
8.4 Marking . 15
8.5 Statement of compliance . 16
9 SCROTUM SHIELDS . 16
9.1 Design . 16
9.2 Materials . 16
9.3 Dimensions . 16

61331-3 © IEC:1998 – 3 –
9.4 Marking . 17
9.5 Statement of compliance . 17
10 OVARY SHIELDS . 17
10.1 Design . 17
10.2 Materials . 17
10.3 Dimensions . 17
10.4 Marking . 18
10.5 Statement of compliance . 18
11 SHADOW SHIELDS . 18
11.1 Design . 18
11.2 Materials . 18
11.3 Dimensions . 18
11.4 Marking . 19
11.5 Statement of compliance . 19

Annex A (normative) Terminology – Index of defined terms . 20
Annex B (informative) Bibliography . 21

Figure 1 – Inside dimensions of PROTECTIVE GLOVES . 12
Figure 2 – Inside minimum dimensions of PROTECTIVE MITTENS . 14

Table 1 – Standard sizes of PROTECTIVE APRONS . 9
Table 2 – Standard sizes of PROTECTIVE GLOVES . 11
Table 3 – Standard sizes of PROTECTIVE GONAD APRONS . 15

– 4 – 61331-3 © IEC:1998
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION –

Part 3: Protective clothing and protective devices for gonads

FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the 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, the IEC publishes International Standards. 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. The 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 the 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 National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical reports or guides and they are accepted by the National Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61331-3 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This bilingual version (2012-11) corresponds to the monolingual English version, published in
1998-11.
The text of this part is based on the following documents:
FDIS Report on voting
62B/347/FDIS 62B/357/RVD
Full information on the voting for the approval of this part can be found in the report on voting
indicated in the above table.
The French version of this standard has not been voted upon.
Annex A forms an integral part of this standard.
Annex B is for information only.

61331-3 © IEC:1998 – 5 –
PROTECTIVE DEVICES AGAINST DIAGNOSTIC MEDICAL X-RADIATION –

Part 3: Protective clothing and protective devices for gonads

1 Scope and object
1.1 Scope
This part of International Standard IEC 61331 applies to PROTECTIVE DEVICES such as
PROTECTIVE CLOTHING for the protection of persons against X-RADIATION up to 150 kV, during
RADIOLOGICAL examinations and interventional procedures.
NOTE PROTECTIVE DEVICES are not intended by themselves to provide complete protection of persons, but are
used to reduce the dose to persons where other methods of protection against X-RADIATION are insufficient or not
applicable.
1.2 Object
This standard deals with:
– general requirements on the ACCOMPANYING DOCUMENTS, and on design and materials used;
– standard sizes, particular design features, minimum ATTENUATION properties of materials,
marking and standardized forms of statements of compliance with this standard.
It covers PROTECTIVE CLOTHING mainly for the protection of the OPERATOR, such as:
– PROTECTIVE APRONS;
– PROTECTIVE GLOVES;
– PROTECTIVE MITTENS;
and PROTECTIVE DEVICES for gonads for the protection of the PATIENT, such as:
– PROTECTIVE GONAD APRONS;
– SCROTUM SHIELDS;
– OVARY SHIELDS;
– SHADOW SHIELDS.
The latter group of PROTECTIVE DEVICES is intended to be used during RADIOLOGICAL
examinations to minimize the effects of IRRADIATION on the reproductive organs particularly with
regard to genetic damage.
2 Normative references
The following normative documents contain provisions which, through reference in this text,
constitute provisions of this part of IEC 61331. At the time of publication, the editions indicated
were valid. All normative documents are subject to revision, and parties to agreements based
on this part of IEC 61331 are encouraged to investigate the possibility of applying the most
recent editions of the normative documents indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
IEC 60788:1984, Medical radiology – Terminology

– 6 – 61331-3 © IEC:1998
IEC 61331-1:1994, Protective devices against diagnostic medical X-radiation – Part 1:
Determination of attenuation properties of materials
3 Terminology
3.1 Degree of requirements
In this standard, certain terms which are not printed in SMALL CAPITALS have particular
meanings, as follows:
– "shall" indicates a requirement that is mandatory for compliance;
– "should" indicates a strong recommendation that is not mandatory for compliance;
– "may" indicates a permitted manner of complying with a requirement or of avoiding
the need to comply;
– "specified" is used to indicate definitive information stated by the MANUFACTURER in
ACCOMPANYING DOCUMENTS or in other documentation relating to the equipment
under consideration, usually concerning its intended purpose, or the
parameters or conditions associated with its use or with testing to determine
compliance.
3.2 Use of terms
In this standard, terms printed in SMALL CAPITALS are used in accordance with their definitions
in IEC 60788, in this standard or in other IEC publications referenced in annex A.
NOTE – Attention is drawn to the fact that, in the case that the concept addressed is not strongly confined to the
definition given in one of the publications listed above, the corresponding term is printed in lower case letters.
An index of defined terms used in this standard is given in annex A.
3.3 Defined terms
For the purpose of this part of IEC 61331 the following additional definitions apply.
3.3.1
PROTECTIVE GONAD APRON
PROTECTIVE APRON worn by the PATIENT to protect the region of the gonads as an alternative to
the use of a SCROTUM SHIELD or an OVARY SHIELD; see rm-64-05 of IEC 60788
3.3.2
SHADOW SHIELD
PROTECTIVE DEVICE to intercept the RADIATION BEAM in the areas of the gonads, to be used when
a SCROTUM SHIELD and an OVARY SHIELD cannot be used
3.3.3
PROTECTIVE MITTEN
PROTECTIVE GLOVE with open palm and separated thumb used where full perception of touch is
essential
4 General
4.1 ACCOMPANYING DOCUMENTS
PROTECTIVE DEVICES shall not be provided without ACCOMPANYING DOCUMENTS.

61331-3 © IEC:1998 – 7 –
The ACCOMPANYING DOCUMENTS shall contain information on the following:
a) identity of the items of PROTECTIVE DEVICE(S) to which they apply, by reference to type or to
individual items, as appropriate;
b) description of all markings on the items, with explanation of their meanings;
c) INSTRUCTIONS FOR USE, which shall contain:
d) recommendations for storage when not in use;
e) recommendations for methods and materials to be used for cleaning and disinfection;
f) recommended method and frequency of periodic inspection by the USER in order to verify
the maintenance of ATTENUATION properties;
g) particulars of compliance with this standard.
Any information included in the ACCOMPANYING DOCUMENTS that is particularly intended to be
read by the PATIENT, shall be repeated in a separate part containing all such information.
4.2 Language of the ACCOMPANYING DOCUMENTS
This standard contains no requirements concerning the language(s) in which the
ACCOMPANYING DOCUMENTS provided are to be written.
Attention is drawn to the fact that when the ACCOMPANYING DOCUMENTS are written in a
language other than that in which they were originally drafted and approved by the
MANUFACTURER of the PROTECTIVE DEVICES, these documents shall be checked carefully by an
expert who, wherever possible, should be authorized by the MANUFACTURER to act in that
capacity.
The ACCOMPANYING DOCUMENTS shall state the language(s) in which they were originally
drafted, approved or supplied by the MANUFACTURER and shall give a reference identifying at
least one original version.
4.3 General requirement on marking
PROTECTIVE DEVICES shall be marked so that their correlation to the pertaining ACCOMPANYING
DOCUMENTS is ensured.
4.4 Design
4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS should be so designed that they
can be put on and taken off without assistance.
4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT shall be designed so that they can
be easily applied, and they should be designed so that they can be properly placed and, where
necessary, fixed by the PATIENTS themselves.
4.5 Materials
4.5.1 The materials effecting the ATTENUATION shall be homogeneously distributed and shall
contain elements of high atomic number.
4.5.2 The ATTENUATION properties shall not vary under conditions of NORMAL USE.
4.5.3 All outer and inner accessible surfaces of PROTECTIVE DEVICES shall be suitable for
cleaning and disinfection.
– 8 – 61331-3 © IEC:1998
4.5.4 It shall not be possible to touch uncovered or uncoated surfaces of metallic lead or lead
compounds.
5 PROTECTIVE APRONS
NOTE – PROTECTIVE APRONS are intended to be worn by persons who are present in the EXAMINATION ROOM during
RADIOLOGICAL examinations with or without interventional procedures. They are intended primarily to protect the
main part of the body of the OPERATOR. To protect the complete body, additional protective devices have to be
used, for example thyroid shields, protective eye glasses or helmets.
For the purpose of this standard, four different categories of PROTECTIVE APRONS are defined:
– light PROTECTIVE APRONS;
– heavy PROTECTIVE APRONS;
– light closed PROTECTIVE APRONS;
– heavy closed PROTECTIVE APRONS.
NOTE Light PROTECTIVE APRONS may be worn for example in the operating theatre and in the gypsum room, or if
the SIGNIFICANT ZONE OF OCCUPANCY is protected against STRAY RADIATION by other PROTECTIVE DEVICES, for example
fixed on the X-RAY EQUIPMENT.
5.1 Design
PROTECTIVE APRONS shall consist of one or more layers of protective material and shall be
designed to cover the front part of the body from the throat down to at least the knees, the
entire breastbone and the shoulders.
The width of the protective material on each shoulder shall be not less than 11 cm and these
shoulder pieces shall extend over the back of the shoulders for at least 15 cm.
Unprotected stitch holes fixing parts together shall be allowed only on the back of a PROTECTIVE
APRON.
NOTE The X-RADIATION through stitch holes fixing the parts together may be neglected on the back because of the
relative movements between the OPERATOR and X-RAY SOURCE.
Closed PROTECTIVE APRONS shall be designed to cover, additionally:
– the sides of the body from not more than 10 cm below the armpit to at least half-way down
the thigh;
– the back down to the knees.
Closed PROTECTIVE APRONS should be designed to permit ventilation. For this purpose,
overlapping fastenings at the sides, the openings of which point towards the back, or a
fastening leaving uncovered a vertical slit in the middle of the back may be provided.
NOTE 1 PROTECTIVE APRONS may consist of two overlapping pieces, a vest and a skirt.
NOTE 2 PROTECTIVE APRONS may have provision for the attachment of additional material to increase the
ATTENUATION EQUIVALENT in areas where sensitive organs may be endangered during particular examinations.
NOTE 3 Closed PROTECTIVE APRONS may have overlapping fastenings at the front.
5.2 Materials
The protective material as well as any fabric covering and binding shall be flexible.
a) The ATTENUATION EQUIVALENT of light PROTECTIVE APRONS shall be not less than
0,25 mm Pb over their entire area.

61331-3 © IEC:1998 – 9 –
b) The ATTENUATION EQUIVALENT of heavy PROTECTIVE APRONS shall be not less than
0,35 mm Pb for the front section, and not less than 0,25 mm Pb for the remaining parts.
c) The ATTENUATION EQUIVALENT of light closed PROTECTIVE APRONS shall be not less than
0,25 mm Pb over their entire area.
d) The ATTENUATION EQUIVALENT of heavy closed PROTECTIVE APRONS shall be not less than
0,35 mm Pb for the front section, and not less than 0,25 mm Pb for the remaining parts.
5.3 Dimensions
PROTECTIVE APRONS shall be classified by size in accordance with table 1 and shall conform to
the dimensions given in table 1, according to their size classification.
Table 1 – Standard sizes of PROTECTIVE APRONS
Standard size Letter Dimensions
symbol cm
A B C
Very short SV 90
Short SS 100
Small Medium SM 110 60 100
Long SL 120
Extra long SE 130
Very short MV 90
Short MS 100
Medium Medium MM 110 60 110
Long ML 120
Extra long ME 130
Short LS 100
Medium LM 110
Large   75        120
Long LL 120
Extra long LE 130
Dimension A is the length from the middle of the shoulder to the lower edge.
Dimension B is the width of the front panel and the width of the back panel of
closed PROTECTIVE APRONS with fasteners at the sides.
Dimension C is the girth of closed PROTECTIVE APRONS with a fastener in the
middle of the front or the back.
Dimensions A, B and C are minimum dimensions.

5.4 Marking
PROTECTIVE APRONS shall carry the information called for under items a) to f) below.
The information shall be marked clearly and permanently, and should be on a label. It shall
include the following:
– 10 – 61331-3 © IEC:1998
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) letter designating the type of PROTECTIVE APRON,
namely L (light), H (heavy), LC (light closed)
or HC (heavy closed) L, H, LC or HC
c) value(s) of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres,
as follows:
– for all PROTECTIVE APRONS, the value applying to the
front section and, if different, the value applying to the
back section Pb 0,35 (front)
Pb 0,25(back)
d) X-RAY TUBE VOLTAGE used for the determination
of the values of the ATTENUATION EQUIVALENT, appended to the
marking given in accordance with item c), by adding an oblique
stroke followed by the value of the X-RAY TUBE VOLTAGE in kilovolts / 100
The FILTRATION used for the determination of the ATTENUATION
EQUIVALENT shall depend on the X-RAY TUBE VOLTAGE according to
table 3 of IEC 61331-1.
e) letter symbols corresponding to the size according to table 1 LM
f) reference to this standard, given as "IEC 61331-3:1998".
5.5 Statement of compliance
If compliance of a PROTECTIVE APRON with this standard is to be stated, it shall be indicated, as
applicable, according to the following example:
1) 2) 3) 4) 5) 6)
Heavy protective apron xyz H Pb 0,35 /100 LM IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
for heavy PROTECTIVE APRON;
3)
ATTENUATION EQUIVALENT;
4)
X-RAY TUBE VOLTAGE (and FILTRATION);
5)
standard size (large medium);
6)
year of publication of this standard.
6 PROTECTIVE GLOVES
NOTE PROTECTIVE GLOVES are intended primarily to be worn by the OPERATOR during those RADIOLOGICAL
examinations or interventional procedures in which the hands and forearms need to be protected whilst in the
RADIATION BEAM or in high intensities of STRAY RADIATION.
6.1 Design
PROTECTIVE GLOVES shall cover the entire hand, without gaps, and at least half of the forearm.
They shall allow washable inner gloves to be worn.
PROTECTIVE GLOVES shall be designed so that the thumb is enclosed separately. The other
fingers should be enclosed separately. The axis of the thumb cover shall be turned against the
palm so as to allow the tip of the thumb to face the tip of the forefinger.

61331-3 © IEC:1998 – 11 –
PROTECTIVE GLOVES shall allow the fingers of the wearer to be closed with ease and the hand to
be moved sideways freely from the wrist.
PROTECTIVE GLOVES shall be made so that at least the required minimum ATTENUATION
EQUIVALENT is effective without any interruption over their entire surface, front and back,
including finger and wrist.
PROTECTIVE GLOVES shall be designed and manufactured so that any cracks and splitting of the
protective material used that could reduce its ATTENUATION properties can be identified by
visual examination.
Any external covering material shall be detachable in order that the protective material can be
examined during routine inspections.
6.2 Materials
The protective material and covering materials used for PROTECTIVE GLOVES shall be flexible.
The protective material of PROTECTIVE GLOVES shall have an ATTENUATION EQUIVALENT of not
less than 0,25 mm Pb over their entire area.
6.3 Dimensions
PROTECTIVE GLOVES may be stated to conform to the standard sizes given in table 2. If so, they
shall be substantially of the shape shown in figure 1 and shall comply with the inside
dimensions given in table 2.
Table 2 – Standard sizes of PROTECTIVE GLOVES
Standard Letter Inside dimension
size symbol cm
Length Half-
circumference
A B C D E
Small S 35 11 7 16 11
Medium M 35 11,5 7 17 12
Large L 35 12 7 18,5 13
Dimensions A to E are shown in figure 1; they are minimum dimensions.

– 12 – 61331-3 © IEC:1998
B
C
E
D
A
IEC  1 507/98
Figure 1 – Inside dimensions of PROTECTIVE GLOVES
6.4 Marking
Each PROTECTIVE GLOVE shall carry the information called for under items a) to e) below.
The information shall be marked clearly and permanently, and shall be attached to the glove
itself; the marking should be near the edge of the cuff and include the following:
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) value of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres Pb 0,25
RAY TUBE VOLTAGE used for the determination of the values
c) X-
of the ATTENUATION EQUIVALENT, appended to the marking given
in accordance with item b), by adding an oblique stroke followed
by the value of the X-RAY TUBE VOLTAGE in kilovolts / 100
The FILTRATION used for the determination of the
ATTENUATION EQUIVALENT shall depend on the X-RAY TUBE VOLTAGE
according to table 3 of IEC 61331-1.
d) if applicable, letter symbols corresponding to the size
according to table 2 MS
e) reference to this standard, given as "IEC 61331-3:1998".
6.5 Statement of compliance
6.5.1 If compliance of PROTECTIVE GLOVES with this standard is to be stated, it shall be
indicated as follows:
1) 2) 3) 4)
Protective glove xyz Pb 0,25 /100 IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
ATTENUATION EQUIVALENT;
3)
X-RAY TUBE VOLTAGE (and FILTRATION);
4)
year of publication of this standard.

61331-3 © IEC:1998 – 13 –
6.5.2 If, in addition, reference is made to a standard size according to table 2, this shall be
indicated by the corresponding letter symbols as follows:
1) 2) 3) 4) 5)
Protective glove xyz Pb 0,25 /100 MS IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
ATTENUATION EQUIVALENT;
3)
X-RAY TUBE VOLTAGE (and FILTRATION);
4)
standard size (medium);
5)
year of publication of this standard.
7 PROTECTIVE MITTENS
NOTE PROTECTIVE MITTENS with open palms are permitted for special procedures where full perception of touch is
essential, for example when handling syringes or during interventional procedures when the possibility cannot be
excluded that the hands or forearms of the OPERATOR come into the RADIATION BEAM or into an area of high
RADIATION intensity due to STRAY RADIATION.
7.1 Design
PROTECTIVE MITTENS shall cover the entire hand except the palm and the inside of the thumb,
and are intended to cover at least half of the forearm.
PROTECTIVE MITTENS shall allow the hand of the wearer to be closed with ease and to be moved
sideways freely from the wrist.
PROTECTIVE MITTENS shall be made so that at least the required minimum ATTENUATION
EQUIVALENT is effective without any interruption over their entire surface, except the palm and
the inside of the thumb.
PROTECTIVE MITTENS shall be designed and manufactured so that any cracks and splitting of the
protective material used that could reduce its ATTENUATION properties can be identified by
visual examination.
7.2 Materials
The protective material and covering materials used for PROTECTIVE MITTENS shall be flexible.
PROTECTIVE MITTENS shall have an ATTENUATION EQUIVALENT of not
The protective material of
less than 0,25 mm Pb over their entire area.
7.3 Dimensions
PROTECTIVE MITTENS may be stated to conform to the standard size given in figure 2. If so, they
shall be substantially of the shape shown in figure 2 and they shall comply with the inside
dimensions given in this figure.

– 14 – 61331-3 © IEC:1998
11 cm
16 cm
35 cm
IEC  1 508/98
Figure 2 – Inside minimum dimensions of PROTECTIVE MITTENS
7.4 Marking
Each PROTECTIVE MITTEN shall carry the information called for under items a) to e) below.
The information shall be marked clearly and permanently, and shall be attached to the mitten
itself; the marking should be near the edge of the cuff and shall include the following:
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) value of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres Pb 0,25
c) X-RAY TUBE VOLTAGE used for the determination of the
ATTENUATION EQUIVALENT, appended to the marking given
in accordance with item b), by adding an oblique stroke followed
by the value of the X-RAY TUBE VOLTAGE in kilovolts / 80
The FILTRATION used for the determination of the
ATTENUATION EQUIVALENT shall depend on the X-RAY TUBE VOLTAGE
according to table 3 of IEC 61331-1.
d) if applicable, the term "Standard size" Standard size
e) reference to this standard, given as "IEC 61331-3:1998".
7.5 Statement of compliance
If compliance of PROTECTIVE MITTENS with this standard is to be stated, it shall be indicated as
follows:
1) 2) 3) 4) 5)
Protective mitten xyz Pb 0,25 /80 Standard size IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
ATTENUATION EQUIVALENT;
3)
X-RAY TUBE VOLTAGE (and FILTRATION);
4)
if applicable;
5)
year of publication of this standard.

61331-3 © IEC:1998 – 15 –
8 PROTECTIVE GONAD APRONS
NOTE PROTECTIVE GONAD APRONS are intended to protect the gonads of PATIENTS during RADIOLOGICAL
examinations of organs other than those in the region of the lower abdomen, in particular during RADIOLOGICAL
examination of the thorax.
8.1 Design
PROTECTIVE GONAD APRONS shall be provided with means for attaching them to the PATIENT and
for keeping them in position during the RADIOLOGICAL examination.
8.2 Materials
The material of PROTECTIVE GONAD APRONS shall be flexible.
The ATTENUATION EQUIVALENT of PROTECTIVE GONAD APRONS shall be not less than 0,5 mm Pb
over their entire area.
8.3 Dimensions
PROTECTIVE GONAD APRONS shall be classified by size in accordance with table 3 and shall
conform to the dimensions shown in table 3.
Table 3 – Standard sizes of PROTECTIVE GONAD APRONS
Standard size Letter symbol Dimensions
cm
Length Width
Children 1 C1 20 25
Children 2 C2 30 30
Adults 1 A1 37 40
Adults 2 A2 40 45
The dimensions given are minimum dimensions.

8.4 Marking
PROTECTIVE GONAD APRONS shall carry the information called for under items a) to e) below.
The information shall be marked clearly and permanently, and include the following:
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) value of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres Pb 0,5
c) X-RAY TUBE VOLTAGE used for the determination of the values
of the ATTENUATION EQUIVALENT, appended to the marking given
in accordance with item b), by adding an oblique stroke followed
by the value of the X-RAY TUBE VOLTAGE in kilovolts / 100
The FILTRATION used for the determination of the
ATTENUATION EQUIVALENT shall depend on the X-RAY TUBE VOLTAGE
according to table 3 of IEC 61331-1.
d) letter symbols corresponding to the size according to table 3 A1
e) reference to this standard, given as "IEC 61331-3:1998".

– 16 – 61331-3 © IEC:1998
8.5 Statement of compliance
If compliance of a PROTECTIVE GONAD APRON with this standard is to be stated, it shall be
indicated as follows:
1) 2) 3) 4) 5)
Protective gonad apron xyz Pb 0,5 /100 A1 IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
ATTENUATION EQUIVALENT;
3)
X-RAY TUBE VOLTAGE (and FILTRATION);
4)
standard size (adults 1);
5)
year of publication of this standard.
9 SCROTUM SHIELDS
NOTE SCROTUM SHIELDS contoured to enclose the male gonads are intended to protect the gonads of PATIENTS
against unnecessary IRRADIATION by the RADIATION BEAM and against SCATTERED RADIATION when the gonads are
close to or within the properly limited RADIATION BEAM for example during RADIOLOGICAL examination of the pelvis.
For the purpose of this standard, two different categories of SCROTUM SHIELDS are defined:
– light SCROTUM SHIELDS;
– heavy SCROTUM SHIELDS.
ACCOMPANYING DOCUMENTS shall contain a
In addition to the requirements of 4.1 the
recommendation to use disposable plastic bags to enclose the scrotum or scrotum and penis,
for hygienic reasons.
9.1 Design
It is essential that the SCROTUM SHIELD fit around the scrotum, or the scrotum and penis,
without gaps.
SCROTUM SHIELDS shall be designed so that the PATIENT can easily put the shield into position
by himself.
The opening admitting the root of the scrotum, or scrotum and penis, shall be as small as
practicable.
SCROTUM SHIELDS shall be provided with the means for keeping them in position during the
entire RADIOLOGICAL examination.
The shields shall consist of protective material covered on all outer and inner surfaces with a
water-resistant material allowing for easy cleaning and disinfection.
9.2 Materials
a) The ATTENUATION EQUIVALENT of light SCROTUM SHIELDS shall be not less than 0,5 mm Pb
over their entire area.
b) The ATTENUATION EQUIVALENT of heavy SCROTUM SHIELDS shall be not less than 1,0 mm Pb
over their entire area.
9.3 Dimensions
SCROTUM SHIELDS shall be provided in a set of suitable sizes.

61331-3 © IEC:1998 – 17 –
9.4 Marking
SCROTUM SHIELDS shall carry the information called for under items a) to d) below.
The information shall be marked clearly and permanently, and include the following:
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) value of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres Pb 1,0
c) X-RAY TUBE VOLTAGE used for the determination of the values
of the ATTENUATION EQUIVALENT, appended to the marking given
in accordance with item b), by adding an oblique stroke followed
by the value of the X-RAY TUBE VOLTAGE in kilovolts / 100
The FILTRATION used for the determination of the
ATTENUATION EQUIVALENT shall depend on the X-RAY TUBE VOLTAGE
according to table 3 of IEC 61331-1.
d) reference to this standard, given as "IEC 61331-3:1998".
9.5 Statement of compliance
If compliance of a SCROTUM SHIELD with this standard is to be stated, it shall be indicated as
follows, for example:
1) 2) 3) 4)
Heavy scrotum shield xyz Pb 1,0 /100 IEC 61331-3:1998
1)
name or trade mark of MANUFACTURER or supplier;
2)
ATTENUATION EQUIVALENT;
3)
X-RAY TUBE VOLTAGE (and FILTRATION);
4)
year of publication of this standard.
10 OVARY SHIELDS
NOTE OVARY SHIELDS, which are often also called "ovarian shields", are intended to protect the gonads of female
PATIENTS against unnecessary IRRADIATION by the RADIATION BEAM when the ovaries are within the properly limited
RADIATION BEAM in the antero-posterior projection, for example during RADIOLOGICAL examination of the pelvis.
10.1 Design
OVARY SHIELDS shall be designed so that they can be applied easily and shall be provided with
means for keeping them in position during the entire RADIOLOGICAL examination.
The shields shall consist of protective material covered on all surfaces with a water-resistant
material allowing for easy cleaning and disinfection.
10.2 Materials
The ATTENUATION EQUIVALENT of OVARY SHIELDS shall be not less than 1,0 mm Pb over their
entire area.
10.3 Dimensions
Except when OVARY SHIELDS are provided with the facility to adjust them to different sizes, they
shall be provided in a set of suitable sizes.

– 18 – 61331-3 © IEC:1998
10.4 Marking
OVARY SHIELDS shall carry the information called for under items a) to d) below.
The information shall be marked clearly and permanently, and include the following:
Examples:
a) name or trade mark of MANUFACTURER or supplier xyz
b) value of the ATTENUATION EQUIVALENT in thickness of lead,
expressed as the symbol Pb followed by the thickness in millimetres Pb 1,0
c) X-RAY TUBE VOLTAGE used for the determination of the values
of the ATTENUATION EQUIVALENT, appended to the marking given
in accordance with item b), by adding an
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