SIST EN 61331-3:2014

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields

This part of IEC 61331 applies to PROTECTIVE DEVICES such as PROTECTIVE CLOTHING and
EYEWEAR 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.
This standard deals with:
– general requirements on the ACCOMPANYING DOCUMENTS, on design and on materials used;
– sizing, 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;
– THYROID COLLARS;
– PROTECTIVE GLOVES;
– PROTECTIVE MITTENS;
– PROTECTIVE EYEWEAR;
and PROTECTIVE DEVICES for the protection of the PATIENT, such as:
– PROTECTIVE GONAD APRONS;
– SCROTUM SHIELDS;
– OVARY SHIELDS;
– SHADOW SHIELDS;
– PROTECTIVE APRONS FOR DENTAL USE.
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.

/

Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical - Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection pour le patient

L'IEC 61331-3:2014 s'applique aux dispositifs de protection radiologique tels que les vêtements de protection radiologique et les lunettes de protection radiologique pour la protection des personnes contre les rayonnements X jusqu'à 150 kV, au cours des examens radiologiques et des interventions. La présente norme traite des exigences générales relatives aux documents d'accompagnement, concernant la conception et les matériaux utilisés ainsi que des dimensions, des caractéristiques de conception particulières, des propriétés d'atténuation 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'operateur, tels que:
- les tabliers de protection radiologique;
- les cache-thyroïdes;
- les gants de protection radiologique;
- les moufles de protection radiologique; et
- les lunettes de protection radiologique. Elle couvre aussi les dispositifs de protection radiologique 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;
- les écrans de protection anti-rayonnement; et
- les tabliers de protection radiologique pour usage dentaire. Le dernier groupe de  dispositifs de protection radiologique est destiné à être utilisé au cours des examens radiologiques afin de réduire le plus possible les effets d'irradiation sur les organes reproducteurs, et en particulier les dommages génétiques. Cette deuxième édition annule et remplace la première édition de l'IEC 61331-3, parue en 1998. Elle constitue une révision technique. Cette deuxième édition a été adaptée pour s'appliquer à la technologie actuelle. Elle inclut une exigence pour l'utilisation d'une méthode améliorée pour la détermination des propriétés d'atténuation sur une plage plus large et avec une meilleure pertinence clinique de qualités de rayonnement appropriée à l'utilisation des appareils. Elle inclut trois dispositifs de protection radiologique supplémentaires, les cache-thyroïdes, les lunettes de protection radiologique et les tabliers de protection radiologique pour usage dentaire.

Sredstva za zaščito pred rentgenskim sevanjem pri medicinski diagnostiki - 3. del: Zaščitno oblačilo, zaščita za oči in zaščitni predpasnik za pacienta (IEC 61331-3:2014)

Ta del standarda IEC 61331 se uporablja za SREDSTVA ZA ZAŠČITO, kot so ZAŠČITNA OBLAČILA in ZAŠČITA ZA OČI za zaščito oseb pred RENTGENSKIM SEVANJEM do 150 kV, med RADIOLOŠKIMI pregledi in intervencijskimi postopki.
OPOMBA: SREDSTVA ZA ZAŠČITO sama po sebi niso namenjena zagotavljanju popolne zaščite oseb, ampak se uporabljajo za omejevanje odmerka, ki ga osebe prejmejo, kadar druge metode za zaščito pred RENTGENSKIM SEVANJEM niso zadostne ali jih ni mogoče uporabiti.
Ta standard obravnava:
– splošne zahteve za SPREMNE DOKUMENTE, zasnovo in uporabljene materiale;
– velikost, posamezne lastnosti zasnove, minimalne SLABILNE lastnosti materialov, oznake in standardizirane obrazce izjav o skladnosti s tem standardom.
Obravnava ZAŠČITNA OBLAČILA zlasti za zaščito UPRAVLJAVCA, kot so:
– ZAŠČITNI PREDPASNIKI;
– OVRATNIKI ZA ŠČITNICO;
– ZAŠČITNE ROKAVICE;
– ZAŠČITNI PALČNIKI;
– ZAŠČITA ZA OČI;
in SREDSTVA ZA ZAŠČITO za zaščito PACIENTA, kot so:
– PREDPASNIKI ZA ZAŠČITO SPOLNIH ŽLEZ;
– ŠČITI ZA MODA;
– ŠČITI ZA JAJČNIKE;
– SENČNI ŠČITI;
– ZAŠČITNI PREDPASNIKI ZA DENTALNO UPORABO.
Zadnja skupina SREDSTEV ZA ZAŠČITO je namenjena uporabi med RADIOLOŠKIMI pregledi, da se čim bolj omejijo učinki OBSEVANJA na reproduktivne organe, zlasti v zvezi s poškodbami genov.

General Information

• Status: Published
• Publication Date: 12-Nov-2014
• ICS: 11.040.50 - Radiographic equipment
• ICS: 13.280 - Radiation protection
• ICS: 13.340.10 - Protective clothing
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 04-Nov-2014
• Due Date: 09-Jan-2015
• Completion Date: 13-Nov-2014
• Ref Project: EN 61331-3:2014 - Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing, eyewear and protective patient shields

Relations

• Replaces: SIST EN 61331-3:1999 - Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing and protective devices for gonads
• Effective Date: 24-Apr-2012
• Replaces: SIST EN 61331-3:1999 - Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing and protective devices for gonads
• Effective Date: 29-Jan-2023
• Revised: SIST EN 61331-3:1999 - Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing and protective devices for gonads
• Effective Date: 06-May-2014
• Replaces: SIST EN 61331-3:1999 - Protective devices against diagnostic medical X-radiation -- Part 3: Protective clothing and protective devices for gonads
• Effective Date: 07-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 61331-3:2014
01-december-2014
1DGRPHãþD
SIST EN 61331-3:1999
6UHGVWYD]D]DãþLWRSUHGUHQWJHQVNLPVHYDQMHPSULPHGLFLQVNLGLDJQRVWLNLGHO
=DãþLWQRREODþLOR]DãþLWD]DRþLLQ]DãþLWQLSUHGSDVQLN]DSDFLHQWD,(&

Protective devices against diagnostic medical X-radiation - Part 3: Protective clothing,
eyewear and protective patient shields
/
Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical
- Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection pour le
patient
Ta slovenski standard je istoveten z: EN 61331-3:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
13.340.10 Varovalna obleka Protective clothing
SIST EN 61331-3:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 61331-3:2014

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SIST EN 61331-3:2014


EUROPEAN STANDARD EN 61331-3

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2014
ICS  Supersedes EN 61331-3:1999
English Version
Protective devices against diagnostic medical X-radiation - Part
3: Protective clothing, eyewear and protective patient shields
(IEC 61331-3:2014)
Dispositifs de protection radiologique contre les Strahlenschutz in der medizinischen Röntgendiagnostik -
rayonnements X pour diagnostic médical - Partie 3: Teil 3: Schutzkleidung, Augenschutz und Abschirmungen
Vêtements et lunettes de protection radiologique, écrans de für Patienten
protection pour le patient (IEC 61331-3:2014)
(CEI 61331-3:2014)
This European Standard was approved by CENELEC on 2014-06-11. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.



European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 61331-3:2014 E

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SIST EN 61331-3:2014
EN 61331-3:2014 - 2 -
Foreword
The text of document 62B/938/FDIS, future edition 2 of IEC 61331-3, prepared by SC 62B, "Diagnostic
imaging equipment", of IEC TC 62, "Electrical equipment in medical practice " was submitted to the IEC-
CENELEC parallel vote and approved by CENELEC as EN 61331-3:2014.
The following dates are fixed:
(dop) 2015-04-24
• latest date by which the document has
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2017-06-11
standards conflicting with the
document have to be withdrawn

This document supersedes EN 61331-3:2002.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.
Endorsement notice
The text of the International Standard IEC 61331-3:2014 was approved by CENELEC as a European
Standard without any modification.

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SIST EN 61331-3:2014
- 3 - EN 61331-3:2014

Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following 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.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD

applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year
IEC 60601-1 AMD 1 2012 Medical electrical equipment_- Part_1: - -
General requirements for basic safety and
essential performance; Amendment_1
IEC 60601-1 2005 Medical electrical equipment -- Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
  +EN 60601- 2010
1:2006/corrigendum
Mar. 2010
  +AC 2014
  +A11 2011
IEC 60601-1-3 2008 Medical electrical equipment -- Part 1-3: EN 60601-1-3 2008
General requirements for basic safety and
essential performance - Collateral Standard:
Radiation protection in diagnostic X-ray
equipment
  +EN 60601-1- 2010
3:2008/corrigendum
Mar. 2010
+A1 2013  +A1 2013
  +AC 2014
IEC 61331-1 2014 Protective devices against diagnostic EN 61331-1 2014
medical X-radiation -- Part 1: Determination
of attenuation properties of materials
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms

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SIST EN 61331-3:2014

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SIST EN 61331-3:2014



IEC 61331-3

®


Edition 2.0 2014-05




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE











Protective devices against diagnostic medical X-radiation –

Part 3: Protective clothing, eyewear and protective patient shields




Dispositifs de protection radiologique contre les rayonnements X pour

diagnostic médical –

Partie 3: Vêtements et lunettes de protection radiologique, écrans de protection


pour le patient














INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

CODE PRIX U


ICS 11.040.50 ISBN 978-2-8322-1564-7



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 61331-3:2014
– 2 – IEC 61331-3:2014 © IEC 2014
CONTENTS

FOREWORD . 5
1 Scope . 7
2 Normative references . 7
3 Terms and definitions. 8
4 General . 9
4.1 ACCOMPANYING DOCUMENTS . 9
4.2 Language of the ACCOMPANYING DOCUMENTS . 9
4.3 General requirement on marking . 9
4.4 Design . 9
4.4.1 PROTECTIVE DEVICES for the protection of OPERATORS . 9
4.4.2 PROTECTIVE DEVICES for the protection of the PATIENT . 10
4.5 Materials . 10
4.5.1 Materials effecting ATTENUATION . 10
4.5.2 Cleaning . 10
4.5.3 Touchable surfaces . 10
5 PROTECTIVE APRONS and THYROID COLLARS . 10
5.1 General . 10
5.2 Design . 10
5.3 Materials . 11
5.4 Dimensions . 11
5.5 Marking . 12
5.6 Statement of compliance . 12
6 PROTECTIVE GLOVES . 13
6.1 General . 13
6.2 Design . 13
6.3 Materials . 13
6.4 Dimensions . 13
6.5 Marking . 14
6.6 Statement of compliance . 15
7 PROTECTIVE MITTENS . 15
7.1 General . 15
7.2 Design . 15
7.3 Materials . 15
7.4 Dimensions . 15
7.5 Marking . 16
7.6 Statement of compliance . 16
8 PROTECTIVE GONAD APRONS . 17
8.1 General . 17
8.2 Design . 17
8.3 Materials . 17
8.4 Dimensions . 17
8.5 Marking . 17
8.6 Statement of compliance . 18

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SIST EN 61331-3:2014
IEC 61331-3:2014 © IEC 2014 – 3–
9 SCROTUM SHIELDS . 18
9.1 General . 18
9.2 Design . 18
9.3 Materials . 19
9.4 Dimensions . 19
9.5 Marking . 19
9.6 Statement of compliance . 19
10 OVARY SHIELDS . 19
10.1 General . 19
10.2 Design . 20
10.3 Materials . 20
10.4 Dimensions . 20
10.5 Marking . 20
10.6 Statement of compliance . 20
11 SHADOW SHIELDS . 21
11.1 General . 21
11.2 Design . 21
11.3 Materials . 21
11.4 Dimensions . 21
11.5 Marking . 21
11.6 Statement of compliance . 21
12 PROTECTIVE APRONS FOR DENTAL USE . 22
12.1 General . 22
12.2 Design . 22
12.3 Materials . 22
12.4 Dimensions . 22
12.5 Marking . 23
12.6 Statement of compliance . 23
13 PROTECTIVE EYEWEAR . 23
13.1 General . 23
13.2 Design . 23
13.3 Materials . 24
13.4 Marking . 24
13.5 Statement of compliance . 24
Bibliography . 25
Index of defined terms used in this standard . 26

Figure 1 – Inside dimensions of PROTECTIVE GLOVES . 14
Figure 2 – Inside minimum dimensions of PROTECTIVE MITTENS . 16

Table 1 – Information and examples for marking PROTECTIVE APRONS and THYROID
COLLARS . 12
Table 2 – Standard sizes of PROTECTIVE GLOVES . 14
Table 3 – Information and examples for marking PROTECTIVE GLOVES . 14
Table 4 – Information and examples for marking PROTECTIVE MITTENS . 16
Table 5 – Standard sizes of PROTECTIVE GONAD APRONS . 17

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SIST EN 61331-3:2014
– 4 – IEC 61331-3:2014 © IEC 2014
Table 6 – Information and examples for marking PROTECTIVE GONAD APRONS . 18
Table 7 – Information and examples for marking SCROTUM SHIELDS . 19
Table 8 – Information and examples for marking OVARY SHIELDS . 20
Table 9 – Information and examples for marking SHADOW SHIELDS . 21
Table 10 – Standard sizes of PROTECTIVE DENTAL APRONS . 22
Table 11 – Information and examples for marking PROTECTIVE APRONS. 23
Table 12 – Information and examples for marking PROTECTIVE EYEWEAR . 24

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SIST EN 61331-3:2014
IEC 61331-3:2014 © IEC 2014 – 5–
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

PROTECTIVE DEVICES AGAINST
DIAGNOSTIC MEDICAL X-RADIATION –

Part 3: Protective clothing, eyewear and protective patient shields

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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61331-3 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This second edition cancels and replaces the first edition of IEC 61331-3, published in 1998. It
constitutes a technical revision. This second edition has been adapted to apply to the present
technology. It includes a requirement to use a better method for the determination of
attenuation properties over a broader and more clinically relevant range of RADIATION
QUALITIES appropriate to the use of the devices. It also covers three additional protective
devices, THYROID COLLARS, PROTECTIVE EYEWEAR and PROTECTIVE APRONS FOR DENTAL
USE.

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SIST EN 61331-3:2014
– 6 – IEC 61331-3:2014 © IEC 2014
The text of this standard is based on the following documents:
FDIS Report on voting
62B/938/FDIS 62B/944/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– requirements and definitions: roman type;
– 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 THIS STANDARD OR AS NOTED: SMALL CAPS.
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.
A list of all parts of the IEC 61331 series, published under the general title Protective devices
against diagnostic medical X-radiation, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until the
stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data related to
the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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SIST EN 61331-3:2014
IEC 61331-3:2014 © IEC 2014 – 7–
PROTECTIVE DEVICES AGAINST
DIAGNOSTIC MEDICAL X-RADIATION –

Part 3: Protective clothing, eyewear and protective patient shields



1 Scope
This part of IEC 61331 applies to PROTECTIVE DEVICES such as PROTECTIVE CLOTHING and
for the protection of persons against X-RADIATION up to 150 kV, during RADIOLOGICAL
EYEWEAR
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.
This standard deals with:
– general requirements on the ACCOMPANYING DOCUMENTS, on design and on materials used;
– sizing, 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;
– THYROID COLLARS;
PROTECTIVE GLOVES;
–
– PROTECTIVE MITTENS;
– PROTECTIVE EYEWEAR;
and PROTECTIVE DEVICES for the protection of the PATIENT, such as:
– PROTECTIVE GONAD APRONS;
– SCROTUM SHIELDS;
– OVARY SHIELDS;
– SHADOW SHIELDS;
– PROTECTIVE APRONS FOR DENTAL USE.
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 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 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD 1:2012

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SIST EN 61331-3:2014
– 8 – IEC 61331-3:2014 © IEC 2014
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
IEC 60601-1-3:2008/AMD1:2013
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61331-1:2014, Protective devices against diagnostic medical X-radiation – Part 1:
Determination of attenuation properties of materials
EN 340:2003, Protective clothing – General requirements
EN 13402-3, Size designation of clothes – Part 3: Measurements and intervals
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC/TR 60788:2004,
IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 60601-1-3:2008 and IEC 60601-1-
3:2008/AMD1:2013 and the following apply.
3.1
AREA DENSITY
W
s
minimum mass per unit area of the protective material used to provide the required LEAD
EQUIVALENT of the device, at all of the stated test values of X-RAY TUBE VOLTAGES
–2
Note 1 to entry: AREA DENSITY is expressed in SI units as kg·m .
3.2
PROTECTIVE APRON FOR DENTAL USE
protective apron worn by the PATIENT to protect the region of the upper torso during
RADIOLOGICAL dental procedures
Note 1 to entry: Such an apron may have an accompanying THYROID COLLAR, separate or attached.
3.3
PROTECTIVE EYEWEAR
protective device made of transparent material to protect the eyes
3.4
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
Note 1 to entry: See also rm-64-05 of IEC TR 60788:2004.
3.5
PROTECTIVE MITTEN
protective glove with open palm and separated thumb used where full perception of touch is
essential
3.6
SHADOW SHIELD
protective device to intercept the radiation beam in the areas of the gonads
Note 1 to entry: A SHADOW SHIELD is to be used when a SCROTUM SHIELD and an OVARY SHIELD cannot be used.

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SIST EN 61331-3:2014
IEC 61331-3:2014 © IEC 2014 – 9–
3.7
THYROID COLLAR
protective device to cover the thyroid gland
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) identification 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) sizing information, in compliance with EN 340:2003 where appropriate, enabling garment
label size information to
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