EN 61331-2:2014

Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates

IEC 61331-2:2014 applies to translucent protective plates used for radiation protection in X-ray diagnosis and in X-ray therapy. It also applies to translucent protective plates used for protection against gamma radiation in nuclear medicine and brachytherapy with automatically-controlled afterloading equipment. It does not cover other translucent radiation protection materials, e.g. leaded glasses or goggles for protection of the operator's eyes (eye spectacles); leaded face shields, which cover the entire face of the operator; patient eye protection; and thyroid/neck protective devices. This Part 2 deals with the requirements on: - geometrical accuracy; - optical quality of the material; - spectral transmittance; - radiation attenuation properties; - marking; and - statement of compliance with this standard. This second edition cancels and replaces the first edition of IEC 61331-2, published in 1994. It constitutes a technical revision. This second edition has been adapted to apply to the present technology. The essential changes and extensions are: - extension of scope to cover all kinds of translucent protective plates and all kinds of radiation qualities and gamma radiation; - removal of definition and requirements for translucent protective plates for visual imaging; - changes of requirements concerning geometrical accuracy and optical quality; - changes of requirements concerning determination of lead equivalent and minimal thickness; and - changes of requirements concerning information and marking.

Strahlenschutz in der medizinischen Röntgendiagnostik - Teil 2: Durchsichtige Schutzplatten

Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical - Partie 2: Plaques translucides de protection radiologique

L'IEC 61331-2:2014 s'applique aux plaques translucides de protection radiologique utilisées pour la radioprotection dans le cadre du diagnostic médical et de la radiothérapie par rayonnement X. Elle s'applique également aux plaques translucides de protection radiologique utilisées pour la protection contre le rayonnement gamma en médecine nucléaire et en curiethérapie avec des appareils de projection de sources à contrôles automatiques. Elle ne couvre pas d'autres matériaux translucides de radioprotection, par exemple: - les verres ou lunettes protectrices au plomb pour les yeux des opérateurs (lunettes oculaires); - les écrans au plomb couvrant tout le visage de l'operateur; - les protections pour les yeux du patient; et - les dispositifs de protection radiologique pour la thyroïde ou le cou. La présente Partie 2 traite des exigences relatives: - à la précision géométrique; - à la qualité optique du matériau; - au facteur de transmission spectrale; - aux propriétés d'atténuation du rayonnement; - au marquage; et - à la déclaration de conformité à la présente norme. Cette deuxième édition annule et remplace la première édition de l'IEC 61331-2, parue en 1994. Elle constitue une révision technique. Cette deuxième édition a été adaptée pour s'appliquer à la technologie actuelle. Les principales modifications et extensions sont les suivantes: - extension du domaine d'application pour couvrir tous les types de plaques translucides de protection radiologique et tous les types de qualités de rayonnement et de rayonnement gamma; - suppression de la définition et des exigences pour les plaques translucides de protection radiologique en imagerie visuelle; - modification des exigences concernant la précision géométrique et la qualité optique; - modification des exigences concernant la détermination de L'équivalent plomb et de l'épaisseur minimale; et - modification des exigences concernant les informations et le marquage.

Sredstva za zaščito pred rentgenskim sevanjem pri medicinski diagnostiki - 2. del: Prosojne zaščitne plošče (IEC 61331-2:2014)

Ta del standarda IEC 61331 velja za PROSOJNE ZAŠČITNE PLOŠČE, ki se uporabljajo za ZAŠČITO PRED SEVANJEM pri rentgenskem diagnosticiranju in rentgenski terapiji. Velja tudi za PROSOJNE ZAŠČITNE PLOŠČE, ki se uporabljajo za zaščito pred SEVANEM GAMA v nuklearni medicini in pri BRAHITERAPIJI z avtomatsko krmiljeno napravo Z NAKNADNIM POLNJENJEM.
Standard ne obravnava drugih prosojnih materialov za ZAŠČITO PRED SEVANJEM, npr.
– osvinčenih očal ali varovalnih očal za zaščito oči UPRAVLJAVCA (očala za oči),
– osvinčenih obraznih ščitov, ki prekrivajo celoten obraz UPRAVLJAVCA,
– zaščite za oči PACIENTA in
– SREDSTEV ZA ZAŠČITO ščitnice/vratu.
Ta 2. del obravnava zahteve za
– geometrijsko natančnost;
– optično kakovost materiala;
– spektralno TRANSMITANCO;
– SLABILNE lastnosti sevanja;
– označevanje;
– izjavo o skladnosti s tem standardom.

General Information

• Status: Published
• Publication Date: 23-Oct-2014
• Withdrawal Date: 10-Jun-2017
• ICS: 11.040.50 - Radiographic equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62B - IEC_SC_62B
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 24-Oct-2014
• Completion Date: 24-Oct-2014
• Directive: 89/686/EEC - Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment
• Ref Project: SIST EN 61331-2:2014 - Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective plates

Relations

• Replaces: EN 61331-2:2002 - Protective devices against diagnostic medical X-radiation - Part 2: Protective glass plates
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2014
1DGRPHãþD
SIST EN 61331-2:2002
6UHGVWYD]D]DãþLWRSUHGUHQWJHQVNLPVHYDQMHPSULPHGLFLQVNLGLDJQRVWLNLGHO
3URVRMQH]DãþLWQHSORãþH,(&
Protective devices against diagnostic medical X-radiation - Part 2: Translucent protective
plates
/
Dispositifs de protection radiologique contre les rayonnements X pour diagnostic médical
- Partie 2: Plaques translucides de protection radiologique
Ta slovenski standard je istoveten z: EN 61331-2:2014
ICS:
11.040.50 Radiografska oprema Radiographic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61331-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.50 Supersedes EN 61331-2:2002
English Version
Protective devices against diagnostic medical X-radiation - Part
2: Translucent protective plates
(IEC 61331-2:2014)
Dispositifs de protection radiologique contre les Strahlenschutz in der medizinischen Röntgendiagnostik -
rayonnements X pour diagnostic médical - Partie 2: Plaques Teil 2: Durchsichtige Schutzplatten
translucides de protection radiologique (IEC 61331-2:2014)
(CEI 61331-2:2014)
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 61331-2:2014 E
Foreword
The text of document 62B/937/FDIS, future edition 2 of IEC 61331-2, 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 61331-2:2014.
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 61331-2:2002.
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 61331-2:2014 was approved by CENELEC as a European
Standard without any modification.
IEC 60601-2-17:2013 NOTE Harmonised as EN 60601-2-17:2014.

- 3 - EN 61331-2:2014
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 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
+A1 2012  +A1 2013
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 60601-2-8 2010 Medical electrical equipment -- Part 2-8: FprEN 60601-2-8 2010
Particular requirements for basic safety and
essential performance of therapeutic X-ray
equipment operating in the range 10 kV to 1
MV
IEC 61331-1 2014 Protective devices against diagnostic EN 61331-1 2014
medical X-radiation -- Part 1: Determination
of attenuation properties of materials
ISO 3534-1 2006 Statistics_- Vocabulary and symbols_- - -
Part_1: General statistical terms and terms
used in probability
IEC/TR 60788 2004 Medical electrical equipment - Glossary of - -
defined terms
ISO/IEC Guide 99 2007 International vocabulary of metrology - Basic - -
and general concepts and associated terms
(VIM)
IEC 61331-2 ®
Edition 2.0 2014-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Protective devices against diagnostic medical X-radiation –

Part 2: Translucent protective plates

Dispositifs de protection radiologique contre les rayonnements X pour

diagnostic médical –
Partie 2: Plaques translucides de protection radiologique

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX L
ICS 11.040.50 ISBN 978-2-8322-1563-0

– 2 – IEC 61331-2:2014 © IEC 2014
CONTENTS
FOREWORD . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Geometrical accuracy of translucent protective plates . 6
4.1 Flatness and minimum thickness . 6
4.2 Edges . 7
5 Optical quality of material . 7
5.1 Inhomogeneities . 7
5.2 Transmittance . 7
6 ATTENUATION properties . 7
6.1 Determination of LEAD EQUIVALENT . 7
6.2 Homogeneity . 7
6.3 Minimum thickness and LEAD EQUIVALENT . 7
6.4 Information . 8
7 Marking . 8
8 ACCOMPANYING DOCUMENTS . 9
9 Statement of compliance . 9
Bibliography . 10
Index of defined terms used in this International Standard . 11

Table 1 – Ratio of LEAD EQUIVALENT and minimum thickness for PROTECTIVE GLASS
PLATES . 8
Table 2 – Information and data for marking PROTECTIVE GLASS PLATES . 8

IEC 61331-2:2014 © IEC 2014 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
PROTECTIVE DEVICES AGAINST
DIAGNOSTIC MEDICAL X-RADIATION –

Part 2: Translucent protective plates

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-
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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
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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 61331-2 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 61331-2, published in 1994.
It constitutes a technical revision. This second edition has been adapted to apply to the
present technology.
The essential changes and extensions are:
extension of scope to cover all kinds of TRANSLUCENT PROTECTIVE PLATES and all kinds of
RADIATION QUALITIES and GAMMA RADIATION;
removal of definition and requirements for TRANSLUCENT PROTECTIVE PLATES for visual imaging;
changes of requirements concerning geometrical accuracy and optical quality;
changes of requirements concerning determination of LEAD EQUIVALENT and minimal thickness;

– 4 – IEC 61331-2:2014 © IEC 2014
changes of requirements concerning information and marking
The text of this standard is based on the following documents:
FDIS Report on voting
62B/937/FDIS 62B
...