IEC 61331-2:2014

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

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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

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
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
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/943/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.
PROTECTIVE DEVICES AGAINST
DIAGNOSTIC MEDICAL X-RADIATION –

Part 2: Translucent protective plates

1 Scope
This part of IEC 61331 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),
OPERATOR,
− leaded face shields, which cover the entire face of the
− 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;
− statement of compliance with this standard.
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/AMD1:2012
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 60601-2-8:2010, Medical electrical equipment – Part 2-8: Particular requirements for
basic safety and essential performance of therapeutic X-ray equipment operating in the range
10 kV to 1 MV
IEC/TR 60788:2004, Medical electrical equipment – Glossary of defined terms

– 6 – IEC 61331-2:2014 © IEC 2014
IEC 61331-1:2014, Protective devices against diagnostic medical X-radiation – Part 1:
Determination of attenuation properties of materials
ISO/IEC Guide 99:2007, International vocabulary of metrology – Basic and general concepts
and associated terms (VIM)
ISO 3534-1:2006, Statistics – Vocabulary and symbols – Part 1: General statistical terms and
terms used in probability
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
PROTECTIVE GLASS PLATE
TRANSLUCENT PROTECTIVE PLATE consisting of mineral glass with SPECIFIED attenuation
properties used for manufacturing of optically clear and optically transparent protective
shielding
Note 1 to entry: Toughening impacts neither the attenuation properties nor optical and geometrical properties of
the TRANSLUCENT PROTECTIVE PLATE consisting of mineral glass.
3.2
PROTECTIVE PLASTIC PLATE
TRANSLUCENT PROTECTIVE PLATE consisting of translucent plastic material with specified
attenuation properties used for manufacturing of optically clear and optically transparent
protective shielding
3.3
TRANSLUCENT PROTECTIVE PLATE
plate consisting of translucent material with SPECIFIED attenuation properties used for
manufacturing of optically clear and optically transparent protective shielding
3.4
TRANSMITTANCE
τ
ratio of the transmitted radiant flux in the range of visible light to the incident flux in the range
of visible light in the given conditions
Note 1 to entry: SI unit: 1. In the practice of the glass-industry it is usual to specify the transmittance in terms of
%.
[SOURCE: IEC 60825-14:2004, 2.69, modified – the definition has been modified to specify
the "range of visible light" and the note to entry has been expanded to address an aspect of
the glass industry.]
4 Geometrical accuracy of translucent protective plates
4.1 Flatness and minimum thickness
On each of the two surfaces of a TRANSLUCENT PROTECTIVE PLATE all points shall be contained
between two parallel planes 0,3 mm apart.
The actual thickness of a TRANSLUCENT PROTECTIVE PLATE shall not be less than the minimum
thickness over its entire area.

The minimum thickness of TRANSLUCENT PROTECTIVE PLATES shall be indicated in units of
millimetres (mm).
NOTE The minimum thickness of the plate over its entire area is relevant for the effectiveness of RADIATION
PROTECTION.
4.2 Edges
The edges of PROTECTIVE GLASS PLATES shall be chamfered.
5 Optical quality of material
5.1 Inhomogeneities
Streaks, bubbles, inhomogeneities and faults of the surface which prevent optical clarity
should not occur.
5.2 Transmittance
PROTECTIVE GLASS PLATES shall have a TRANSMITTANCE equal to or greater than 80 % at a
glass thickness of 10 mm for light of a wavelength of 550 nm. The UNCERTAINTY of test
methods for determination of TRANSMITTANCE shall not exceed 2 %. This UNCERTAINTY applies
to a CONFIDENCE LEVEL of 95 %.
6 ATTENUATION properties
6.1 Determination of LEAD EQUIVALENT
NOTE The RADIATION PROTECTION shielding needed for a special purpose is usually estimated in thickness of
lead. Therefore it is necessary to know the LEAD EQUIVALENT of the TRANSLUCENT PROTECTIVE PLATE.
The LEAD EQUIVALENT of a TRANSLUCENT PROTECTIVE PLATE shall be determined and specified
according to the methods described in IEC 61331-1. LEAD EQUIVALENT shall be measured by
use of the NARROW BEAM CONDITION or BROAD BEAM CONDITION for appropriate standard
RADIATION QUALITIES chosen from Tables 1 and 2 of IEC 61331-1. If a measurement is not
possible because of a lack of suitable radiation sources, e.g. for special photon-emitting
RADIONUCLIDES, they shall be calculated according to the methods described in IEC 61331-1.
The chosen condition shall be indicated according to 6.4 and Clause 7, whereby N stands for
NARROW BEAM CONDITION, B stands for BROAD BEAM CONDITION and C is used in case of
calculated LEAD EQUIVALENT .
Both conditions are allowed, but the end user has to decide which condition is the most
suitable one for its application for RADIATION PROTECTION shielding.
6.2 Homogeneity
LEAD EQUIVALENT shall not be less than the specified value over the entire
The value of the
area of a TRANSLUCENT PROTECTIVE PLATE.
6.3 Minimum thickness and LEAD EQUIVALENT
NOTE 1 TRANSLUCENT PROTECTIVE PLATES are usually ordered by their LEAD EQUIVALENT. Therefore it is useful to
know the relation between a given minimum thickness and the corresponding LEAD EQUIVALENT.
The ratio of the LEAD EQUIVALENT as determined according to 6.1 and the minimum thickness
as determined according to 4.1 of a PROTECTIVE GLASS PLATE shall not be less than 0,22 for all
RADIATION QUALITIES listed in Table 1 of IEC 61331-1 with X-RAY TUBE VOLTAGES 50 kV to
150 kV. Examples of minimum thicknesses and their LEAD EQUIVALENT are given in Table 1.

– 8 – IEC 61331-2:2014 © IEC 2014
NOTE 2 The exact value of the ratio of the LEAD EQUIVALENT and the minimum thickness of a PROTECTIVE GLASS
PLATE depends on the RADIATION QUALITY.
Table 1 – Ratio of LEAD EQUIVALENT and minimum thickness for PROTECTIVE GLASS PLATES
Ratio of
Minimum thickness LEAD EQUIVALENT
LEAD EQUIVALENT and
mm mm Pb
minimum thickness
3,5 0,77 0,22
5 1,10 0,22
6 1,32 0,22
7 1,54 0,22
8,5 1,87 0,22
10 2,20 0,22
6.4 Information
Information about the LEAD EQUIVALENT shall be provided in mm Pb together with the method
used for the determination and the RADIATION QUALITY or radionuclide for which it is SPECIFIED
to be used.
Either the information shall be provided in the form of ACCOMPANYING DOCUMENTS or it shall be
ensured that the information can be obtained by using the marking according to Clause 7.
If care must be taken in the use of cleaning agents, sufficient guidance for proper cleaning
shall be contained in the ACCOMPANYING DOCUMENTS.
7 Marking
PROTECTIVE GLASS PLATE shall be permanently marked on one surface with the information as
indicated in Table 2. The marking shall be legible and recognizable from the other surface and
shall be affixed at a distance of not less than 10 mm from one corner.
Table 2 – Information and data for marking PROTECTIVE GLASS PLATES
INFORMATION Data
a Name of MANUFACTURER or supplier ABC
Trade mark or type of glass or identification DEF
b corresponding with ACCOMPANYING DOCUMENTS
Minimal thickness in brackets as determined (uvw)
c according to 4.2
EAD EQUIVALENT expressed in thickness of lead xy mmPb
L
d followed by the symbol Pb
Key indicator of beam condition for measurement N: NARROW BEAM
or calculation of LEAD EQUIVALENT B: BROAD BEAM
e C. calculated
X-RAY TUBE VOLTAGE or GAMMA RADIATION energy or See IEC61331-1
code of RADIONUCLIDE respectively according to 6.1
f
Statement of compliance with this International
g Standard according to Clause 9.

8 ACCOMPANYING DOCUMENTS
If PROTECTIVE GLASS PLATES are provided with ACCOMPANYING DOCUMENTS, the ACCOMPANYING
DOCUMENTS shall clearly state the identification of the PROTECTIVE GLASS PLATE to which they
refer.
All markings required in Clause 7 shall be stated in the ACCOMPANYING DOCUMENTS.
9 Statement of compliance
If for a PROTECTIVE GLASS PLATE compliance with this part of the International Standard shall
be stated, this shall be indicated as in the following example:
1) 2) 3) 4) 5) 6) 7)
protective glass plate ABC DEF (8,5) 2,5 mm Pb N 150 kV IEC 61331-2:2014
1) name of MANUFACTURER or supplier ;
2) trademark or type of glass;
3) minimum thickness;
4) LEAD EQUIVALENT;
5) indicator for beam condition of measurement or calculation of LEAD EQUIVALENT;
6) X-RAY TUBE VOLTAGE in kV or GAMMA RADIATION energy in keV or code of RADIONUCLIDE;
7) year of publication of this standard.

– 10 – IEC 61331-2:2014 © IEC 2014
Bibliography
IEC 60050-393:2003, International Electrotechnical Vocabulary – Part 393: Nuclear
instrumentation – Physical phenomena and basic concepts (withdrawn)
IEC 60601-2-17:2013, Medical electrical equipment – Part 2-17: Particular requirements for
the basic safety and essential performance of automatically-controlled brachytherapy
afterloading equipment
IEC 60825-14:2004, Safety of laser products – Part 14: A user's guide

Index of defined terms used in this International Standard
NOTE In the present document terms defined either in IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012,
IEC 60601-1-3:2008 and IEC 60601-1-3:2008/AMD1:2013, IEC 60601-2-8:2010, ISO/IEC guide 99,
IEC/TR 60788:2004, ISO 3534-1:2006 or in this International Standard have been used. These defined terms can
be looked up at the IEC website http://std.iec.ch/glossary .
ACCOMPANYING DOCUMENTS . IEC 60601-1:2005, 3.4
AFTERLOADING . IEC/TR 60788:2004, rm-42-54
BRACHYTHERAPY . IEC 60601-2-8:2010, 201.3.201
BROAD BEAM CONDITION . IEC/TR 60788:2004, rm-37-25
CONFIDENCE LEVEL . IEC 60050-393:2003, 393-18-31
GAMMA RADIATION . IEC 60601-1-3:2008, 3.53
LEAD EQUIVALENT . IEC/TR 60788:2004, rm-13-38
MANUFACTURER .
...