CEN/TR 14715:2004

SLOVENSKI STANDARD
01-september-2004
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Safety of machinery - Ionizing radiation emited by machinery - Guidance for the
application of technical standards in the design of machinery in order to comply with
legislative requirements
Sicherheit von Maschinen - Von Maschinen emittierte ionisierende Strahlung - Leitfaden
zur Anwendung vontechnischen Normen bei der Konstruktion von Maschinen um den
gesetzlichen Anforderungen zu entsprechen
Sécurité des machines - Rayonnements ionisants émis par les machines - Guide pour
l'application des normes techniques dans la conception des machines afin de satisfaire
aux exigences réglementaires
Ta slovenski standard je istoveten z: CEN/TR 14715:2004
ICS:
13.110 Varnost strojev Safety of machinery
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN/TR 14715
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
June 2004
ICS 13.220.10
English version
Safety of machinery - Ionizing radiation emited by machinery -
Guidance for the application of technical standards in the design
of machinery in order to comply with legislative requirements
Sécurité des machines - Rayonnements ionisants émis par Sicherheit von Maschinen - Von Maschinen emittierte
les machines - Guide pour l'application des normes ionisierende Strahlung - Leitfaden zur Anwendung von
techniques dans la conception des machines afin de technischen Normen bei der Konstruktion von Maschinen
satisfaire aux exigences réglementaires um den gesetzlichen Anforderungen zu entsprechen

This Technical Report was approved by CEN on 3 November 2003. It has been drawn up by the Technical Committee CEN/TC 114.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 14715:2004: E
worldwide for CEN national Members.

Contents
1 Scope .4
2 Relevant legislation .4
2.1 European Directives .4
2.1.1 Machinery Directive 98/37/EC (Currently under revision) .4
2.1.2 Directive 96/29/EURATOM on Basic Safety Standards for the protection of the health of
workers and the general public against the dangers arising from ionizing radiation.4
2.2 National Legislation.5
3 Standard Technical Specifications .6
4 Other Sources of Information.6
5 Methodology for compliance with Machinery Directive - Radiation.6
5.1 General.6
5.2 Full compliance with ESR .7
5.3 Alternative approach to compliance with ESR .7
5.3.1 General.7
5.3.2 Reduction of emission levels .7
5.3.3 Methods for limiting the access to irradiated area.8
5.3.4 Further actions.9
6 Measurement of Radiation Emissions.9
7 Instructions for Use .9
Annex A (informative) Examples of technical standards relating to ionizing radiation emissions from
machinery .10
A.1 Type C Standards relating to machines that may emit ionizing radiation.10
A.2 Type B Standards on shielding properties of materials against ionizing radiation .15
A.3 Type B Standards relating to measurement of ionizing radiation emissions .16
Annex B (informative) Examples of documents published by International, European and national
organisations.26
Bibliography .27
Foreword
This document CEN/TR 14715:2004 has been prepared by Technical Committee CEN/TC 114 “Safety of
machinery”, the secretariat of which is held by DIN.
Annexes A and B are informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Report: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom
Introduction
Machines may emit ionizing radiation either from incorporated radioactive sources or high voltage accelerators (e.g.
X-ray machines). Exposure of people to ionizing radiation staying close to the machinery may present a risk to
health. To control these health risks, requirements are specified in European and National legislation. The
legislation that regulates the design, manufacture and supply of machines is the European Machinery Directive,
(98/37/EC). Systems for the protection of workers against the effects of ionizing radiation are specified in a
EURATOM Directive (96/29/EURATOM). Detailed technical features are set out in international, European and
national standards.
1 Scope
The purpose of this report is to give guidance on:
a) how to comply with the relevant legislative requirements, and
b) how to take into account the technical recommendations specified in International, European and National
Standards
when machines emitting ionizing radiation are designed and built.
2 Relevant legislation
2.1 European Directives
2.1.1 Machinery Directive 98/37/EC (Currently under revision)
One of the purposes of this Directive is to provide a uniform approach to maintaining or improving the level of
safety design of machinery. The Annex 1 to the Machinery Directive lists all the essential health and safety
requirements (ESRs) relating to the design and construction of machinery. Of these, ESR 1.5.10 for 'Radiation'
states:
"Machinery must be so designed and constructed that any emission of (Proposed amendment specifies both
ionizing and non-ionizing, Revision COM (2000) 899 final 2001-01-26) radiation is limited to the extent necessary
for its operation and that the effects on exposed persons are non-existent or reduced to non-dangerous
proportions."
This document gives guidance on how to comply with ESR 1.5.10 or, if it is not possible during the design or
building stage to reduce the emission levels to non-dangerous proportions, how to proceed in order to fulfil the
Machinery Directive.
When considering ionizing radiation emissions, there can be no impediment to supply of the machines within the
European Union if the requirements of the ESR 1.5.10 [ESR 1.6.11 in proposed Amendment, Revision COM (2000)
899 final 2001-01-26] have been achieved.
2.1.2 Directive 96/29/EURATOM on Basic Safety Standards for the protection of the health of workers and
the general public against the dangers arising from ionizing radiation
The requirements for the health protection of the general public and workers against the dangers of ionizing
radiation are laid down in Council Directive 96/29/EURATOM. This Directive is based on the principles put forward
by the International Commission for Radiation Protection (ICRP) in their Publication N° 60.
EURATOM Directive contains among others requirements such as:
a) maximum permissible doses compatible with adequate safety;
b) maximum permissible levels of exposure and contamination;
c) fundamental principles governing the health surveillance of workers.
In addition to the requirements for restricting exposure and dose limitation, the Council Directive 96/29/EURATOM
also make provisions for the appointment of qualified experts, designation of areas and workers, local rules,
monitoring the exposure of employees, medical supervision, notification of work activities, record keeping, etc.
There are also requirements for the investigation of high individual exposures and incidents or accidents involving
significant contamination or releases of radioactive material.
The EURATOM Directive requires potential users of sources of ionizing radiation either to give a prior report of their
intention to the relevant national authority (see article 3 (1) of EURATOM Directive) or to obtain an authorisation
from the national competent authority (see article 4 of EURATOM Directive).
As an exception, for sources considered as safe, article 3 (2) of EURATOM Directive allows the use of radioactive
substances or electrical apparatus emitting ionizing radiation without reporting or authorisation if specified
requirements are fulfilled.
For machines this exception apply if the following conditions are fulfilled:
a) machines containing radioactive sources which do not exceed defined quantities, in terms of activity or mass
activity concentration (see Annex 1 of EURATOM Directive);
b) machines containing radioactive sources exceeding the quantities or concentration values specified in a),
provided that:
1) it is of a type approved by the national competent authority;
2) if the incorporated radioactive source is constructed in the form of a sealed source;
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3) it does not cause, in normal operating conditions, a dose rate exceeding 1 μSv.h at a distance of 0,1 m
from any accessible surface of the machine;
4) conditions for disposal have been specified by the national competent authority;
c) operation of machines containing electrical apparatus provided that:
1) it is of a type approved by the national competent authority;
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2) it does not cause, in normal operating conditions, a dose rate exceeding 1 μSv.h at a distance of 0,1 m
from any accessible surface of the apparatus.
If a machine complies with one of the requirements specified under a), b) or c) it can be considered that the
machine complies also with the ESR 1.5.10 of Machinery Directive.
2.2 National Legislation
European Directives are directed at the Member States (MS), who have to incorporate the requirements into their
national legislation. National legislation for the design, construction and supply of machines have to contain
identical requirements to those set out in the Machinery Directive. European Directives for the protection of people
(e.g. 96/29/EURATOM) specify minimum requirements which may be more restrictively transcribed into national
legislation to provide a higher level of protection. Therefore users of machines emitting ionizing radiation will not
only have to comply with the national legislation arising from European Directives but also with any increased
national requirements to protect people.
3 Standard Technical Specifications
International, European and National Standards may give useful background material for designers, manufacturers
and users of machines emitting ionizing radiation. Standards may also provide technical specifications that are
relevant:
 to the measurement of ionizing radiation emissions;
 to describe techniques or give information on the reduction of emissions from machines;
 to provide data on the shielding properties of various materials.
Examples of such standards are listed in Annex A.
4 Other Sources of Information
It is recognised that there is a large volume of technical information available in the form of technical reports,
recommendations or professional guidelines giving useful background material for designers, manufacturers and
users of machines emitting ionizing radiation.
Organisations preparing such documents are for example:
 International Commission for Radiological Protection (ICRP);
 International Atomic Energy Agency (IAEA);
 Organisation for Economic Co-operation and Development/Nuclear Energy Agency (OEC
...