SIST EN IEC 63322:2025
(Main)Security of ME equipment containing high-activity sealed radioactive sources (IEC 63322:2025)
Security of ME equipment containing high-activity sealed radioactive sources (IEC 63322:2025)
IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.
Sicherheit medizinischer elektrischer Geräte, die hochradioaktive umschlossene Strahlenquellen enthalten (IEC 63322:2025)
Sécurité des appareils EM contenant des sources radioactives scellées de haute activité (IEC 63322:2025)
L'IEC 63322:2025 définit les exigences de sécurité relatives aux APPAREILS EM qui utilisent des SOURCES RADIOACTIVES SCELLEES de haute activité, directement ou indirectement, pour un traitement médical et d'autres procédures cliniques. Les APPAREILS EM qui contiennent des SOURCES RADIOACTIVES SCELLEES définies comme SOURCES RADIOACTIVES de Catégorie 1, 2 et 3 par l'AIEA [6] sont soumis au présent document. L'objet du présent document est de spécifier les exigences relatives à la sécurité des APPAREILS EM qui contiennent des SOURCES RADIOACTIVES SCELLEES de haute activité dans le but de réduire le plus possible le risque d'accès non autorisé aux SOURCES RADIOACTIVES SCELLEES contenues, et de servir de base à d'autres normes. Le présent document contient des exigences pour le FABRICANT des APPAREILS EM et, séparément, pour l'ORGANISME RESPONSABLE en ce qui concerne la sécurité sur le site pendant l'utilisation et le stockage. Les exigences du présent document s'appliquent lorsque les SOURCES RADIOACTIVES SCELLEES sont contenues dans les APPAREILS EM, c'est-à-dire à partir du moment auquel les SOURCES RADIOACTIVES SCELLEES sont insérées dans les APPAREILS EM, pendant l'UTILISATION PREVUE et lorsque les APPAREILS EM ne sont pas employés pour leur UTILISATION PREVUE ou sont retirés de l'utilisation normale, jusqu'à leur mise hors service, c'est-à-dire jusqu'au retrait définitif de toutes les SOURCES RADIOACTIVES SCELLEES des appareils.
Varnost medicinske električne (ME) opreme, ki vsebuje visokoaktivne zaprte radioaktivne vire (IEC 63322:2025)
Ta dokument določa varnostne zahteve za MEDICINSKO ELEKTRIČNO (ME) OPREMO, ki (ne)posredno uporablja visokoaktivne ZAPRTE RADIOAKTIVNE VIRE za medicinsko zdravljenje in druge klinične postopke.
Ta dokument obravnava MEDICINSKO ELEKTRIČNO OPREMO, ki vsebuje ZAPRTE RADIOAKTIVNE VIRE, ki jih IAEA [6] opredeljuje kot RADIOAKTIVNE VIRE kategorije 1, 2 in 3.
Cilj tega dokumenta je določitev zahtev za varnost MEDICINSKE ELEKTRIČNE OPREME, ki vsebuje visokoaktivne ZAPRTE RADIOAKTIVNE VIRE, da se zmanjša tveganje nepooblaščenega dostopa do ZAPRTIH RADIOAKTIVNIH VIROV, ter zagotovitev podlage za druge standarde. Ta dokument vsebuje zahteve za PROIZVAJALCA MEDICINSKE ELEKTRIČNE OPREME in ločeno za ODGOVORNO ORGANIZACIJO glede varnosti na lokaciji med uporabo in shranjevanjem.
Zahteve tega dokumenta se uporabljajo, kadar so ZAPRTI RADIOAKTIVNI VIRI v MEDICINSKI ELEKTRIČNI OPREMI, tj. od trenutka, ko so ZAPRTI RADIOAKTIVNI VIRI vstavljeni v MEDICINSKO ELEKTRIČNO OPREMO, med PREDVIDENO UPORABO in ko se MEDICINSKA ELEKTRIČNA OPREMA ne uporablja za PREDVIDENO UPORABO oziroma je izločena iz uporabe, do razgradnje opreme, tj. dokler niso vsi ZAPRTI RADIOAKTIVNI VIRI trajno odstranjeni iz opreme.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2025
Varnost medicinske električne (ME) opreme, ki vsebuje visokoaktivne zaprte
radioaktivne vire (IEC 63322:2025)
Security of ME equipment containing high-activity sealed radioactive sources (IEC
63322:2025)
Sicherheit medizinischer elektrischer Geräte, die hochradioaktive umschlossene
Strahlenquellen enthalten (IEC 63322:2025)
Sécurité des appareils EM contenant des sources radioactives scellées de haute activité
(IEC 63322:2025)
Ta slovenski standard je istoveten z: EN IEC 63322:2025
ICS:
11.040.50 Radiografska oprema Radiographic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 63322
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2025
ICS 11.040.50
English Version
Security of ME equipment containing high-activity sealed
radioactive sources
(IEC 63322:2025)
Sécurité des appareils EM contenant des sources Sicherheit medizinischer elektrischer Geräte, die
radioactives scellées de haute activité hochradioaktive umschlossene Strahlenquellen enthalten
(IEC 63322:2025) (IEC 63322:2025)
This European Standard was approved by CENELEC on 2025-09-01. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 63322:2025 E
European foreword
The text of document 62C/945/FDIS, future edition 1 of IEC 63322, prepared by SC 62C "Equipment
for radiotherapy, nuclear medicine and radiation dosimetry" of IEC/TC 62 "Medical equipment,
software, and systems" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC
as EN IEC 63322:2025.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-09-30
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-09-30
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 63322:2025 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standard indicated:
IEC 60601-2-11:2013 NOTE Approved as EN 60601-2-11:2015 (not modified)
IEC 60601-2-17:2013 NOTE Approved as EN 60601-2-17:2015 (not modified)
ISO/IEC 17025 NOTE Approved as EN ISO/IEC 17025
ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified) + A11:2021
ISO/TR 24971:2020 NOTE Approved as CEN ISO/TR 24971:2020 (not modified)
IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified)
IEC 62052-31:2024 NOTE Approved as EN IEC 62052-31:2024 (not modified)
IEC 61675-2:2015 NOTE Approved as EN 61675-2:2015 (not modified)
IEC 62598:2011 NOTE Approved as EN 62598:2013 (not modified)
IEC 60601-2-64:2014 NOTE Approved as EN 60601-2-64:2015 (not modified)
ISO/IEC 80079-34:2018 NOTE Approved as EN ISO/IEC 80079-34:2020 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments)
applies.
NOTE 1 Where 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.cencenelec.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
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
- - + A13 2024
IEC 63322 ®
Edition 1.0 2025-07
INTERNATIONAL
STANDARD
Security of ME equipment containing high-activity sealed radioactive sources
ICS 11.040.50 ISBN 978-2-8327-0530-8
IEC 63322:2025-07(en)
IEC 63322:2025 © IEC 2025
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Overview of requirements and responsibilities . 12
4.1 General . 12
4.2 ASSUMPTION OF THREAT . 12
4.3 VULNERABILITY assessment . 13
4.4 Required physical resistance of three groups of ME EQUIPMENT. 13
4.5 SECURITY CULTURE . 13
4.6 Responsibilities for the security of ME EQUIPMENT of SECURITY GROUPS A, B
and C . 13
4.6.1 General . 13
4.6.2 Overview of requirements for the MANUFACTURER . 14
4.6.3 Overview of requirements for the RESPONSIBLE ORGANIZATION . 14
5 Testing the compliance of ME EQUIPMENT of SECURITY GROUPs A, B and C with the
requirements of this document . 15
5.1 General . 15
5.2 TYPE TESTS and SITE TESTS . 15
5.3 Test grades. 15
5.3.1 For the MANUFACTURER . 15
5.3.2 For the RESPONSIBLE ORGANIZATION . 16
5.4 Determination of the physical resistance . 16
5.4.1 General . 16
5.4.2 Calculation of RESISTANCE VALUES to determine compliance with the
required RESISTANCE GRADE . 16
5.5 Certificate of compliance . 17
5.5.1 General . 17
5.5.2 Complying with the required RESISTANCE GRADE of the SECURED ME
EQUIPMENT . 17
6 Requirements for security of ME EQUIPMENT belonging to SECURITY GROUPs A, B
and C . 17
6.1 General . 17
6.2 SECURITY GROUP of the ME EQUIPMENT . 17
6.3 VULNERABILITY assessment performed by the MANUFACTURER . 18
6.4 Requirements for the SECURITY ARRANGEMENT of ME EQUIPMENT of SECURITY
GROUP A, B and C . 19
6.4.1 General . 19
6.4.2 Resistance requirements for STATIONARY ME EQUIPMENT of SECURITY
GROUPS A, B and C . 19
6.4.3 Resistance requirements for MOBILE ME EQUIPMENT of SECURITY GROUPS
A, B and C . 20
6.5 Requirements for INTRUSION detection for STATIONARY and MOBILE ME
EQUIPMENT . 20
6.6 Requirements on the interface between the system designed to detect
INTRUSION on the ME EQUIPMENT and the security system of the RESPONSIBLE
ORGANIZATION . 21
IEC 63322:2025 © IEC 2025
6.7 ACCOMPANYING DOCUMENTATION – SITE SECURITY GUIDE provided by the
MANUFACTURER . 21
6.8 Markings and identifications provided by the MANUFACTURER . 21
6.9 Replacement of a security component . 21
7 Requirements for the security of the location in which ME EQUIPMENT in SECURITY
GROUPS A, B and C is used or stored . 22
7.1 GENERAL . 22
7.2 VULNERABILITY assessment . 22
7.3 Requirements when ME EQUIPMENT is placed in a SECURE ROOM . 22
7.4 Markings and identifications provided by the RESPONSIBLE ORGANIZATION . 23
7.5 ACCESS CONTROL system. 23
7.6 Emergency procedures in the case of a security event . 24
7.7 Emergency during ongoing treatment . 24
7.8 SITE SECURITY MANUAL. 25
Annex A (informative) Background material . 26
A.1 Overview . 26
A.2 Scope (Clause 1) . 27
A.3 Normative references (Clause 2) . 28
A.4 Terms and definitions (Clause 3) . 28
A.5 Overview of requirements and responsibilities (Clause 4) . 29
A.6 General requirements for testing of ME EQUIPMENT of SECURITY GROUPS A, B
and C (Clause 5) . 30
A.7 Requirements for security of ME EQUIPMENT of SECURITY GROUPS A, B and C . 32
A.8 Requirements for security of the location in which the ME EQUIPMENT of
SECURITY GROUPS A, B and C is used or stored (Clause 7) . 34
Annex B (normative) Testing of physical resistance of SECURED ME EQUIPMENT –
Relationship between EN 1143-1:2019 and this document . 36
B.1 General . 36
B.2 Compliance and testing . 36
Annex C (normative) Test specifications and tables of attack tools . 37
C.1 Overview . 37
C.2 Classification and requirements . 37
C.3 TECHNICAL DOCUMENTATION . 38
C.4 Test specimen . 39
C.5 Tool attack test . 39
C.6 Anchoring strength test of SECURED ME EQUIPMENT with a mass less than
2 000 kg . 44
C.7 Test report . 46
C.8 Marking . 46
C.9 Tables of attack tools . 46
Annex D (informative) VULNERABILITY assessment . 53
D.1 Overview . 53
D.2 Background . 53
D.3 General aspects . 54
D.4 Ranking VULNERABILITIES and ACCESS PATHWAYS . 56
D.5 Reducing VULNERABILITIES . 56
D.6 VULNERABILITY assessment – MANUFACTURER . 58
D.7 VULNERABILITY assessment – RESPONSIBLE ORGANIZATION . 60
Bibliography . 63
IEC 63322:2025 © IEC 2025
Index of defined terms . 65
Figure C.1 – Example of loading equipment . 45
Figure D.1 – Examples of how VULNERABILITIES in an ACCESS PATHWAY can be
structured . 54
Table 1 – ME EQUIPMENT, SECURITY GROUPS and RESISTANCE GRADE requirements . 13
Table 2 – Resistance requirements for ME EQUIPMENT of SECURITY GROUP A to C . 18
Table A.1 – Overview of presently used ME-EQUIPMENT and associated SECURITY GROUP . 32
Table C.1 – Minimum requirements for classification of SECURED ME EQUIPMENT into
RESISTANCE GRADES . 38
Table C.2 – Hand (dis)assembling tools . 47
Table C.3 – Hand gripping tools . 47
Table C.4 – Hand levering tools . 47
Table C.5 – Hand sawing/filling/cutting and drilling tools . 48
Table C.6 – Hand hammering tools . 48
Table C.7 – Specially made tools . 48
Table C.8 – Electric powered tools, without impact . 49
Table C.9 – Electric powered tools, with impact option . 49
Table C.10 – Electric powered impacting machine tools, without rotation . 49
Table C.11 – Electric powered cutting/slitting machine tools . 50
Table C.12 – Thermal cutting/melting tools . 50
Table C.13 – Accessories for tools of Table C.2 up to Table C.12 . 51
Table C.14 – Miscellaneous "tools" . 52
Table C.15 – Non-tools . 52
Table D.1 – The 5 Ds of security . 55
Table D.2 – Dependencies . 57
IEC 63322:2025 © IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
Security of ME equipment containing high-activity
sealed radioactive sources
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) IEC draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). IEC takes no position concerning the evidence, validity or applicability of any claimed patent rights in
respect thereof. As of the date of publication of this document, IEC had not received notice of (a) patent(s), which
may be required to implement this document. However, implementers are cautioned that this may not represent
the latest information, which may be obtained from the patent database available at https://patents.iec.ch. IEC
shall not be held responsible for identifying any or all such patent rights.
IEC 63322 has been prepared by subcommittee SC 62C: Equipment for radiotherapy, nuclear
medicine and radiation dosimetry, of IEC technical committee TC 62: Medical equipment,
software, and systems. It is an International Standard.
The text of this International Standard is based on the following documents:
Draft Report on voting
62C/945/FDIS 62C/950/RVD
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this International Standard is English.
IEC 63322:2025 © IEC 2025
In this document, the following print types are used:
– requirements and definitions: roman type;
– test specifications: italic 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 IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn, or
• revised.
IEC 63322:2025 © IEC 2025
INTRODUCTION
st
Two new international treaties were entered into force in the early 21 century, namely the
International Convention on the Suppression of Acts of Nuclear Terrorism (2007) [1] and the
Amendment to the Convention on the Physical Protection of Nuclear Material (2016) [2].
International treaties contain obligations to be implemented by each State Party, i.e.,
commitments to make every effort to prevent unlawful access to radioactive materials, such as
SEALED RADIOACTIVE SOURCES. While the international treaties are binding to the State Parties,
they do not contain requirements that are directly applicable or useful for the different target
groups of this document, the MANUFACTURERS of ME EQUIPMENT and the RESPONSIBLE
ORGANIZATION as the equipment user. This document provides requirements on how to secure
ME EQUIPMENT in order to protect against unauthorized access of the SEALED RADIOACTIVE
SOURCES contained and on SECURITY ARRANGEMENTS in the location in which the ME EQUIPMENT
is used or stored. These requirements are consistent with the intentions and goals of the
international treaties.
Aware of the need and the urgency for a standard that aims at protecting ME EQUIPMENT
containing high-activity SEALED RADIOACTIVE SOURCES from unauthorized access, 20
participating members of the National Committees voted in February 2020 in favor of
establishing a security standard to address this risk.
This document complements safety standards for ME EQUIPMENT containing high-activity SEALED
RADIOACTIVE SOURCES, for example [3] and [4], by addressing security, and therefore deviates
somewhat from the structure established by IEC 60601-1 for standards that are defined as
safety standards only. This document does not in any way impact on the implementation of, or
adherence to, the requirements of IEC 60601-1 regarding BASIC SAFETY and ESSENTIAL
PERFORMANCE.
The MANUFACTURER and the RESPONSIBLE ORGANIZATION both have responsibilities for the secure
use of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES. This document
establishes security requirements for the two entities based on an assumption of the threat.
The requirements are strictly separated in different clauses for the MANUFACTURER and the
RESPONSIBLE ORGANIZATION to facilitate certification. The appropriate national regulators and
other competent organizations will provide additional input regarding the threat level and in
response to a security event. The MANUFACTURER of ME EQUIPMENT containing high-activity
SEALED RADIOACTIVE SOURCES will have responsibility for the requirements that relate to the ME
EQUIPMENT itself, such as the equipment's design, the use of materials and components, and
other measures that will increase the equipment's physical resistance against attempts to
remove the SEALED RADIOACTIVE SOURCES unlawfully, including devices that provide a warning
in case of such an attempt.
The RESPONSIBLE ORGANIZATION will have responsibility for the security requirements that relate
to the location where the equipment is used or stored, that the staff is well informed and that
there are actions planned in case there is a security event. The implementation of a SECURITY
CULTURE [5] supported by the leadership of the RESPONSIBLE ORGANIZATION will be both
necessary and important to maintain effectiveness of the security system.
The compliance with the requirements of this document will be objectively tested by an
accredited test house. A certificate will communicate compliance with this document and help
to build trust among the users and with patients and the public. The overall impact of all
measures taken by the MANUFACTURER and by the RESPONSIBLE ORGANIZATION will contribute to
reducing the risk that perpetrators can succeed in attempts to illegally access and remove the
SEALED RADIOACTIVE SOURCES from the ME EQUIPMENT.
___________
Numbers in square brackets refer to the Bibliography
IEC 63322:2025 © IEC 2025
The methodology, including the numerical parameters, expressed in EN 1143-1:2019 is used
to quantify the required physical resistance of SECURED ME EQUIPMENT against unauthorized
removal of the SEALED RADIOACTIVE SOURCES.
IEC 63322:2025 © IEC 2025
1 Scope
This document establishes security requirements of ME EQUIPMENT using high-activity SEALED
RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures.
ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3
RADIOACTIVE SOURCES by IAEA [6] are subject to this document.
The object of this document is to specify requirements for the security of ME EQUIPMENT
containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of
unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis
for other standards. This document contains requirements for the MANUFACTURER of the ME
and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location
EQUIPMENT
during use and storage.
The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained
in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into
the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for
its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e.
SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.
until all
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 60601-1:2005/AMD1:2020
EN 1143-1:2019, Secure storage units – Requirements, classification and methods of test for
resistance to burglary – Part 1: Safes, ATM safes, strongroom doors and strongrooms
EN 1300:2023, Secure storage units – Classification for high security locks according to their
resistance to unauthorized opening
EN 1627:2021, Pedestrian doorsets, windows, curtain walling, grilles and shutters - Burglar
resistance - Requirements and classification
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following
addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE The Nuclear safety and security glossary from the International atomic energy agency can also be used.
IEC 63322:2025 © IEC 2025
3.1
ASSUMPTION OF THREAT
set of assumptions used to set the level of the threat
Note 1 to entry: The ASSUMPTION OF THREAT is used when performing risk assessments in general and
VULNERABILITY assessments in particular.
3.2
ACCESS PATHWAY
AP
time-ordered steps in a path or route that one or more persons can take to arrive at the
target in the desired location
3.3
BASIC VALUE
BV
number in RESISTANCE UNITS allocated to a particular tool
Note 1 to entry: The BASIC VALUE represents problems in obtaining, transporting, conditions (e.g. water cooling and
power availability) and using the relevant tool at the site in question, and the necessary knowledge and experience
for its efficient use.
[SOURCE: EN 1143-1:2019, 3.16]
3.4
BOLTWORK
mechanism by which a closed door is held such that, until it is in the withdrawn position, the
door cannot be opened
Note 1 to entry: The term BOLTWORK is used only in Annex C.
[SOURCE: EN 1143-1:2019, 3.18], modified – The note to entry has been added.
3.5
CABINET
storage unit which protects its contents against burglary and when closed has at least one
internal side ≤ 1 m length
[SOURCE: EN 1143-1:2019, 3.1, modified – Adaptation from the definition of a safe.]
3.6
COMPLEMENTARY SECURITY ARRANGEMENT
temporary SECURITY ARRANGEMENT deemed necessary to protect against criminal or intentional
unauthorized acts during the time permanent protective measures are disabled or absent or
their effectiveness reduced
Note 1 to entry: An example of a COMPLEMENTARY SECURITY ARRANGEMENT is a guard on duty when all or a part of
the permanent protective measures are disabled, which can be the case during service and maintenance. Another
example when COMPLEMENTARY SECURITY ARRANGEMENTS can be needed is when moving an equipment between two
protected areas.
3.7
DUMMY SOURCE
source capsule without radioactive material inside with the same form and exterior dimensions
as the SEALED SOURCE used in the ME EQUIPMENT
Note 1 to entry: DUMMY SOURCES are used during testing of the ME EQUIPMENT to establish the RESISTANCE GRADE.
IEC 63322:2025 © IEC 2025
3.8
INTRINSIC SECURITY
protection against unauthorized attempts to remove the SEALED RADIOACTIVE SOURCES that is
either built into the ME EQUIPMENT, added to or attached to the ME EQUIPMENT during installation,
and that will remain attached to the ME EQUIPMENT during NORMAL USE
3.9
INTRUSION
unauthorized act of compromising a system
[SOURCE: IEC TS 62443-1-1:2009, 3.2.63, modified – The reference in the definition has been
deleted.]
3.10
INTRUSION DETECTION SYSTEM
system that contains the capability to detect an INTRUSION and also contains an alarm function
that is activated should an INTRUSION be detected
3.11
OPERATING TIME
time during which a tool is used attempting to create a change in the test specimen
Note 1 to entry: In the context of this document, there are also OPERATING TIMES considered during which no visible
modifications/changes are caused to the test specimen.
[SOURCE: EN 1143-1:2019, 3.12]
3.12
RESISTANCE GRADE
classification designation for burglary resistance
[SOURCE: EN 1143-1:2019, 3.14]
3.13
RESISTANCE UNIT
RU
burglary resistance which results from one minute's use of a tool carrying the coefficient 1 and
the BASIC VALUE 0
[SOURCE: EN 1143-1:2019, 3.13]
3.14
RESISTANCE VALUE
numerical value in RESISTANCE UNITS calculated for each test
[SOURCE: EN 1143-1:2019, 3.15]
3.15
SECURE ROOM
room with characteristics that provide protection against burglary and, when closed, has internal
side lengths in all directions > 1 m
Note 1 to entry: The definition is adapted from the definition of strongroom in EN 1143:2019-1, 3.4.
Note 2 to entry: In this document, a SECURE ROOM can either be 1) a radiation therapy treatment room or 2) a room
that has been modified to increase its resistance to burglary. The requirements that need to be fulfilled for a SECURE
ROOM are stated in 7.3.
IEC 63322:2025 © IEC 2025
3.16
SECURED ME EQUIPMENT
ME EQUIPMENT designed with INTRINSIC SECURITY, or ME EQUIPMENT placed in a CABINET or in a
SECURE ROOM that complies with the requirements for security in this document
3.17
SECURITY ARRANGEMENT
measures intended to protect against criminal or intentional unauthorized acts involving or
directed at SEALED RADIOACTIVE SOURCES
3.18
SECURITY CULTURE
assembly of characteristics, attitudes and behaviours of individuals, organizations and
institutions which serves as a means to support, enhance and sustain security
[SOURCE: IAEA Nuclear Safety and Security Glossary, 2022 (Interim) Edition, modified –
The term "nuclear security" has been replaced with "security".]
3.19
SECURITY GROUP
ME EQUIPMENT subject to this document that contains SEALED SOURCES of IAEA Category 1,
Category 2, or Category 3 are referred to three groups A, B and C, with different security
requirements
Note 1 to entry: The security requirements of the SECURITY GROUPS are based on a graded approach.
3.20
SITE SECURITY GUIDE
MANUFACTURER giving a suggested outline of the SECURITY
planning guide written by the
ARRANGEMENTS to be considered for the security of the location in which the ME EQUIPMENT is
used or stored
3.21
SITE SECURITY MANUAL
manual documenting the policies, procedures and SECURITY ARRANGEMENTS that the
RESPONSIBLE ORGANIZATION has adopted and implemented according to the requirements of this
document
3.22
TOOL COEFFICIENT
number in RESISTANCE UNITS per minute allocated to a group of tools
Note 1 to entry: The TOOL COEFFICIENT represents factors such as noise, smoke, fumes and other effects, which
increase the likelihood of a burglary attack being detected.
[SOURCE: EN 1143-1:2019, 3.17]
3.23
VULNERABILITY
physical feature or operational attribute that renders an entity, asset, system, network, facility,
activity or geographic area open to exploitation or susceptible to a given threat
[SOURCE: IAEA Nuclear Safety and Security Glossary, 2022 (Interim) Edition]
IEC 63322:2025 © IEC 2025
4 Overview of requirements and responsibilities
4.1 General
Both the MANUFACTURER and the RESPONSIBLE ORGANIZATION have responsibilities to ensure that
ME EQUIPMENT with high-activity SEALED RADIOACTIVE SOURCES can be used securely, and this
document includes separate requirements for the MANUFACTURER and for the RESPONSIBLE
. Clause 4 gives an overview of the requirements on the MANUFACTURER and the
ORGANIZATION
RESPONSIBLE ORGANIZATION. All explicit requirements are listed in Clauses 6 and 7, respectively.
The MANUFACTURER will address all requirements related to the design and construction of the
ME EQUIPMENT, and the RESPONSIBLE ORGANIZATION will address the requirements related to the
local installation and organizational measures to be implemented.
The SECURITY ARRANGEMENTS provided by the MANUFACTURER and by the RESPONSIBLE
shall not affect the INTENDED USE, the ESSENTIAL PERFORMANCE, BASIC SAFETY, and
ORGANIZATION
serviceability, as defined in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020 and in particular standards such as [3] and [4].
The requirements stated in this document for the ME EQUIPMENT shall be met whether the
SECURITY ARRANGEMENTS are integrated in the design and construction of a new ME EQUIPMENT
or if they are retrofitted to an existing model of the ME EQUIPMENT. For an existing model of the
ME EQUIPMENT, compliance with IEC 60601-1 will be based on the version in force at the time of
the original compliance assessment.
TECHNICAL DOCUMENTATION, manuals, and procedures required for the operation and storage of
the ME EQUIPMENT can contain security sensitive information. The MANUFACTURER and the
RESPONSIBLE ORGANIZATION shall ensure that the information is protected at the appropriate
level.
SSUMPTION OF THREAT
4.2 A
Security risk management and VULNERABILITY assessment shall be performed under the
ASSUMPTION OF THREAT:
following
• the INTRUSION is performed by one person, or a small group of persons, with intention to
perform an unauthorized act, and that could blend in with the categories of people that are
normally found at the site;
• an INSIDER can be involved;
• the location of the ME EQUIPMENT is known;
• the perpetrators have full information regarding the construction of the ME EQUIPMENT;
• operating procedures and control functions for the ME EQUIPMENT are known;
• the perpetrators will have access to hand/machine tools;
• the attack can be assisted by cyber INTRUSION into the ME EQUIPMENT's control system.
It is assumed that the tools carried by the perpetrators have capacities and characteristics that
are comparable to the capacities and characteristics of the tools used to test compliance of the
ME EQUIPMENT with the required RESISTANCE GRADE.
IEC 63322:2025 © IEC 2025
4.3 VULNERABILITY assessment
The VULNERABILITY of ME EQUIPMENT in this context is an assessment of the ease with which an
unauthorized person can access the ME EQUIPMENT itself, and then remove the SEALED
RADIOACTIVE SOURCES contained in the ME EQUIPMENT. The results of the VULNERABILITY
assessment serve as the basis for the design of the SECURITY ARRANGEMENTS required for the
ME EQUIPMENT, as well as for the SECURITY ARRANGEMENTS in the location in which the ME
EQUIPMENT is used or stored. The ASSUMPTION OF THREAT stated in 4.2 will be used in the
assessment. Annex D contains a guide to the performance of a VULNERABILITY assessment by
the MANUFACTURER and the RESPONSIBLE ORGANIZATION.
4.4 Required physical resistance of three groups of ME EQUIPMENT
The ME EQUIPMENT subject to this document contains SEALED RADIOACTIVE SOURCES with
different activities (denoted A). The IAEA has analyzed most radionuclides and established the
activity above which the security of the sources should be considered. This activity value is
referred to as the D-value of the radionuclide. The IAEA has grouped the sources into five
categories based on the A/D-ratios (denoted A/D-values). ME EQUIPMENT subject to this
document contains SEALED RADIOACTIVE SOURCES of IAEA Categories 1 to 3 (see also Annex A).
Such ME EQUIPMENT, for the purposes of this document, is grouped into three SECURITY GROUPS,
A, B and C according to Table 1.
Table 1 – ME EQUIPMENT, SECURITY GROUPS and RESISTANCE GRADE requirements
A/D-values Minimum required
SECURITY GROUP of
RADIOACTIVE SOURCE Category RESISTANCE GRADE of the
ME EQUIPMENT
SECURED ME EQUIPMENT
A 1 000 ≤ A/D 1 III
B 10 ≤ A/D < 1 000 2 II
C 3 I
1 ≤ A/D < 10
The specific security requirements for the different SECURITY GROUPS are given in Clause 6.
This document uses the methodology developed for EN 1143-1:2019 to define the requirement
of physical resistance for the SECURITY ARRANGEMENTS used for ME EQUIPMENT containing SEALED
RADIOACTIVE SOURCES. It also aligns to EN 1143-1:2019 for the procedure to be applied in the
TYPE TESTING of compliance with the required RESISTANCE GRADE. The methodology and testing
procedure are given in Annex B and Annex C.
4.5 SECURITY CULTURE
The impl
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