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)
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.
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