EN IEC 63322 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM September2025 ICS11.040.50 English Version Security of ME equipment containing high-activity sealed radioactivesources (IEC 63322:2025) Securite des appareils EM contenant des sources Sicherheit medizinischer elektrischer Gerate, die radioactives scellees de haute activite 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 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 Turkiye and the United Kingdom. EuropeanCommitteeforElectrotechnical Standardization Comite Europeen de Normalisation Electrotechnique Europaisches Komitee fir 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.ENIEC63322:2025E ENIEC63322:2025 (E) European foreword for radiotherapy,nuclear medicine andradiation dosimetry"of IEC/TC62"Medical equipment, software, andsystems"was submittedto the IEC-CENELEC parallelvote andapproved byCENELEC asENIEC63322:2025 The following dates are fixed: latest date by which the document has to be implemented at national (dop) 2026-09-30 latest date by which the national standards conflicting withthe(dow) 2028-09-30 documenthavetobe withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.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 Anyfeedback 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 Thetextof theInternational StandardIEC63322:2025wasapprovedbyCENELECasa 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/IEC17025 NOTE Approved as ENISO/IEC 17025 ISO 14971:2019 NOTE Approved as EN ISO 14971:2019 (not modified)+A11:2021 ISO/TR24971:2020 NOTE ApprovedasCENISO/TR24971:2020 (notmodified) IEC 62366-1:2015 NOTE Approved as EN 62366-1:2015 (not modified) IEC62052-31:2024 NOTEApprovedasENIEC 62052-31:2024 (notmodified) IEC 61675-2:2015 NOTE Approved as EN 61675-2:2015 (not modified) IEC62598:2011 NOTEApproved as EN 62598:2013 (not modified) IEC 60601-2-64:2014 NOTE Approvedas EN60601-2-64:2015 (not modified) ISO/IEC80079-34:2018 NOTE Approved as ENISO/IEC 80079-34:2020 (notmodified) 2 ENIEC 63322:2025 (E) 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 undated references, the latest edition of the referenced document (including any amendments) applies. NOTE1 Where an International Publication has b