EN IEC 81001-5-1 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHE NORM February2022 ICS 11.040.01; 35.240.80 English Version Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle (IEC 81001-5-1:2021) Logiciels de sante et securite, efficacite et srete des Gesundheitssoftwareund Gesundheits-IT-Systeme systemes TI de sante - Partie 5-1 : Surete - Activites du Sicherheit, Effektivitat und Security - Teil 5-1: Security - cycle de vie du produit Aktivitaten im Produktlebenszyklus (IEC 81001-5-1:2021) (IEC 81001-5-1:2021) This European Standard was approved by CENELEC on 2022-01-20. 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 ManagementCentreortoanyCENELECmember. 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 samestatusastheofficialversions. 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, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comite Europeen de Normalisation Electrotechnique Europaisches Komitee fir Elektrotechnische Normung CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @ 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref.No.EN IEC 81001-5-1:2022 E EN IEC 81001-5-1:2022 (E) European foreword The text of document 62A/1458/FDIS, future edition 1 of IEC 81001-5-1, prepared by SC 62A "Common aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 81001-5-1:2022. The following dates are fixed: latest date by which the document has to be implemented at national (dop) 2022-10-20 latest date by which the national standards conflictingwiththe(dow)2025-01-20 document have to be withdrawn Attention is drawn to the possibility that some of the elements of this document may be the subject of Any feedback and questions on this document should be directed to the users' national committee. A completelistingofthesebodiescanbefoundontheCENELECwebsite. The text of the International Standard IEC 81001-5-1:2021 was approved by CENELEC as a EuropeanStandardwithoutanymodification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 62304:2006 NOTE Harmonized as EN 62304:2006 (not modified) IEC 62443-3-2 NOTE Harmonized as EN IEC 62443-3-2 IEC62443-3-3 NOTE Harmonized as EN IEC 62443-3-3 IEC 62443-4-1:2018 NOTE Harmonized as EN IEC 62443-4-1:2018 (not modified) IEC 62443-4-2:2019 NOTE Harmonized as EN IEC 62443-4-2:2019 (not modified) IEC 62740:2015 NOTE Harmonized as EN 62740:2015 (not modified) IEC 82304-1:2016 NOTE Harmonized as EN 82304-1:2017 (not modified) ISO/TS14441 NOTE Harmonized as CEN ISO/TS 14441 ISO 14971:2019 NOTE Harmonized as EN ISO 14971:2019 (not modified) +A11:2021 ISO/IEC 27000:2018 NOTE Harmonized as EN ISO/IEC 27000:2020 (not modified) ISO 27789 NOTE Harmonized as EN ISO 27789 ISO 27799 NOTE Harmonized as EN ISO 27799 ISO/IEC29147 NOTEHarmonized as EN ISO/IEC 29147 ISO/IEC 30111 NOTE Harmonized as EN ISO/IEC 30111 2 EN IEC 81001-5-1:2022 (E) ISO 13485:2016 NOTE Harmonized as EN ISO 13485:2016 (not modified) +A11:2021 IEC 62366