UNE Spanish standard UNE-EN IS0 81060-2:2020/A2 Normalizaclon Espafiola November 2024 Non-invasive sphygmomanometers Part 2: Clinical investigation of intermittent automated measurement type Amendment 2 (IS0 81060-2:2018/Amd 2:2024) This amendment has been prepared by the Technical Committee CTN-UNE 111 Surgical and medical devices the Tecnologia Fenin Sanitaria Secretariat of which is held by FENIN. AsociacionEspanola Calle de Génova, 6 915294900 de Normalizacion 28004 Madrid. Espana info@une.org - www.une.org UNE-EN IS0 81060-2:2020/A2 Non-invasive sphygmomanometers Part 2: Clinical investigation of intermittent automated measurement type Amendment 2 (IS0 81060-2:2018/Amd 2:2024) Esfigmomanometros no invasivos. Parte 2: Investigacion clinica del tipo de medicion automatizada intermitente.Modificacion2(is0810602:2018/Amd2:2024) Sphygmomanometres non invasifs. Partie 2: Investigation clinique pour type ponctuel a mesurage automatique. Amendment 2 (IS0 81060-2:2018/Amd 2:2024). This amendment is the official English version of EN IS0 81060-2:2019/A2:2024, which adopts IS0 81060-2:2018/Amd 2:2024. This amendment was published as UNE-EN IS0 81060-2:2020/A2:2024, which is the definitive Spanish version and which may include additional national content clearly identified as such. UNE The remarks to this document must be sent to Asociacion Espanola de Normalizacion Génova, 6 28004 MADRID-Espana de Tel.: 915 294 900 info@une.org Espanola www.une.org @UNE2024 ReproductionisprohibitedwithouttheexpressconsentofUNE Asociacion All intellectual property rights relating to this standard are owned by UNE. EN1IS0 81060-2:2019/A2 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM April 2024 ICS 11.040.10 English Version Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (IS0 81060-2:2018/Amd 2:2024) Sphygmomanometres non invasifs - Partie 2: Nichtinvasive Blutdruckmessgerate - Teil 2: Klinische Investigation clinique pour type ponctuel a mesurage Prifung der intermittierenden automatisierten Bauart automatique - Amendment 2 (is0 81060-2:2018/Amd - Anderung 2 (IS0 81060-2:2018/Amd 2:2024) 2:2024) This amendment A2 modifies the European Standard EN IS0 81060-2:2019; it was approved by CEN on 26 February 2024. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment into the relevant national standard without any alteration.Up-to-datelists and bibliographical reference member. This amendment exists in three official versions (English, French, German). A version in any other language made by translation samestatusastheofficial versions. Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and United Kingdom. de Normalizacion, UNE cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHESKOMITEEFURNORMUNG Espanola CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @2024CEN All rights ofexploitation inanyformand byanymeansreserved Ref.No.ENIS081060-2:2019/A2:2024E worldwide for CEN national Members. Asociacion