EN IS0 80601-2-79 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM September 2024 ICS 11.040.10 Supersedes EN IS0 80601-2-79:2019 English Version Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (IS0 80601-2-79:2024) Appareils électromédicaux - Partie 2-79: Exigences Medizinische elektrische Gerate - Teil 2-79: Besondere particulieres pour la sécurité de base et les Festlegungen fur die grundlegende Sicherheit und die performancesessentiellesdeséquipements wesentlichenLeistungsmerkmalevon d'assistance ventilatoire en cas de trouble ventilatoire Heimbeatmungsgeraten zur Atemunterstitzung von (IS0 80601-2-79:2024) Patienten mit Atmungsbeeintrachtigungen (IS0 80601- 2-79:2024) This European Standard was approved by CEN on 5 August 2024. CEN 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 CEN 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 CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, 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, Tirkiye and United Kingdom cer EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @2024CEN Ref. No. EN IS0 80601-2-79:2024 E All rightsofexploitationinanyformandbyanymeans reserved worldwide for CEN national Members. EN IS0 80601-2-79:2024 (E) Contents Page 2 EN IS0 80601-2-79:2024 (E) European foreword This document (EN IS0 80601-2-79:2024) has been prepared by Technical Committee IS0/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment" the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2025, and conflicting national standards shall be withdrawn at the latest by March 2025. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN IS0 80601-2-79:2019. Any feedback and questions on this document should be directed to the users' national standards body/nationalcommittee.AcompletelistingofthesebodiescanbefoundontheCENwebsite According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and the United Kingdom. Endorsement notice The text of IS0 80601-2-79:2024 has been approved by CEN as EN IS0 80601-2-79:2024 without any modification. 3