EN IS0 80369-2 EUROPEAN STANDARD NORME EUROPEENNE EUROPAISCHE NORM August 2024 ICS 11.040.20; 11.040.10 English version Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (IS0 80369-2:2024) Verbindungsstuicke mit kleinem Durchmesser fur Raccordsdepetitetaillepourliquidesetgazutilisés dansledomainedelasanté-Partie2:Raccords Flissigkeiten und Gase in medizinischen destines a des applications respiratoires (IS0 80369- Anwendungen - Teil 2: Verbindungsstucke fur 2:2024) respiratorische Anwendungen (IS0 80369-2:2024) This European Standard was approved by CEN on 3 July 2024. CEN and 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 concerningsuchnationalstandardsmaybeobtained onapplicationtotheCEN-CENELECManagement Centreorto any CENand CENELECmember. 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 and CENELEC member into its own language and notified to the CEN-CENELEC ManagementCentrehasthesamestatusastheofficialversions. CENand CENELECmembersarethenational standardsbodies and nationalelectrotechnical committeesof 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, Tiurkiye and United Kingdom. cen CENELEC CEN-CENELECManagementCentre: Rue de la Science 23, B-1040 Brussels 2024CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN IS0 80369-2:2024 E reserved worldwidefor CENnational Membersand for CENELEC Members EN IS0 80369-2:2024 (E) Contents Page European foreword... Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 2 EN IS0 80369-2:2024 (E) European foreword This document (EN IS0 80369-2:2024) has been prepared by Technical Committee IS0/TC 210 "Quality management and corresponding general aspects for products with a health purpose including medical devices" in collaboration with Technical Committee CEN-CENELEC/ JTC 3 "Quality management and corresponding general aspects for medical devices" the secretariat of which is held by NEN. 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 February 2025, and conflicting national standards shall be withdrawn at the latest by February 2025. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights. This document has been prepared under a standardization request addressed to CEN and CENELEC by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States. For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document. Any feedback and questions on this document should be directed to the users' national standards body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC websites. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway