ENISO 7197 EUROPEAN STANDARD NORMEEUROPEENNE EUROPAISCHE NORM November 2024 ICS 11.040.40 Supersedes EN IS0 7197:2009 English Version Neurosurgical implants - Sterile, single-use hydrocephalus shunts (IS0 7197:2024) Implants neurochirurgicaux - Systemes de dérivation Neurochirurgische Implantate - Sterile Hydrozephalus- stériles,nonréutilisables,pourhydrocéphalie (iso ShuntszumEinmalgebrauchundderenBestandteile 7197:2024) (ISO 7197:2024) This European Standard was approved by CEN on 28 July 2024. European Standard the status ofanational standard without anyalteration.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 Centre has the same status as the official versions. CEN members arethenational standardsbodies 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, Turkiye and United Kingdom. cer EUROPEANCOMMITTEEFOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELECManagementCentre:RuedelaScience23,B-1040Brussels 2024CEN All rights of exploitation in any form and by any means reserved Ref. No. EN IS0 7197:2024 E worldwidefor CENnational Members. EN IS0 7197:2024 (E) Contents Page and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered....4 2 EN IS0 7197:2024 (E) European foreword This document (EN IS0 7197:2024) has been prepared by Technical Committee IS0/TC 150 "Implants for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants" the secretariat of which is held by DIN. 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of an identical text or by endorsement, at the latest by May 2025, and conflicting national standards shall be withdrawn at the latest by May 2025.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 7197:2009. This document has been prepared under a standardization request addressed to CEN 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 website. 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 3