ISO INTERNATIONAL STANDARD 25539-3 First edition 2011-12-01 CardiovascularimplantsEndovascular devices- Part 3: Venacavafilters Implantscardiovasculaires-Dispositifsendovasculaires- Partie3:Filtrescaves Referencenumber ISO25539-3:2011(E) ISO2011 etromHS Not for Resele ISO25539-3:2011(E) COPYRIGHTPROTECTEDDOCUMENT @ISO2011 All rights reserved.Unless otherwise specified,no part of this publicationmaybereproduced orutilized in anyform orby anymeans, ISO's member body in the country of the requester. ISOcopyrightoffice Casepostale56.CH-1211Geneva 20 Tel.+4122749 0111 Fax+41227490947 [email protected] Published in Switzerland ISO2011-Allrightsreserved Copyrig ional Organization orStandardizato Noreproductionof networkingpemitedwtiout license fiomH Not for Resele ISO25539-3:2011(E) Contents Page Foreword Introduction vi 1 Scope.. 2 Normative references.... 3 Terms and definitions..... 4 General requirements.. 4.1 Classification ... 5 4.2 Size... 5 Intended performance.. 6 Design attributes 6.1 General..... 6.2 Sheath/dilatorkit for endovascular filtersystem... 5 6.3 Filter system..... 6.4 6.5 Optionalfilter 6 6.6 Sheath/dilatorkitforendovascularretrieval/conversionsystem .6 6.7 Retrieval/conversionsystem....... 6.8 Endovascularsystems.... 7 Materials. 8 Design evaluation.. 8.1 8.2 Sampling. 8.3 Conditioning oftest samples.... 8.4 Reporting.... 8.5 Benchandanalyticaltests. .9 8.6 Preclinical in vivo evaluation. 24 8.7 Clinical evaluation..... 9 Post-market surveillance 32 10 Manufacturing.... 11 Sterilization...... 11.1 Products supplied sterile.. 32 11.2 Products supplied non-sterile.. .33 11.3 Sterilization residuals...... 12 Packaging.. .33 12.1 Protectionfromdamageinstorageandtransport.... .33 12.2 12.3 Information suppliedbythemanufacturer. AnnexA(informative)AttributesofendovasculardevicesVenacavafilters-Technicaland clinicalconsiderations........ AnnexB (informative)Descriptionsof potential device effects offailure andfailuremodes and descriptionsofdetrimentalclinicaleffects....... AnnexC(informative)Benchandanalyticaltests.... Annex D (informative) Test methods .......... andandiaonghtsreserved mi ewithISc Not for Resele ISO25539-3:2011(E) AnnexE(informative)Examplesoftermsforclinical useofvena cavafilters ...86 ISO2011-Allrightsreserved Standardizatio Nmwutlicnro Not for Resele ISO25539-3:2011(E) Foreword (ISOmemberbodies).The work of preparing International Standards is normally carried out through ISO technical committees.Each memberbodyinterested inasubjectforwhichatechnical committeehasbeen non-governmental,in liaison with isO,also take part in the work.isO collaborates closely with the International ElectrotechnicalCommission(IEC)onall mattersofelectrotechnical standardization. International Standardsaredrafted inaccordancewiththerulesgiven intheISO/lEDirectives,Part2. adopted by the technical committees are circulated to the memberbodies for voting.Publication as an InternationalStandardrequires approvalbyatleast75%of thememberbodiescastingavote Attention is drawnto thepossibilitythat some of the elements ofthisdocument maybethe subjectof patent rights.isO shall notbeheld responsiblefor identifyinganyorall suchpatent rights. ISO25539-3waspreparedbyTechnicalCommitteeISO/TC150,Implantsforsurgery,SubcommitteeSC2 Cardiovascularimplantsandextracorporealsystems devices: Part1:Endovascularprostheses Part2:Vascularstents Part 3:Vena cava filters andardizaton'ghtsreserved Not forResele ISO25539-3:2011(E) Introduction Thispartof ISO25539providesminimum requirementsforendovasculardevicesandthemethods oftestthat will enabletheirevaluation.It isderived fromISO/TS15539,which servesasa rationalefor itsrequirements. iSO/TS15539wasdevelopedbyfirstidentifyingthedesignrequirements forthesedevices and listing the potential failure modes and potential device and detrimental clinical effects. Tests were then identified to addresseachof the failure modes.The requirements specified in thispart of iSO25539 are based on that assessment. @