EN ISO 25539-3:2011

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)

ISO 25539-3:2011 specifies requirements for vena cava filters, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
The following are within the scope of ISO 25539-3:2011:
        vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites;
       sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter.
       delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter.
       optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning.
The following are outside the scope of ISO 25539-3:2011:
       temporary filters (e.g. tethered) that need to be removed after a defined period of time;
       coatings, surface modifications, and/or drugs;
       issues associated with viable tissues and non-viable biological materials;
       degradation and other time-dependent aspects of absorbable materials;
       procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 3: Hohlvenenfilter (ISO 25539-3:2011)

Dieser Teil von ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissensstandes Anforderungen an Hohlvenenfilter fest. Im Hinblick auf die Sicherheit enthält er Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe/Materialien, die Bewertung der Konstruktion, die Herstellung, die Sterilisation, die Verpackung sowie die Bereitstellung von Informationen durch den Hersteller. Dieser Teil von ISO 25539 ergänzt ISO 14630, die die allgemeinen Anforderungen an die Funktion nicht aktiver chirurgischer Implantate festlegt.
Folgendes liegt innerhalb des Anwendungsbereichs dieses Teils von ISO 25539:
Hohlvenenfilter, die eingesetzt werden, um durch mechanische Filtration in der Vena cava inferior (untere Hohlvene) Lungenembolien zu verhindern: Dieser Teil von ISO 25539 kann auf an anderen Positionen des Venensystems implantierte Filter (z. B. Vena cava superior, V.v. iliacae) anwendbar sein, behandelt jedoch nicht speziell die Anwendung von Filtern an anderen Implantationspositionen;
Einführschleusen-/Dilatator-Einheiten, vorausgesetzt sie stellen einen integralen Bestandteil des Zugangs, der Einführung oder der Rückholung/Konversion des Hohlvenenfilters dar;
Einführsysteme, vorausgesetzt sie stellen einen integralen Bestandteil bei der Entfaltung des Hohlvenenfilters dar;
optionale Filter, die rückgeholt oder konvertiert werden können, sowie permanente Filter mit ihren zugehörigen endovaskulären Systemen werden von der Norm abgedeckt. Dieser Teil von ISO 25539 kann hinsichtlich der Bewertung der Neuplatzierung der Filter nach chronischer Implantation anwendbar sein, behandelt jedoch nicht speziell die Neuplatzierung von Filtern.
Folgendes liegt außerhalb des Anwendungsbereichs dieses Teils von ISO 25539:
temporäre Filter (z. B. "gebundene" Filter), die nach einer festgelegten Zeitspanne wieder entfernt werden müssen;
Beschichtungen, Oberflächenmodifikationen und/oder Medikamente;
Aspekte, die mit lebensfähigem Gewebe und lebensunfähigen biologischen Stoffen in Zusammenhang stehen;
Abbau und andere zeitabhängige Erscheinungen von absorbierbaren Stoffen;
vor dem Hohlvenenfilterverfahren angewendete Verfahren und Geräte/Implantate (z. B. Venen-punktionskanülen).

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3: Filtres caves (ISO 25539-3:2011)

L'ISO 25539-3:2011 spécifie les exigences relatives aux filtres pour veine cave, selon les connaissances médicales actuelles. En ce qui concerne la sécurité, elle donne les exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant. L'ISO 25539-3:2011 constitue un complément à l'ISO 14630 qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
Les éléments suivants sont traités dans le domaine d'application de l'ISO 25539-3:2011:
les filtres pour veine cave utilisés pour prévenir les embolies pulmonaires par filtration mécanique de la veine cave inférieure. Bien que l'ISO 25539-3:2011 puisse être utile pour les filtres implantés dans d'autres emplacements veineux (par exemple dans la veine cave supérieure, les veines iliaques), elle ne traite pas spécifiquement de l'utilisation des filtres dans d'autres sites d'implantation;
les ensembles gaine/dilatateur, s'ils font partie intégrante de l'accès, du largage ou du retrait/de la conversion du filtre cave;
les systèmes de pose, s'ils font partie intégrante du déploiement du filtre cave;
les filtres optionnels pouvant être retirés ou convertis et les filtres permanents ainsi que leurs systèmes endovasculaires associés. Bien que l'ISO 25539-3:2011 puisse être utile pour l'évaluation du repositionnement des filtres après une implantation à demeure, elle ne traite pas spécifiquement du repositionnement des filtres.
Les éléments suivants sont exclus du domaine d'application de l'ISO 25539-3:2011:
les filtres temporaires (par exemple maintenus en place au moyen d'un cathéter support) qui ont besoin d'être retirés après une période de temps définie;
les revêtements, les modifications de surface et/ou les médicaments;
les problèmes liés aux tissus viables et aux matériaux biologiques non viables.
la dégradation ainsi que d'autres aspects des matériaux résorbables dépendant du temps;
les modes opératoires et les dispositifs (par exemple aiguille d'accès veineux) utilisés avant le mode opéraroire de pose des filtres pour veine cave.

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 3. del: Filtri "vena cava" (ISO 25539-3:2011)

Ta del standarda ISO 25539 določa zahteve za filtre »vena cava«, ki temeljijo na trenutnem medicinskem znanju. V zvezi z varnostjo podaja zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec. Ta del standarda ISO 25539 dopolnjuje standard ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov. Naslednji izdelki spadajo na področje uporabe tega dela standarda ISO 25539: – filtri »vena cava« za preprečevanje pljučne embolije z mehansko filtracijo v spodnji votli veni (IVC). Ta del standarda ISO 25539 je lahko uporaben za filtre, ki so implantirani na drugih venskih lokacijah (npr. zgornja votla vena, iliakalne vene), vendar izrecno ne obravnava uporabe filtrov na drugih mestih implantacije; – kompleti    tulcev/dilatorjev, če so sestavni del dostopa, aplikacije ali odvzema/predelave filtra »vena cava«; – aplikacijski sistemi, če so sestavni del namestitve filtra »vena cava«; – opcijski filtri, ki se jih lahko odvzame ali predela, in stalni filtri s povezanimi znotrajžilnimi sistemi. Ta del standarda ISO 25539 je lahko uporaben za vrednotenje premeščanja filtrov po kronični implantaciji, vendar izrecno ne obravnava premeščanja filtrov.

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2011
• Withdrawal Date: 22-Oct-2024
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 25539-3:2012 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)

Relations

• Replaces: EN 12006-3:1998+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
• Effective Date: 14-Dec-2011
• Replaced By: EN ISO 25539-3:2024 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2024)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2012
1DGRPHãþD
SIST EN 12006-3:2000+A1:2009
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO)LOWULYHQD
FDYD,62
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-
3:2011)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 3: Hohlvenenfilter (ISO
25539-3:2011)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3: Filtres pour veine
cave (ISO 25539-3:2011)
Ta slovenski standard je istoveten z: EN ISO 25539-3:2011
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 25539-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2011
ICS 11.040.40 Supersedes EN 12006-3:1998+A1:2009
English Version
Cardiovascular implants - Endovascular devices - Part 3: Vena
cava filters (ISO 25539-3:2011)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 3: Filtres caves (ISO 25539-3:2011) Teil 3: Hohlvenenfilter (ISO 25539-3:2011)
This European Standard was approved by CEN on 30 November 2011.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-3:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 25539-3:2011) has been prepared by Technical Committee ISO/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 June 2012, and conflicting national standards shall be withdrawn at
the latest by June 2012.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 12006-3:1998+A1:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 25539-3:2011 has been approved by CEN as a EN ISO 25539-3:2011 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission to
provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on
medical devices as amended by Directive 2007/47/EC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between Directive 93/42/EEC and this European Standard

Clause(s)/sub-clause(s) Essential Requirements (ERs) of Qualifying remarks/notes
of this European Directive 93/42/EEC
Standard
6,8,10 and 12 7.2
7 7.3
st
6 7.5 1 sentence
6 and 7 7.6
7 8.2
12.1.5 8.3
11.1 8.4
11.2 8.5
nd
6 and 7 9.2, 2 indent
12.2.2 13.3 a)
12.2.2 13.3 b)
12.2.2 13.3 c)
12.2.2 13.3 d)
12.2.2 13.3 e)
12.2.2 13.3 f)
12.2.2 13.3 i)
12.2.2 13.3 k)
12.2.2 13.3 m)
5 13.5
12.3.2 13.6 g)
12.3.2 13.6 k)
12.3.2 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 25539-3
First edition
2011-12-01
Cardiovascular implants — Endovascular
devices —
Part 3:
Vena cava filters
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 3: Filtres caves
Reference number
ISO 25539-3:2011(E)
©
ISO 2011
ISO 25539-3:2011(E)
©  ISO 2011
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO 2011 – All rights reserved

ISO 25539-3:2011(E)
Contents Page
Foreword . v
Introduction . vi
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 2
4  General requirements . 5
4.1  Classification . 5
4.2  Size . 5
5  Intended performance . 5
6  Design attributes . 5
6.1  General . 5
6.2  Sheath/dilator kit for endovascular filter system . 5
6.3  Filter system . 5
6.4  Filter . 5
6.5  Optional filter . 6
6.6  Sheath/dilator kit for endovascular retrieval/conversion system . 6
6.7  Retrieval/conversion system . 6
6.8  Endovascular systems . 6
7  Materials . 7
8  Design evaluation . 7
8.1  General . 7
8.2  Sampling . 7
8.3  Conditioning of test samples . 8
8.4  Reporting . 8
8.5  Bench and analytical tests . 9
8.6  Preclinical in vivo evaluation . 24
8.7  Clinical evaluation . 28
9  Post-market surveillance . 32
10  Manufacturing . 32
11  Sterilization . 32
11.1  Products supplied sterile. 32
11.2  Products supplied non-sterile . 33
11.3  Sterilization residuals . 33
12  Packaging . 33
12.1  Protection from damage in storage and transport . 33
12.2  Marking . 34
12.3  Information supplied by the manufacturer . 35
Annex A (informative) Attributes of endovascular devices — Vena cava filters — Technical and
clinical considerations . 37
Annex B (informative) Descriptions of potential device effects of failure and failure modes and
descriptions of detrimental clinical effects . 51
Annex C (informative) Bench and analytical tests . 55
Annex D (informative) Test methods . 59
ISO 25539-3:2011(E)
Annex E (informative) Examples of terms for clinical use of vena cava filters .86
Bibliography .88

iv © ISO 2011 – All rights reserved
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