SIST EN ISO 25539-3:2012

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

1.1 This International Standard 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. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
1.2 The scope of this Part includes vena cava filters used to prevent pulmonary embolism by mechanical filtration in the vena cava.
1.3 Sheath/dilator kits are included in the standard if they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter.
1.4 Delivery systems are included in the standard, if they comprise an integral component of the deployment of the vena cava filter.
1.5 Optional filters that may be retrieved or converted and permanent filters as well as their associated endovascular systems are included in the standard.
1.6 Temporary filters (e.g., tethered) that must be removed after a defined period of time are excluded from the scope of this standard.
1.7 Coatings, surface modifications, and/or drugs are excluded from the scope of this standard.
1.8 Procedures and devices (e.g., venous entry needle) used prior to the vena cava filter procedure are excluded from the scope of this standard

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 pour veine cave (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: Published
• Public Enquiry End Date: 09-Sep-2010
• Publication Date: 24-Jan-2012
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Dec-2011
• Due Date: 12-Feb-2012
• Completion Date: 25-Jan-2012
• 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: EN ISO 25539-3:2011 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)

Relations

• Replaces: SIST EN 12006-3:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
• Effective Date: 01-Mar-2012
• Revised: oSIST prEN ISO 25539-3:2023 - Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 25539-3:2012
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
SIST EN ISO 25539-3:2012 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 25539-3:2012

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SIST EN ISO 25539-3:2012


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.

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SIST EN ISO 25539-3:2012
EN ISO 25539-3:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 25539-3:2012
EN ISO 25539-3:2011 (E)
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.
3

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SIST EN ISO 25539-3:2012
EN ISO 25539-3:2011 (E)
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.

4

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SIST EN ISO 25539-3:2012

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

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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)

COPYRIGHT PROTECTED DOCUMENT


©  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
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland

ii © ISO 2011 – All rights reserved

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SIST EN ISO 25539-3:2012
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 2011 – All rights reserved iii

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SIST EN ISO 25539-3:2012
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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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 25539-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular
devices:
 Part 1: Endovascular prostheses
 Part 2: Vascular stents
 Part 3: Vena cava filters

© ISO 2011 – All rights reserved v

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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
Introduction
This part of ISO 25539 provides minimum requirements for endovascular devices and the methods of test that
will enable their evaluation. It is derived from ISO/TS 15539, which serves as a rationale for its requirements.
ISO/TS 15539 was developed by first identifying the design requirements for these devices and listing the
potential failure modes and potential device and detrimental clinical effects. Tests were then identified to
address each of the failure modes. The requirements specified in this part of ISO 25539 are based on that
assessment.


vi © ISO 2011 – All rights reserved

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SIST EN ISO 25539-3:2012
INTERNATIONAL STANDARD ISO 25539-3:2011(E)

Cardiovascular implants — Endovascular devices —
Part 3:
Vena cava filters
1 Scope
This part of ISO 25539 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. This part of
ISO 25539 supplements ISO 14630, which specifies general requirements for the performance of non-active
surgical implants.
The following are within the scope of this part of ISO 25539:
 vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava
(IVC). While this part of ISO 25539 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 this part of ISO 25539 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 this part of ISO 25539:
 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10993 (all parts), Biological evaluation of medical devices
© ISO 2011 – All rights reserved 1

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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 14630, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630 and the following apply.
3.1
access site
vein that is used for accessing the vena cava
EXAMPLE Jugular vein; femoral vein; subclavian vein; antecubital vein.
3.2
adverse event
clinical event
complication, failure or device-related observation with preclinical in vivo and clinical use of the endovascular
system or endovascular retrieval/conversion system
NOTE 1 This term relates to the definition of a hazardous situation that might lead to harm, as found in ISO 14971,
when the consequences are to the patient.
NOTE 2 A clinical event might lead to a detrimental clinical effect.
3.3
conversion system
component of the endovascular conversion system that is intended to structurally alter an optional filter after
implantation so that it no longer functions as a filter
3.4
delivery system
component of the filter system, excluding the sheath/dilator, used to deliver the filter to the targeted position
and to deploy the filter
NOTE The delivery system is removed after filter placement.
3.5
determine
requirement to quantitatively appraise or analyse
NOTE Also see evaluate (3.9).
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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
3.6
detrimental clinical effect
discernable negative effect due to an adverse event or device failure
NOTE Descriptions of potential device effects of failure and failure modes and of detrimental clinical effects are given
in Annex B.
3.7
endovascular filter system
filter system and sheath/dilator kit
See Figure 1.
Endovascular filter system
Filter system Sheath/dilator kit
Filter Delivery system

Figure 1 — Example of endovascular filter system
3.8
endovascular retrieval/conversion system
retrieval/conversion system and sheath/dilator kit
See Figure 2.
Endovascular retrieval/conversion
system
Retrieval/conversion system
Sheath/dilator kit
(e.g. snare or retrieval cone)

Figure 2 — Example of endovascular retrieval/conversion system
NOTE The term retrieval/conversion is used to describe either the retrieval or the conversion system and does not
imply that one system can be used for both purposes.
3.9
evaluate
requirement to qualitatively appraise or analyse
NOTE Also see determine (3.5).
3.10
filter formation
manufacturer's specified final expanded geometric configuration of the filter in the vena cava
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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
3.11
filter system
component of the endovascular filter system that consists of the filter and delivery system
3.12
filter system orientation
orientation (e.g. jugular, femoral) of the loaded filter within the delivery system, based on the designated
access site (e.g. jugular, femoral, subclavian, antecubital)
3.13
implantation site
location of placement within the body
3.14
potential effect of failure
possible consequence of the failure mode on the device or patient
NOTE See introduction to Annex A for further clarification. This term relates to the definition of hazard as found in
ISO 14971:2007, 2.3.
3.15
potential failure mode
difficulty or failure that might be encountered and that could result in consequences (potential effects of
failure) for the patient or device
NOTE This term relates to the definition of hazard as found in ISO 14971:2007, 2.3.
3.16
retrieval system
component of the endovascular retrieval system that is intended to remove a specific filter in accordance with
the instructions for use (IFU)
3.17
sheath/dilator
kit that includes an introducer sheath and dilator and that is used to access the target deployment, retrieval, or
conversion location
3.18
vena cava filter
filter
implant
transluminally placed implant, which is used to prevent pulmonary embolism by mechanical filtration
3.18.1
optional filter
permanent filter that can be optionally removed (retrievable filter), or permanent filter that can be optionally
altered structurally after implantation, so that it no longer functions as a filter (convertible filter)
3.18.2
permanent filter
filter that is designed to permanently function as a filter
NOTE All optional filters are also permanent filters. Permanent filters might or might not incorporate design
characteristics that allow for retrieval or conversion, and might or might not be labelled for use of these optional features.
4 © ISO 2011 – All rights reserved

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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
4 General requirements
4.1 Classification
A vena cava filter system shall be designated by its access site (see 3.1), orientation (see 3.12), implantation
site (see 3.13), type (see 3.18), materials of construction, and any surface modifications, coatings, and/or
drugs.
4.2 Size
The size of a filter shall be designated by the sizes of vena cava intended to be treated, if applicable.
5 Intended performance
The requirements of ISO 14630 apply.
6 Design attributes
6.1 General
The requirements of ISO 14630 apply. The design attributes for vena cava filters are listed in Tables A.3 to
A.9, with reference to the preclinical testing necessary for evaluation of the design. It is recognized that not all
tests identified in a category will be necessary or practical for any given filter and/or system. The tests
considered and the rationale for selection and/or waiving of tests shall be recorded.
6.2 Sheath/dilator kit for endovascular filter system
The design attributes needed to meet consistently the intended performance of the sheath/dilator shall also
take into account at least the following:
a) the ability to permit safe access to the intended deployment location;
b) the ability to permit safe withdrawal of the dilator;
c) the ability to perform cavagrams.
6.3 Filter system
The design attributes needed to meet consistently the intended performance of the filter system shall also take
into account at least the following:
a) the ability to permit safe deliverability of the filter to the intended deployment location;
b) the ability to permit accurate and safe deployment of the filter;
c) the ability to permit safe withdrawal of the delivery system and introducer sheath following deployment.
6.4 Filter
The design attributes needed to meet consistently the intended performance of the filter shall also take into
account at least the following:
a) the ability to ensure effective fixation in the intended location within the vena cava;
b) the ability to maintain adequate integrity;
© ISO 2011 – All rights reserved 5

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SIST EN ISO 25539-3:2012
ISO 25539-3:2011(E)
c) the ability to capture clots in the blood, while allowing acceptable blood flow;
d) the compatibility of the filter dimensions for use with specified caval diameters;
e) the compatibility with exposure to magnetic resonance imaging (MRI) fields.
6.5 Optional filter
In addition to the attributes listed in 6.4, the design attributes needed to meet consistently the intended
performance of optional filters shall take into account at least the following:
a) the ability to be engaged;
b) the ability to be retrieved/converted;
c) the ability to maintain structural integrity associated with retrieval, if applicable;
d) the ability for converted filters to maintain structural integrity after conversion, if applicable.
6.6 Sheath/dilator kit for endovascular retrieval/conversion system
The design attributes needed to meet consistently the intended performance of the sheath/dilator kit for
retrieval or conversion shall also take into account at least the following:
a) the ability to permit safe access to the intended retrieval/conversion location;
b) the ability to permit safe withdrawal of the dilator;
c) the ability to perform cavagrams.
6.7 Retrieval/conversion system
The design attributes needed to meet consistently the intended performance of the retrieval/conversion
system shall also take into account at least the following:
a) the ability to permit safe deliverability to the filter location;
b) the ability to permit safe engagement with the filter;
c) the ability to permit safe retrieval/conversion of the filter;
d) the ability to permit safe withdrawal of the retrieval/conversion system, with any previously removed
implanted components and introducer sheath, following retrieval/conversion.
6.8 Endovascular systems
The design attributes needed to meet consistently the intended performance of all endovascular systems shall
also take into account at least the following:
a) the requirements of ISO 10993-1 and other approp
...

SLOVENSKI STANDARD
oSIST prEN ISO 25539-3:2010
01-september-2010
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO)LOWULYHQD
FDYD,62',6
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS
25539-3:2010)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 3: Hohlvenenfilter (ISO/DIS
25539-3:2010)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 3: Filtres pour veine
cave (ISO/DIS 25539-3:2010)
Ta slovenski standard je istoveten z: prEN ISO 25539-3
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
oSIST prEN ISO 25539-3:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 25539-3:2010

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oSIST prEN ISO 25539-3:2010


EUROPEAN STANDARD
DRAFT
prEN ISO 25539-3
NORME EUROPÉENNE

EUROPÄISCHE NORM

April 2010
ICS 11.040.40
English Version
Cardiovascular implants - Endovascular devices - Part 3: Vena
cava filters (ISO/DIS 25539-3:2010)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 3: Filtres pour veine cave (ISO/DIS 25539-3:2010) Teil 3: Hohlvenenfilter (ISO/DIS 25539-3:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 285.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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 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.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 25539-3:2010: E
worldwide for CEN national Members.

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oSIST prEN ISO 25539-3:2010
prEN ISO 25539-3:2010 (E)
Contents Page
Foreword .3

2

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oSIST prEN ISO 25539-3:2010
prEN ISO 25539-3:2010 (E)
Foreword
This document (prEN ISO 25539-3:2010) 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 document is currently submitted to the parallel Enquiry.
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(s).
Endorsement notice
The text of ISO/DIS 25539-3:2010 has been approved by CEN as a prEN ISO 25539-3:2010 without any
modification.

3

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oSIST prEN ISO 25539-3:2010

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oSIST prEN ISO 25539-3:2010
DRAFT INTERNATIONAL STANDARD ISO/DIS 25539-3
ISO/TC 150/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2010-04-01 2010-09-01
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Cardiovascular implants — Endovascular devices —
Part 3:
Vena cava filters
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 3: Filtres pour veine cave
ICS 11.040.40
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2010

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
PDF disclaimer
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not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
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Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
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Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2010 – All rights reserved

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Definitions. 2
4 General requirements. 5
4.1 Classification. 5
4.2 Size. 5
5 Intended performance . 5
6 Design attributes. 6
6.1 General. 6
6.2 Sheath/dilator kit for endovascular filter system . 6
6.3 Filter system . 6
6.4 Filter. 6
6.5 Optional filter. 6
6.6 Sheath/dilator kit for endovascular retrieval/conversion system. 7
6.7 Retrieval/conversion system . 7
6.8 Endovascular systems . 7
7 Materials. 7
8 Design evaluation . 8
8.1 General. 8
8.2 Sampling. 8
8.3 Conditioning of test samples. 9
8.4 Reporting . 9
8.5 Bench and analytical tests. 10
8.6 Preclinical in vivo evaluation. 26
8.7 Clinical evaluation. 31
9 Post market surveillance. 36
10 Manufacturing . 36
11 Sterilisation. 36
11.1 Products supplied sterile . 36
11.2 Products supplied nonsterile . 37
11.3 Sterilisation residuals. 37
12 Packaging. 37
12.1 Protection from damage in storage and transport. 37
12.2 Marking. 37
12.3 Information supplied by the manufacturer. 39
Annex A (informative) Attributes of endovascular devices – vena cava filters — Technical and
clinical considerations . 41
Annex B (informative) Definitions of Potential Failure Modes and Effects of Failure. 61
© ISO 2010 – All rights reserved iii

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
Annex C (informative) Bench and analytical tests . 67
Annex D (informative) Test methods . 76
Annex E (informative) Examples of some terms for clinical use of vena cava filters . 108
Bibliography . 110





iv © ISO 2010 – All rights reserved

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 25539-3 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
ISO 25539 consists of the following parts, under the general title Cardiovascular implants —
Endovascular devices:
⎯ Part 1: Endovascular prostheses
⎯ Part 2: Vascular stents
⎯ Part 3: Vena cava filters
© ISO 2010 – All rights reserved v

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
Introduction
This International Standard has been prepared in order to provide minimum requirements for
endovascular devices and the methods of test that will enable their evaluation. It is the third and final Part
of a proposed three-Part standard, addressing vena cava filters; Part 1 addresses endovascular
prostheses, Part 2 addresses vascular stents. ISO/TS 15539, from which this Part is derived, serves as a
rationale for the requirements of this International Standard. The Technical Specification was developed
by first identifying the design requirements for these devices and listing the potential failure modes and
potential device and detrimental clinical effects. Tests were then identified to address each of the failure
modes. The requirements provided in this International Standard are based on that assessment.

vi © ISO 2010 – All rights reserved

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oSIST prEN ISO 25539-3:2010
DRAFT INTERNATIONAL STANDARD    ISO/DIS 25539-3
Cardiovascular implants — Endovascular devices —
Part 3:
Vena cava filters
1 Scope
1.1 This International Standard 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. It should be considered as a supplement to ISO 14630, which
specifies general requirements for the performance of non-active surgical implants.
1.2 This Part of ISO 25539 includes vena cava filters used to prevent pulmonary embolism by
mechanical filtration in the inferior vena cava. While this standard might be useful with respect to
filters implanted in other venous locations (e.g., superior vena cava, iliac veins), this standard does
not specifically address use of filters in other implantation sites.
1.3 Sheath/dilator kits are included in the standard if they comprise an integral component of the
access, delivery or retrieval/conversion of the vena cava filter.
1.4 Delivery systems are included in the standard if they comprise an integral component of the
deployment of the vena cava filter.
1.5 Optional filters that can be retrieved or converted and permanent filters as well as their associated
endovascular systems are included in the standard. While this standard might be useful with
respect to evaluation of repositioning filters after chronic implantation, this standard does not
specifically address filter repositioning.
1.6 Temporary filters (e.g., tethered) that have to be removed after a defined period of time are
excluded from the scope of this standard.
1.7 Coatings, surface modifications, and/or drugs are excluded from the scope of this standard.
1.8 Procedures and devices (e.g., venous entry needle) used prior to the vena cava filter procedure
are excluded from the scope of this standard.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
© ISO 2010 – All rights reserved 1

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 10555-1, Sterile, single-use intravascular catheters — Part 1: General requirements
ISO 10993, Biological evaluation of medical devices (series)
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14155, Clinical investigation of medical devices (series)
ISO 14630, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 14971, Medical devices — Application of risk management to medical devices
3 Definitions
For the purposes of this International Standard, the definitions in ISO 14630 and the following apply:
NOTE Potential device effects of failure and failure modes and detrimental clinical effects are defined in Annex
B. Bench and analytical tests are described in Annex C.
3.1
access site
vein that is used for accessing the vena cava
NOTE  Examples of access sites include jugular, femoral, subclavian, antecubital veins.
3.2
adverse events
clinical events
complications, failures or device related observations with preclinical in vivo and clinical use of the
endovascular system or endovascular retrieval/conversion system
NOTE 1 This term relates to the definition of a hazardous situation that might lead to harm as found in ISO 14971
when the consequences are to the patient.
NOTE 2 A clinical event might lead to a detrimental clinical effect.

3.3
conversion system
component of the endovascular conversion system that is intended to structurally alter an optional filter
after implantation so that it no longer functions as a filter
2 © ISO 2010 – All rights reserved

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3

3.4
delivery system
component of the filter system, excluding the sheath/dilator, used to deliver the filter to the targeted
position and to deploy the filter
NOTE The delivery system is removed after filter placement.
3.5
determine
requirement to quantitatively appraise or analyse
NOTE Also see evaluate.
3.6
detrimental clinical effect
discernable negative effect due to an adverse event or device failure
NOTE  A list of detrimental clinical effects is contained in Annex B.
3.7
endovascular filter system
filter system and sheath/dilator kit
EXAMPLE
Endovascular Filter System
Filter System Sheath/dilator Kit
Filter
Delivery System

3.8
endovascular retrieval/conversion system
retrieval/conversion system and sheath/dilator kit
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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
EXAMPLE
Endovascular Retrieval/Conversion System
Retrieval/Conversion System
Sheath/dilator Kit
(e.g., snare or retrieval cone)

NOTE The term retrieval/conversion is used to describe either the retrieval or conversion system and does not
imply that one system can be used for both purposes.
3.9
evaluate
requirement to qualitatively appraise or analyse
NOTE Also see determine.
3.10
filter formation
manufacturer’s specified final expanded geometric configuration of the filter in the vena cava
3.11
filter system
component of the endovascular filter system that consists of the filter and delivery system
3.12
filter system orientation
orientation (e.g., jugular, femoral) of the loaded filter within the delivery system based on the designated
access site (e.g., jugular, femoral, subclavian, antecubital)
3.13
implantation site
location of placement within the body

3.14
potential effects of failure
possible consequences of the failure mode on the device or patient
NOTE Refer to the introduction in Annex A for further clarification. This term relates to the definition of hazard as
found in ISO 14971.
3.15
potential failure modes
difficulties or failures that might be encountered that could result in consequences (potential effects of
failure) to the patient or device
NOTE This term relates to the definition of hazard as found in ISO 14971.
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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
3.16
retrieval system
component of the endovascular retrieval system that is intended to remove a specific filter in accordance
with the instructions for use (IFU)
3.17
sheath/dilator
kit that includes an introducer sheath and dilator that is used to access the target deployment, retrieval, or
conversion location
3.18
vena cava filter
filter
implant
transluminally placed implant, which is used to prevent pulmonary embolism by mechanical filtration
3.18.1
optional filter
permanent filter that can be optionally removed (retrievable filter) or permanent filter that can be optionally
altered structurally after implantation to no longer function as a filter (convertible filter)
3.18.2
permanent filter
filter that is designed to permanently function as a filter
NOTE All optional filters are also permanent filters. Permanent filters might or might not incorporate design
characteristics that allow for retrieval or conversion, and might or might not be labelled for use of these optional
features.
4 General requirements
4.1 Classification
A vena cava filter system shall be designated by its access site (see 3.1), orientation (see 3.12),
implantation site (see 3.13) type (see 3.18), materials of construction, and any surface modifications,
coatings, and/or drugs.
4.2 Size
The size of a filter shall be designated by the sizes of vena cava intended to be treated, if applicable.
5 Intended performance
The requirements of ISO 14630 apply.
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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
6 Design attributes
6.1 General
The requirements of ISO 14630 apply. The design attributes for vena cava filters are listed in Tables A.3
through A.9 (Annex A) with reference to the preclinical testing necessary for the evaluation of the design.
It is recognised that not all tests identified in a category will be necessary or practical for any given filter
and/or system. The tests considered and the rationale for selection and/or waiving of tests shall be
recorded.
6.2 Sheath/dilator kit for endovascular filter system
The design attributes to consistently meet the intended performance of the sheath/dilator shall additionally
take into account at least the following:
a) the ability to permit safe access to the intended deployment location;
b) the ability to permit safe withdrawal of the dilator;
c) the ability to perform cavagrams;
6.3 Filter system
The design attributes to consistently meet the intended performance of the filter system shall additionally
take into account at least the following:
a) the ability to permit safe deliverability of the filter to the intended deployment location;
b) the ability to permit accurate and safe deployment of the filter;
c) the ability to permit safe withdrawal of the delivery system and introducer sheath following
deployment.
6.4 Filter
The design attributes to consistently meet the intended performance of the filter shall additionally take into
account at least the following:
a) the ability to ensure effective fixation in the intended location within the vena cava;
b) the ability to maintain adequate integrity;
c) the ability to capture clots in the blood, while allowing acceptable blood flow;
d) the compatibility of the filter dimensions for use with specified caval diameters;
e) the compatibility with exposure to magnetic resonance imaging (MRI) fields.
6.5 Optional filter
In addition to the attributes listed in 6.4, the design attributes to consistently meet the intended
performance of optional filters shall take into account at least the following:
6 © ISO 2010 – All rights reserved

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oSIST prEN ISO 25539-3:2010
ISO/DIS 25539-3
a) the ability to be engaged;
b) the ability to be retrieved/converted;
c) the ability to maintain structural integrity associated with retrieval, if applicable;
d) the ability for converted filters to maintain structural integrity after conversion, if applicable.
6.6 Sheath/dilator kit for endovascular retrieval/conversion system
The design attributes to consistently meet the intended performance of the sheath/dilator kit for retrieval
or conversion shall additionally take into account at least the following:
a) the ability to permit safe access to the intended retrieval/conversion location;
b) th
...