EN ISO 25539-3:2011

SLOVENSKI STANDARD
01-marec-2012
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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
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 copyright@iso.org
Web www.iso.org
Published in Switzerland
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

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 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

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 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).
2 © ISO 2011 – All rights reserved

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
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

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 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 appropriate parts of the ISO 10993 series (biocompatibility);
b) the sterility assurance;
c) the ability to control blood loss (haemostasis);
d) the visibility under fluoroscopy or other technologies.
6 © ISO 2011 – All rights reserved

ISO 25539-3:2011(E)
7 Materials
The requirements of ISO 14630 apply. Additional testing specific to certain materials (e.g. nitinol, titanium, and
stainless steel) should be performed to determine the appropriateness of the material for use in the design.
For example, nitinol materials dependent on shape memory properties should be subjected to testing in order
to assess transformation properties.
8 Design evaluation
8.1 General
The requirements of ISO 14630 apply. A risk assessment shall be carried out and the requirements of
ISO 14971 shall apply.
Because optional filters can be used as permanent filters, testing appropriate for a permanent filter shall be
conducted for optional filters. Additional testing is appropriate for optional filters.
Justification shall be provided for the design attributes not evaluated.
NOTE All tests might not be appropriate for all filter system designs.
At the time of publishing this edition of this part of ISO 25539, it is impossible to account for all future and
emerging technologies. New filter systems will need to be evaluated following the basic requirements of this
part of ISO 25539. Testing beyond the scope of this part of ISO 25539 might also be necessary to
characterize new filter systems. Consideration shall be given to the failure modes of the filter systems and
their effects on the performance of the implant in identifying the appropriate testing.
Whenever changes are made in filter type, materials, construction, configuration, implantation site, or
processing methods, an appropriate analysis of the potential impact of the change on the failure modes and
performance of the filter system shall be performed. Appropriate testing shall be conducted as deemed
necessary.
The use of a control device for comparison should be considered in the evaluation of certain design attributes.
Testing to establish the labelled shelf-life shall be conducted by repeating appropriate tests. Justification for
the selection of tests shall be provided.
8.2 Sampling
A sampling plan shall be used which will ensure that adequate representation of the data has been obtained
for each characteristic measured. It shall be verified that the design attributes of the sheath/dilator kit for the
endovascular filter system, filter system, filter, optional filter, sheath/dilator kit for the endovascular
retrieval/conversion system, and filter retrieval/conversion system are representative of the devices to be
released for distribution, including all sizes and orientations.
The samples selected for each test shall at a minimum represent the worst case(s). Consideration shall be
given to filter size, delivery system sizes (diameter and length) and orientation, and implant conditions (e.g.
intended vena cava size and shape). Analysis might be necessary to identify the samples with the greatest
potential for failure under specified implant conditions.
Sampling should ensure adequate representation (e.g. multiple lots) of the expected variability in device
characteristics.
A rationale should be provided for sample selection. For all tests, the number of samples shall be justified.
ISO 25539-3:2011(E)
8.3 Conditioning of test samples
All samples shall be subjected to sterilization, including multiple sterilizations, if appropriate, unless
justification is provided for use of nonsterilized products.
Samples should be subjected to conditions normally encountered that might affect the test results.
Conditioning should include preparation of the sheath/dilator kit, loading of the filter inside the delivery
catheter, preconditioning of the filter and retrieval/conversion system, and deployment of the filter, as stated in
the IFU.
A simulated physiological environment (e.g. a temperature-controlled water bath) should be used when
appropriate.
8.4 Reporting
For the purposes of this part of ISO 25539, reporting is carried out at the request of a national regulatory
authority.
The test report for the preclinical in vitro testing should include an executive summary of all testing. This
summary should include identification of tests, with the rationale for the omission of any tests identified in
Annex C or the selection of alternative tests. The information provided in each test report should be based
upon a prospectively defined test protocol.
A summary of results, with acceptance criteria and any potential clinical significance of the results, should be
included and may be in tabular form. Consideration shall be given to the anatomical, physiological and
morphological conditions of the intended use when establishing the acceptance criteria. Justification and
clinical applicability of acceptance criteria for each test shall be provided. A table of contents should be
provided and pages should be numbered sequentially.
Individual test reports should include the following information.
a) Purpose: state the purpose of the test as it corresponds to this part of ISO 25539.
b) Materials: list all materials (e.g. test articles with lot/serial numbers or other appropriate means of
traceability, equipment) used in performing the test, using figures and diagrams as appropriate.
c) Sampling: state the sampling plan, including the basis for and the number of samples tested; the
selection of test article shall be justified (e.g. sizes, conditioning).
d) Acceptance criteria: state the acceptance criteria for the test results.
e) Test method: describe in detail the method used to perform the test, including any prospectively defined
inspection procedures, and provide a justification for critical test parameters.
f) Protocol deviations: describe any deviations and their potential significance on the interpretation of the
results.
g) Expression of results: describe testing results using the units indicated in the test method.
h) Conclusion: state conclusions, based on comparing results to acceptance criteria, including any potential
clinical significance of these results.
8 © ISO 2011 – All rights reserved

ISO 25539-3:2011(E)
8.5 Bench and analytical tests
Testing of the sheath/dilator kit for the endovascular filter system, filter system, filter, optional filter,
sheath/dilator kit for endovascular retrieval/conversion system, and filter retrieval/conversion systems shall be
conducted for evaluating the design attributes described in Clause 6, as applicable. The appropriate tests for
evaluating each design attribute are based on the potential associated failure modes, device effects and
detrimental clinical effects of failure. This information is outlined in Tables 2 to 8, and fully described in
Annex A.
NOTE Annex C provides a list of bench and analytical tests.
In Tables 2 to 8, potential effects of failure are identified. The specific effects of the failure modes can be
clinical or device-related, and are listed separately. Regarding the clinical effects of failure, the comment
“observation that might lead to a non-specific clinical event or use of additional devices or procedures”
(designated as ACE3 in Table 1) only appears in Tables 2 to 8 when it is the only identified potential
detrimental clinical effect of failure. This effect is applicable for all potential failure modes, but is not repeated
to decrease redundancy. “Death” is not listed in the tables, though it is a known potential effect, because this
event is correlated to the severity of the failure and is not helpful in identifying tests to evaluate device function.
To minimize redundancy, commonly listed groups of clinical effects have been assigned abbreviations as
described in Table 1. These abbreviations are used throughout this part of ISO 25539.
Table 1 — Associated detrimental clinical effects key
ACE1 ACE2 ACE3
 Caval injury or damage  Arrhythmia  Filter thrombosis Observation that might lead
to a non-specific clinical
 Embolization  Branch vessel occlusion  Lung damage
event or use of additional
 Haematoma  Cardiac damage  Intimal tear
devices or procedures
 Vascular trauma  Cardiac tamponade  Pulmonary embolism
 Caval injury or damage  Trauma to adjacent
structures
 Caval perforation
 Vascular trauma
 Oedema
 Vessel occlusion
 Embolization
8.5.1 Sheath/dilator kit for endovascular filter system
8.5.1.1 General
The ability of the sheath/dilator kit to permit safe and consistent access to the intended location shall be
assessed.
The associated device-related/procedure-related functions, potential failure modes and potential device and
detrimental clinical effects of failure to be considered are listed in Table 2.
ISO 25539-3:2011(E)
Table 2 — Sheath/dilator kit for endovascular filter system
Potential effect(s) Potential effect(s)
Function(s) Potential failure mode(s)
of failure (device) of failure (clinical)
Ability to access with  Difficult/unable to push  Access failure  ACE1
sheath/dilator kit sheath/dilator to target
 Accessory device failure  Air embolism
site
 Dilator damage
 Dilator difficult/unable to
 Sheath damage
track over guidewire
 Sheath/dilator is
incompatible with
accessory devices
 Sheath is incompatible
with dilator
 Bond joint separation  Dilator damage  ACE2
Ability to withdraw dilator
 Foreign body
embolization
 Withdrawal failure
Ability to perform cavagram  Hub separation  Sheath damage  Inadequate cavagram
 Catheter burst  Dilator damage  ACE2
 Inadequate contrast flow  Leakage of contrast
media
 Foreign body
embolization
 Withdrawal failure
Testing shall include the items listed in 8.5.1.2 to 8.5.1.7, as appropriate to the design of the sheath/dilator kit.
8.5.1.2 Catheter burst
Determine the burst pressure for catheters used for cavagrams.
8.5.1.3 Dimensional verification and component dimensional compatibility
Evaluate the dimensions of the sheath/dilator kit for compatibility with the dimensions of recommended
accessories and/or conformance with design specifications.
8.5.1.4 Power injection
Determine the amount and location of contrast leakage from a system during power injection.
8.5.1.5 Simulated use
8.5.1.5.1 General
Evaluate the performance of the sheath/dilator kit using a model or models that simulate(s) the intended use
conditions.
8.5.1.5.2 Ability to access
Evaluate the ability of the sheath/dilator kit to access the deployment location in the anatomical model(s).
10 © ISO 2011 – All rights reserved

ISO 25539-3:2011(E)
8.5.1.5.2.1 Flex/kink
Evaluate the ability of the sheath/dilator kit to bend in order to accommodate the minimum radius or angle it
will be required to negotiate during access and delivery.
8.5.1.5.2.2 Pushability
Evaluate the ability of the sheath/dilator kit to be pushed or positioned by an operator without bending or
buckling.
8.5.1.5.2.3 Trackability
Evaluate the ability of the sheath/dilator kit to advance through the vessel to the target site using the
recommended accessories.
8.5.1.5.3 Ability to withdraw
Evaluate the ability of the dilator to be withdrawn from the deployment location in the anatomical model(s).
8.5.1.6 Tensile strength
Determine the tensile strength of relevant components including bond joints and/or fixed connections of the
system.
8.5.1.7 Torsional bond strength
Determine the torque/rotation required to break joints and/or materials in the appropriate sheath/dilator kit
components, if appropriate for the intended clinical use.
8.5.2 Filter system
8.5.2.1 General
The ability of the filter system to permit safe and consistent delivery, deployment and withdrawal shall be
assessed.
The associated device-related/procedure-related functions, potential failure modes, and potential device and
detrimental clinical effects of failure to be considered are listed in Table 3.
ISO 25539-3:2011(E)
Table 3 — Filter system
Potential effect(s) Potential effect(s)
Function(s) Potential failure mode(s)
of failure (device) of failure (clinical)
Ability to deliver filter to  Inability to load filter (if  Delivery failure  ACE2
implant site prior to applicable)
 Delivery system damage  ACE3
deployment
 Filter system is
 Sheath damage
incompatible with sheath
 Foreign body
 Inability to advance filter
embolization
to target site
 Deployment failure
 Generation of particles
 Filter fracture
from system
 Filter migration
 Premature release of filter
 Inadequate filter
 Damage to sheath and/or
formation
filter system
 Unacceptable filter tilting
 Damage of filter
 Misplacement
 Filter system damage
 Filter damage
Ability to deploy filter  Damage to sheath and/or  Delivery failure  ACE1
filter system
 Filter system damage  ACE2
 Damage of filter
 Foreign body  ACE3
 Inability to activate embolization
deployment mechanism
 Sheath damage
 Difficult to deploy
 Filter damage
 Inaccurate deployment in
 Filter fracture
relationship to target site
 Filter migration
 Inability to completely
 Inadequate filter
separate filter from
formation
delivery system
 Unacceptable filter tilting
 Partial deployment of
 Withdrawal failure
filter
 Deployment failure
 Inadequate filter
formation
 Misplacement
 Unacceptable filter tilting
 Delivery system damage
 Inadequate filtration
 Excessive filtration
Ability to withdraw delivery  Inability to withdraw filter  Withdrawal failure  ACE2
system and introducer delivery system
 Delivery system damage  ACE3
sheath
 Damage to filter
 Foreign body
 Damage to delivery embolization
system
 Filter damage
 Inability to completely
 Filter fracture
separate filter from
 Filter migration
delivery system
 Inadequate filter
 Change in formation
formation
 Unacceptable filter tilting
 Inadequate filtration
 Excessive filtration
Testing shall include the items listed in 8.5.2.2 to 8.5.2.6, as appropriate to the design of the filter system.
12 © ISO 2011 – All rights reserved

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