EN ISO 7198:2017

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)

ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
NOTE          Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE          Requirements for endovascular prostheses are specified in ISO 25539‑1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE          Requirements for vascular stents are specified in ISO 25539‑2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that a

Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Prothesen - Tubulare vaskuläre Transplantate und Gefäßpatches (ISO 7198:2016)

1.1   Diese Internationale Norm legt, beruhend auf dem gegenwärtigen medizinischen Wissensstand, Anforderungen an die Bewertung von Gefäßprothesen sowie Anforderungen an Nomenklatur, Konstruktions¬merk¬male und Herstellerinformationen fest. Eine Anleitung zur Entwicklung von In-vitro-Prüfverfahren ist in einem informativen Anhang zu dieser Internationalen Norm enthalten. Diese Internationale Norm kann als Ergänzung zur ISO 14630:2012 betrachtet werden, die allgemeine Anforderungen an die Leistung nichtaktiver chirurgischer Implantate festlegt.
ANMERKUNG   Aufgrund der Variationen in der Konstruktion der durch diese Internationale Norm abgedeckten Implan¬tate sowie in einigen Fällen aufgrund der relativ neuen Entwicklung einiger dieser Implantate (z. B. bioabsorbierbare Gefäßprothesen, durch Tissue-Engineering hergestellte zellbasierte Gefäßprothesen) stehen nicht immer annehmbare genormte In-vitro-Prüfungen und klinische Ergebnisse zur Verfügung. Sobald weitere wissenschaftliche und klinische Daten verfügbar sind, wird eine entsprechende Überarbeitung dieser Internationalen Norm erforderlich.
1.2   Diese Internationale Norm gilt für sterile schlauchförmige Gefäßtransplantate, die unter Anwendung chirurgischer Verfahren mit direkter Visualisierung anstelle von Durchleuchtung oder anderen indirekt bildgebenden Verfahren (z. B. Computertomographie oder bildgebende Kernspintomographie) implantiert werden und dafür vorgesehen sind, Segmente des menschlichen Gefäßsystems zu ersetzen, einen Bypass oder Shunt zwischen diesen zu bilden, sowie für Gefäßpatches, die für die Reparatur und Rekonstruktion des Gefäßsystems vorgesehen sind.
1.3   Gefäßprothesen, die aus synthetischen textilen sowie synthetischen nichttextilen Materialien hergestellt werden, liegen im Anwendungsbereich dieser Internationalen Norm.
1.4   Während Gefäßprothesen, die vollständig oder teilweise aus Materialien nicht lebensfähiger biolo-gischer Herkunft bestehen, einschließlich durch Tissue-Engineering hergestellte Gefäßprothesen, vom Anwendungsbereich abgedeckt sind, behandelt diese Internationale Norm nicht die Herkunftsbestimmung, Entnahme, Herstellung sowie alle Prüfanforderungen in Bezug auf biologische Materialien. Darüber hinaus wird darauf hingewie¬sen, dass für Gewebe menschlichen oder tierischen Ursprungs unterschiedliche gesetzliche Anforderungen gelten können.
1.5   Verbund-, beschichtete, Komposit- und extern verstärkte Gefäßprothesen liegen im Anwendungs-bereich dieser Norm.
1.6   Endovaskuläre Prothesen, die mithilfe von Kathetereinführung und indirekter Visualisierung implantiert werden, sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen. Diese Internationale Norm umfasst Informationen zur Entwicklung geeigneter Prüfverfahren für Transplantatmaterialien; die entsprechende Verweisung erfolgt in ISO 25539 1 für Materialien, die bei der Herstellung endovaskulärer Prothesen (d. h. Stent-Transplantate) zum Einsatz kommen.
ANMERKUNG   Anforderungen an endovaskuläre Prothesen sind in ISO 25539 1 festgelegt.
1.7   Die Klappenkomponente von Klappen-Conduits, die mit einem schlauchförmigen Gefäßtransplantat hergestellt werden, sowie die Kombination der Klappenkomponente und des schlauchförmigen Gefäßtrans¬plantats sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen. Diese Internationale Norm kann hilfreich sein bei der Identifizierung der angemessenen Bewertung des schlauchförmigen Gefäßtransplantats eines Klappen-Conduits; spezifische Anforderungen an und Prüfverfahren für diese Implantate werden jedoch nicht beschrieben.
1.8   Kardiale und perikardiale Patches, Gefäßstents, Zubehör wie z. B. Anastomosegeräte, Klammerappa-rate, Tunneler und Nahtmaterial sowie Tupfer sind vom Anwendungsbereich dieser Internationalen Norm ausgenommen.
ANMERKUNG   Anforderungen an Gefäßstents sind in ISO 25539 2 festgelegt.
1.9   Anforderungen an das Aussäen von Zellen
(...)

Implants cardiovasculaires et systèmes extracorporels - Prothèses vasculaires - Greffons vasculaires tubulaires et pièces vasculaires (ISO 7198:2016)

L'ISO 7198:2016 spécifie les exigences relatives à l'évaluation des prothèses vasculaires et les exigences relatives à la nomenclature, aux caractéristiques de conception et aux informations fournies par le fabricant, sur la base des connaissances médicales actuelles. Les lignes directrices relatives à l'élaboration des méthodes d'essai in vitro figurent dans l'annexe informative de l'ISO 7198:2016. Elle peut être considérée comme un complément à l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
NOTE          En raison des variantes de conception des implants traités dans l'ISO 7198 :2016 et, dans certains cas, du caractère relativement récent de l'élaboration de certains de ces implants (par exemple: les prothèses vasculaires bioabsorbables et les prothèses vasculaires issues de l'ingénierie tissulaire à partir de cellules), il n'existe pas toujours de résultats d'essai in vitro ni de résultats cliniques normalisés acceptables. Lorsque de nouvelles données scientifiques et cliniques seront disponibles, il sera nécessaire de procéder à une révision appropriée de l'ISO 7198 :2016.
Elle est applicable aux greffons vasculaires tubulaires stériles implantés au moyen de techniques chirurgicales avec visualisation directe, par opposition à l'imagerie radioscopique et autres procédés d'imagerie indirecte (par exemple: la tomodensitométrie ou l'imagerie par résonance magnétique), et destinés à remplacer ou contourner des segments du système vasculaire chez l'Homme ou à créer des dérivations entre plusieurs de ces segments; elle est également applicable aux pièces vasculaires destinées à la réparation et à la reconstruction du système vasculaire.
Les prothèses vasculaires fabriquées à partir de matériaux synthétiques textiles et de matériaux synthétiques non textiles entrent dans le domaine d'application de l'ISO 7198:2016.
Bien que les prothèses vasculaires entièrement ou partiellement constituées de matériaux d'origine biologique non viables, y compris les prothèses vasculaires issues de l'ingénierie tissulaire, entrent dans le domaine d'application de l'ISO 7198:2016, celle-ci ne traite pas de l'origine, de la collecte, de la fabrication, ni de l'ensemble des exigences d'essai applicables aux matériaux biologiques. En outre, il est noté que des exigences réglementaires différentes peuvent exister pour les tissus d'origine humaine et animale.
Les prothèses vasculaires composées, à revêtement, composites et à renfort externe entrent dans le domaine d'application de l'ISO 7198:2016.
Les prothèses endovasculaires implantées au moyen d'un système de pose de cathéter et de visualisation indirecte sont exclues du domaine d'application de l'ISO 7198:2016. Elle inclut des informations sur l'élaboration de méthodes d'essai adaptées pour les matériaux prothétiques, référencées dans l'ISO 25539‑1 pour les matériaux utilisés dans la fabrication des prothèses endovasculaires (c'est-à-dire les greffons-endoprothèses).
NOTE          Les exigences relatives aux prothèses endovasculaires sont spécifiées dans l'ISO 25539‑1.
La valve des conduits à valve constitués d'un composant à greffon vasculaire tubulaire et la combinaison du composant à valve et du composant à greffon vasculaire tubulaire sont exclues du domaine d'application de l'ISO 7198:2016. Elle peut être utile pour identifier l'évaluation appropriée du composant à greffon vasculaire tubulaire d'un conduit à valve; néanmoins, les exigenc

Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Žilne proteze - Cevasti vsadki s srčnimi zaklopkami (tubularni grafti) in žilne proteze (ISO 7198:2016)

1.1Ta mednarodni standard določa zahteve za ocenjevanje žilnih protez in zahteve glede nomenklature, oblike in informacij, ki jih proizvajalec zagotavlja na podlagi trenutnega medicinskega znanja. Smernice za razvoj preskusnih metod in vitro so zajete v informativnem dodatku tega standarda. Ta standard je treba obravnavati kot dodatek k standardu ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov. V zvezi z varnostjo podaja zahteve za predvideno zmogljivost, obliko, materiale, ovrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec. Ta standard je dodatek k standardu ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov. OPOMBA: Zaradi razlik v zasnovi vsadkov, ki so zajeti v tem mednarodnem standardu, in ker so bili v nekaterih primerih nekateri od teh vsadkov (npr. bioresorbilne žilne proteze, žilne proteze, izdelane na osnovi celičnega tkiva) razviti nedavno, sprejemljivi standardizirani preskusi in vitro in klinični rezultati niso vedno na voljo. S pojavom novih znanstvenih in kliničnih podatkov bodo potrebne ustrezne revizije tega dokumenta.  1.2   Ta mednarodni standard se uporablja za sterilne cevaste žilne proteze, ki se vsadijo s kirurškimi tehnikami neposredne vizualizacije v nasprotju s fluoroskopskimi tehnikami ali tehnikami posrednega slikanja (npr. računalniško tomografijo ali tehnikami slikanja z magnetno resonanco), ki so namenjene za zamenjavo, obhod ali ustvarjanje obvodov med segmenti ožilja pri ljudeh in žilnimi protezami, namenjenimi za zdravljenje ali obnovo ožilja.   1.3   Žilne proteze, izdelane iz sintetičnih tekstilnih materialov, in sintetični netekstilni materiali spadajo na področje uporabe tega standarda.  1.4   Čeprav žilne proteze, ki so delno ali v celoti izdelane iz neživih bioloških materialov, vključno z žilnimi protezami, izdelanimi iz tkiva, spadajo na področje uporabe, ta standard ne obravnava posebej virov, pridobivanja, izdelave in vseh zahtev za preskušanje bioloških materialov.  Poleg tega je treba upoštevati, da morda obstajajo različne zakonodajne zahteve za tkiva, pridobljena iz človeških in živalskih virov.

General Information

• Status: Published
• Publication Date: 28-Feb-2017
• Withdrawal Date: 30-Mar-2020
• 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
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Mar-2017
• Completion Date: 01-Mar-2017
• 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 7198:2017 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)

Relations

• Replaces: EN 12006-2:1998+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 08-Mar-2017

Overview

EN ISO 7198:2017 (ISO 7198:2016) is an international standard for cardiovascular implants and extracorporeal systems, specifically addressing vascular prostheses - tubular vascular grafts and vascular patches. It specifies requirements for evaluation, nomenclature, design attributes, and manufacturer information based on current medical knowledge. An informative annex offers guidance for developing in vitro test methods. ISO 7198 is intended as a technical supplement to ISO 14630:2012 (general requirements for non‑active surgical implants).

Key topics and technical requirements

• Scope and device types: Applies to sterile tubular vascular grafts implanted by direct‑visualization surgical techniques and to vascular patches for repair/reconstruction. Includes synthetic textile and non‑textile grafts, coated/composite/reinforced designs, and non‑viable biological materials (but not sourcing/manufacture/testing specifics for biological tissues).
• Exclusions: Endovascular prostheses (catheter‑delivered stent‑grafts), valve components of valved conduits, vascular stents, cardiac/pericardial patches, and accessory devices (suturing devices, staplers, pledgets) are explicitly excluded.
• Design and labelling: Requirements for configuration designation, size designation, intended clinical use designation, materials classification, and information supplied by the manufacturer (e.g., sterilization status, storage/expiration, dimensional data).
• Performance and testing guidance: Intended performance criteria and guidance for development of in vitro test methods (informative annex). The standard references relevant biological evaluation and sterilization standards (e.g., ISO 10993 series, ISO 11135/11137, ISO 11607).
• Limitations and future revision: Notes that for newer technologies (bioabsorbable grafts, cell‑based tissue engineered prostheses) standardized tests and clinical data may be limited; revisions will follow as scientific evidence emerges.

Practical applications

• Use ISO 7198 to define product specifications, sizing conventions and manufacturer labelling for vascular grafts and patches.
• Guide preclinical evaluation plans and in vitro test method development for graft materials and coatings.
• Support regulatory documentation, risk management, and conformity assessment for non‑endovascular vascular prostheses.
• Inform procurement, clinical engineering and hospital formularies about device designation and intended use.

Who should use this standard

• Medical device manufacturers and R&D engineers designing tubular vascular grafts and patches
• Regulatory affairs and quality assurance teams preparing conformity and technical files
• Test laboratories developing material/performance assays
• Clinicians and hospital procurement specialists seeking standardized device information

Related standards

• ISO 14630 (non‑active surgical implants)
• ISO 25539‑1 (materials for endovascular prostheses / stent‑grafts)
• ISO 25539‑2 (vascular stents)
• ISO 10993 series (biological evaluation)
• ISO 11135 / ISO 11137 / ISO 11607 (sterilization and packaging)

Keywords: ISO 7198, vascular prostheses, tubular vascular grafts, vascular patches, in vitro test methods, cardiovascular implants, non‑active surgical implants, medical device standards.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2017
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SIST EN 12006-2:2000+A1:2009
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Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular
vascular grafts and vascular patches (ISO 7198:2016)
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Prothesen -
Tubulare vaskuläre Transplantate und Gefäßpatches (ISO 7198:2016)
Implants cardiovasculaires et systemes extracorporels - Prothèses vasculaires (ISO
7198:2016)
Ta slovenski standard je istoveten z: EN ISO 7198:2017
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.

EN ISO 7198
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN 12006-2:1998+A1:2009
English Version
Cardiovascular implants and extracorporeal systems -
Vascular prostheses - Tubular vascular grafts and vascular
patches (ISO 7198:2016)
Implants cardiovasculaires et systèmes extracorporels Kardiovaskuläre Implantate und extrakorporale
- Prothèses vasculaires - Greffons vasculaires Systeme - Vaskuläre Prothesen - Tubulare vaskuläre
tubulaires et pièces vasculaires (ISO 7198:2016) Transplantate und Gefäßpatches (ISO 7198:2016)
This European Standard was approved by CEN on 8 July 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7198:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on medical devices . 6

European foreword
This document (EN ISO 7198:2017) 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 September 2017, and conflicting national standards
shall be withdrawn at the latest by March 2020.
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 12006-2:1998+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(s).
For relationship with EU Directive(s), 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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7198:2016 has been approved by CEN as EN ISO 7198:2017 without any modification.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlations between undated normative references and dated EN and ISO standards
Equivalent dated standard
Normative references as
listed in Clause 2
EN ISO
ISO 10993 (all parts) EN ISO 10993-1:2009 ISO 10993-1:2009
EN ISO 10993-2:2006 ISO 10993-2:2006
EN ISO 10993-3:2014 ISO 10993-3:2014
EN ISO 10993-4:2009 ISO 10993-4:2002 and
ISO 10993-4:2002/Amd 1:2006
EN ISO 10993-5:2009 ISO 10993-5:2009
EN ISO 10993-6:2009 ISO 10993-6:2007
EN ISO 10993-7:2008 and ISO 10993-7:2008 and
EN ISO 10993-7:2008/AC:2009 ISO 10993-7:2008/Cor 1:2009
EN ISO 10993-9:2009 ISO 10993-9:2009
EN ISO 10993-10:2013 ISO 10993-10:2010
EN ISO 10993-11:2009 ISO 10993-11:2006
EN ISO 10993-12:2012 ISO 10993-12:2012
EN ISO 10993-13:2010 ISO 10993-13:2010
EN ISO 10993-14:2009 ISO 10993-14:2001
EN ISO 10993-15:2009 ISO 10993-15:2000
EN ISO 10993-16:2010 ISO 10993-16:2010
EN ISO 10993-17:2009 ISO 10993-17:2002
EN ISO 10993-18:2009 ISO 10993-18:2005
- ISO/TS 10993-19:2006
- ISO/TS 10993-20:2006
ISO 11135 EN ISO 11135:2014 ISO 11135:2014
ISO 11137 (all parts) EN ISO 11137-1:2015 ISO 11137-1:2006 and
ISO 11137-1:2006/Amd 1:2013
EN ISO 11137-2:2015 ISO 11137-2:2013
EN ISO 11137-3:2006 ISO 11137-3:2006
ISO 11607-1 EN ISO 11607-1:2009 and ISO 11607-1:2006 and
EN ISO 11607-1:2009/A1:2014 ISO 11607-1:2006/Amd 1:2014
ISO 14155 EN ISO 14155:2011 and ISO 14155:2011 and
EN ISO 14155:2011/AC:2011 ISO 14155:2011/Cor. 1:2011
Equivalent dated standard
Normative references as
listed in Clause 2
EN ISO
ISO 14160 EN ISO 14160:2011 ISO 14160:2011
ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012
ISO 14937 EN ISO 14937:2009 ISO 14937:2009
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 17665 (all parts) EN ISO 17665-1:2006 ISO 17665-1:2006
CEN ISO/TS 17665-2:2009 ISO/TS 17665-2:2009
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to voluntary means of conforming to essential
requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L 169].
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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Essential Requirements Clause(s)/subclause(s) of Remarks/Notes
(ERs) of Directive this European Standard
93/42/EEC
7.1, first indent 6.2 d), 6.3 d), 6.4 b) and c) With respect to the first indent of ER 7.1,
manufacturing is not covered by this
standard.
Toxicity and flammability are not covered
by this standard.
For tubular vascular grafts, the first indent
of ER 7.1 is covered by 6.2 d).
For vascular patches, the first indent of ER
7.1 is covered by 6.3 d).
For coatings, the first indent of ER 7.1 is
covered by 6.4 b) and c).
7.1, second indent 8.5.2, 8.6, 8.7
Essential Requirements Clause(s)/subclause(s) of Remarks/Notes
(ERs) of Directive this European Standard
93/42/EEC
7.2 Clause 12 Covered for design to protect patients from
sterilization when the device is used.
Manufacturing and packing to minimize
these risks are not addressed.
8.1 Clause 12 and 13.5 Requirements are included for devices that
are supplied sterile. Maintenance of
sterility in transit is addressed.
Minimizing contamination during use is
not addressed.
Risk of infection to the user and third party
are not addressed.
8.3 Clauses 11, 12, 13 Sterility assurance, manufacturing,
packaging design and maintenance of
sterility are addressed.
8.4 Clauses 11, 12 Manufacturing, sterilization validation and
routine control are addressed.
8.7 13.6.1 i)
9.2, first indent 4.2, 8.7.2.3, 8.7.2.4, 8.7.3.3 Dimensions must be specified and
dimensional verification required.
13.1 13.6
13.3 a) 13.6.1 The standard does not address the
requirement regarding the authorized
representative where the manufacturer
does not have a registered place of
business in the Community.
13.3 b) 13.6.1 b), c), d), e), f), g) ER 13.3 b) is only satisfied in respect of the
information specified in the standard
clauses.
13.3 c) 13.6.1 i) ER 13.3 c) is only satisfied if the word
“STERILE” (or the harmonized symbol) is
used.
13.3 d) 13.6.1 k) Only covered if the batch code is preceded
by the word LOT.
13.3 e) 13.6.1 m) ER 13.3 e) is only satisfied if the expiration
date in the format year and month is given.
13.3 f) 13.6.1 i) Consistency of marking across the
community is not covered.
13.3 i) 13.6.1 o) Covered for storage instructions.
13.3 k) 13.6.1 n) ER 13.3 k) is only satisfied in respect of
damage to the packaging.
Essential Requirements Clause(s)/subclause(s) of Remarks/Notes
(ERs) of Directive this European Standard
93/42/EEC
13.3 m) 13.6.1 j)
13.6 a) 13.6.3 b), 13.6.3 c), 13.6.3 d), Covered for the items listed in 13.3 c), f), i)
13.6.3 f) (handling is not covered), j), and k).
Note:
• 13.3 c) is covered by 13.6.3 d),
• 13.3 f) is covered by 13.6.3 d),
• 13.3 i) is covered by 13.6.3 f),
• 13.3 j) is covered by 13.6.3 c)
• 13.3 k) is covered by 13.6.3 b)
13.6 b) 13.6.3 a), b) Performance is not covered.
13.6 c) 13.6.3 c) Methods for preparation and implantation
techniques. Use of endovascular systems
involve use of additional medical devices
(e.g. syringes, wire guides).
13.6 d) 13.6.3 c) First part covered (installation and
preparation for operation only).
13.6 i) 13.6.3 c)
13.6 q) 13.6.3 g)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 7198
Second edition
2016-08-01
Cardiovascular implants and
extracorporeal systems — Vascular
prostheses — Tubular vascular grafts
and vascular patches
Implants cardiovasculaires et systèmes extracorporels — Prothèses
vasculaires — Greffons vasculaires tubulaires et pièces vasculaires
Reference number
ISO 7198:2016(E)
©
ISO 2016
ISO 7198:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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www.iso.org
ii © ISO 2016 – All rights reserved

ISO 7198:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 6
4.1 Configuration designation for tubular vascular grafts . 6
4.2 Size designation . 7
4.2.1 Uniform straight tubular vascular grafts . 7
4.2.2 Uniform bifurcated tubular vascular grafts . 7
4.2.3 Tapered tubular vascular grafts . 7
4.2.4 Other configurations of tubular vascular grafts . 7
4.2.5 Vascular patches . 7
4.3 Materials . 7
4.3.1 General. 7
4.3.2 Classification of tubular vascular grafts and vascular patches . 7
4.3.3 Nomenclature . 8
4.4 Intended clinical use designation . 8
5 Intended performance . 9
6 Design attributes . 9
6.1 General . 9
6.2 Tubular vascular grafts . 9
6.3 Vascular patches . 9
6.4 Coatings .10
6.5 Drug coatings and drug-eluting coatings .10
7 Materials .10
8 Design evaluation .10
8.1 General .10
8.2 Sampling .11
8.3 Conditioning of test samples .11
8.4 Reporting .11
8.5 Biocompatibility .12
8.5.1 Residual chemicals .12
8.5.2 Biocompatibility .12
8.6 Biostability.12
8.7 Bench and analytical tests .13
8.7.1 General.13
8.7.2 Tubular vascular grafts .13
8.7.3 Vascular patches .15
9 Preclinical in vivo evaluation test methods for vascular prostheses .16
9.1 Preclinical in vivo evaluation .16
9.1.1 Purpose .16
9.1.2 Specific aims .17
9.1.3 Protocol considerations .17
9.1.4 Data acquisition .17
9.1.5 Test report and additional information .18
10 Clinical investigation methods for vascular prostheses .19
10.1 Clinical investigation .19
10.1.1 Purpose .19
10.1.2 Specific aims .19
ISO 7198:2016(E)
10.1.3 Protocol considerations .19
10.1.4 Data acquisition .20
10.1.5 Final report .23
10.2 Post market surveillance .24
11 Manufacturing .24
12 Sterility .24
13 Packaging and labelling .25
13.1 General .25
13.2 Unit container .25
13.3 Outer container .25
13.4 Shipping container.25
13.5 Maintenance of sterility in transit .25
13.6 Marking .25
13.6.1 Container label .25
13.6.2 Record label . .26
13.6.3 General information and instructions for use .26
Annex A (informative) Test methods .27
Bibliography .54
iv © ISO 2016 – All rights reserved

ISO 7198:2016(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 7198:1998), which has been technically
revised.
ISO 7198:2016(E)
Introduction
This International Standard has been prepared in order to provide minimum requirements for tubular
vascular grafts and vascular patches, including guidance on the methods of test that will enable their
evaluation. This International Standard is an update of ISO 7198:1998, necessary given the introduction
of new standards for endovascular prostheses, vascular stents and vascular device-drug combination
products.
This International Standard covers vascular prostheses implanted using direct visualization surgical
techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography
or magnetic resonance imaging). ISO 25539-1 specifies requirements and testing guidelines for
endovascular prostheses, implanted using catheter delivery and non-direct visualization. Since the
design of endovascular prostheses often involves the use of materials that are used in traditional
vascular prostheses, some of the methods to evaluate these materials are contained in this International
Standard and referenced in the endovascular prostheses standard (ISO 25539-1).
It is recognized by this ISO committee that many forms of tubular vascular grafts and vascular patches
have been shown to be a safe and effective means to surgically restore blood flow in various indications
over many years. This update is not intended to significantly change the manner in which tubular
vascular grafts have been evaluated or to add new requirements. Therefore, manufacturers can rely on
evaluation and historical data gathered under ISO 7198:1998 to meet the requirements that have not
changed in the current standard. The committee recognizes that, with the addition of requirements for
vascular patches and references to device-drug combination requirements in other ISO documents, a
reasonable amount of time (e.g. one to three years) might be needed to become fully compliant with this
International Standard.
vi © ISO 2016 – All rights reserved

INTERNATIONAL STANDARD ISO 7198:2016(E)
Cardiovascular implants and extracorporeal systems —
Vascular prostheses — Tubular vascular grafts and
vascular patches
1 Scope
1.1 This International Standard specifies requirements for the evaluation of vascular prostheses
and requirements with respect to nomenclature, design attributes and information supplied by the
manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test
methods is included in an informative annex to this International Standard. This International Standard
can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the
performance of non-active surgical implants.
NOTE Due to the variations in the design of implants covered by this International Standard and, in some
cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses,
cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results
are not always available. As further scientific and clinical data become available, appropriate revision of this
International Standard will be necessary.
1.2 This International Standard is applicable to sterile tubular vascular grafts implanted by
direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g.
computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts
between segments of the vascular system in humans and vascular patches intended for repair and
reconstruction of the vascular system.
1.3 Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials
are within the scope of this International Standard.
1.4 While vascular prostheses that are made wholly or partly of materials of non-viable biological
origin, including tissue engineered vascular prostheses are within the scope, this International Standard
does not address sourcing, harvesting, manufacturing and all testing requirements for biological
materials. It is further noted that different regulatory requirements might exist for tissues from human
and animal sources.
1.5 Compound, coated, composite, and externally reinforced vascular prostheses are within the scope
of this standard.
1.6 Endovascular prostheses implanted using catheter delivery and non-direct visualization are
excluded from the scope of this International Standard. This International Standard includes information
on the development of appropriate test methods for graft materials, referenced in ISO 25539-1 for
materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539-1.
1.7 The valve component of valved conduits constructed with a tubular vascular graft component,
and the combination of the valved component and the tubular vascular graft component, are excluded
from the scope of this International Standard. This International Standard can be helpful in identifying
the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific
requirements and testing are not described for these devices.
ISO 7198:2016(E)
1.8 Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices,
staplers, tunnelers and sutures, and pledgets are excluded from the scope of this International Standard.
NOTE Requirements for vascular stents are specified in ISO 25539-2.
1.9 Requirements regarding cell seeding are excluded from the scope of this International Standard.
Tissue engineered vascular prostheses that contain or are manufactured using cells present many
distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced
with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in
this International Standard can be a useful guide for certain testing requirements for these cell-based
products.
1.10 Pharmacological aspects of drug-eluting or drug-coated vascular prostheses are not addressed in
this International Standard.
NOTE Requirements for vascular device-drug combination products are specified in ISO 12417-1.
1.11 Degradation, tissue ingrowth and/or tissue replacement, and other time-dependent aspects of
absorbable vascular prostheses are not addressed in the standard.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
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 for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for medical devices
ISO 14630:2012, 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 (all parts), Sterilization of health care products — Moist heat
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630:2012 and the
following apply.
2 © ISO 2016 – All rights reserved

ISO 7198:2016(E)
3.1
adverse event
adverse change in health that occurs in a subject who participates in a study while receiving the
treatment or within a specified time after receiving treatment
Note 1 to entry: Adverse events are categorized by the system affected (e.g. cardiac, vascular, respiratory,
neurological, renal, gastro-intestinal).
Note 2 to entry: This definition is not applicable for routine, post-approval event reporting.
3.2
bifurcation
site of division of one vascular tube (trunk or body) into two branches (limbs)
3.3
biological material
material of animal or vegetable origin that may have been modified or treated by chemical processes,
but excluding any material derived from fossil biological remains
3.4
biostability
ability of a material to maintain its physical and chemical integrity after implantation in living tissue
3.5
coating
organic or inorganic material, other than living cells, intentionally applied by a manufacturer to
substrate prosthesis
Note 1 to entry: This coating can be intended to be permanent or temporary, can be applied to the external and/or
internal surface, and/or can be impregnated into the structure of the substrate prosthesis (3.30).
3.6
compliance
ability of a prosthesis to elastically expand and contract in the circumferential direction in response to
a pulsatile pressure
3.7
component
substance used during manufacture whether or not it is intended to remain as a consistent element of
the device
3.8
composite prosthesis
vascular prosthesis in which the construction and/or material of construction varies in a segmental
manner along the length
EXAMPLE Prosthesis in which the proximal portion is of crimped knitted fabric and the distal portion is of
an aldehyde-treated animal vascular tube.
Note 1 to entry: It is important to note the difference between a composite and compound prosthesis (3.9).
3.9
compound prosthesis
vascular prosthesis whose wall is constructed of materials from more than one source which is of
uniform construction along the length of the prosthesis
Note 1 to entry: It is important to note the difference between a compound and composite prosthesis (3.8).
Note 2 to entry: A substrate prosthesis with a coating, that is, a coated vascular prosthesis, is an example of a
compound prosthesis. This type of vascular prosthesis is commonly referred to as coated prosthesis rather than
a compound prosthesis.
ISO 7198:2016(E)
3.10
configuration
geometry of prosthesis
EXAMPLE Straight, bifurcated, tapered.
3.11
construction
type of structure of a prosthesis
EXAMPLE Knitted, woven, nonwoven, expanded polymer.
3.12
crimp
creases or folds manufactured into a prosthesis to permit elongation and reduce kinking
3.13
determine
quantitatively appraise or analyse
3.14
endovascular prosthesis
endovascular graft
endovascular implant
prosthesis (including modular components) delivered and deployed using a delivery system, which
resides partially or completely within a blood vessel or vascular conduit to form an internal bypass or
shunt between sections of the vascular system
3.15
evaluate
qualitatively appraise or analyse
3.16
factory anastomosis
factory manufactured seam-line in which two or more edges of graft material are joined (e.g. sewn)
together
3.17
fibril
strand of material which originates from one or more nodes and terminates at one or more nodes
3.18
graft material
textile or non-textile, non-metallic material [e.g. polyethylene terephthalate (PET),
polytetrafluoroethylene (PTFE), polyurethane] used in the construction of a vascular prostheses or to
line or cover the mechanical support structures of an endovascular prosthesis or to provide a vascular
conduit for blood flow
3.19
host
recipient of an implant in a preclinical in vivo study
3.20
implantable state
condition of a prosthesis that has been prepared in accordance with the manufacturer’s instruction
prior to implantation, or of a material of construction that has undergone the same process of
sterilization and/or preparation
Note 1 to entry: Preparation does not include preclotting (3.26) but does include any recommended method of
washing or soaking.
4 © ISO 2016 – All rights reserved

ISO 7198:2016(E)
3.21
integral water permeability
volume of water which passes through the wall of a tubular vascular graft, or representative tubular
segment, in a specified time under a specified pressure
3.22
inter-nodal distance
distance between two nodes of expanded polymers
3.23
leakage
volume of water which passes through flaws in a water-impermeable vascular prosthesis in a specified
time under a specified pressure
Note 1 to entry: Leakage may be either through small defects in the wall of a continuous tube or through an
anastomosis constructed by the manufacturer.
Note 2 to entry: Leakage is not the same as porosity (3.25).
3.24
node
solid region within a material at which fibrils originate and converge
3.25
porosity
estimate or index of the ratio of the void within a material to the total volume occupied by the material
including the voids
Note 1 to entry: See void (3.36).
Note 2 to entry: Porosity may be expressed as the percentage void to the total area of volume, mean distance
between nodes, or mean pore diameter.
Note 3 to entry: Porosity is not the same as leakage (3.23) or water permeability (3.38).
3.26
preclotting
procedure whereby blood or blood fractions are allowed to penetrate and coagulate within the
inter
...