SIST EN ISO 7198:2017

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

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 standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.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 standard is supplemental to ISO 14630, 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 document will be necessary.
1.2   This International Standard includes is applicable to sterile tubular vascular prostheses 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 nontextile materials are included in thewithin the scope of this 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, thise standard does not specifically address sourcing, harvesting,  and manufacturing and all testinfg requirements for biological materials.  It is further noted that different regulatory requirements may exist for tissues from human and animal sources.

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 systemes extracorporels - Prothèses 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
• Public Enquiry End Date: 29-Oct-2014
• Publication Date: 06-Apr-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Mar-2017
• Due Date: 19-May-2017
• Completion Date: 07-Apr-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: EN ISO 7198:2017 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)

Relations

• Replaces: SIST EN 12006-2:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 01-May-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7198:2017
01-maj-2017
1DGRPHãþD
SIST EN 12006-2:2000+A1:2009
9VDGNLLPSODQWDWL]DVUFHLQRåLOMHWHU]XQDMWHOHVQLSUHWRþQLVLVWHPLäLOQHSURWH]H
&HYDVWLYVDGNLVVUþQLPL]DNORSNDPLWXEXODUQLJUDIWLLQåLOQHSURWH]H,62

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
SIST EN ISO 7198:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7198:2017

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SIST EN ISO 7198:2017


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.

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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

2

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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.
3

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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
4

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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
5

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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
6

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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.
7

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SIST EN ISO 7198:2017
EN ISO 7198:2017 (E)
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.
8

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SIST EN ISO 7198:2017
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

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SIST EN ISO 7198:2017
ISO 7198:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© 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

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SIST EN ISO 7198:2017
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 2016 – All rights reserved iii

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SIST EN ISO 7198:2017
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

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SIST EN ISO 7198:2017
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
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
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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
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Any tra
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