prEN ISO 7198

SLOVENSKI STANDARD
01-julij-2026
Vsadki (implantati) za srce in ožilje ter zunajtelesni pretočni sistemi - Žilne proteze
- Cevasti vsadki s srčnimi zaklopkami (tubularni grafti) in žilne proteze (ISO/DIS
7198:2026)
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular
vascular grafts and vascular patches (ISO/DIS 7198:2026)
Kardiovaskuläre Implantate und extrakorporale Systeme - Vaskuläre Prothesen -
Tubulare vaskuläre Transplantate und Gefäßpatches (ISO/DIS 7198:2026)
Implants cardiovasculaires et systèmes extracorporels - Prothèses vasculaires -
Greffons vasculaires tubulaires et pièces vasculaires (ISO/DIS 7198:2026)
Ta slovenski standard je istoveten z: prEN ISO 7198
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.

DRAFT
International
Standard
ISO/DIS 7198
ISO/TC 150/SC 2
Cardiovascular implants and
Secretariat: ANSI
extracorporeal systems — Vascular
Voting begins on:
prostheses — Tubular vascular
2026-05-27
grafts and vascular patches
Voting terminates on:
2026-08-19
Implants cardiovasculaires et systèmes extracorporels —
Prothèses vasculaires — Greffons vasculaires tubulaires et pièces
vasculaires
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 7198:2026(en)
DRAFT
ISO/DIS 7198:2026(en)
International
Standard
ISO/DIS 7198
ISO/TC 150/SC 2
Cardiovascular implants and
Secretariat: ANSI
extracorporeal systems — Vascular
Voting begins on:
prostheses — Tubular vascular
grafts and vascular patches
Voting terminates on:
Implants cardiovasculaires et systèmes extracorporels —
Prothèses vasculaires — Greffons vasculaires tubulaires et pièces
vasculaires
ICS: 11.040.40
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7198:2026(en)
ii
ISO/DIS 7198:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements . 7
4.1 Configuration designation for tubular vascular grafts .7
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 .8
4.3 Materials .8
4.3.1 General .8
4.3.2 Classification of tubular vascular grafts and vascular patches .8
4.3.3 Nomenclature .8
4.4 Intended clinical use designation .9
5 Intended performance . 9
6 Design attributes . 9
6.1 General .9
6.2 Tubular vascular grafts .9
6.3 Vascular patches .10
6.4 Implant Coatings .10
6.5 Drug coatings and drug-eluting coatings .10
7 Materials . 10
8 Design evaluation .11
8.1 General .11
8.2 Sampling .11
8.3 Conditioning of test samples . 12
8.4 Reporting . 12
8.5 Biocompatibility . 13
8.6 Biostability . 13
8.7 Bench and analytical tests . 13
8.7.1 General . 13
8.7.2 Tubular vascular grafts .14
8.7.3 Vascular patches .17
9 Preclinical in vivo evaluation test methods for vascular prostheses .18
9.1 Preclinical in vivo evaluation .18
9.1.1 Purpose .18
9.1.2 Specific aims .19
9.1.3 Protocol considerations .19
9.1.4 Data acquisition . . .19
9.1.5 Test report and additional information . 20
10 Clinical investigation methods for vascular prostheses .21
10.1 Clinical investigation .21
10.1.1 Purpose .21
10.1.2 Specific aims .21
10.1.3 Protocol considerations .21
10.1.4 Data acquisition . . . 22
10.1.5 Final report . 25

iii
ISO/DIS 7198:2026(en)
10.2 Post market surveillance . 26
11 Manufacturing .26
12 Sterility .26
13 Packaging and labelling .26
13.1 General . 26
13.2 Unit container . 26
13.3 Outer container . 26
13.4 Shipping container .27
13.5 Maintenance of sterility in transit .27
13.6 Marking .27
13.6.1 Container label .27
13.6.2 Record label . 28
13.6.3 General information and instructions for use . 28
Annex A (informative) Relationship between testing requirements, device attributes, and
potential failure modes and guidance for the creation of a device evaluation strategy .29
Annex B (informative) Description of clinical effects of failure.38
Annex C (informative) Description of device effects of failure .39
Annex D (informative) Application of ISO 17327-1 for coated vascular prostheses .40
Annex E (informative) Test methods .45
Bibliography .79

iv
ISO/DIS 7198:2026(en)
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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This third edition cancels and replaces the second edition (ISO 7198:2016), which has been technically
revised
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 7198:2026(en)
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 7198:2016.
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).
This revised document introduces methodology to identify appropriate testing and analyses for a specific
vascular prosthesis, designated as the device evaluation strategy. The requirement regarding the device
evaluation strategy is in Clause 8.1. Annex A provides guidance for developing a focused device evaluation
strategy table that is specific to the unique characteristics of a device, device design modifications, or
changes in intended use. Annex A also provides guidance for the development of a comprehensive device
evaluation strategy table that may be used when it is not sufficient to focus only on the unique characteristics
or changes.
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. Guidance is provided for using a comprehensive device evaluation strategy for approval
or reapproval of a device where previous nonclinical testing and historical clinical data are available. Thus,
nonclinical testing data obtained according to a previous version of this standard and historical clinical data
may be justified to be used to satisfy the new version of this standard.
The requirements regarding sampling have been updated with clarification for selecting device sizes or
portions of the device to be tested.
A requirement for a durability assessment, including creep evaluation and/or cyclic pressurization was
added. The durability assessment may include the totality of the available information regarding the
vascular prosthesis (e.g. historical clinical data, literature, material data, comparison to a commercially
available device) in place of testing.
A requirement for evaluation of visibility of vascular prostheses that are intended to be visible with imaging
techniques post-implantation was added. A requirement for determination of the appropriate MR safety
term as defined by ASTM 2503 was added.
A requirement and associated test method for tubular vascular prostheses indicated for vascular access
using needle puncture for evaluation of integral water permeability/leakage after dialysis puncture were
added. A maximum area of puncture was added to the test methods related to repeated puncture (i.e.
strength and permeability).
Additional elastic mechanics equations have been added, as an option, to convert the measured external
diameter to the internal diameter associated with the measurement of dynamic radial compliance.
For coated vascular prostheses, Annex D was added to aid the user in meeting the requirements of
ISO 17327-1. ISO 17327-1 has a broad scope, including all non-active surgical implants, and thus only some
of the requirements in ISO 17327-1 are applicable to coated vascular prostheses. Annex D clarifies how
ISO 12417-1, ISO/TS 17137, and ISO 7198 satisfy the requirements of ISO 17327-1.

vi
DRAFT International Standard ISO/DIS 7198:2026(en)
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/DIS 7198:2026(en)
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 are referred to in the text in such a way that some or all of their content constitutes
requirements 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 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 — 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 14630:2012 and the following
apply.
ISO/DIS 7198:2026(en)
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
compliance
ability of a prosthesis to elastically expand and contract in the circumferential direction in response to a
pulsatile pressure
3.6
component
substance used during manufacture whether or not it is intended to remain as a consistent element of the
device
3.7
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 (3.8).
3.8
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 (3.7).
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.
3.9
configuration
geometry of prosthesis
EXAMPLE Straight, bifurcated, tapered.

ISO/DIS 7198:2026(en)
3.10
construction
type of structure of a prosthesis
EXAMPLE Knitted, woven, nonwoven, expanded polymer.
3.11
crimp
creases or folds manufactured into a prosthesis to permit elongation and reduce kinking
3.12
determine
quantitatively appraise or analyse
3.13
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
3.14
evaluate
qualitatively appraise or analyse
3.15
factory anastomosis
factory manufactured seam-line in which two or more edges of graft material are joined (e.g. sewn) together
3.16
fibril
strand of material which originates from one or more nodes and terminates at one or more nodes
3.17
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
3.18
host
recipient of an implant in a preclinical in vivo study
3.19
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.
3.20
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
3.21
inter-nodal distance
distance between two nodes of expanded polymers

ISO/DIS 7198:2026(en)
3.22
implant coating
surface coating (3.29) or surface modification (3.30)
Note 1 to entry: Implant coating is considered a constituent of an implant.
Note 2 to entry: A laminate, i.e. a composite material made of multiple layers of the same or different materials with
the same or different internal structures assembled sandwich-like and bonded by heat, pressure, welding, soldering
or adhesives, is not in itself considered an implant coating. But the exposed surface of the laminate can be an implant
coating.
Note 3 to entry: A covering, for example additional material (e.g. a graft) added to a structure (e.g. a stent) specifically
to bridge elements of the structure for the sole purpose of reducing the permeability of the structure, is not considered
an implant coating.
[SOURCE: ISO 17327-1:2018, 3.1]
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 (3.39).
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 (3.41).
3.26
preclotting
procedure whereby blood or blood fractions are allowed to penetrate and coagulate within the interstices of
a porous prosthesis to decrease the permeability
3.27
prosthesis
device which replaces or substitutes for an anatomical part or deficiency
3.28
substrate prosthesis
vascular prosthesis to which a coating meeting the definition of implantcoating (3.22) is applied to result in
a compound prosthesis
3.29
surface coating
layer of material with any different property than the substrate that is intentionally added to the substrate
Note 1 to entry: The coating can partially or fully cover the substrate surface.
Note 2 to entry: The term includes surface coatings created as a result of additive manufacturing.

ISO/DIS 7198:2026(en)
[SOURCE: ISO 17327-1:2018, 3.1]
3.30
surface modification
intentional conversion or reconstruction of the surface of the original substrate to form a new surface
material consisting of components of the substrate’s own material and possibly foreign material and forming
a surface layer with different properties
[SOURCE: ISO 17327-1:2018, 3.1]
3.31
synthetic material
substance of nonbiological source that is produced and/or polymerized by chemical or physical means
Note 1 to entry: Chemically modified materials derived from fossil biological remains (e.g. petroleum or oil) are
considered to be synthetic.
3.32
synthetic nontextile prosthesis
vascular prosthesis manufactured made from synthetic materials using nontextile processes
EXAMPLE Prostheses made from extruded polymer, expanded polymer.
3.33
synthetic textile prosthesis
vascular prosthesis made from synthetic yarns using textile fabrication methods
EXAMPLE Prostheses made by knitting, weaving, or braiding of synthetic yarns.
3.34
tubular vascular graft
prosthesis used to replace, bypass, or form shunts between sections of the vascular system, implanted using
direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging
Note 1 to entry: Examples of non-direct imaging are computerized tomography and magnetic resonance imaging.
3.36
usable length
length of a prosthesis available for implantation, determined under a specified fixed load
Note 1 to entry: The load may be zero for certain prostheses.
3.37
vascular patch
non-tubular prosthesis intended for repair and reconstruction of the vascular system
EXAMPLE Flat sheet of material.
3.38
vascular prosthesis
tubular vascular graft or vascular patch
3.39
void
proportion of the wall of a vascular prosthesis that is not occupied by the material of construction.
3.40
water entry pressure
pressure at which water passes from the inner wall to the outer wall of a vascular prosthesis

ISO/DIS 7198:2026(en)
3.41
water permeability
volume of water that passes during a specified period through a unit area of the graft material under a
specified pressure
-2 -1
Note 1 to entry: The water permeability is usually determined as mL cm min at an applied pressure of 16 kPa
(120 mmHg).
Note 2 to entry: Water permeability is not the same as porosity (3.25).
3.42
xenograft
heterograft
implant material made from the tissues of an animal of a different species from the host or patient
4 General requirements
4.1 Configuration designation for tubular vascular grafts
The configuration of a tubular vascular graft shall be designated by its geometry, e.g. straight, bifurcated, or
tapered.
Some prostheses can be manufactured for specific applications, such as an axillo-bifemoral prosthesis, and
shall be designated by their intended clinical use, not as “bifurcated.”
4.2 Size designation
4.2.1 Uniform straight tubular vascular grafts
The size of a straight uniform tubular vascular graft shall be designated by the following characteristics:
a) nominal relaxed internal diameter of the device, expressed in millimeters;
b) nominal pressurized internal diameter of the device, expressed in millimeters, under a distending
pressure of at least 16 kPa (120 mmHg), if this diameter changes by more than 10 % while under
pressure;
c) minimum usable length, expressed in centimeters.
4.2.2 Uniform bifurcated tubular vascular grafts
The size of uniform bifurcated tubular vascular graft shall be designated by the nominal relaxed internal
diameters and the minimum usable overall length of the main tube and its branches. Pressurized internal
diameters shall also be designated if required [see 4.2.1 b)]. Diameters shall be expressed in millimetres and
length expressed in centimeters.
4.2.3 Tapered tubular vascular grafts
The size of a tapered tubular vascular graft shall be designated by the nominal relaxed internal diameters
of its ends and its minimum usable length. Nominal pressurized internal diameters shall also be designated
if required [see 4.2.1 b)]. Diameter shall be expressed in millimeters and length expressed in centimeters.
4.2.4 Other configurations of tubular vascular grafts
For other configurations (e.g. an axillo-bifemoral prosthesis), the principal length(s), the nominal relaxed
internal diameter(s), and the nominal pressurized internal diameter(s), if required, shall be designated.
Diameter shall be expressed in millimetres and length expressed in centimetres.

ISO/DIS 7198:2026(en)
4.2.5 Vascular patches
The size of a vascular patch shall be designated by its nominal length and width. It shall also be identified by
its wall thickness, if appropriate.
4.3 Materials
4.3.1 General
Vascular prostheses and their materials of construction shall be described according to the applicable
clauses below.
4.3.2 Classification of tubular vascular grafts and vascular patches
The classification of a tubular vascular graft or a vascular patch shall be designated by one of the following:
a) synthetic textile (e.g. knitted, woven);
b) synthetic nontextiles (e.g. extruded polymer, expanded polymer);
c) biological (e.g. xenograft, human tissues with and without viable cells);
d) compound, (i.e. other than coated);
e) composite;
f) coated.
NOTE Although a coated vascular prosthesis is a type of compound prosthesis, the term coated is more specific
and more commonly used.
4.3.3 Nomenclature
4.3.3.1 General
Materials shall be described according to the applicable clauses below.
4.3.3.2 Synthetic materials
Syn
...